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MANUAL DE PROCEDIMIENTOS
CRITERIOS DE APLICACIÓN DE LA NORMA NMX-EC-17025-IMNC-2006/ISO/IEC17025:2005
PARA LABORATORIOS EN CIENCIA FORENSE
GUÍA
CONTENIDO
0 INTRODUCCIÓN 1
1 OBJETIVO 1
2 CAMPO DE APLICACIÓN Y ALCANCE 1
3 TERMINOS Y DEFINICIONES 2
4 DOCUMENTOS DE REFERENCIA 7
5 CRITERIOS GENERALES 8
6 REQUISITOS DE GESTIÓN 9
7 REQUISITOS TÉCNICOS 24
ANEXO A 56
0 INTRODUCCIÓN
Esta edición de los criterios de aplicación fue realizada por la entidad mexicana de
acreditación, a.c., a través de la experiencia obtenida de su aplicación práctica en los
procesos de evaluación y acreditación con base en la norma NMX-EC-17025-IMNC-
2006/ISO/IEC17025:2005 y enriquecida mediante las aportaciones realizadas por los
grupos de trabajo de Ciencia Forense y el comité de evaluación de laboratorios de Ciencia
Forense.
1 OBJETIVO
La ciencia forense se refiere al examen de las escenas del crimen, recuperación de las
evidencias o pruebas de evidencia, exámenes de laboratorio, interpretación de los
resultados y la presentación de las conclusiones alcanzadas para fines de inteligencia o
MOTIVO:
FECHA DE EMISION FECHA ENTRADA VIGOR HOJA
REVISIÓN
DOCTO No.
2018-04-30 2018-08-01 1 DE 55
MP-FE011-04
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para su uso en los tribunales. Las actividades van desde el análisis instrumental con
resultados inequívocos, tales como la determinación de alcohol en sangre y la medición del
índice de refracción de vidrio, investigación de incendios sospechosos, accidentes de
tráfico, trabajo de comparación como el examen de escritura a mano y marca de
herramientas, que es en gran medida de carácter subjetivo, pero que con la formación,
pueden producir resultados consistentes entre los científicos forenses.
Las técnicas que se utilizan en los laboratorios en ciencias forenses incluyen, pero no se limitan a:
Este documento debe ser aplicado por el personal de la rama de Laboratorios de Ciencia Forense,
miembros del Padrón Nacional de Evaluadores de ema miembros de comisiones de opinión
técnica, subcomités y comités de evaluación, para el proceso de evaluación y acreditación y en
cualquier tipo de trámite que se refiera a los laboratorios de Ciencia Forense solicitantes ante la
entidad mexicana de acreditación, a.c.
3. TÉRMINOS Y DEFINICIONES
3.1 Laboratorio en ciencia forense. Es un laboratorio que examina evidencia física y datos
relacionados con hechos posiblemente delictuosos y que proporciona un testimonio de
opinión (dictamen pericial) con respecto a dicha evidencia ante un tribunal legal.
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Laboratorios privados o institucionales: Los mismos que para un laboratorio oficial además
de particulares.
3.3 Muestra. Elemento a ensayar o a analizar, tal como se describe en el punto 5.8 de la
norma NMX-EC-17025-IMNC-2006 / ISO 17025:2005. En el área de ciencia forense son
los indicios, huellas o vestigios del hecho delictuoso, así como de los instrumentos, objetos
o productos del delito.
3.5 Caso de investigación. Es toda aquella petición o solicitud penal, civil, administrativa o
particular recibida en el laboratorio, la cual es atendida y se le da respuesta a través de un
informe, dictamen o certificado.
3.6 Número o clave de identificación única. Es para muestras o solicitudes del cliente y será
el número con que se identifica durante todo el proceso y debe ser trazable (rastreable),
puede estar compuesto por letras, números o como el laboratorio lo defina según su marco
legal.
3.7 Muestra Control. Muestra de un material de características conocidas para verificar las
condiciones de operación de equipo, analista y materiales.
3.9 Laboratorio oficial. Se consideran a los laboratorios que son parte de las procuradurías
de justicia federales o estatales o los que son auxiliares de las procuradurías o de alguna
dependencia u órgano gubernamental, por ejemplo: SEMEFO, Instituto Jalisciense de
Ciencias Forenses, de acuerdo al marco legal vigente.
3.10 Laboratorio institucional. Se consideran a los laboratorios que son parte de una
institución educativa pública o privada, por ejemplo: de la UNAM, BUAP, etc.
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El evaluador lo debe
solicitar como documento
de referencia,
Procedimiento técnico específico para
Método de ensayo (generalmente una norma,
desarrollar un ensayo (prueba).
(prueba) indicado en el alcance de
la acreditación) para
compararlo con el
procedimiento interno.
Se encuentra descrito
Secuencia lógica de operaciones, descrita generalmente dentro del
Método de medición genéricamente, usada en la realización de documento de referencia.
mediciones El evaluador no lo debe
solicitar.
Conjunto de operaciones, descritas
Se encuentra descrito
Procedimiento de específicamente, usadas en la realización
específicamente dentro
medición de mediciones particulares de acuerdo a
del procedimiento interno.
un método dado.
Este documento lo debe
Procedimiento Interno, Trascripción específica para las
solicitar el evaluador para
PNT, Instructivo condiciones del laboratorio de lo
compararlo con el método
Técnico, Protocolo establecido en el método de ensayo
de ensayo (prueba) y
interno, entre otros. (prueba).
evaluarlo en sitio.
3.14 Contrato. Un contrato puede ser cualquier acuerdo escrito u oral para proveer servicios
forenses.
Nota: Un contrato no necesariamente involucra una paga por el servicio y puede ser
obligatorio por ley y puede necesitar estar conforme a los requisitos legales locales,
regionales o nacionales.
3.15 Declaración en los tribunales. Una declaración en los tribunales es un reporte escrito de
los resultados e interpretación de exámenes/estudios entregados a los tribunales
(juzgados). Dichos reportes pueden estar en el formato prescrito en la legislación y pueden
también estar en formato electrónico. Las declaraciones pueden ser entregadas a
investigadores oficiales, miembros del poder judicial y otras partes interesadas.
3.16 Hallazgos críticos. Son observaciones y resultados que tienen un impacto significativo en
las conclusiones alcanzadas y las opiniones e interpretaciones provistas. Además, éstas
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3.17 Cliente. El cliente es normalmente una organización y/o persona que solicita a la unidad
forense que lleve a cabo todo o una parte específica en el proceso de ciencia forense. Este
término también se refiere al “usuario” o bien puede ser un cliente interno. Si el trabajo es
requerido por vía legal (ejemplo: orden de los tribunales) o los resultados del examen /
peritaje deben ser provistos a un miembro del sistema judicial, entonces el sistema judicial
será considerado el cliente.
3.18 Equipo. Se refiere a las herramientas, instrumentos, software, reactivos y químicos que
son usados como parte de un proceso de ciencia forense, el cual requiere ser monitoreado
y controlado.
3.19 Examen / peritaje. Este término se utiliza en este documento para referirse al muestreo,
análisis, inspección visual, comparaciones, interpretaciones y opiniones.
3.20 Indicio / evidencia. Es un elemento, ítem o muestra recuperada y/o recabada como parte
de una investigación. Esto incluye todo lo recuperado en el proceso de la ciencia forense,
tales como; hisopos, objetos completos y residuos, los cuales pueden incluir artículos
derivados como moldes de huellas de pisadas o el levantamiento de huellas digitales. Se
puede referir a dichos indicios / evidencias como medios de prueba.
3.21 Instalaciones. Se refiere a cualquier medio físico usado para proteger la integridad de los
indicios / evidencias, el desarrollo de exámenes o apoyo a cualquier otro aspecto del
proceso de ciencia forense, por ejemplo, instalaciones permanentes, oficinas, toldos de
protección, bodegas de evidencia, unidades móviles, laboratorio móvil y vehículos de la
unidad forense.
3.22 Unidad Forense. Es una entidad jurídica o una parte definida de una entidad jurídica que
realiza cualquier parte del proceso de la ciencia forense.
Nota 2: Otros términos que pueden ser útiles para transmitir el elemento de imparcialidad
son: objetividad; independencia; ausencia de conflictos de interés, sesgos y prejuicio; la
neutralidad; la justicia; la receptividad; la tendencia a no tomar partido; desapego y
equilibrio.
3.24 Investigador. Una persona, sin importar como sea nombrado, capacitado para realizar
exámenes y/o investigaciones de la escena del crimen. Otros nombres que se utilizan para
esta función son, por ejemplo, Perito, Agente Investigador o Unidades de Policía Facultada
para el procesamiento del lugar de intervención.
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3.29 Muestreo. Es un proceso definido en el cual una parte de una sustancia, material o producto
es tomada para proveer una muestra representativa del total para exámenes. El proceso
debe estar basado en técnicas estadísticamente válidas tanto como sea posible. Una
muestra es una porción extraída de la población para el propósito del examen / peritaje para
determinar los atributos del total.
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En ciencias forenses, “muestra” es también usado para describir objetos físicos recolectados
como indicios o ítems, o un subconjunto de éstos. Estos indicios o ítems pueden ser
recolectados utilizando otro criterio diferente que el criterio estadístico convencional, por
ejemplo, muestras recolectadas en el lugar de intervención.
En éste documento la palabra “muestreo” será utilizado para ambos propósitos. Se requiere
una estrategia de muestreo, plan de muestreo o procedimientos de muestreo para poder
identificar las muestras que deben ser tomadas, y la secuencia para el desempeño de
diferentes muestreos.
3.30 Estrategia de muestreo: Es el enfoque general de la toma y/o recolección de los indicios
y/o ítems.
3.32 Procedimiento de muestreo: Es el método usado para recolectar los indicios y/o ítems.
4 DOCUMENTOS DE REFERENCIA
Para la correcta interpretación y aplicación del presente documento se deben utilizar los
siguientes documentos en su edición vigente:
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5 CRITERIOS GENERALES
6 REQUISITOS DE GESTIÓN
Nota importante: A lo largo del presente documento, los números indicados en corchetes “[
]” son la referencia a los requisitos de la norma NMX-EC-17025-IMNC-2006 / ISO/IEC
17025:2005.
Organización [4.1]
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El laboratorio debe:
b) Analizar y documentar todas las actividades que realiza, que sean diferentes a las de
ensayo para determinar si se producen conflictos de interés en personal clave de la
organización. En el caso que el laboratorio pertenezca a una organización más grande
el análisis debe incluir las actividades realizadas por dicha organización [4.1.4].
El personal del laboratorio no debe intervenir en los casos que existan relaciones
familiares, amistosas, sentimentales o de cualquier otra índole de acuerdo a lo
establecido en el marco legal vigente.
c) Definir las responsabilidades del personal clave y documentar las medidas a adoptar
para garantizar que se eliminen los conflictos de interés que pudiera haber identificado
[4.1.4].
La unidad forense deberá tener una política clara y un procedimiento para señalar y
asignar personal con la responsabilidad para el lugar de intervención. Una persona
competente como responsable para el caso dependiendo de [4.1.4]:
Legislación/ políticas
Tipos de investigación: volumen de investigación contra investigación mayor.
El carácter del caso, la complejidad u otras condiciones en el lugar de intervención.
e) Documentar las actividades que se realicen con el fin de asegurar que todo el personal
del laboratorio (incluyendo personal directivo) está libre de cualquier presión o
influencia indebida, interna o externa, comercial, financiera o de otro tipo que pueda
perjudicar la calidad de su trabajo; [4.1.5 b].
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no sólo el área del laboratorio que solicita la acreditación, y debe reflejar la posición del
laboratorio dentro de la organización. Pueden presentarse organigramas parciales de
cada sección o departamento [4.1.5 e].
La supervisión constante debe incluir todas las etapas y actividades del proceso
(materiales reactivos, equipo, resultados de sus análisis y dictamen o informe) [4.1.5
g].
j) Las responsabilidades y perfiles de puestos de los analistas deben definirse para los
laboratorios oficiales conforme a la Ley aplicable y para los laboratorios privados e
institucionales conforme a los reglamentos propios de cada laboratorio. [4.1.5 f].
k) Definir y documentar claramente sobre qué puesto (s) recae la responsabilidad sobre
las operaciones técnicas y la provisión de los recursos necesarios para asegurar la
calidad requerida en las operaciones del laboratorio [4.1.5 h].
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El laboratorio debe:
a) Definir los objetivos generales del laboratorio.
c) Evidenciar que cuando se han realizado cambios al sistema de gestión estos han sido
informados a todo el personal involucrado [4.2.7].
b) Ser factibles de medir con el fin de poder establecer la eficacia del sistema de gestión
[4.2.2].
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b) Contar con la autoridad y proporcionar los recursos necesarios para hacer los cambios
para la mejora.
Este es el momento cuando el investigador forense recibe una comisión. En este caso, el
investigador forense necesitará recibir información específica de los clientes, y puede
también necesitar dar instrucciones a los clientes. Este es también el momento cuando la
unidad forense asigna autoridad claramente definida y responsabilidad para la
investigación en el lugar de intervención y en cada lugar individual. Aspectos de la norma,
que tal vez estén incluidos aquí, son la revisión del contrato, subcontratación y nombrar a
las personas responsables.
La unidad forense debe tener un sistema que asegure que las próximas asignaciones sean
revisadas prontamente y manejadas apropiadamente o, cuando sea necesario,
rechazadas, de acuerdo a las políticas y procedimientos definidos.
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f) Para solicitudes de rutina o trabajo repetido, las revisiones tal vez se limiten a
consideraciones de tiempo y recursos humanos y un registro de aceptación, en tales
casos sería la aceptación firmada por una persona autorizada apropiadamente.
Para cualquier lugar específico, los siguientes aspectos deben ser considerados:
a) Jurisdicción;
b) Integridad del lugar de intervención;
c) Condiciones ambientales;
d) Necesidad de algún equipo especial o competencias especiales;
e) Problemas de salud y seguridad;
f) Tamaño y complejidad del lugar de intervención y necesidad de recursos adicionales;
g) Asignación de responsabilidad de un lugar de intervención y coordinación de la
responsabilidad para varios.
El retorno o desecho de indicios y material retenido deberá estar de acuerdo con el cliente
y los registros escritos. Cualquier variación de lo que fue acordado durante el contrato
inicial deberá estar registrado.
Instrucciones al cliente:
En algunas circunstancias tal vez sea apropiado para la unidad forense dar algunas
instrucciones al cliente de cómo preservar el lugar de intervención. Sin embargo, la
cantidad de conocimiento concerniente al manejo del lugar de intervención puede estar
limitado y por lo tanto tal vez sea difícil dar instrucciones exactas.
La unidad forense encontrara situaciones donde los recursos adicionales sean necesarios.
Las necesidades pueden ser solventadas por el uso de personal contratado, otro de
soporte técnico o subcontratando el trabajo.
En todos los casos donde personal contratado u otro de soporte técnico sean asignados, la
unidad forense deberá proveer evidencia de su competencia para las tareas asignadas.
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La unidad forense tal vez no siempre tenga la competencia específica o la capacidad para
todos los exámenes/pruebas necesarios, en ese caso tal vez necesite el uso de otros
recursos diferentes a los propios. Por ejemplo, que sea otra unidad forense o de expertos
de otra unidad forense. En estos casos se debería considerar lo siguiente:
Cuando a un laboratorio oficial le solicitan un ensayo que no puede realizar, puede sugerir
a la instancia correspondiente quien puede realizar ese ensayo solicitado, sin embargo
esto no es considerado subcontratación. Tampoco se considera subcontratación cuando
las muestras se remiten para su estudio a otras procuradurías haciendo uso del convenio
interprocuradurías o convenios con otras instancias, como universidades [4.5.1].
Evidenciar la aceptación del cliente del servicio subcontratado previo a la realización del
trabajo. [4.5.2].
Es posible que el laboratorio de ensayo entregue los resultados subcontratados con base
en sus propios formatos, en este caso deberá mantener los informes remitidos por el
laboratorio subcontratado e indicar claramente en el informe que dichos ensayos son
subcontratados.
Evitar hacer cualquier forma de uso del símbolo de acreditación de ema o alusión alguna a
la acreditación, en los cuales no estén perfectamente definidos los alcances de
acreditación y el trabajo subcontratado, que puedan dar lugar a una interpretación
incorrecta por parte del cliente.
Consumibles:
La calidad del material de referencia y reactivos deberá ser apropiada para el propósito del
procedimiento usado. Números de lote de materiales de referencia y reactivos críticos
deberán ser registrados. Todos los reactivos críticos deberán ser aprobados para su
confiabilidad.
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a) Nombre;
b) Concentración (cuando sea apropiado);
c) Fecha de preparación y de expiración;
d) Identidad de quien prepara;
e) Condiciones de almacenamiento, si es relevante;
f) Advertencias de riesgos, donde sea necesario.
El laboratorio debe:
a) Utilizar por lo menos una forma de obtener información de retorno del cliente, ésta
puede incluir, pero no limitarse a: encuestas realizadas a los clientes en forma
periódica sobre el desempeño del laboratorio, solicitud de realimentación a través de la
página web del laboratorio, una declaración en los informes de resultados solicitando
comentarios del cliente, comunicación con el cliente sobre aclaración de informes,
quejas, y/o resultados de auditorías del cliente. Para laboratorios de primera parte
pueden solicitarse comentarios en las reuniones internas y presentar evidencia.
Quejas [4.8]
El laboratorio debe:
Evidenciar que las quejas presentadas por sus clientes y otras partes son resueltas, así
como notificar al afectado su respuesta en un plazo no mayor a diez días hábiles, o en su
caso el periodo que establezca el marco legal vigente.
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Las respuestas a las quejas, sugerencias y oportunidades de mejora deben incluir una
evaluación del impacto potencial en cualquier actividad que se ha llevado a cabo por la
unidad forense. En el caso de que se demuestre que pudo haber existido un impacto en
cualquier trabajo, se debe actuar con base en el procedimiento de trabajo no conforme.
Las quejas pueden ser recibidas de diferentes fuentes como: clientes, víctimas del delito,
unidades de policía, otros departamentos dentro de la misma organización, por ejemplo:
laboratorio, unidad de criminalística, agentes investigadores y del poder judicial.
Por último, cuando una sentencia del tribunal ha sido apelada de manera exitosa y se deba
a cualquier trabajo realizado por el laboratorio, éste deberá ser evaluado a través del
proceso de acción correctiva o cualquier otro proceso de mejora.
El seguimiento continuo puede ser llevado de diferentes formas, por ejemplo; revisión por
pares, ensayos de aptitud y ejercicios de colaboración, auditorías y quejas de clientes.
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Mejora [4.10]
Para lograr la mejora pueden considerarse entre otras las siguientes acciones:
El laboratorio debe:
a) Contar con registros de todas las actividades realizadas para las acciones correctivas
siempre que exista una no conformidad derivada de cualquier fuente (queja y/o
reclamación, auditorías internas y externas, evaluaciones de ema, supervisión, trabajo
de ensayo no conforme cuando aplique, revisiones por la alta dirección, u otras), desde
la investigación de las causas hasta la verificación de la eficacia de las acciones
tomadas.
b) Documentar e implementar al menos una técnica formal de análisis de la causa raíz del
problema u otra herramienta de gestión de la calidad para realizar la investigación de la
(s) causa (s) raíz del problema, por ejemplo: diagramas causa-efecto, técnica de los 5
porqués, etc. esto no implica que deba existir un procedimiento de la herramienta
utilizada. El grupo evaluador verificará que la técnica de análisis de la causa raíz del
problema haya sido aplicada correctamente y que las acciones correctivas
correspondan a la magnitud del problema y sus riesgos.
c) Existirán acciones correctivas para las cuales la efectividad se verificará en la siguiente
evaluación por parte de la entidad [4.11.4].
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para problemas existentes y está enfocada a prevenir la recurrencia del problema, mientras
que la acción preventiva se aplica a problemas potenciales y está enfocada a prevenir la
ocurrencia del problema.
Los registros pueden conservarse en papel o en forma electrónica, con base en el marco
legal vigente durante un periodo mínimo de 4 años o en su caso el periodo que establezca
el marco legal vigente (el mayor de ellos).
Todos los registros técnicos o cualquier registro generado por el sistema de gestión del
laboratorio deben incluir el número interno de control; en el caso de los registros técnicos el
número interno de control de dictamen pericial.
El laboratorio debe:
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f) Elaborar los registros en forma legible, con tinta indeleble y no hacer uso de corrector
en los mismos.
g) Cancelar todos los espacios en blanco en los registros (electrónicos o en papel) que
debieron ser llenados y que por alguna causa justificada no son utilizados, en bitácoras
o cualquier tipo de registro.
La unidad forense debe tener procedimientos documentados para asegurar que se crea
y se mantiene un registro con cada caso bajo investigación. La información que se va a
incluir en registros del caso , debe estar documentada y puede incluir pero no se limita a
registros de cualquier comunicación con el cliente (verbal o escrita), revisión de
contratos, requerimientos y acuerdos de los exámenes y las pruebas con el cliente,
registros de evidencia, las descripciones de indicios incluyendo empaque y sellado,
citaciones, registros de observaciones y resultados de pruebas / exámenes, referencia
de procedimientos utilizados, diagramas, impresiones, fotografías, videos.
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6. Aunque se realicen cambios en cualquier registro, se debe conservar una copia del
registro inicial para que pueda ser revisada la información, ya sea física o en
electrónico. Cuando una prueba o examinación sea rechazada, se debe registrar la
razón por la cual fue rechazada, junto con la fecha e identificación de quién la
rechazó.
9. Cada página de todo documento en los registros del caso debe ser rastreable al
mismo. Debe haber un mecanismo con el cuál la integridad de la documentación sea
mantenida. Esto significa, por ejemplo, que debe ser fácil detectar si un documento se
añadió al archivo después de la fecha o se ha extraviado.
10. La copia de los registros generados por la unidad forense, usadas como parte del
archivo de un caso, deben estar enumeradas para indicar el total de páginas.
11. Se deben mantener los registros de la “cadena de custodia” que detallen cuando una
persona u organización toma posesión de un indicio /ítem de prueba desde su
recepción, durante el proceso de almacenamiento y, cuando aplique, la devolución al
cliente que lo remite o el desecho del indicio.
12. La definición y proceso aceptado para “cadena de custodia” necesita ser adaptado a
los requisitos legales. Cualquier transferencia del material debe ser registrado. Los
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13. Los equivalentes electrónicos de iniciales escritas a mano o firmas son aceptadas
cuando la unidad forense pueda demostrar que dichas iniciales o firma solo pueden
ser aplicadas por el mismo individuo representado por las mismas.
14. Si el registro se hace en electrónico, deberá haber un método que prevenga que los
documentos/ datos sean removidos y además, deberá haber un método para saber
que registros deben ser guardados y en qué lugar.
15. En general, los registros deberían estar hechos de manera permanente, por ejemplo,
los registros a mano deben ser con tinta permanente. Puede haber excepciones
cuando el ambiente prevenga el uso de tinta, además, puede ser apropiado hacer
diagramas y bocetos en lápiz, incluyendo lápices de colores.
16. Cuando se hagan abreviaciones en los registros deben ser completamente claras y
entendibles.
Las auditorías internas pueden ser realizadas tanto por un auditor interno como por un
auditor externo contratado para tal fin, y tienen diferentes objetivos a la evaluación de la
ema.
La auditoría interna en ningún caso puede ser sustituida por auditorías externas, tales
como las realizadas por el cliente, la ema, organismos de certificación, etc.
Cabe aclarar que las acciones correctivas derivadas de las no conformidades generadas
de las auditorías internas pueden encontrarse en proceso de atención al momento de
realizar la evaluación en sitio por parte de la entidad, con fines de acreditación es requisito
indispensable cerrar aquellas no conformidades detectadas en la auditoría interna.
El laboratorio debe:
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auditor interno y evidenciar que todos los que participen como auditores internos están
calificados con base en dicho perfil, incluyendo auditores externos para la realización
de la auditoría interna, sé sugiere basar dicho perfil en la NMX-CC-SAA-19011-IMNC-
2002 / ISO 19011 [4.14.1].
La unidad forense debe tener un programa de testificación para asegurar que las personas
que trabajan en la organización tengan la competencia que se requiere.
Los factores que deben ser considerados cuando se decida el acercamiento que se debe
tener para el examen del lugar, incluyen pero no se limitan a:
La testificación no solo cubre la parte procesal del trabajo, sino que también debe ir hacia
la profundidad de la competencia técnica del personal y su habilidad para tomar decisiones
relevantes en el lugar de intervención.
La revisión por la alta dirección debe ser realizada por personal, con la autoridad para
tomar decisiones y proveer los recursos necesarios para realizar cambios y mejoras al
sistema de gestión.
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b) Mantener evidencia de que se realiza una revisión por la alta dirección por lo menos
una vez cada doce meses, dicha evidencia debe incluir una recopilación y análisis de
la información de entrada para la revisión por la dirección indicada en cada uno de los
puntos del requisito 4.15.1 de la norma NMX-EC-17025-IMNC-2006 / ISO/IEC
17025:2005 [4.15.1].
c) Realizar la revisión de los objetivos del sistema de gestión y dar una conclusión sobre
si se están cumpliendo o no.
d) Evidenciar que la revisión por la alta dirección está enfocada al laboratorio y que se
toman en cuenta todos los puntos del requisito 4.15.1 de la norma NMX-EC-17025-
IMNC-2006 / ISO/IEC 17025:2005 aun cuando se conduzca para un sistema de
gestión basado en una norma diferente (ej. ISO 9001).
7 REQUISITOS TÉCNICOS
Personal [5.2]
La unidad forense debe tener una política que asegure que el personal es competente para
llevar a cabo el trabajo requerido. El sistema de gestión debe definir cada rol en la unidad
forense, sus limitaciones y requisitos específicos de calificaciones, formación, experiencia y
conocimiento para las tareas asignadas de cada rol. Aun teniendo calificación, formación,
experiencia y conocimiento no garantiza competencia práctica ni buen juicio. Por lo tanto,
la gestión o el personal responsable deben ser capaces de demostrar con evidencia
objetiva que todo el personal es competente mediante evaluaciones de su conocimiento y
habilidades con base en criterios definidos.
La unidad forense debe asegurar que el personal temporal es competente y trabaja acorde
al sistema de gestión de la unidad (ver requisito 4.5 subcontratación).
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Cada unidad forense debe llevar un registro actualizado de la capacitación que cada
miembro ha recibido. Éstos registros deben incluir calificaciones académicas y
profesionales, cursos internos y externos y capacitación relevante (y re capacitación
cuando sea necesario) recibida mientras se trabaja en la unidad forense. Los registros
deben ser suficientemente detallados para proveer evidencia de que cada miembro de la
unidad forense ha sido capacitado apropiadamente y su competencia para llevar a cabo
una tarea o prueba ha sido formalmente evaluada. Éstos registros deben ser conservados
por un período definido con base en el requisito (4.13 control de registros).
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El código de conducta también debe ser aplicable a todo el personal, permanente, temporal
y bajo contrato.
En caso de que durante una visita de vigilancia, por situaciones extraordinarias fuera del
control del laboratorio, alguno de los signatarios y/o personal operativo no se encuentre
presente y por lo tanto no sea posible su evaluación, el grupo evaluador levantara el
hallazgo, de acuerdo a lo indicado en los criterios de clasificación de no conformidades
MP-FE007.
I. Para el personal operativo, es decir todos aquellos que realizan en forma total o parcial
muestreos, ensayos y/o calibraciones, se debe:
II. Para todo el personal propuesto como signatario, que realizan ensayos y/o calibraciones
y/o realizan funciones de supervisión de muestreo se debe tener evidencia de:
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Nota: Para los casos en que el personal de nivel supervisión o gerencial (jefes,
supervisores, gerentes, directores, etc.), soliciten ser signatarios autorizados deberán
cumplir con lo establecido en el punto 5.2 II
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Una persona no podrá ser signatario autorizado de dos o más laboratorios con diferente
razón social.
Una persona podrá ser signatario de un máximo 3 laboratorios pertenecientes a una misma
razón social, siempre y cuando se mantengan los registros correspondientes y sea
evaluado en cada laboratorio, además de que demuestre conocimiento de los documentos
del sistema de gestión de la calidad y técnicos del laboratorio. El laboratorio debe notificar
a la entidad si tiene establecido dentro de su operación esquemas de trabajo como el que
se menciona, mediante un escrito o mediante la propia la solicitud de acreditación.
Se puede tener un mismo signatario para varias ramas o áreas, siempre y cuando se
demuestre su competencia técnica en cada una y se trate del mismo laboratorio y razón
social.
I. Debe existir un registro que avale la distribución y responsabilidad de todas las llaves,
tarjetas magnéticas, etc., limitado al personal designado por el director del laboratorio
para tener acceso.
II. Las instalaciones deben ser monitoreadas durante las horas en que el personal está
ausente, por medio de una alarma o personal de seguridad.
III. Las condiciones ambientales dentro de las instalaciones del laboratorio, o cualquier
lugar donde se realicen exámenes y pruebas, se deberán definir las condiciones si son
críticas para la obtención de los resultados, las cuales deberán monitorearse y
registrase.
IV. Se requiere cuidado especial en los laboratorios de pruebas forenses que participan en
el análisis o en la determinación de materias traza, incluyendo el ADN. La separación
física es indispensable en donde implique la posibilidad de que exista contaminación
cruzada. Se debe utilizar equipo de protección personal que garantice tanto la
seguridad del personal, como la integridad de la muestra. Las áreas especiales deben
ser reservadas para este tipo de trabajo, el acceso a estas áreas debe ser restringido y
la labor debe ser llevada a cabo de manera cuidadosa y controlada. Se deben
mantener los registros apropiados para demostrar este control. También puede ser
necesario llevar a cabo la supervisión de las condiciones ambientales, de los equipos,
las áreas de trabajo, ropa e insumos.
V. Cuando sea posible, la unidad forense debe ser capaz de identificar la contaminación
potencial y su origen. Esto puede requerir la recolección de antecedentes para
referencia si se obtienen resultados inusuales (por ejemplo, la base de datos de ADN /
huellas dactilares/ calzado de personal / visitantes, entre otros).
VI. El acceso al área de operaciones de la unidad forense debe ser controlado. Las
condiciones ambientales deberán ser consideradas para prevenir la pérdida o deterioro
del indicio. De igual manera, cuando no sea posible controlar las condiciones
ambientales significativas, éstas deberán ser registradas.
VII. Los visitantes deben tener acceso restringido a las áreas operativas de la unidad
forense. Se debe guardar un registro de todos los visitantes en las áreas operativas del
laboratorio.
VIII. Las áreas de almacenamiento de evidencia deben ser seguras para evitar el robo o la
interferencia y debe haber un acceso limitado y controlado. Las condiciones de
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I. Generalidades
d) La validación y/o confirmación del método se deberá realizar en forma inicial y/o
cuando existan cambios críticos en la metodología, equipos, instalaciones, etc.
[5.4.2].
f) Los estudios de validación son requeridos para todos los métodos, incluyendo los
comparativos. Los estudios de validación pueden ser conducidos por una comunidad
científica (como es el caso de métodos estandarizados o publicados) o por la unidad
forense por si misma (como en el caso de los métodos desarrollados por la unidad o
cuando se hicieron modificaciones significativas a métodos previamente validados.
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g) Cuando desarrolle sus procesos, la unidad forense debe mostrar con evidencia
objetiva que ha asegurado los factores que pueden incluir en los resultados y tener
registros de estos, ejemplos de tales procesos son: el proceso de construir la
estrategia cuando se llega al lugar de investigación, protección y preservación de
indicios, identificación de indicios relevantes y el proceso de interpretación. El
propósito de esto es asegurar la reproducibilidad y repetibilidad del proceso y así
asegurar que personas diferentes lleguen a resultados compatibles.
h) Cuando un método ha sido validado por otra organización, la unidad forense debe
revisar los registros de validación para asegurar que la validación realizada se ajusta
al propósito. Es entonces cuando es posible para la unidad forense sólo llevar a
cabo una verificación del método para demostrar que la unidad es competente para
realizar el examen /prueba. Cualquier proceso de verificación /validación llevado a
cabo por el laboratorio, debe ser documentado y los registros deben ser mantenidos.
i) Cuando aplique, los procedimientos técnicos usados por una unidad forense
deberán ser validados o verificados antes de ser usados en un caso o aplicados en
un lugar de investigación. Una excepción de esto sería, cuando se encuentran
nuevas sustancias, por ejemplo, una droga. En cualquier circunstancia el
procedimiento técnico usado deberá ser validado o verificado antes de que cualquier
resultado sea reportado. Los métodos pueden ser validados por comparación con
otros métodos establecidos usando materiales de referencia certificados (cuando
estén disponibles) o materiales de características conocidas. Al validar los métodos
de prueba las siguientes variables entre otras pueden ser necesario determinarlas
cuando sea apropiado, por ejemplo; cuando el método sea cualitativo o cuantitativo:
✓ Alcance de método:
▪ Uso previsto y sus limitantes
✓ Muestreo
▪ Estrategia de muestreo
✓ Preparación de muestra
▪ Homogeneidad de muestra
✓ Examinación
• Exactitud
• Precisión
• Medición de la incertidumbre
• Efectos de la matriz
• Interferencia
• Límite de detección
• Límite de cuantificación
• Linealidad
• Estabilidad de los componentes medidos
• Especificidad y selectividad
• Repetibilidad
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• Reproducibilidad
• Robustez
✓ Interpretación
• Reproducibilidad
• Robustez
• Características de desempeño
• Hipótesis o escenarios
• Bases de datos
• Evaluación estadística
• Limitación de conclusiones
• Literatura científica
k) Las unidades forenses deberían tener un procedimiento para identificar los exámenes
/pruebas realizadas con poca frecuencia. Para esos exámenes/pruebas hay tres
métodos para demostrar competencia, y cualquiera de los tres serían igualmente
válidos. Estos son:
Para todos los tipos de métodos mencionados la validación del método debe incluir las
especificaciones de los requisitos, determinación de las características del método, una
HOJA DOCTO. No.
30 de 59 MP-FE011-04
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verificación de que se pueden cumplir los requisitos usando dicho método y una
declaración en la validez.
Para los métodos de ensayo que involucren realizar otras pruebas para la
determinación del resultado final, dichas pruebas serán sujetas a evaluación y deben
cumplir con los requisitos de la calidad establecidos por el laboratorio, la norma técnica
y la norma 17025.
b) Se debe:
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año, en este caso, con el fin de demostrar que la competencia técnica se mantiene, se
debe:
V. En el caso de que el laboratorio desee acreditar paquetes de marca comercial (kits con
reactivos preparados):
Evitar manejarlo como pruebas rápidas porque en ocasiones no los son y puede confundir,
utilizar pruebas publicadas en normas oficiales, nacionales y/o internacionales o por
organizaciones técnicas reconocidas, son acreditables cuando el laboratorio se apegue en
su totalidad a lo establecido en el método publicado.
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Equipo [5.5]
El equipo que influya en la calidad del examen o prueba debe ser etiquetado o identificado
de alguna forma. El equipo puede ser propio, prestado, rentado, contratado, arrendado o
provisto de alguna otra manera.
El laboratorio que desee obtener la acreditación debe estar provisto del equipo propio
necesario para realizar el muestreo y los métodos de ensayo contenidos en el alcance de
la acreditación, o en su defecto contar con un contrato de arrendamiento financiero con
opción a compra o con contratos de arrendamiento puro por un periodo definido de los
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De acuerdo a lo que aplique, el laboratorio deberá mantener como parte del historial del
equipo información que avale la compra o renta del equipo, tal como:
▪ Facturas de compra.
▪ Contrato de arrendamiento financiero con opción a compra.
▪ Contrato de arrendamiento puro por un periodo no menor a un año, en caso de
acreditaciones iniciales debe tener una antigüedad de vigencia de al menos seis
meses al día de la evaluación en sitio.
▪ Evidencia de donación del equipo al laboratorio.
Los contratos deben incluir las condiciones en las que se renta el equipo en cuanto a
instalación, calibración, verificación y mantenimiento del mismo y quien es el responsable
de proveer dichos servicios y el tiempo de arrendamiento. El laboratorio debe evidenciar la
forma en que se asegura de que se cumplan dichas condiciones.
a) Tener disponibles en los sitios donde se utilizan, los procedimientos vigentes para la
operación [5.5.3], mantenimiento [5.5.3], almacenamiento [5.5.6], calibración [5.5.2] y
verificación [5.5.10] del equipo.
b) Establecer específicamente sobre que personal recae la responsabilidad del manejo,
calibración y mantenimiento del equipo [5.5.3].
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c) Como parte del sistema de calidad, se requiere que el laboratorio maneje un programa
para el mantenimiento y la calibración de los equipos utilizados en el laboratorio [5.5.2]
d) Mantener registros del cumplimiento de los programas de calibración y mantenimiento
de todo el equipo y cada elemento del mismo, dichos registros deben contener: fecha,
el sitio donde se realizó la actividad, persona que lo realizó, así como los detalles de
almacenamiento entre usos [5.5.5].
e) Analizar el efecto que tiene la ausencia de los instrumentos, cuando son enviados a
calibración externa, sobre la rutina normal de operación del laboratorio y tomar
acciones al respecto [5.5.9].
f) Realizar en sitio la calibración de los equipos que sean sensibles al movimiento, es
decir en donde opera [5.5.2].
g) Estar contenidas en los procedimientos de manejo de equipo, las precauciones a tomar
para su manejo o traslado, en el caso de equipos o patrones sensibles al movimiento
[5.5.6].
h) Documentar los procedimientos para realizar las comprobaciones intermedias para
mantener la confianza en el estado de calibración de los equipos, patrones de
referencia, de transferencia o de trabajo y de los materiales de referencia y en caso de
que el equipo no las requiera, documentar la justificación técnica. [5.5.10] y [5.6.3.3].
Examinar los efectos sobre los ensayos o calibraciones realizadas anteriormente a la
detección de un equipo fuera de especificaciones, desajustado o fuera de calibración,
deben existir registros de aplicación de los procedimientos de control de trabajo de
ensayo o calibración no conforme, incluida la notificación a los clientes que sean
afectados.
Donde el software sea usado, se debe demostrar que es apropiado para el propósito. Esto
puede ser a través de la verificación de la funcionalidad del mismo, por ejemplo, el uso de
una hoja de cálculo para calcular valores, o pudiera ser parte de una validación más amplia
del proceso de ciencia forense en el cual es usado, por ejemplo, el uso de base de datos
para características de comparación específica.
La unidad forense deberá tener políticas escritas y procedimientos que definan las
condiciones bajo las cuales el equipo puede ser usado. Las políticas y procedimientos
deberían también estar en el lugar para el uso de equipo desechable, para asegurar que el
equipo no contribuye a la contaminación a través de su mal uso o reutilización.
Las instalaciones y equipamiento deben sólo ser usadas por personal autorizado. Cuando
el equipamiento no esté bajo el control directo de la unidad forense, ésta deberá verificar
que el equipo reúne todos los requisitos antes de cada uso. Mediciones típicas incluirán
inspección visual, verificación de funcionamiento y/o calibración. El procedimiento de
verificación debe ser documentado y los registros de verificación deberán ser mantenidos.
Registros de equipo:
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Los registros deberán ser mantenidos para cada parte del equipo y su software que tenga
efecto significativo en los exámenes o pruebas que realiza.
Se espera que los registros emitidos por todas las unidades forenses estén de acuerdo con
los requerimientos especificados en la norma ISO/IEC 17025, con base en el requisito
5.5.5.
Los microscopios deben tener servicio y ser limpiados periódicamente. Deben tomarse
medidas para asegurarse de que los microscopios son apropiados para lo que se va usar y
deben ser utilizados únicamente por personal competente. Donde los microscopios se
utilizan para la medición se orientará con base en el párrafo (d) del presente criterio.
c) Equipos volumétricos
El equipo volumétrico en general se mantendrá por examen visual y limpieza, pero los
controles de calibración y funcionamiento, deberán ser realizados antes de su uso inicial y
en los intervalos en función del tipo y frecuencia de uso.
d) Instrumentos de medición :
Termómetros, balanzas, densitómetros, cromatógrafos, espectrómetros y
espectrofotómetros, refractómetros, auto analizadores, secuenciadores de ADN.
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Colecciones de referencias:
No todos los equipos, o elementos del mismo, usados para realizar ensayos o calibraciones
deben ser calibrados.
b) Para muchos de los análisis, la “Calibración” puede llevarse a cabo utilizando materiales de
referencia que contengan los analito a prueba, elaborados en el laboratorio a partir de
productos químicos de pureza y composición conocida o matrices estándar. Por otra parte
los materiales de referencia de las pruebas se pueden comprar, con la declaración del
fabricante o certificado. Siempre que sea posible, los laboratorios deben abastecerse de
los materiales de referencia de proveedores competentes [5.6.2.2.2].
c) Las colecciones y/o bibliotecas de referencia de los datos o materiales que son
encontrados u obtenidos en el trabajo de casos y que se mantienen para propósito de
identificación, comparación e interpretación (ejemplo espectros de masas, pinturas de
vehículos de motor, lentes o faros de vehículos, muestras de drogas, estilos de impresión
de máquinas, fragmentos de madera, balas, cartuchos, perfiles de ADN, registros de
frecuencia)deben ser completamente documentados, identificados y controlados
adecuadamente [5.6.3.2].
Muestreo [5.7]
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Las escenas conocidas generalmente como "delito grave" como violación o asesinato,
requieren estricta atención para su control y preservación. El acceso al lugar de
intervención debería ser controlado y limitado, llevando a cabo la creación de al menos un
acordonamiento para acceso; en algunos casos se puede utilizar un segundo
acordonamiento interno. Se debe conservar un registro de todas las personas que entraron
y salieron del lugar de intervención.
Todo el personal que entre en la escena debe utilizar equipo de protección personal que
asegure que no contamina la escena. La unidad forense deberá identificar en el momento
oportuno los objetos utilizados o consumidos, para asegurar que los indicios recuperados
de otra escena no son contaminados.
En esta etapa se determinará el plan estratégico y esto puede incluir las siguientes
preguntas:
• ¿Qué sucedió?
• ¿Dónde sucedió?
• ¿Cuándo ocurrió?
• ¿Cómo sucedió?
• ¿Quién participó?
• ¿Por qué ocurrió?
La unidad forense determinará qué conforma el lugar de intervención y determinará cuáles
son los requisitos de la investigación. También tendrá que decidir sobre las técnicas/equipo
necesarios, determinar las muestras que deben tomarse y luego decidir sobre la secuencia
de muestreo y/o análisis. Se registrarán todos estos aspectos.
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La determinación del tipo de delito será decidida normalmente por el cliente antes de que
sea asignada a la unidad forense para llevar a cabo la investigación. La unidad forense
debería tener una política que indique diferentes niveles de investigación del lugar de
intervención en relación al tipo del delito, como para distinguir entre “delitos menores” o
“delitos mayores” o usar otra clase designación. Esta política debería incluir una indicación
escrita de las competencias requeridas como: métodos, equipos, técnicas y recursos
necesarios dependiendo del tipo de crimen.
Una vez que se ha realizado la evaluación del lugar de intervención, que incluye cualquier
discusión con el investigador policial o el primero que llegue al lugar de intervención, es
aceptable que la unidad forense pueda determinar un objetivo diferente de la investigación
que lo que fue definido inicialmente (ver 4.4.1 en este documento). En ese caso, esto deberá
ser registrado claramente, aclarado, y donde sea apropiado, autorizado por el cliente. En
esta etapa puede ser necesaria la decisión de un patrón de búsqueda.
Muestreo [5.7]
Con el fin de identificar las muestras que deben tomarse y la secuencia a realizar, se
requiere de procedimientos de plan de muestreo, muestreo estratégico y los diferentes
muestreos y/o exámenes/pruebas.
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Cuando una unidad forense está trabajando bajo la dirección de otra organización, que ya
ha llevado a cabo la estrategia y planificación de la muestra, entonces la unidad forense
sólo tiene que seguir su propio procedimiento de muestreo.
La unidad forense deberá contar con políticas y procedimientos para asegurar que tengan
equipo adecuado, instalaciones y técnicas disponibles. Para determinar esto, se debe
considerar lo siguiente:
Una unidad forense con la responsabilidad principal del lugar de intervención puede
considerar necesario, en algunas circunstancias, solicitar el apoyo de otras unidades
forenses o subcontratistas para procesar adecuadamente el lugar de intervención.
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Antes que los indicios sean recolectados, la unidad forense debería considerar las
condiciones encontradas en el lugar, para asegurar que los indicios pueden ser
recuperados y documentados con la mínima alteración posible. Donde sea necesario y
dependiendo de las opciones técnicas, los indicios se preparan para el simple proceso de
toma. Se debe considerar la secuencia de la toma de las muestras.
La documentación del lugar de intervención debe ser realizada antes de que comience el
examen y durante toda la investigación. La documentación puede hacerse, por ejemplo:
• por escrito o dibujo,
• por grabación de voz,
• por fotografías,
• en vídeo o
• escaneo láser 3D.
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• Evaluar la pertinencia
• Documentar
• Recoger
• Identificar (etiquetar)
• Preservar y proteger
• Embalar
• Transportar
Para los efectos legales, la unidad forense deberá mantener el “registro de cadena de
custodia” mientras estén bajo su control los indicios. Este registro deberá detallar cada
persona u organización que toma posesión de un indicio o, alternativamente, la ubicación
de ese indicio (por ejemplo, si está en almacenamiento).
Pruebas:
La unidad forense puede realizar pruebas, incluyendo pero no limitativo a las mediciones
cuantitativas y pruebas presuntivas o de selección, como parte de la investigación de un
lugar de intervención.
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Si la unidad está acreditada con la norma ISO / IEC 17025, entonces los requisitos
pertinentes están cubiertos en esta norma en particular.
Algunos ejemplos de equipo portátil que necesita calibración o verificación antes de ser
llevado y utilizado en el lugar de intervención con un programa de mantenimiento
preestablecido, son los siguientes:
Algunos ejemplos de los consumibles críticos que serán probados por su fiabilidad en el
lugar antes de su uso, son las siguientes:
• Los kits de prueba para: la sangre, por ejemplo pruebas peroxidasa; semen, por
ejemplo, la fosfatasa ácida; fármacos, por ejemplo Marquis,
• Detección y mejora de los productos químicos, por ejemplo Luminol, Leuco cristal
violeta.
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También, la irregularidad de un indicio podría ser, que otro indicio no se encuentra, que hay
dudas sobre la idoneidad o su integridad.
También puede cubrirla recopilación de información a través de otras fuentes, como las
empresas de telefonía móvil, CCTV, la recolección de muestras de posibles sospechosos o
de las víctimas, y las pruebas a los efectos dela eliminación.
Las discusiones en el lugar de intervención serán sostenidas con las personas apropiadas
dependiendo del sistema legal en el país, por ejemplo policía, médicos, peritos, jueces,
magistrados y fiscales.
Si la visita inicial en el lugar muestra que las condiciones del contrato revisado no
estuvieran acordes con la situación en el lugar, entonces los pasos relevantes de la
revisión del contrato tal vez necesiten ser repetidos.
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Sin embargo, los procedimientos que son implementados para mantener la integridad del
lugar de intervención dependen de la naturaleza del hallazgo y su escena. Lugares de
intervención, tales como robos, pueden ser procesados por el investigador con sólo el
equipo de protección básica y sin necesidad de controles de acceso. En el caso de lugares
de intervención en el exterior pueden requerir un mayor control del perímetro demandante
y procedimientos para recuperar y preservar la evidencia que en las escenas en interiores.
Los registros de las revisiones sobre los hallazgos críticos deberán indicar que cada
hallazgo crítico ha sido comprobado, especificando quién y cuándo se comprobó. Esto
puede indicarse de diferentes maneras, incluyendo los registros de cada hallazgo; un
resumen de los resultados o una declaración en este sentido en los registros. Los registros
deberán indicar si el hallazgo crítico se ha acordado, o la acción tomada si este no era el
caso.
Muestreo:
a) Para los efectos legales, las unidades forenses deberán ser capaces de demostrar que
las muestras examinadas y dictaminadas son las que fueron enviadas. Un registro de
"cadena de custodia" se mantendrá a partir de la recepción de las muestras, detallando
cada persona que toma posesión de una muestra o, alternativamente, la ubicación de
esa muestra (por ejemplo, si se encuentra en almacenamiento).
b) Cuando las muestras son recuperadas por la unidad forense, por ejemplo, toma de
fibras con cinta adhesiva, portaobjetos de microscopio, etc., se iniciará un registro de
cadena de custodia y se incluirá en el expediente.
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Las áreas de almacenamiento para las muestras deberán ser seguros para evitar el
robo o la interferencia y su acceso será limitado y controlado. Las condiciones de
almacenamiento deben ser tales que se evite la pérdida, deterioro y contaminación, y
mantengan la integridad y la identidad de la muestra. Esto se aplica tanto antes como
después de haber realizado exámenes. Cuando se manejen artículos perecederos, se
reducirá al mínimo cualquier deterioro de los mismos.
g) En todos los casos, cada persona que realiza muestreo, exámenes o pruebas será
considerado responsable de la manipulación, procesamiento, toma de muestras y el
examen de cada muestra en la forma y secuencia más apropiada.
h) Para efectos legales, los laboratorios de ciencia forense deben ser capaces de
demostrar que las muestras examinadas y reportadas sean las que fueron remitidas al
laboratorio. Un registro de una "cadena de custodia" debe ser mantenido desde la
recepción de las muestras que detalle cada persona que tome posesión de una muestra
o, alternativamente, su ubicación [5.8.1]
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k) Incluir dentro de sus procedimientos una cadena de custodia para los casos donde la
muestra es recolectada dentro y fuera de las instalaciones del laboratorio, con la
intención de identificar los casos en que la muestra es requerida por varios
departamentos o áreas para realizar otros análisis. Cuando aplique, se deben
establecer los pesos, cantidades o volúmenes de sustancia o muestra que se extraen
por cada una de ellas y cada muestra(s) subdividida(s) debe seguir con los
procedimientos para el manejo de las muestras de ensayo establecidos por el
laboratorio.
l) Demostrar que la muestra examinada y sobre la cual se informó, fue la que se presentó
al laboratorio. El registro de cadena de custodia se debe mantener desde el momento
en que se recibe y debe reflejar todas las transferencias. El registro debe dar detalles
de cada persona que entra en posesión o ubicación de la misma [5.8.1]. Como mínimo
el registro debe incluir:
m) Deben existir procedimientos documentados que describan las medidas tomadas para
asegurar objetos expuestos en el proceso de ser examinados [5.8.4]
p) Contar con una política que establezca que las muestras en proceso de análisis pueden
quedar en espera de conclusión siempre y cuando exista una justificación para ello
[5.8.4].
q) Contar con procedimientos para asegurar que cada muestra sea identificada y trazable
documentalmente al número de identificación única. Para los casos donde la muestra
no es apta para ser marcada, se debe etiquetar su próximo recipiente [5.8.4].
s) Contar con procedimientos para asegurar que las muestras recolectadas en el lugar de
intervención por personal del laboratorio se protejan de transferencias cruzadas,
pérdida o contaminación y cambios nocivos o perjudiciales, ya sea colocándolas en un
recipiente o contenedor limpio o estéril según sea su caso, etiquetándolo, sellándolo y
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u) En los casos en que aplique, asegurar que las muestras de referencia cumplan con los
requisitos de cadena de custodia indicados anteriormente en este documento para las
muestras, así como la protección, sellado, etiquetado y almacenamiento [5.8.4].
Nota: Los incisos IX) a XIV) aplican en los casos donde se requieren testigos para
realizar estudios comparativos correspondientes, por ejemplo: casquillos percutidos por
arma de fuego en estudio por expertos en balística. Así como, la impresión de fichas
decadactilares para estudio comparativo o ingreso en AFIS (Sistema Automatizado de
Identificación de Huellas Dactilares)
• Colecciones de referencia;
• Los materiales de referencia certificados y materiales de referencia generados
internamente;
• Tablas estadísticas;
• Los controles positivos y negativos;
• Gráficos de control;
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Dependiendo del examen particular que se esté realizando, la unidad forense puede hacer
uso de uno o varios de estos ejemplos para demostrar que el examen está 'bajo control'.
Los procedimientos de control de calidad necesarios en cualquier área particular de trabajo
serán determinados por la unidad forense responsable del trabajo, en base a las mejores
prácticas profesionales. Los procedimientos deberán ser documentados y los registros
deberán conservarse para demostrar que se han tomado todas las medidas de control de
calidad adecuadas, que todos los resultados del control de calidad son aceptables o, en
caso contrario, que la acción correctiva se ha implementado.
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e) Presentar registros de las acciones planeadas realizadas para corregir los problemas
que se detecten derivados del control de la calidad.
f) Presentar registros de que se han realizado las acciones como trabajo de ensayo no
conforme (4.9) en los casos en que se detecten datos de control de la calidad fuera de
los criterios de aceptación.
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▪ Repeticiones periódicas del ensayo en muestras retenidas, realizadas por dos o más
analistas o técnicos.
Esto permite conocer la precisión entre analistas o técnicos en un determinado método
de ensayo, así como identificar desviaciones significativas en los resultados de un
analista o técnico en particular.
Esta sección se refiere a cualquier interpretación y reporte de resultados que puede tener
lugar inmediatamente después de la investigación del lugar de intervención.
El informe debe contener todos los resultados de los exámenes realizados y las
observaciones pertinentes, así como los hallazgos y, cuando resulte pertinente y admisible,
conclusiones a las que se llegaron a partir de dichos resultados. El informe debe contener
cualquier información sobre la que versen las interpretaciones.
La unidad forense tendrá que desarrollar su propio formato y la lista de contenido de sus
informes. Para los principios generales de interpretación y presentación de informes.
Exámenes:
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• La capacidad de los exámenes de ciencias forenses para ayudar a resolver los problemas
identificados;
• Urgencia y prioridad de las necesidades del cliente;
• Información apropiada de antecedentes;
• Las alternativas a las propuestas que ya han sido proporcionados por el cliente;
• Recursos disponibles a la unidad forense;
• Los expertos que se puedan necesitar y/o consultar antes del examen o prueba;
• Los exámenes que tienen el potencial de proporcionar la mayoría de la información en
respuesta a las diversas propuestas y alternativas;
• Problemas que podrían afectar a la integridad de los elementos objeto de examen o
prueba;
• Las restricciones que puedan existir, por ejemplo, la necesidad de preservar el material
para otros fines, costos, etc.;
• Exámenes u otras actividades que pueden tener un efecto destructivo para exámenes
posteriores;
• Coordinación para exámenes multidisciplinarios para determinar la muestra (s) que deben
tomarse y la secuencia de muestreo o de examen;
• Servicios de examen que están disponibles actualmente en los laboratorios;
• Consideración de las precauciones contra la contaminación apropiada para los exámenes
en discusión y todo tipo de evidencia que potencialmente puedan estar disponibles;
• La revisión progresiva de la estrategia de evaluación y pruebas conforme nuevos hallazgos
significativos;
• Lo que es técnicamente posible y que vale la pena para satisfacer las necesidades
del cliente, incluyendo a la defensa.
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Esta es la etapa en la que la unidad que realiza los exámenes y pruebas evalúa e interpreta
los resultados de los exámenes y pruebas basadas en la solicitud y en la información
suministrada durante el proceso.
Interpretación de resultados:
La interpretación se hace cuando las conclusiones se basan en algo más que el resultado de
la prueba realizada, por ejemplo, las conclusiones extraídas de las observaciones en el lugar
de intervención. Tanto en el trabajo de laboratorio, como el del lugar de intervención, habrá
conclusiones obtenidas sobre la base de observaciones y pruebas visuales, sin que
necesariamente se realicen exámenes objetivos.
Las interpretaciones deberán basarse en estudios robustos. En los casos en que esto no sea
posible, la interpretación, al menos, se apoyará en un cuerpo de evidencia documentado
(registros).
Cuando se realicen interpretaciones, las limitaciones del examen utilizado deberán ser
consideradas plenamente. Por ejemplo, conclusiones definitivas no se tomarán de una
prueba presuntiva.
El personal de la unidad forense debe tener acceso a los resultados y hallazgos completos,
comprensibles y exactos de la prueba, y consultar fuentes confiables de información
pertinentes para apoyar la interpretación. La interpretación de resultados y hallazgos en el
contexto del caso es posible cuando hay disponible suficiente información sobre el caso.
Debe definirse una hipótesis basada en los resultados y la información disponible. Las
hipótesis alternativas también deben ser consideradas.
Competencia:
El personal que interprete los resultados será evaluado y considerado competente antes de
que reporte declaraciones que incluyan la interpretación y opinión de los resultados y los
hallazgos.
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Es necesario que haya una definición clara de los requisitos de competencia y criterios para
interpretaciones.
Se acepta que los laboratorios de ciencia forense pueda no incluir todos los elementos en la
“Audiencia de juicio oral" que se detallan en la sub-cláusula 5.10 del ISO / IEC 17025, ya que el
formato de estos documentos se prescribe en legislación.
Por lo tanto, los laboratorios de ciencia forense pueden elegir adoptar uno o varios de los
siguientes medios para cumplir estos requisitos: [5.10.2.]
• la preparación de un informe de prueba, que incluya toda la información requerida por la norma
ISO / IEC 17025;
• la preparación de un anexo para la Declaración de la Corte, que incluya cualquier información
adicional requerida por la norma ISO / IEC 17025;
• el aseguramiento que el registro del caso relacionado con una investigación específica deba
contener toda la información relevante requerida por la norma ISO/ IEC 17025
IDENTIFICACIÓN DE CAMBIOS
Todos los
Todas Se revisó y actualizó todo el documento.
capítulos
Observaciones:
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Anexo A
DISCIPLINAS DE ACREDITACIÓN
LABORATORIOS EN CIENCIA FORENSE
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“IMPARCIALIDAD”
Los riesgos para la imparcialidad del laboratorio son fuentes potenciales de sesgos que pueden
comprometer, o pueden razonablemente comprometer la capacidad del laboratorio de tomar una
decisión no sesgada. Los riesgos se originan por diversos tipos de actividades, relaciones, y otras
circunstancias. El laboratorio debería identificar los tipos de riesgos originados, analizar los efectos
de estos riesgos y evaluar el impacto potencial sobre la imparcialidad del alcance de las
actividades del laboratorio.
El laboratorio debería tener implementadas salvaguardas que mitiguen o eliminen los riesgos para
la imparcialidad. Las salvaguardas pueden incluir prohibiciones, restricciones, divulgaciones,
política procedimientos, prácticas, normas, reglas, disposiciones institucionales, y condiciones
ambientales. Estas deberían ser revisadas periódicamente para asegurar su continua aplicabilidad.
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e) Las reglas, normas, y códigos de conducta profesional que rigen el comportamiento de los
integrantes del laboratorio;
f) El establecimiento de sanciones, y la posibilidad de tales acciones por la entidad de acreditación
y otros;
g) La responsabilidad legal afrontada por el laboratorio.
h) El mantenimiento de un entorno profesional y una cultura en el laboratorio que apoye el
comportamiento.
i) Las políticas, procedimientos, y prácticas directamente relacionadas para mantener la
imparcialidad del personal del laboratorio;
j) Las políticas, procedimientos y prácticas para la contratación, la formación, la promoción, y la
permanencia del personal así como las políticas, procedimientos y prácticas sobre recompensas
que enfaticen la importancia de la imparcialidad, los riesgos potenciales planteados por
circunstancias diversas que el personal en el laboratorio que puede afrontar, y la necesidad del
personal del laboratorio para evaluar su imparcialidad en relación a un cliente específico, después
de considerar las salvaguardas existentes para mitigar o eliminar esos riesgos.
a) las presiones y otros factores que podrían dar como resultado, o podría esperarse
razonablemente que dieran como resultado, decisiones sesgadas de las actividades del
laboratorio: esto es, riesgos para la imparcialidad del personal del laboratorio;
b) las salvaguardas que pueden reducir o eliminar los efectos de esas presiones y otros factores;
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El laboratorio podría evaluar el riesgo para la imparcialidad al considerar los tipos y la importancia
de los riesgos para la imparcialidad, los tipos y la eficacia de las salvaguardas. Este principio
básico describe un proceso por el cual el laboratorio podría identificar y evaluar el nivel de riesgo
para la imparcialidad que proviene de actividades diversas, relaciones u otras circunstancias.
El nivel de riesgo para la imparcialidad puede ser expresado como un punto sobre una línea
continua que se extiende desde “ningún riesgo para la imparcialidad” hasta “el riesgo máximo para
la imparcialidad”. El laboratorio podría evaluar el nivel aceptable del riesgo para la imparcialidad. Si
es inaceptable, el laboratorio podría decidir qué salvaguarda adicional (incluyendo la prohibición) o
combinación de salvaguardas podrían reducir el riesgo para la imparcialidad hasta un nivel de
riesgo aceptablemente bajo.
La tabla 1 describe una forma para determinar el nivel aceptable de riesgo para la
imparcialidad.
No existe el Riesgo remoto Riesgo medio Riesgo alto para la Riesgo máximo
riesgo para la para la para la imparcialidad: Es para la
imparcialidad: Es imparcialidad: imparcialidad: Es probable que la imparcialidad. Es
altamente Es improbable posible que la objetividad esté prácticamente
improbable que que la objetividad esté comprometida seguro que la
la objetividad objetividad esté comprometida objetividad está
esté comprometida comprometida
comprometida
El laboratorio El laboratorio El laboratorio El laboratorio tiene Los servicios no
tiene tiene tiene implementado un pueden ser
implementado un implementado implementado un proceso para proporcionados
proceso para un proceso proceso para evaluar riesgo
evaluar el riesgo para evaluar evaluar riesgo
riesgo
Demostrar la Demostrar la Demostrar la Los servicios no
objetividad del objetividad del objetividad del pueden ser
laboratorio alcance de las alcance de las proporcionados
actividades del actividades del
laboratorio laboratorio
Demostrar la Demostrar la Los servicios no
imparcialidad de imparcialidad de los pueden ser
los resultados de resultados de los proporcionados
los servicios servicios
proporcionados proporcionados
Demostrar la clara Los servicios no
separación de las pueden ser
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No existe el Riesgo remoto Riesgo medio Riesgo alto para la Riesgo máximo
riesgo para la para la para la imparcialidad: Es para la
imparcialidad: Es imparcialidad: imparcialidad: Es probable que la imparcialidad. Es
altamente Es improbable posible que la objetividad esté prácticamente
improbable que que la objetividad esté comprometida seguro que la
la objetividad objetividad esté comprometida objetividad está
esté comprometida comprometida
comprometida
diferentes entidades proporcionados
legales en el grupo
que proporciona los
servicios
Dado que existen ciertos factores en el entorno en el cual las actividades del laboratorio se llevan a
cabo (por ejemplo, que el ensayo o calibración está pagada por el cliente en todos los casos) el
riesgo para la imparcialidad no siempre puede ser eliminado por completo y, por consiguiente, el
laboratorio siempre acepta algún riesgo de que la objetividad esté comprometida. No obstante, en
presencia de riesgos para la imparcialidad, el laboratorio debería considerar que sólo un nivel muy
bajo de riesgo de imparcialidad sea aceptable.
Algunos riesgos para la imparcialidad pueden afectar sólo a ciertas personas o grupos dentro del
laboratorio y la importancia de algunos riesgos puede ser diferente para grupos o personas
diferentes.
Para garantizar que el riesgo para la imparcialidad esté en un nivel aceptablemente bajo, el
laboratorio podría identificar a las personas particulares o grupos afectados de forma diferente por
los riesgos para la imparcialidad, y la importancia de estos riesgos.
Diferentes tipos de salvaguardas pueden ser apropiados para grupos y personas diferentes
dependiendo de sus actividades.
Prohibida la reproducción parcial o total de este documento sin previa autorización del Director Ejecutivo de
ema.
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MANUAL OF PROCEDURES
CRITERIA FOR THE APPLICATION OF THE STANDARD ISO/IEC 17025: 2017 FOR FORENSIC
SCIENCE LABORATORIES
GUIDE
TABLE OF CONTENTS
CHAPTER SUBJECT
PAGE
0 INTRODUCTION 1
1 PURPOSE 1
2 FIELD OF APPLICATION AND SCOPE 1
3 TERMS AND DEFINITIONS 2
4 REFERENCE DOCUMENTS 7
5 GENERAL CRITERIA 7
6 MANAGEMENT REQUIREMENTS 7
7 TECHNICAL REQUIREMENTS 42
ANNEX A 57
0 INTRODUCTION
This edition of the application criteria was prepared by the entidad mexicana de
acreditación, a.c., ("Mexican Accreditation Entity"), with its experience in the practical
application of assessment and accreditation processes based on the Standard
ISO/IEC17025:2017 and was enriched by contributions from the forensic science working
groups and the Assessment Committee for Forensic Science Laboratories.
1 PURPOSE
This document intends to clarify the interpretation of the technical and management
requirements of Standard ISO/IEC 17025:2017, which have been identified as critical for
forensic science laboratories. It also intends to establish requirements to supplement those
mentioned in the Standard ISO/IEC17025:2017 and is part of the assessment criteria to be
used in assessment and accreditation processes for forensic science laboratories.
MOTIVE:
ISSUE DATE EFFECTIVE DATE PAGE
REVISION
DOCUMENT No.
2018-04-30 2018-08-01 1 OF 50
MP-FE011-04
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Techniques used in forensic science laboratories include but are not limited to:
• -Color tests
• -Chemiluminescence
• -Chromatography
• -Atomic absorption and emission spectrometry
• -Ultraviolet-visible and infrared spectrophotometry
• -Optical and electron microscopy
• -Serology
• -Electrophoresis
• -Metallurgy
• -Autoradiography
• -DNA testing
• -Mass spectrometry
• -Nuclear magnetic resonance spectroscopy
• -Physical measurements, such as weight, volume, length, density, and refractive index
• -X-ray analysis
• -Immunoassays
• -Visual inspection
• -Computer simulation
This document shall be implemented by Forensic Science Laboratories personnel, members of the
ema´s National Assessors Registry, members of technical opinion commissions, and assessment
committees and subcommittees for the assessment and accreditation process and in any type of
procedure in reference to forensic science laboratories applying to the entidad mexicana de
acreditación, a.c.
3.1 Forensic science laboratory: A laboratory that examines physical evidence and data
relating to acts of a potentially criminal nature, and provides expert testimony on such
evidence before a court of law.
3.3 Sample: In forensic science, these can be the exhibits, fingerprints, or traces of a criminal
act, as well as the instruments, objects, or proceeds of an offense.
3.4 Chain of custody: The control procedure applied to a material exhibit (sample) of a crime,
whether it is a trace, fingerprint, a means to commit a crime, a material object related to a
crime, or the proceeds of a crime. The procedure begins with the exhibit being located by an
authority, police officer, or agent of a public prosecutor’s office and ends when the competent
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2 of 62 MP-FE011-04
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3.5 Case under investigation: Any criminal, civil, administrative, or private petition or request
received by the laboratory, which is addressed and responded to in the form of a report,
opinion, or certificate.
3.6 Unique identification number or key: For customer samples or requests and will be the
number with which they are identified throughout the process. It shall be traceable and may
be composed of letters, numbers, or whatever the laboratory determines according to its legal
framework.
3.7 Control sample: A sample of a material of known characteristics to verify the conditions of
equipment operation, analysts, and materials.
3.8 Legal framework in force:. The set of constitutional amendments, laws and corresponding
regulations, codes, internal regulations, agreements, conventions, and other legal documents
that are applicable in each federal entity where the laboratory or the institution to which it
belongs carries out its activities
3.9 Official laboratory: A laboratory that is part of a federal or state public prosecutor's office or
that is an auxiliary of a public prosecutor's office or any governmental body or dependency,
such as: SEMEFO or the Jalisco Institute of Forensic Sciences, in accordance with the legal
framework in force.
3.10 Institutional laboratory: A laboratory that is part of a public or private educational institution,
such as UNAM, BUAP, etc.
3.11 Because of the great importance of properly distinguishing between the relationships and
differences between the concepts of measurement methods, test methods, measurement
procedures, testing procedures, internal procedures, protocols, and others, the following
explanatory table has been prepared:
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3.12 Competence: The combination of education, training, skills, and experience; where relevant,
personal attributes should be demonstrated as well.
3.13 Contamination: The introduction of substances or traces of matter into the exhibit/evidence
(item) any time in the forensic process.
3.15 Court statement: A written report on the results and interpretation of the
examinations/studies submitted to the courts. These reports can be in the format prescribed
by law and may also be in an electronic format the statements may be delivered to official
investigators, members of the judiciary, and other interested parties.
3.16 Critical findings: Observations and results that have a significant impact on the conclusions
reached and the provided opinions and interpretations. Furthermore, these observations and
results may not be repeated or be examined in the absence of the exhibit/evidence or sample,
and/or may be interpreted differently.
3.17 Customer: Usually an organization and/or person requesting that the forensic unit carry out
all or a specific part of the forensic process. This term also refers to a "user" or can be an
internal customer. If the work is required by law (e.g., by a court order) or if the results of the
examination/testing shall be provided to a member of the judicial system, then the judicial
system shall be considered the customer
3.18 Equipment: The tools, instruments, software, reagents, and chemicals that are used as part
of a forensic process and need to be to be monitored and controlled.
3.19 Examination/test: This term is used in this document to refer to the sampling, analysis, visual
inspection, comparisons, interpretations, and opinions.
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3.21 Facilities: Any physical environment used to protect the integrity of exhibits/evidence,
testing, or support for any other aspect of the forensic process, e.g., permanent facilities,
offices, protective canopies, evidence storages, mobile units, mobile laboratories, and
forensic unit vehicles.
3.22 Forensic Unit: A legal entity or a defined part of a legal entity that performs any part of the
forensic process.
Note 1: Objectivity means that there is no conflict of interest or that any conflict of interest is
resolved in a way so that it does not adversely influence the forensic unit’s subsequent
activities.
Note 2: Other terms that may be useful to convey the element of impartiality are objectivity;
independence; absence of conflicts of interest, bias, and prejudice; neutrality; fairness;
receptiveness; the tendency to not take sides; detachment; and balance.
3.24 Investigator: A person, regardless of the name used, trained to examine and/or investigate
crime scenes. Other names for this position include forensic expert, investigating officer, or
police units authorized to process crime scenes.
3.25 Non-conforming examinations and tests (non-conforming test work): Any aspect of the
work of the forensic unit, including the crime scene examination, laboratory examinations,
sampling, testing, results, or expert witness testimony not in conformity with the policies or
procedures of the respective forensic unit, or that fail to comply with the requirements agreed
upon with the customer, e.g., the use of out-of-specification equipment, erroneous
identification of a substance, or the incorrect interpretation of a blood pattern.
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3.27 Reference collection: The collection of stable materials, substances, objects, or artifacts of
known origin or known properties that can be used to determine the origin or properties of an
unknown material.
3.28 Reference material: A material sufficiently homogeneous and stable with respect to one or
two specific properties that has been previously established as fit for the measurement process
to be undertaken.
3.29 Sampling: A defined process in which part of a substance, material, or product is taken to
provide a representative sample of the whole for examinations. The process shall be based on
statistically valid techniques to the extent possible A sample is a portion extracted from a
population for the purpose of the examination to determine the attributes of the whole.
In the forensic sciences, a "sample" is also used to describe physical objects collected as
exhibits or items, or a subset of these. These exhibits or items can be collected using another
criterion distinct from the conventional statistical criterion, such as samples collected at the
crime scene.
The word "sampling" will be used in this document for both purposes. A sampling strategy, a
sampling plan, or sampling procedures are required in order to identify the types of samples
that need to be collected, and the sequence to carry out the different samplings.
3.30 Sampling strategy: The general approach to taking and/or collecting exhibits and/or items.
3.31 Sampling plan: The method for implementation of the sampling strategy.
3.32 Sampling procedure: The method used to collect the exhibits and/or items.
3.33 Crime scene: A place where an allegedly criminal act has taken place or where exhibits related
to it has been located or provided. Official Federal Gazette: 02/12/2015
AGREEMENT A/009/15 establishing the guidelines to be observed by public servants involved
in the field of chain of custody.
Note: The forensic process is not restricted to situations in which the incident and its purpose are
connected to the investigation of a crime. Other examples include civil litigation, paternity testing,
environmental protection, illegal gambling control, and other activities related to gambling.
3.34 Validation: Confirmation by examination and providing objective evidence to meet the
specific requirements for a given purpose.
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4 REFERENCE DOCUMENTS
For the proper interpretation and application of this document, the current editions of the
following documents shall be used:
4.1 ISO/IEC 17025:2017, “General requirements for the competence of testing and calibration
laboratories”.
4.5 ILAC-G24 / OIML D 10 2007, “Guidelines for the determination of calibration intervals of
measuring instruments ”.
4.6 APLAC TC 002 “Internal Audits for Laboratories and Inspection Bodies
4.7 APLAC TC 004, " Method of stating test and calibration results and compliance with
specification"
4.8 APLAC TC 005, " Interpretation and guidance on the estimation of uncertainty of
measurement in testing".
4.10 APLAC TC 012, Guidelines for Acceptability of Chemical Reference Materials and
Commercial Chemicals for Calibration of Equipment used in Chemical Testing"
4.11 APLAC TC 013 Guidance for the assessment, reassessment, and surveillance of "key
activities" at laboratories with multiple location
4.14 ILAC G17, " Introducing the Concept of Uncertainty of Measurement in Testing in Association
with the Application of the Standard ISO/IEC 17025 "
4.15 ILAC G18, “Guideline for the Formulation of Scopes of Accreditation for Laboratories ”
4.17 ILAC G24 “Guidelines for the determination of calibration intervals of measuring instruments”
4.18 ILAC G8, " Guidelines on the Reporting of Compliance with Specification"
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4.23 ILAC R7, “Rules for the use of the ILAC MRA Mark”
5 GENERAL CRITERIA
All procedures required as such in the Standard ISO/IEC 17025:2017 shall be documented,
which means that they shall be in writing, whether on paper or in electronic form, and be part
of the management system established by the laboratory.
To supplement the general criteria of ISO/IEC 17025:2017, the assessors and technical
experts shall use the checklists issued by the disciplines of accreditation as developed by the
Forensic Science Assessment Committee, which are approved and published by the entidad
mexicana de acreditación a.c.
6 MANAGEMENT REQUIREMENTS
Important Note: Throughout this document, the numbers indicated in brackets ("[ ]") refer to
the requirements of the Standard ISO/IEC 17025:2017.
Impartiality [4.1]
The Annex to this document provides a way of how to identify the risks to impartiality, this
document is one of several alternatives on how to do it and therefore it is a guide document
to give greater clarity to the laboratory on how to comply with this requirement.
The risks to the impartiality of the laboratory should be considered when events occur that
could be related to the impartiality of the laboratory or its personnel. [4.1.1]
The laboratory's top management must have a documented statement of its commitment to
impartiality in carrying out laboratory activities, managing conflicts of interest and
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guaranteeing the objectivity of its activities. The actions emanating from senior management
should not contradict this statement. [4.1.2]
One way for executive team to emphasize their commitment to impartiality is to make relevant
statements and public policies that are available. [4.1.2]
The laboratory must demonstrate that all its personnel (including managerial personnel) are
free from any undue pressure or influence, internal or external, commercial, financial or
otherwise that may affect the impartiality of their work. [4.1.2]
The laboratory should describe any relationship that could affect its impartiality to a relevant
degree, using organizational diagrams or other means. Examples of relationships that could
influence fairness include, but are not limited to: - Relationships with a parent organization. -
Relations with departments within the same organization. - Relations with related companies
or organizations. - Relations with regulators or dependencies. - Relations with clients. - Staff
relations. - Relations with organizations of design, manufacture, suppliers, installation,
acquisitions, possession, use or maintenance of the sampled or tested elements. [4.1.4]
The laboratory must have a mechanism to minimize or eliminate the risks to impartiality
identified in accordance with [4.1.4]
If new risks are identified during their activities, they should be included in the analysis that
was carried out to comply with 4.1.4 of ISO / IEC 17025: 2017. [4.1.5]
If the risk is not eliminated, it must at least be demonstrated what safeguards or actions it
considers to be minimized or not presented. [4.1.5]
The laboratory must have declared in the management system the way in which the
laboratory ensures, that the management of the information derived from its activities is
handled in a confidential manner, as well as establishing what information will be of the
general public and which it will be handled in a confidential manner. [4.2.1]
The laboratory must document the manner in which it will comply with this requirement and
must maintain the records evidencing compliance with these activities. 4.2 General. [4.2.2]
The laboratory should demonstrate that all personnel that are part of the organization that
have a relationship with the sampling and testing activities or that act on behalf of the
laboratory maintain the confidentiality of the information obtained or created during the
performance of their activities. [4.2.4]
In the case of laboratories of the prosecutors or federal, state or local government agencies,
laboratory personnel may be prevented from providing their services in a particular way or in
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any other activity that directly or indirectly impacts the service provided in the organization,
Consider this according to the current legal framework of each institution. [4.2.4]
Laboratory personnel should not intervene in cases of family, friendly, sentimental or any
other type of relationship according to what is established in the current legal framework.
[4.2.4]
The main responsibility of each place of intervention lies with the investigator assigned to be
in charge of the case, which must be documented in a file of the case.
All kinds of responsibility should be clearly identified in particular if the personnel of different
units of the organization are involved. [5.1]
• Demonstrate the legal personality that assumes the legal responsibilities derived from its
activity.
The responsibilities and job profiles of the analysts must be defined for the official laboratories
according to the applicable law and for the private and institutional laboratories according to
the regulations of each laboratory. [5.1]
The laboratory should clearly define and document which position (s) responsibility for
technical operations and provision of resources is necessary to ensure the quality required
in laboratory operations, as well as specify their functions and responsibilities, including cases
when This consists of more than one person. [5.2]
The forensic unit must have a clear policy and a procedure for identifying and assigning
personnel with responsibility for the place of intervention. A competent person as responsible
for the case depending on: [5.2]
• Legislation / policies
• Types of research: volume of research against major research.
• The nature of the case, the complexity or other conditions in the place of intervention.
The laboratory must have an updated organizational chart (s) clearly reflecting its
organization and the management of the activities, its place in the head office and the
relationships between management, technical operations and support services. [5.5 a)]
The laboratory must specify the responsibility, authority and interrelation of all personnel who
manage, perform and verify work that affects the results of laboratory activities. [5.5 b]
The staff that supervises must have specific experience in the area to be supervised. In cases
where the laboratory is integrated by a single person, such supervision may be justified by
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evidence of revisions to the critical points of the sampling or testing processes determined by
the laboratory's own management system. [5.5 b.1]
The laboratory must have documented the procedures that guarantee the coherent
application of its activities and the validity of the results. [5.5 c)]
The constant supervision must include all the stages and activities of the process (reactive
materials, equipment, results of their analysis and opinion or report)
The laboratory must present evidence of the effectiveness of the communication. The
communication can be reflected in the definition of the processes and the planning of the
management system. The communication regarding the effectiveness of the management
system can be achieved through different means, such as: memos, emails, meetings, etc.
[5.7 a)]
The laboratory should demonstrate that the integrity of the management system is maintained
when there are changes. [5.7 b)]
Personnel [6.2]
The laboratory must document and demonstrate that all personnel who participate in
laboratory activities, whether internal or external, in an impartial, competent manner and work
according to the laboratory's management system. [6.2.1]
The laboratory must present the contract or contractual relationship with all the personnel
involved in the sampling activities, tests or other personnel that perform any activity within
the laboratory. [6.2.1]
The entidad mexicana de acreditación uses the definition of an authorized signatory, even
though ISO / IEC 17025: 2017 does not include it and whose definition is found in
accreditation procedure MP-FP-002 (in force). [6.2.1]
The test reports can be signed by the legal representative to comply with procedures before
dependencies or legal effects, which does not mean that it was who technically approved
such reports, in this case, it must be demonstrated through the traceability of the results that
the samples or tests that were endorsed by an authorized laboratory signatory. [6.2.1]
The technical performance tests should only be carried out initially and / or when there are
critical changes in the methodology, equipment, facilities, etc. for each test procedure and
only all personnel carrying out tests or calibrations and / or measurements must present them.
[6.2.1]
When a change of facilities or domicile is carried out, and there are no changes in the
personnel that is an authorized and operational signatory, the performance tests in the new
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facilities should not be performed again, it should be considered as indicated in the operation
instruction MP-TS079 (in force). [6.2.1]
A person may be a signatory of two or more laboratories belonging to the same company
name, as long as the corresponding records are kept and evaluated in each laboratory, in
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The evaluation of the personnel must be done to the signatory personnel and to all the
operative, supervisory and managerial personnel that is directly or indirectly involved in the
operation of the laboratory, as described below: [6.2.3]
I.- For all personnel carrying out tests, whether or not they are proposed as signatories, they
must demonstrate the following:
• Maintain records of the evaluation of the effectiveness of the training actions implemented.
• Records of the results of the technical performance tests on the samplings and / or tests
performed, such as: repeatability and reproducibility tests, for the aforementioned the
verification in the technical verification lists should be verified, if applicable.
• This evaluation must be carried out for each sampling procedure or initial trial and when
there are critical changes in the methodology, equipment, facilities, etc.
II. - For all signatory personnel (whether or not proposed as such) that do not perform test
activities:
III. - For the operating personnel, that is, all those who carry out, in a total or partial manner,
sampling or testing, it must:
• Demonstrate knowledge (in theoretical and practical form) of technical procedures, based
on the scope of accreditation requested and according to their functions and responsibilities.
• Maintain records of the evaluation of the effectiveness of the training actions implemented.
Note: In case the personnel described in numerals II and III of this point have carried out at
least one test, they must present technical performance tests.
The personnel shall demonstrate evidence of qualification according to the established in the
norms, procedures, etc., that are within the scope of the accreditation.
In case of deviations in the samplings and / or tests, the laboratory must present everything
related to 7.10 of ISO 17025: 2017.
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The forensic unit must have a policy that ensures that the personnel is competent to carry
out the required work. The management system must define each role in the forensic unit, its
limitations and specific requirements of qualifications, training, experience and knowledge for
the assigned tasks of each role. Even having a qualification, training, experience and
knowledge does not guarantee practical competence or good judgment. Therefore,
management or responsible personnel must be able to demonstrate with objective evidence
that all personnel are competent through assessments of their knowledge and skills based
on the defined criteria.
The forensic unit must ensure that the temporary staff is competent and works according to
the management system of the unit, if applicable.
In the evaluation of the competence of the personnel, the forensic unit must ensure that,
when applicable, the personnel must have relevant knowledge of the technology used in the
crime, example: firearms, and the technology used for the investigation of the crime, example:
fingerprints, genetic profiles, blood spatter patterns. They must also have sufficient
competence and experience to recognize the meaning of anything unusual, for example: a
mounted robbery or altered samples.
The training must be up to date, have a defined training program and the evaluation of the
competence must be carried out at all levels of professional development of the person
involved. When training in specific techniques or tests, acceptance criteria must be assigned
to demonstrate the effectiveness of the training, for example; the observation of relevant
points of the test by competent personnel, satisfactory results in the sample analysis of quality
assurance, correlation of results with those obtained by other trained personnel. When
necessary, training programs should also include training in the presentation of evidence in
courts or tribunals.
The assessment of the competence can be carried out in different ways, depending on the
task that is carried out:
✓ Practical exercises
✓ Direct observation by competent personnel
In some cases, a combination of the competency assessment will be the most appropriate
approach.
Each forensic unit must keep an updated record of the training each member has received.
These records must include academic and professional qualifications, internal and external
courses, and relevant training (and retraining when necessary) received while working in the
forensic unit. The records must be sufficiently detailed to provide evidence that each member
of the forensic unit has been properly trained and their competence to carry out a task or test
has been formally evaluated. These records must be kept for a defined period based on the
requirement.
There must be an induction procedure for new staff to the forensic unit, which defines the
training and supervision required. This procedure may vary depending on the skill,
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qualifications and experience of those who will be trained. The individual training program
should be based on your skills, specialized knowledge and experience.
The forensic unit must also have procedures for ongoing training and maintenance of
competence and skills.
When hiring personnel from another organization (including another forensic unit), their
competence must be verified by the forensic unit.
A code of conduct (or whatever it is decided to call it) for the forensic unit must be in force
and should cover ethical conduct, confidentiality, impartiality, personal security, relations with
other members of the forensic unit (Conflict of Interest) and any other issue is required for
the assurance of the appropriate conduct of the personnel.
The code of conduct must also be applicable to all personnel, permanent, temporary and
under contract.
The authorization of the personnel must be based on the evidence of their experience,
knowledge and technical competence, this must be documented in the laboratory
management system. [6.2.6]
The storage areas include warehouses or warehouses transitory, mobile, fixed, temporary,
permanent and any area intended for that activity.
I. There shall be a record to ensure the distribution of and responsibility for all the keys,
magnetic cards, etc., limited to the personnel designated by the laboratory director for
access.
II. Facilities shall be monitored during hours when personnel are absent by means of an
alarm or security personnel.
III. Environmental conditions inside the laboratory facilities, or any other place where
examinations and tests are performed, shall be defined if they are critical in obtaining
results, and shall be monitored and recorded.
IV. Special care is needed in forensic testing laboratories involved in the analysis or
determination of trace substances, including DNA. Physical separation is essential
wherever there is a possibility of cross-contamination. Personal protective equipment
shall be used to ensure both personnel safety and sample integrity. The special areas
shall be reserved for this type of work; access to these areas shall be restricted and the
work shall be undertaken in a careful and controlled manner. The appropriate records
shall be kept to demonstrate this control. It may also be necessary to monitor
environmental conditions, equipment conditions, work areas, clothing, and supplies.
V. When possible, the forensic unit shall be able to identify potential contamination and its
source. This may require the collection of background information for reference if unusual
results are obtained (e.g., a database for DNA/fingerprints/personnel footwear/visitors/et
al.).
VI. Access to the area of operations of the forensic unit shall be controlled. The
environmental conditions shall be considered in order to prevent the loss or deterioration
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Once the place of intervention has been evaluated, which includes any discussion with the
police investigator or first respondent, the forensic unit can determine a scope of the
investigation different from the initial one. In that case, you must register and clarify as
appropriate and authorized by the client. At this stage it may be necessary to decide what the
search pattern will be.
The laboratory must carry out at least once every 12 months the revision of the measures to
control the facilities. [6.3.4]
The laboratory that performs activities in sites outside its facilities (sampling and / or testing)
must present records of the conditions under which they were performed and must ensure
compliance with the specifications indicated in the standards, procedures and reference
methods.
Equipment [6.4]
The laboratory that wishes to obtain the accreditation must be provided with the necessary
equipment to carry out the sampling and the test methods contained in the scope of the
accreditation, or in its absence, have a financial lease contract with option to purchase.
According to what applies, the laboratory must maintain as part of the history of the equipment
information that supports the purchase or lease of the equipment, such as:
• Purchase invoices.
• Financial lease agreement with an option to purchase no more than six months and must
be valid for one month prior to the on-site visit.
• Evidence of donation of the equipment to the laboratory.
Agreements shall include the conditions under which the equipment is rented, regarding its
installation, calibration, verification, and maintenance, the part responsible for providing such
services, and the lease period. The laboratory shall demonstrate how it is ensured that these
conditions will be met.
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a) keep records of inspections performed prior to its use to check for damage or
malfunctions.
b) ensure that the equipment will receive the same treatment in terms of intermediate
inspections and/or calibrations as the laboratory’s own equipment before, during, and at
the end of the period of use.
c) submit the certificates and/or calibration reports, as well as equipment inspection records.
d) the equipment shall be integrated into all aspects of the management system as if it were
the laboratory’s own equipment, including the necessary training for its proper operation.
In addition, for both the laboratory’s own equipment and rented equipment, the laboratory
shall:
a) Make available the procedures in force for the operation [5.5.3], maintenance [5.5.3],
storage [5.5.6], calibration, [5.5.2] and inspection [5.5.10] of the equipment in all sites
where it is used.
b) Specifically establish which personnel will be responsible for the handling, calibration,
and maintenance of the equipment [5.5.3].
c) As part of the quality system, the laboratory is required to manage a program for the
maintenance and calibration of equipment used in the laboratory [5.5.2].
d) Keep records of compliance with the calibration and maintenance programs for all
equipment and each equipment element. Such records shall contain the date, the site
where the activity was carried out, the person who carried it out, as well as the details on
storage between uses [5.5.5].
e) Analyze the effect that the absence of the instruments has on the normal routine of
laboratory operations when they are sent away for external calibration, and implement
actions on the matter [5.5.9].
f) Perform on-site calibration of equipment that is sensitive to movement,,i.e., at the place
where it is operated [5.5.2].
g) Ensure that precautions for the handling or transportation of equipment or standards that
are sensitive to movement are contained in equipment handling procedures [5.5.6].
h) Document procedures to perform intermediate checks in order to maintain confidence in
the calibration status of the equipment; reference, transfer, or working standards; and
reference materials. In the event that the equipment does not require such checks,
document the technical justification [5.5.10 and 5.6.3.3]. Examine effects on the tests or
calibrations performed prior to detecting a piece of equipment that is out of specification,
out of adjustment, or out of calibration; there shall be records of the use of procedures
for control of non-conforming test and/or calibration work, including the notice given to
any affected customers.
Wherever software is used, it shall be demonstrated that it is appropriate for the purpose This
may be done with an inspection of the software functionality, for example, the use of a
spreadsheet to calculate values, or it could be as part of the broader validation of the forensic
science process in which the software is used, such as the use of databases for matching
specific characteristics
The forensic unit shall have written policies and procedures defining the conditions under
which equipment can be used. Policies and procedures should also be in place for the use of
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disposable equipment to ensure that such equipment does not contribute to contamination
through misuse or reuse.
The facilities and equipment shall only be used by authorized personnel. When equipment
not under the direct control of the forensic unit is used, the unit shall verify that the equipment
meets all requirements before each use. Typical measures would include visual inspection,
functional inspection, and/or calibration. The inspection procedure shall be documented and
inspection records shall be kept.
Some pieces of equipment used at the scene of crime have self-assessment, some are not
subject to effects of transportation and require only inspection, and others may require use
of reference materials that validate the calibration and function status as shown to
be satisfactory. Inspections of equipment performance shall be conducted by personnel with
the recognized competence to operate and inspect the equipment.
Equipment records:
Records shall be kept for each part of the equipment and its software significant to the
examinations/tests that are performed.
It is expected that the records issued by all forensic units will be in accordance with the
requirements specified in ISO/IEC 17025, based on Requirement 5.5.5.
To run a maintenance and calibration program, the laboratories require the equipment used
in a laboratory. Equipment used in a forensic laboratory is very broad due to the different
scientific disciplines and techniques involved, as exemplified in the following cases:
a) General service equipment not directly used for measurements (e.g., stirrers, non-
volumetric glassware, chambers, cooling spaces, thermocyclers). Such equipment is
generally maintained through visual inspection, security controls, and cleaning when
necessary. Calibrations or functioning checks will only be necessary where the
equipment configuration may significantly affect the test or analysis result (for example,
the temperature of a muffle furnace or a constant temperature bath).
Microscopes shall have service and be periodically cleaned. Measures shall be taken to
ensure that the microscopes are appropriate for their intended use, and they shall be
employed only by competent personnel. The use of microscopes for measurements shall be
guided by paragraph (d) of this criterion.
c) Volumetric equipment
Volumetric equipment is generally maintained through visual inspection and cleaning, but
calibration and functioning controls shall be performed prior to its initial use and at the
intervals appropriate to the type and frequency of use.
d) Measurement instruments:
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e) It is often possible to construct performance tests or suitable checks in test methods (for
example, chromatography systems, measurement of the refractive index of glass). Such
controls shall be documented and shall be completed successfully before the equipment
is used or until the results are duly accepted.
Correct use combined with periodic checks, cleaning, and calibration will not necessarily
ensure that a measurement instrument or detection system is functioning properly. It is for
this reason that the frequency of performance checks shall be determined by the need, type,
and previous performance of the equipment. Therefore, when appropriate, periodic checks
shall be performed and acceptability limits will be assigned. The frequency of these
examinations shall be determined by need, type, and previous performance of the equipment.
In the case of equipment that by its nature requires an installation or performance rating
(Incubators, Chromatographs, autoclaves, etc.), it must be considered [6.4.4]
The laboratory should consider what is established in the reference standards, traceability
and uncertainty technical guides and technical checklists. [6.4.5]
The laboratory must define and document the equipment that affects the validity of the results,
including the specifications and technical characteristics and accuracy required. [6.4.6]
The laboratory must justify and document the calibration periods of the equipment and / or
critical measurement patterns based on frequency of use and / or statistical techniques.
Basing said justification and documentation on the recommendations of ILAC-G24 / OIML D
10 or do so in accordance with the provisions of the applicable checklists. [6.4.7]
Have a procedure and a program to carry out the verifications and / or intermediate checks
of the status of the equipment calibration and / or measurement standards, as well as the
criteria to accept or reject the calibration status. It is suggested to revise NMX-CC-10012-
IMNC-2004 / ISO 10012: 2003 for more details. In the cases in which the test and / or
calibration method explicitly indicates these periods, subject to them. In no case the results
of the verification and / or verification replace a calibration. [6.4.10]
For greater precision in the way in which this requirement must be fulfilled, follow what is
established in the current PT.
The data reference collections or samples / materials representative of those found in cases,
which are maintained for identification, comparison or interpretation purposes (for example
mass spectra, vehicle engine paint, headlight glasses, drug samples , typewriter printing
styles, wood fragments, bullets, cartridges, DNA profiles, frequency database, etc.) must be
fully documented, unequivocally identified and appropriately controlled.
Not all the equipment or elements thereof, used to perform tests must be calibrated.
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b) For many of the analyzes, "Calibration" can be carried out using reference materials
containing the analytes tested, made in the laboratory from chemicals of purity and known
composition or standard matrices. On the other hand, the reference materials of the tests can
be purchased, with the declaration of the manufacturer or certificate. Wherever possible,
laboratories should source the reference materials from competent suppliers.
c) The collections and / or reference libraries of the data or materials that are found or
obtained in the work of cases and that are maintained for the purpose of identification,
comparison and interpretation (example mass spectra, paints of motor vehicles, lenses or
vehicle headlights, drug samples, machine printing styles, wood fragments, bullets,
cartridges, DNA profiles, frequency records) must be fully documented, identified and
properly controlled.
d) Comply with the current "Traceability of measurements" policy of the mexican accreditation
entity.
The laboratory must inform clearly and unambiguously before starting any work the
accredited scope and present evidence of the client's acceptance.
To ensure that the supplied sampling and testing services meet the requirement, the
laboratory must consider at least the following: [6.6.2 c)]
Whether they are accredited suppliers or, if they are not available, they meet the requirements
established in the current ISO17025 standard.
For the rest of the services, the laboratory will define its own criteria.
c) The Laboratory must present evidence of the evaluations and actions established for its
approved suppliers.
Consumables:
The quality of the reference material and reagents shall be appropriate for the purpose of the
procedure used. Batch numbers of reference materials and critical reagents shall be
recorded. All critical reagents shall require approval for reliability.
a) Name;
b) Concentration (where appropriate);
c) Date of preparation and expiration;
d) Identity of the person who prepared them;
e) Storage conditions, if relevant;
f) Hazard warnings, where necessary.
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The forensic unit shall define and document its policies and procedures for the selection and
use of acquired external services, equipment, and supplies that would affect the quality of the
service. It shall have procedures and criteria for the inspection, acceptance/rejection, and
storage of consumable materials, e.g., consumables used at the crime scene, during
analysis, and personal protective equipment.
Appropriate quality records for external services, supplies, and products purchased shall be
established and kept for a period of time as defined in the management system. This shall
include batch number records for all reagents, control materials, and calibrators; the date of
receipt; and the date on which the material is placed in service.
The specific activities to which this requirement refers are sampling and testing services,
within the scope of accreditation. [7.7.1 c)]
The laboratory must inform the client in a clear and unambiguous way the services provided
externally and present evidence of the above.
This is the time when the forensic investigator is assigned a task or intervention. In this case,
the forensic investigator will need to receive specific information from clients, and may also
need to give instructions to clients. This is also the time when the forensic unit assigns the
clearly defined authority and responsibility for the investigation in the place of intervention
and in each individual place. Aspects of the standard, which may be included here, are
contract review, subcontracting and naming the responsible persons.
Due to the nature of the crime scene investigation, the scope of an assignment
is not always clear before the investigation has begun.
It is the forensic unit’s responsibility to make sure that any work undertaken by it is within its
scope of competence.
The forensic unit shall have a system to ensure that subsequent assignments are reviewed
promptly and managed appropriately or, when necessary, rejected, according to the policies
and procedures defined.
When decisions are made at the crime scene, the following issues shall be considered:
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b) The scope, terms, and conditions of the assignment in question to the extent that they
are available and understood, in order to allow clear instructions to be carried out;
c) The use of appropriate resources, facilities, and equipment;
d) Constant monitoring of the forensic unit, assignments, and tasks;
e) Monitoring of completed assignments or tasks to ensure that they meet requirements
and have been properly carried out;
f) For routine or repeat work requests, review may be limited to considerations of time and
human resources and a record of acceptance; in such cases, it would be the acceptance
signed by a duly authorized person.
a) Jurisdiction;
b) Integrity of crime scene;
c) Environmental conditions;
d) The need for any special equipment or special competencies;
e) Health and safety problems;
f) Size and complexity of the crime scene and the need for additional resources;
g) Assignment of responsibility for a crime scene and coordination of responsibility for
several parties.
In situations where verbal agreements are accepted, the organization shall maintain a record
of all requests and instructions received verbally, including at least the subject, date, time,
name of the person who made the request, and the agreement reached. Any initial request,
or a modification to it, should preferably be made in writing by the requesting party.
The return or disposal of exhibits and retained material shall take place be in accordance with
the customer and the written records. Any change from the agreement made in the initial
contract shall be recorded.
In some circumstances, it may be appropriate for the forensic unit to give the customer some
instructions on how to preserve the crime scene. However, the level of knowledge on how to
handle the crime scene may be limited, and it may therefore be difficult to give exact
instructions.
Establish and document, in the quality management system, how the customer may clearly
and unambiguously become acquainted with the scope of accreditation and the non-
accredited scope (when applicable) before commencing any work [4.4.1].
The forensic unit will encounter situations where additional resources are necessary. Such
needs can be met by the use of contracted personnel, technical support personnel, or by
subcontracting the work.
In all cases where contracted personnel or technical support personnel are assigned, the
forensic unit shall provide evidence of their competence for the assigned tasks.
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In all cases of subcontracting, the forensic unit shall provide appropriate evidence of the
competence of the subcontracted agency, such as accreditation. If the laboratory does not
have accreditation, it shall be responsible for verifying and demonstrating compliance with
the Standard ISO/IEC 17025:2017 by the subcontracted entity through certificates or
assessment records for the qualified personnel in accordance with appropriate procedures.
The forensic unit may not always have the specific competency or ability for all necessary
examinations/tests. In this case, it may require the use of resources other than its own, e.g.,
another forensic unit or experts from another forensic unit. In such cases, the following should
be considered:
When a test is requested from an official laboratory that it cannot perform, it may give the
corresponding agency suggestions as to who can perform the requested test. However, this
is not considered subcontracting, nor is it subcontracting when samples are sent away to be
studied by other prosecutors’ offices under the shared agreement of prosecutors’ offices or
other agreements with other organizations, such as universities [4.5.1].
Demonstrate the customer’s acceptance of the subcontracted service prior to performing the
work [4.5.2].
Clearly identify the subcontracted methods, both in the contract accepted by the customer
and in certificates and reports [5.10.6].
It is possible that the test laboratory may deliver subcontracted results based on its own
forms. In this case, it shall keep the reports sent by the subcontracted laboratory and clearly
indicate in the report that these tests are subcontracted.
Avoid any use of the ema accreditation symbol or any reference to accreditation when the
scope of accreditation and the subcontracted work are not perfectly defined, as they may lead
to an incorrect interpretation by the customer.
In the event that the laboratory establishes its own acceptance and rejection criteria for the
declaration of conformity, the criteria must be based on recognized technical literature and
show evidence of communication and acceptance with the client. [7.1.3]
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Document all the sampling methods, testing included in the scope of their accreditation
(including the procedures for handling, transport, storage and preparation of the elements to
be tested and) and have them available for consultation in the place where the testing
activities are carried out.
It is possible to refer to the technical standard for the development of a test method, provided
that there is a particular procedure that indicates the specific details of the method that are
not included in the aforementioned technical standard such as: facilities, equipment,
preparation, care and disposition of the element subject to testing, etc.
a) Demonstrate that occasional deviations from the methods (as long as they do not
involve changes in the test method) and documented procedures are: technically
justified, authorized by the laboratory function with authority to allow such deviations
and accepted by the client in writing; as long as these deviations do not affect the
test results.
b) For methods of testing Mexican official standards and Mexican standards referenced
in the former, deviations from the methods are not accepted, unless the standard
refers to reference materials, equipment and instruments obsolete or out of the
market, in this case, the deviation must be accepted by the corresponding
dependence, should be consider the Article 49 of the Federal Law of Metrology and
Standardization and the Article 36 of the Regulation of the Federal Law of Metrology
and Standardization.
I. General information
b) Document and implement procedures for the handling of the data from tests and
calibrations when computers or automated equipment are used. In this case, the
integrity and confidentiality of the data can be given by the access level of the
previously defined and documented user keys [5.4.7.2].
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d) Validation and/or confirmation of the method shall be carried out initially and/or when
there are critical changes to the methodology, equipment, facilities, etc. [5.4.2].
e) All methods shall be fully documented, including quality control procedures and, where
appropriate, the use of reference materials.
f) Validation studies are required for all methods, including comparative ones. Validation
studies are required for all methods, including comparative ones. The validation
studies may be conducted by a scientific community (as in the case of standardized or
published methods) or by the forensic unit alone (as in the case of the methods
developed by the unit or when significant changes have been made to previously
validated methods).
g) When developing its processes, the forensic unit shall show with objective evidence
that it has reviewed the factors that may influence the results, and shall have records
of these. Examples of such processes include the process of creating a strategy when
visiting the crime scene, protection and preservation of exhibits, identification of
relevant evidence, and the interpretation process. The purpose of this is to ensure the
reproducibility and repeatability of the process and thereby ensure that different people
achieve compatible results.
h) When a method has been validated by another organization, the forensic unit shall
review the validation records to ensure that the validation carried out complies with the
purpose. It then becomes possible for the forensic unit to carry out only an inspection
of the method to show that the unit is competent to carry out the examination/test. Any
verification/validation process carried out by the laboratory, shall be documented and
records shall be kept.
i) When applicable, the technical procedures used by a forensic unit shall be validated
or verified before being used in a case or applied at a crime scene. An exception to
this would be if new substances are found, e.g., a drug. In all circumstances, the
technical procedure used shall be validated or verified before any result is reported.
The methods can be validated by comparison with other established methods using
certified reference materials (when available) or materials with known characteristics.
When validating the test methods, it may be necessary to determine the following
variables, among others, when appropriate, e.g., whether the method may be
qualitative or quantitative:
✓ Scope of method:
▪ Intended use and its limitations
✓ Sampling
▪ Sampling Strategy
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✓ Sample Preparation
▪ Homogeneity of the sample
✓ Examination
• Accuracy
• Precision
• Measurement uncertainty
• Matrix effects
• Interference
• Detection limit
• Quantification limit
• Linearity
• Stability of measured components
• Specificity and selectivity
• Repeatability
• Reproducibility
• Robustness
✓ Interpretation
• Reproducibility
• Robustness
• Performance characteristics
• Hypothesis or scenarios
• Databases
• Statistical assessment
• Limitations of conclusions
• Scientific literature
j) Interpretation of the results and findings shall be based on robust and documented
procedures. In cases where robust studies are not available, the interpretation shall at
least be supported by a documented evidence structure (records)
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4. Profile, competence, and skills of the personnel that carry out the method as
established by the laboratory itself or by the requirements of the method or
procedure.
5. Study of repeatability and reproducibility in compliance with the acceptance criteria
(when specified by the method) or, where applicable, the criteria established by the
laboratory through the performance data.
6. The evidence of the trueness and precision assessment of the measurement method
through experimentation that makes it possible to assess the bias and the
repeatability of the method in the laboratory, either using reference materials or
through an interlaboratory comparison; see updated standard series NMX-CH-5725-
IMNC.
For all the mentioned types of methods, the validation of the method shall include the
specification of the requirements, the determination of the characteristics of the method, a
specification that the requirements can be met using that method, and a statement on the
validity.
The validation evidence can be contained in a procedure, included or referenced in the quality
manual, or even in the technical procedures themselves.
a) Keep records of the validation in methods developed by the laboratory showing that the
method or procedure is consistent with the proposed use.
b) Document the influence of changes to the previously validated non-standard methods.
c) Document and validate the changes to the standard methods. When a method is written
in one manner and is carried out in another, it is a deviation from the method, not a
change.
For test methods that involve other tests for the determination of the final result, such tests
will be subject to assessment and shall comply with the quality requirements established by
the laboratory, the technical standard, and standard 17025.
For determinations based solely on mathematical calculations that require other test results,
the laboratory shall apply for the accreditation of all the tests involved in obtaining the data
for the final calculation.
II. In the case of newly established laboratories or newly implemented test methods
(including sampling), the following considerations shall be taken into account:
• It is necessary to:
1. Perform at least one statistically valid interlaboratory test for each of these methods
or technical procedures contained in the scope of accreditation;
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2. Perform at least three complete practical test exercises showing records from the
record of introduction of the test element, the preparation of the sample, the
performing of the test, to the preparation of the report of results; all of the above is
for each of the methods or technical procedures contained in the scope of
accreditation applied for.
III. Methods not carried out regularly are understood to be previously accredited test
methods (including sampling) that have not been performed in a year. In this case, in
order to demonstrate that technical competence is maintained, it is necessary to:
IV. In the event that the laboratory desires to accredit trademarked packages (kits with prepared
reagents):
Avoid handling them as rapid tests, because they are sometimes not such and may be
confused. Use tests published in national and/or international official standards, or by
recognized technical organizations. They are accreditable when the laboratory fully adheres
to the published method.
For standard methods or procedures, the laboratory shall obtain and present objective
evidence confirming the method to demonstrate that it meets the method’s specifications and
that it has the technical competence to adequately operate it, taking into consideration its
own facilities, equipment, and personnel [5.4.2].
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2. Interferences
3. Homogeneity of samples
4. Specificity
5. Stability of measured compounds
6. Distribution of population
7. Precision
8. Percentage of recovery or relative error
9. Limit of detection
10. Limit of quantification
11. Linear and working range
12. Reproducibility
13. Repeatability
14. Uncertainty
For confirmation of qualitative methods with a result not based on a measurement, the
confirmation of the method will be accepted through the correct application of the method
by the laboratory, taking into account its own facilities, equipment, and personnel [5.4.2].
The evidence for confirmation of the method can be contained in a procedure, included
or referenced in the quality manual, or even in the technical procedures themselves.
The verification of the methods must be carried out according to the following:
For standardized methods or procedures, the laboratory must perform and present objective
evidence of the verification of the method to demonstrate that it meets the specifications of
the method and has the technical competence to carry it out properly taking into account its
own facilities, equipment, personnel.
The verification of the method must be carried out according to the following:
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Or those that are specified in the reference standards and technical checklists.
For all the mentioned types of methods, the validation of the method shall include the
specification of the requirements, the determination of the characteristics of the method, a
specification that the requirements can be met using that method, and a statement on the
validity.
The validation evidence can be contained in a procedure, included or referenced in the quality
manual, or even in the technical procedures themselves.
d) Keep records of the validation in methods developed by the laboratory showing that the
method or procedure is consistent with the proposed use.
e) Document the influence of changes to the previously validated non-standard methods.
f) Document and validate the changes to the standard methods. When a method is written
in one manner and is carried out in another, it is a deviation from the method, not a
change.
For test methods that involve other tests for the determination of the final result, such tests
will be subject to assessment and shall comply with the quality requirements established by
the laboratory, the technical standard, and standard 17025.
For determinations based solely on mathematical calculations that require other test results,
the laboratory shall apply for the accreditation of all the tests involved in obtaining the data
for the final calculation.
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Validation for qualitative methods should include the specifications of the method
requirements and should at least show evidence of the reliability of the results through the
forms of quality control.
In the case of newly established laboratories or newly implemented test methods (including
sampling), the following considerations shall be taken into account:
Through practice and documentation, demonstrate the knowledge, experience, and training
of personnel involved according to each method or technical procedure contained in the
scope of accreditation.
It is necessary to:
1. Show the technical aptitude tests according to what is described in the application
criteria.
2. Perform at least one statistically valid interlaboratory test for each of these methods
or technical procedures contained in the scope of accreditation;
3. Perform at least three complete practical test exercises showing records from the
record of introduction of the test element, the preparation of the sample, the
performing of the test, to the preparation of the report of results; all of the above is
for each of the methods or technical procedures contained in the scope of
accreditation applied for. It will be understood by methods that are not carried out
regularly, those methods of testing (including sampling) previously accredited that
have not been carried out in a year, in this case, in order to demonstrate that the
technical competence is maintained, it must be:
a) Demonstrate supervision in each of the services given to the client.
b) Present evidence of the accomplishment of at least one practical exercise of
complete test from the registration of the element of essay, the preparation of the
sample, the accomplishment of the essay, until the elaboration of the report of results.
These practical exercises may include the services that the client has requested.
When there is an update in the reference method, the laboratory must show evidence of the
verification according to the changes of the updated method.
In the case that the laboratory wishes to accredit methodologies that include packages of
commercial brands (prepared and pre-calibrated reagents): provided that the corresponding
validation is evidenced (according to the requirements of the method).
However, in case a laboratory wishes to accredit this type of methods, its request will be
presented to the corresponding collegiate bodies for analysis and to decide if its accreditation
is feasible.
Rapid tests (kits) described in scientific texts or publications, as well as those developed or
adapted by the laboratory, may be accredited as long as they demonstrate by objective
evidence compliance with the following requirements that apply:
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Demonstrate that occasional deviations from the methods (as long as they do not involve
changes in the test method) and documented procedures are: technically justified, authorized
by the laboratory function with authority to allow such deviations and accepted by the client
in writing; as long as these deviations do not affect the test results. [7.2.1.7]
For methods of testing Mexican official standards and Mexican standards referenced in the
former, deviations from the methods are not accepted, unless the standard refers to reference
materials, equipment and instruments obsolete or out of the market, in this case, the deviation
must be accepted by the corresponding dependence, should be consider the Article 49 of the
Federal Law of Metrology and Standardization and the Article 36 of the Regulation of the
Federal Law of Metrology and Standardization.
The validation must include procedures for sampling, handling and transport of the test items.
b. For trials involving analytical measurements:
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• Study of repeatability and reproducibility in compliance with the acceptance criteria when
specified by the method, or in its case the criteria established by the laboratory through the
performance data.
• The evidence of the evaluation of the accuracy and precision of the measurement method
by means of experimentation, which allows to evaluate the bias and the repeatability of the
method in the laboratory, either by using reference materials or by an interlaboratory
comparison, consult the series of standards NMX-CH-5725-IMNC.
For all types of methods mentioned for analytical measurements described above, the
validation of the method should include the specifications of the requirements, determination
of the characteristics of the method, a verification that the requirements can be met using
said method and a declaration in the validity.
Evidence of validation can be contained in a procedure, included or referenced in the quality
manual or even in the same technical procedures.
a) Keep records of the validation in methods developed by the laboratory showing that the
method or procedure is consistent with the proposed use.
b) Document the influence of changes to the previously validated non-standard methods.
c) Document and validate the changes to the standard methods. When a method is written
in one manner and is carried out in another, it is a deviation from the method, not a
change.
For test methods that involve other tests for the determination of the final result, such tests
will be subject to assessment and shall comply with the quality requirements established by
the laboratory, the technical standard, and standard 17025.
For determinations based solely on mathematical calculations that require other test results,
the laboratory shall apply for the accreditation of all the tests involved in obtaining the data
for the final calculation.
For qualitative analytical measurements, the validation does not apply, however, the reliability
of its results can be demonstrated through its form (s) of quality control.
In the case of newly established laboratories or newly implemented test methods (including
sampling), the following considerations shall be taken into account:
It is necessary to:
Show the evidence of technical performance according to what is described in the
application criteria.
It will be understood by methods that are not carried out regularly, those methods of
testing (including sampling) previously accredited that have not been carried out in a
year, in this case, in order to demonstrate that the technical competence is maintained,
it must be:
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IV. In the event that the laboratory wishes to accredit trademark packages (kits with
prepared and pre-calibrated reagents):
It is clarified that the methods of commercial brand packs are only useful as
semiquantitative or field measurements and at no time can they substitute or be
alternative methods to the standardized methods, since they are not methods that can
demonstrate that they are technically similar or superior to the established in Mexican or
international standards.
However, in case a laboratory wishes to accredit this type of methods, its request will be
presented to the corresponding collegiate bodies for analysis and to decide if its
accreditation is feasible.
The rapid tests published in official, national and / or international norms or by recognized
technical organizations are creditable when the laboratory adheres in full to what is
established in the published method.
Sampling [7.3]
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the total number of required analytical determinations while assuring that all relevant
legal and scientific requirements are met.
In order to identify the samples that need to be taken, and the sequence of performing
different sampling and/or examinations/tests, a sampling strategy, sampling plan and
sampling procedures are required.
In determining the sampling strategy, sampling plans and sampling procedures to be used,
the following factors shall be considered:
When a forensic unit is working under the direction of another organization that has
already carried out the sample strategy and plan, the forensic unit then only needs to
follow its own sampling procedure.
The forensic unit shall have policies and procedures to ensure that it has the appropriate
equipment, facilities, and techniques available. To determine this, the following shall be
considered:
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• Weather conditions that might affect the crime scene or the exhibits located
there
• Crime scene control considerations that may alter or contaminate the exhibit.
• Additional processing techniques to be conducted at the crime scene that may
require specialized personnel.
• Procedures and policies shall also include the actions needed when it is
determined that the forensic unit cannot fulfill the crime scene service request.
A forensic unit with primary responsibility for a crime scene may find it necessary,
in some circumstances, to solicit the support of other forensic units or
subcontractors to adequately process a crime scene.
Any forensic unit or subcontractor attending a crime scene for the first time shall
first inquire about the involvement of any other forensic units or subcontractors. If
any are identified, communications should occur with the other forensic units or
subcontractors before any other crime scene activity commences.
The integrity of the crime scene, the chain of custody of exhibits gathered from the
crime scene, and the unintentional destruction of available exhibits are all important
considerations in coordinating the efforts of multiple forensic units or
subcontractors.
The forensic unit will conduct the crime investigation in accordance with the
processes and procedures established in its management system.
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Before exhibits are recovered, the forensic unit should consider the conditions
encountered on site to ensure that the exhibits can be recovered and documented
with the least possible alteration. Where necessary and depending on the technical
options, the exhibits are prepared for the sample taking process. Consideration
shall be given as to the sequence in which samples are taken.
Documentation of the crime scene shall be made before the examination starts and
throughout the investigation. Documentation can be made, for example:
• In writing or drawing,
• By voice recording,
• By photographs,
• On video, or
• 3D laser scanning.
All conducted activities, observations, findings and conclusions reached during the scene
examination will be recorded. The records shall be sufficient for another competent person to
understand and assess the crime scene.
The forensic unit shall perform a search pattern according to a structured procedure, at least
in the area of felony offenses. Records of this shall be kept. The collection of exhibits shall be
conducted in accordance with the processes and procedures in the management system. The
collected exhibits shall be clearly and unambiguously identified to enable systematic
assessment.
Exhibits collected and the locations where they were found will be documented or described
using suitable procedures, e.g., measurements, plans, diagrams, photography,
photogrammetry, so that the exhibits can be identified at all times and the locations at which
they were found can be determined. The identification of the exhibits shall
be correlated with the report.
Appropriate precautions and procedures are required and shall be observed when dealing
with potentially dangerous substances and samples.
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For legal purposes, the forensic unit shall maintain a "chain of custody record" for exhibits
while under its control. This record shall detail each person or organization who takes
possession of an exhibit or, alternatively, the location of that exhibit (e.g. if in storage).
The acceptable definition and procedure for "chain of custody" shall be adapted to the legal
provisions. The forensic unit shall take appropriate precautions to ensure that the identified
exhibits taken for further examination are recovered, stored, and transported, without loss or
contamination (from the environment, weather, people etc.).
Normally, it would be expected that forensic personnel will continually review the plan and
strategy for the crime scene crime investigation. Any revision shall be recorded.
Testing:
The forensic unit may perform testing, including but not limited to quantitative measurements
and presumptive or screening tests, as part of a crime scene investigation.
If the unit is accredited to ISO/IEC 17025, then relevant requirements are covered in that
particular standard.
Some examples of critical consumables that shall be tested for their reliability at the scene
before use are the following:
• Test kits for blood, e.g., peroxidase tests, semen e.g. acid phosphatase, drugs e.g.
Marquis,
• Detecting and enhancement chemicals e.g. Luminol, Leuco Crystal Violet.
The result of the test shall be recorded. Equipment in mobile laboratories used at the scene
shall meet the same requirements as equipment in stationary laboratories.
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This is the stage where the forensic unit determines if the purpose of the examination has
been fulfilled, if further examination is necessary and is possible, or whether the crime scene
examination has been completed. At this stage, the forensic unit will also decide whether
samples need to be sent away for further examination and testing.
Review of crime scene findings in the context of the request and strategy:
Anomalies and irregularities are findings and observations at the crime scene that do not fit
into the general expectation of the crime scene, e.g., the presence of a motor vehicle at a
robbery with a body in the back of the car.
Additionally, the irregularity of an exhibit could be that another exhibit is missing, or that there
is doubt about the suitability or integrity of the exhibit.
It may also cover collecting information through other sources like mobile
phone companies, CCTV, collecting samples from potential suspects or from victims, and
tests for purposes of elimination.
This is when the forensic unit arrives at the crime scene and takes actions to protect the
integrity of the crime scene and assess it.
The discussions at the crime scene will be held with the appropriate people, depending on
the legal system in the country, e.g., police, medics, examiners, judge, magistrates, and
prosecutors.
If the initial visit at the scene shows that the conditions of the reviewed contract were not
consistent with the situation at the scene, then the relevant steps of the contract review may
need to be repeated.
Maintaining the integrity of the scene and evidential items is essential. Personal protective
equipment, such as using gloves and face masks, and limiting access to personnel with
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examination and testing duties, are examples of steps taken to prevent contamination, and
the use of tents to protect from rain is an example of preventing degradation.
However, the procedures that are implemented to maintain crime scene integrity depend on
the nature of the crime and its scene. Crime scenes such as burglaries can be processed by
an investigator with only basic protective equipment and without the need for access controls.
However, outdoor scenes may require more demanding perimeter control and procedures for
recovery and preservation of evidence than is the case with indoor scenes.
The records of the reviews of critical findings shall indicate that each critical finding has been
checked, specifying by whom the checks were performed and when. This may be indicated
in a number of ways, including records of each finding, a summary of the results, or a
statement to this effect in the records. The records shall indicate if the critical finding has
been agreed, or the action taken if this was not the case.
Where an inspection of critical findings is the only quality control procedure, such as blood
pattern analysis, footwear comparison, crime scene interpretation, or
damage identification and interpretation, then this control shall be performed without
knowledge of the original result and this independence shall be
identifiable based on the records.
Sampling:
Selection, recovery, prioritization, and sampling of materials from submitted test items are
important parts of the forensic science process. Laboratories shall ensure that there are
documented procedures and training programs to cover this aspect of their work and that
detailed competency/training records are kept for all personnel involved.
a) For legal purposes, forensic units shall be able to demonstrate that the samples examined
and reported on were those submitted. A "chain of custody" record shall be maintained
from the receipt of samples, detailing each person who takes possession of a sample or,
alternatively, the location of such sample (e.g. if in storage).
b) When samples are recovered by the forensic unit, e.g. fiber tape lifts, microscope slides,
etc., a chain of custody record will be commenced and included in the file.
c) There shall be documented procedures that describe the measures taken to ensure
sample integrity when a sample is left unattended in the process of being examined.
d) Facilities, techniques, and equipment required: Access to the operational area of the
laboratory shall be controllable and limited. Visitors shall not have unrestricted access to
the operational areas of the laboratory. There shall be a record of all visitors to the
operational areas of the laboratory.
Sample storage areas shall be secure to prevent theft or interference, and access to them
shall be limited and controlled. The storage conditions shall be such as to prevent loss,
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deterioration, and contamination, and to maintain the integrity and identity of the sample.
This applies both before and after examinations have been performed. Where perishable
items are handled, any deterioration of the items shall be minimized.
g) In all cases, each person performing sampling, examinations, or testing shall be deemed
responsible for the handling, processing, taking of samples, and examination of each
sample in the most appropriate manner and sequence.
h) For legal purposes, forensic science laboratories shall be able to demonstrate that the
samples examined and reported on were those submitted to the laboratory. A "chain of
custody" record shall be maintained from the receipt of samples, detailing each person
who takes possession of a sample, or, alternatively, the location of such sample [5.8.1].
i) Subsequent laboratory examination/tests: This is the stage when the forensic unit
determines where the sample will be sent, depending on the type of examination to be
performed.
j) The forensic unit shall ensure that the samples identified and collected for subsequent
examination are recovered, stored, and transported without contamination (from the
environment, weather, people, etc.) or deterioration, and with due regard to their integrity
and the chain of custody. Where perishable items are handled, any deterioration of the
items shall be minimized.
k) A chain of custody shall be included in the procedures for cases where the sample is
collected inside and outside of the laboratory facilities, with the intention of identifying
cases where the sample is required by various departments or areas for further analysis.
When applicable, it shall be necessary to set the weights, quantities, or volumes to be
extracted from each substance or sample, and each sub-divided sample(s) shall proceed
to the procedures for the handling of test samples as established by the laboratory.
l) It shall be demonstrated that the sample examined and reported on was the one submitted
to the laboratory. The chain of custody record shall be kept from the time of receipt and
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shall reflect all transfers. The record shall provide details of each person who comes into
possession of the sample or the sample’s location [5.8.1]. The record shall at least include:
m) There shall be documented procedures that describe the measures taken to secure
objects left unattended in the process of being examined [5.8.4]
n) It shall be ensured that any sample not in process of analysis is placed in a receptacle,
container, or drawer to protect it from cross-transfer, loss, or contamination. Such samples
shall be stored with a proper stamp [5.8.4].
o) The storage area shall be protected from cross-transfers, loss, or contamination, and from
harmful or damaging changes to the samples.
p) There shall be a policy establishing that samples in process of analysis may be remain
pending when it is justified [5.8.4].
q) There shall be procedures to ensure that each sample is identified and traceable through
documentation to its unique identification number. For cases where the sample is not fit
to be marked, its subsequent container shall be labeled [5.8.4].
r) Photographs or film negatives shall be treated as samples when latent fingerprints may
only be recorded or collected by such means [5.8.5].
s) There shall be procedures to ensure that samples collected at the crime scene by
laboratory personnel are protected from cross-transfers, loss, or contamination, and from
harmful or damaging changes to the samples by placing them in a clean or sterile
container or receptacle (as applicable), labeling and stamping the container or receptacle,
and initialing its stamp in order to transport it to the laboratory. Further measures shall be
taken to preserve the sample and make it secure prior to its final packaging. The sample
collected at the crime scene shall be identified, packaged, stamped, and recorded in the
chain of custody [5.8.4]
t) Where applicable, there shall be procedures for the operation of database or records of
individual characteristics. The laboratory shall establish whether the information in the
database or records of individual characteristics is being treated as a sample, reference
sample, or documentation for analysis [5.8.4].
u) In applicable cases, it shall be ensured that reference samples comply with the chain of
custody requirements listed earlier in this document for samples, as well as their
protection, stamping, labeling, and storage [5.8.4].
v) Samples from a database or records of individual characteristics that are to not be treated
as evidence shall comply with Sections XII, XIII, and XIV.
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w) Each sample from a database or records of individual characteristics that are under the
laboratory’s the control shall be identified in an unambiguous manner.
y) Access to samples from a database or records of individual characteristics that are under
the laboratory’s control shall be restricted for persons without the laboratory director’s
authorization.
Note: Sections IX) to (XIV) apply in cases where there is a need for witnesses to perform
comparative studies, e.g., spent casings from a firearm under study by ballistics experts,
as well as ten-print cards for comparative study or entry into the Automated Fingerprint
Identification System (AFIS).
Carry out backups of all the records maintained electronically in the period that the laboratory
establishes in its management system.
In the case of laboratories that do not yet provide testing services, they should initiate the preservation
of their records from the start of the activities described in the section "Methods of testing and
calibration and validation of the method" of this document, referring to laboratories of new creation.
Procedures for the control of quality records and technicians may be included in the procedures of
the management system from which they are derived.
- Use logbooks, notebooks or formats expressly designed to ensure the integrity of the
information (all with consecutive folio number on each sheet, or consecutive date,
etc.) and to record the data derived from the testing process.
- Do not use loose sheets of paper (without coding or folio) to record sample data, test.
- Elaborate the records in legible form, with indelible ink and not use corrector in them.
a) Cancel all the blank spaces in the registers (electronic or paper) that must have been
filled out and that for some justified reason are not used, in logs or any type of registry.
The laboratory must maintain a record of each investigation case and must assign an
internal control number through a unique identification system for each case record, and
when applicable must be related to the research case with which the samples enter the
laboratory.
The records can be kept on paper or electronically, based on the current legal framework
for a minimum period of 4 years or, if applicable, the period established by the current
legal framework (the largest of them).
The laboratory must establish the time (period) of storage of the records in their own
facilities and their subsequent destination based on the current legal framework.
Likewise, the laboratory must consider that the time of retention of the records depends
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directly on the legally established time or until the clarification of the possibly criminal fact
being investigated, as well as any other record of the management system.
All technical records or any record generated by the laboratory management system must
include the internal control number; in the case of technical records, the internal number
of expert opinion control.
Note: The investigation case can be identified through the following: the preliminary
investigation number, the criminal case, file number, investigation folder, departure
number, registration number, etc.
The forensic unit must have documented procedures to ensure that a record is created
and maintained with each case under investigation. The information that will be included
in the case records must be documented and may include but is not limited to records of
any communication with the client (verbal or written), review of contracts, requirements
and agreements of the exams and tests with the client, records of evidence, descriptions
of signs including packaging and sealing, citations, records of observations and test /
examination results, reference of procedures used, diagrams, impressions, photographs,
videos.
The necessary records must be kept support / verify / corroborating the conclusions,
which should be such that in the absence of the analyst / examiner, another competent
analyst / examiner can evaluate what has been carried out and interpret the data and if
necessary repeat the analysis.
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8) Manual calculations and information transfers that are not part of a validated
electronic process must be checked by a second person. The case record must
include an indication that those evaluations have been carried out, by whom and
when.
9) Every page of every document in the case records must be traceable to it. There
must be a mechanism with which the integrity of the documentation is
maintained. This means, for example, that it should be easy to detect if a
document was added to the file after the date or has been lost.
10) The copy of the records generated by the forensic unit, used as part of the file of
a case, must be listed to indicate the total number of pages.
11) Records of the "chain of custody" must be kept that detail when a person or
organization takes possession of a sign / item of evidence from its reception,
during the storage process and, when applicable, the return to the client that
forwards or the scrap of the sign.
12) The definition and accepted process for "chain of custody" needs to be adapted
to the legal requirements. Any transfer of the material must be registered. The
records related to the chain of custody shall be retained in accordance with the
requirements for other records of the case.
13) Electronic equivalents of handwritten initials or signatures are accepted when the
forensic unit can demonstrate that said initials or signature can only be applied
by the same individual represented by them.
14) If the registration is done electronically, there must be a method that prevents
the documents / data from being removed and, in addition, there must be a
method to know what records should be kept and in what place.
15) In general, records should be made permanently, for example, records by hand
must be in permanent ink. There may be exceptions when the environment
prevents the use of ink, and it may be appropriate to make diagrams and
sketches in pencil, including colored pencils.
16) When abbreviations are made in the records should be completely clear and
understandable
To comply with this requirement, it is necessary to review the provisions of the current
Uncertainty Policy. [7.6]
The laboratory should take into consideration the contributions to the uncertainty of
measurement indicated in the reference standards, traceability and uncertainty technical
guides and technical checklists. [7.6.1]
For a particular method in which the measurement uncertainty of the results established
and verified, does not need to evaluate the measurement uncertainty for each result, if
the laboratory can demonstrate that the critical factors of influence identified are under
control. [7.6.3]
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a) Define and implement a procedure for the assurance of the validity of its test results,
appropriate to the type of work performed and the number of analysts or technicians
performing the tests or calibrations, for each of the methods or technical procedures
included in the scope of accreditation.
b) Apply at least one quality control for each test method (including sampling) referred to
in the scope of accreditation, of those indicated in number 7.7.1 of subparagraph a) to k).
The application of this form of quality assurance must be carried out with satisfactory
results according to the frequency of performance of the tests or calibrations, based on
the period defined in the technical verification list or in accordance with the provisions of
the procedure itself or method. If there is not a defined frequency considering the previous
points, the laboratory should apply quality control in a period no longer than twelve
months.
c) In the event that the laboratory establishes its own acceptance and rejection criteria
for quality control, the criteria must be based on recognized technical literature and / or
be established through the application of statistical techniques.
d) Present records of the actions planned to correct the problems that are detected due to
quality control.
The analytical development should be supervised by the use of quality control plans that
are appropriate for the type and frequency of the examination carried out by the forensic
unit.
The range of quality control activities available includes the use of:
• Reference collections;
• Certified reference materials and reference materials generated internally;
• Statistical tables;
• Positive and negative controls;
• Control charts;
• Replication of the exam;
• Alternative methods;
• Repeat examination;
• Samples in the limit of detection, regulations or internal rules;
• Independent reviews (verification) by other authorized personnel.
Depending on the particular exam being performed, the forensic unit may use one or
more of these examples to demonstrate that the exam is 'under control'. The quality
control procedures required in any particular area of work will be determined by the
forensic unit responsible for the work, based on the best professional practices. The
procedures should be documented, and records kept to demonstrate that all appropriate
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quality control measures have been taken, that all quality control results are acceptable
or, otherwise, that the corrective action has been implemented.
An effective means of the forensic unit to monitor their performance, both against their
own requirements as well as against the performance of their peers, is to participate in
the proficiency testing programs. When participating in the proficiency testing programs,
the procedures of the documented tests of the forensic unit should be used. Performance
in the programs will be subject to periodic review and when necessary, corrective actions
will be taken. The proficiency test records should include:
a) Document and implement a set of procedures for quality assurance, which must be
determined by the personnel responsible for the work in the laboratory, based on the best
professional practices of the laboratories, appropriate to the type of work performed and
the number of analysts or technicians who perform the tests or calibrations, for each of
the methods or technical procedures included in the scope of accreditation.
b) Apply at least one quality control for each test method referred to in the scope of
accreditation and / or apply the quality assurance procedures that the test method itself
establishes that must be performed, to monitor the validity of the results of each trial. The
application of this form of quality assurance must be carried out with satisfactory results
according to the frequency of performance of the tests or calibrations, based on the
procedure itself or method. If there is not a defined frequency considering the previous
points, the laboratory should apply quality control in a period no longer than twelve
months.
c) Analyze the data obtained in the assurance scheme of the quality of the results using
methodologies that objectively allow to generate corrective and / or improvement actions.
d) Establish and document the predefined acceptance and rejection criteria for the quality
control data obtained by the laboratory. If the test method already has them established
or refers to another document, they should be applied. In case the laboratory establishes
them, the criteria should be based on recognized technical literature and / or established
through the application of statistical techniques.
e) Present records of the planned actions taken to correct the problems that are detected
as a result of quality control.
f) Submit records that the actions have been carried out as non-conforming test work
(4.9) in cases where quality control data are detected outside the acceptance criteria.
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g) Comply with the current "Fitness Testing" policy of the Mexican accreditation entity. The
fact that there are no aptitude testing programs by ema in some technical areas does not
imply that the laboratory should not comply with this point. The laboratory must present
evidence that it conducted an investigation of the proficiency testing programs available
in the branches or areas within the scope of its accreditation (accepted by ema), based
on the practical guide for proficiency testing programs.
h) If you have documented in your management system proficiency tests as the form of
quality control, you must submit evidence of satisfactory participation every 12 months
for each test method.
In the case of analytical measurements, the laboratory may use expired reference materials
(RM) as control samples for statistical process quality control, provided that the RMs are
periodically verified and identified for exclusive use in quality control. The laboratory should
monitor the process and apply good practices to ensure RM stability. It must also be
documented and ensured that if the RM goes outside its process control limits, a
nonconformity will arise.
▪ Regular and scheduled use of reference materials and other materials of known
characteristics, for example: control samples, during the performance of the test
methods.
If this practice is carried out routinely, it allows the use of control charts and follow up
on the levels of precision and accuracy achieved by the laboratory in carrying out the
methods.
▪ Regular repetitions of the test to the same sample (or measurement equipment),
performed by the same analyst or technician (repeatability tests), or to make internal
proficiency testing schemes between analysts or technicians.
This allows knowing and monitoring the repeatability achieved by each analyst or
technician in the laboratory.
▪ Periodic repetition of the test in retained samples, carried out by two or more analysts
or technicians.
This allows to know the precision between analysts or technicians in a certain test
method, as well as to identify significant deviations in the results of a particular
analyst or technician.
▪ Testing of the same sample in a programmed manner, by different test methods or
two different samples tested on the same equipment.
▪ Registration and monitoring of test results obtained by clients or suppliers of the
laboratory on the same sample.
This allows, having enough data, the use of control charts to know and monitor the
level of precision of the results among the laboratories involved. The data obtained
can be compared with published reproducibility data for the particular method, if
available, as long as the two laboratories use the same method.
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This allows the laboratory to compare its performance with the participating laboratories that
perform the same test methods. This practice provides a warning mechanism to detect faults
in the methods or techniques used, in the laboratory analysts or in the equipment used, which
would not be possible to know by other means. It also provides a way to know the
reproducibility of specific test methods.
The laboratory should demonstrate its performance through participation in aptitude tests or
interlaboratory comparisons: [7.7.2]
b) In the event that the Ability Testing programs are not available or are not appropriate to
the scope of the accreditation, the laboratories must demonstrate their performance by
participating in inter-laboratory comparisons of the tests within the scope of accreditation
according to the document of " Classification of sub-sections and disciplines for participation
in proficiency testing programs of clinical, forensic and research laboratories ", at least once
within the accreditation cycle.
The interlaboratory comparisons that are accepted for compliance with this requirement are
all those that demonstrate that they have considered the requirements indicated in 4.4 to 4.7
of ISO 17043. [7.7.2]
Reports of test results in which a laboratory refers to the accreditation granted by ema, using
or not the accreditation symbol, must clearly specify the accredited scope or identify the tests
that are within or outside the scope of accreditation.
The report issued must contain the results obtained from the test or sampling may include a
statement about compliance or non-compliance with the requirements or a given specification
[see 7.8.6 and 7.8.7]
Test result reports can not be called "Certificate of Analysis," "Certificate of Compliance,"
"Laboratory Report," or in any other way that suggests a product certification or verification
activity.
The laboratory must keep within its records a true copy of the original test report delivered to
the client, this can be in paper or electronic format (pdf format).
Test laboratories should report the uncertainty using two significant figures.
The test results must be expressed in accordance with current NOM-008-SCFI, based on
Article V of the Federal Law on Metrology and Standardization. It can be expressed as
indicated by the technical standard of the test, however, it must include the value in
accordance with the NOM-008-SCFI, in force.
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In the test report, the laboratory can use the comma or the decimal point indistinctly, however,
this use must be consistent in the body of the report.
Reports can be issued in print or electronically, as long as the requirements of this document
are met. [7.8.1.2]
This section refers to any interpretation and report of results that may take place immediately
after the investigation of the place of intervention.
The report must contain all the results of the examinations carried out and the pertinent
observations, as well as the findings and, when it is pertinent and admissible, conclusions
reached from these results. The report must contain any information about the interpretation.
The forensic unit will have to develop its own format and the content list of its reports. For the
general principles of interpretation and reporting.
Exams:
This is the stage at which the staff of the forensic unit determines an examination strategy,
chooses the methods and procedures, and decides on the sequence of sampling,
examination and testing. This will be done according to the client's requirements as part of
the contract review.
However, the provision of this information should not compromise the impartiality of any
subsequent examination.
When the forensic unit defines the evaluation and test strategy, it must take into account,
when applicable, the following:
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• The restrictions that may exist, for example, the need to preserve the material for other
purposes, costs, etc .;
• Exams or other activities that can have a destructive effect for later examinations;
• Coordination for multidisciplinary exams to determine the sample (s) to be taken and the
sampling or examination sequence;
• Exam services that are currently available in the laboratories;
• Consideration of precautions against appropriate contamination for the examinations under
discussion and all kinds of evidence that may potentially be available;
• The progressive review of the evaluation and testing strategy according to new significant
findings;
• What is technically possible and worthwhile to meet the needs of the client, including the
defense.
This is the stage in which the unit that conducts the exams and tests evaluates and interprets
the results of examinations and tests based on the request and the information provided
during the process.
Interpretation of results:
The interpretation is made when the conclusions are based on something more than the
result of the test carried out, for example, the conclusions drawn from the observations in the
place of intervention. Both in the laboratory work, as well as in the place of intervention, there
will be conclusions obtained based on observations and visual tests, without necessarily
having objective examinations.
The interpretations should be based on robust studies. In cases where this is not possible,
the interpretation, at least, will be supported by a body of documented evidence (records).
When interpretations are made, the limitations of the test used must be fully considered. For
example, definitive conclusions will not be taken from a presumptive test.
The staff of the forensic unit should have access to the complete, understandable and
accurate results and findings of the test, and consult reliable sources of relevant information
to support the interpretation. The interpretation of results and findings in the context of the
case is possible when sufficient information about the case is available. A hypothesis based
on the results and the available information must be defined. Alternative hypotheses should
also be considered.
When necessary, the client will be asked to provide sufficient information about the samples
and the circumstances at the site of intervention. The lack of this information may limit the
possibility of an adequate interpretation.
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Competence:
The staff interpreting the results will be evaluated and considered competent before they
report statements that include the interpretation and opinion of the results and findings.
It is necessary that there be a clear definition of the competence requirements and criteria for
interpretations.
In the field of forensic science laboratories, the opinions, reports or certificates issued are
particularly important, since such reports, reports or certificates are used in the presentation
of evidence and arguments before the courts, where the use of the scientific evidence allows
corroborating or contradicting theories of persecution or defense. In addition, the reports,
reports or certificates must comply with the legal provisions in criminal justice that govern at
the national, state and local levels. Therefore, in order to establish clearly and unambiguously
what the reports, reports or certificates issued by the forensic laboratories must contain in
order to comply with the ISO / IEC 17025: 2017 standard and in the right column, the indicates
the criteria to apply
It is accepted that the forensic science laboratories may not include all the elements in the
"Hearing trial", since the format of these documents is prescribed in legislation.
Therefore, forensic science laboratories may choose to adopt one or more of the following
means to meet these requirements:
• the preparation of a test report, including all the information required by ISO / IEC 17025;
• the preparation of an annex to the Court's Declaration, which includes any additional
information required by ISO / IEC 17025;
• the assurance that the case record related to a specific investigation must contain all the
relevant information required by ISO / IEC 17025
Only a valid reason is considered not to include all the information indicated in subsection a)
to p), is that the laboratory does not perform any of these activities. [7.8.2.1]
For testing laboratories, the report must include the signatures of the responsible personnel
who carried out the test, the sampling when applicable and the one approved, as well as
name and position. [7.8.1.2. or)]
The laboratory must guarantee the use of secure computer tools for the printing of digital
signatures in the test or sampling reports, which may be of the type of the advanced electronic
signature or similar, it is not allowed to use codes, alpha numeric keys, names or initials that
can not be verified electronically.
If a user of the service requests the printing of a test report or physical sampling, it will be the
body's decision to provide it or establish the conditions under which it can do so, as part of
the customer service and to satisfy a specific need, as well as notify it in a timely manner. the
same.
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When the client is the one who prescribes the decision rule, or is prescribed in regulations or
normative documents, it is not necessary to consider the level of risk in addition.
Maintain the record of the risk analysis when the applied decision rule is not provided by a
standard, guideline or client.
In all cases, the laboratory must identify the change in the report and in case the change
modifies the previously issued result, the laboratory must include in the report the reason for
the change.
Complaints [7.9]
Demonstrate that the complaints submitted by its customers and other parties have been
resolved, and inform the affected party of its response within a period not exceeding ten
business days or, where applicable, the period set by the legal framework.
The laboratory shall have a documented procedure for the resolution of complaints from its
internal and external customers. Additionally, it shall prepare a record for follow-up on
complaints and implement its procedure for corrective action, including the analysis of
causes.
Responses to complaints, suggestions, and opportunities for improvement shall include an
assessment of the potential impact on any activity that has been carried out by the forensic
unit. In the event that it is proven that there might have been an impact on any task, action
shall be taken based on the procedure for non-conforming work.
Complaints may be received from different sources such as customers, crime victims, police
units or other departments within the same organization, such as the laboratory, the
criminology unit, investigating officers, and the judiciary.
Finally, when a court judgment has been successfully appealed and was due to any work
performed by the laboratory, this shall be assessed through the corrective action process or
any other process for improvement.
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The non-conforming test work can be presented in any of the stages of the test process (from
the sample taking), so the applicable procedures must contemplate this scope and all the
clauses of the requirement.
When an evaluation detects a nonconformity that directly affects the test result, in addition to
the above, the laboratory should be able to identify all the non-conforming test work generated
or, failing that, from the last evaluation to the one that was subject and for the closure of the
nonconformity must present evidence of what is mentioned in the requirement 7.10 of ISO /
IEC17025: 2017, and derived from the analysis of the importance of non-conforming work the
notification to all customers who are provided non-conforming * products.
Commercial software for general use in the field of application for which it was designed is
considered to be sufficiently validated.
Evidence that when changes have been made to the management system they have been
informed to all the personnel involved.
Demonstrate that there are no contradictions or conflicts between different documents of the
management system that could call into question the integrity of the same.
The requirements for the accessibility and control of documents apply for permanent
installations and all the sites or locations where the work is carried out, for example: place of
intervention. [8.3.1]
All records must be kept for a minimum period of 4 years, or if applicable, the period
established by the applicable legal provisions (the largest of them).
Carry out backups of all the records maintained electronically in the period that the laboratory
establishes in its SG.
In the case of laboratories that still do not provide testing services, they should start the
preservation of their records as of the start of the activities.
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Procedures for the control of quality records and technicians may be included in the
procedures of the management system from which they are derived.
- Do not use loose sheets of paper (without coding or folio) to record test data.
- Elaborate the records in legible form, with indelible ink and not use corrector in them.
- Cancel all the blank spaces in the records (electronic or paper) that must have been filled
out and that for some justified reason are not used, in logs or any type of record.
The laboratory should document in its management system the way in which it performs risk
analysis and how it will monitor actions to minimize risks. [8.5.1]
To achieve the improvement, the following actions can be considered among others: [8.6.1]
Maintain records that show that the information obtained from customer feedback is analyzed
in its entirety and used to initiate improvement actions. [8.6.2]
a) The laboratory must present a record of the evaluation of the need for actions to eliminate
the causes of non-compliance
b) In the case of non-conformities that require corrective actions, they will be considered
closed when their effectiveness is implemented and evaluated by the same laboratory,
which, in addition, must demonstrate that there is no potential recurrence in any other
part of the activities inherent to the laboratory.
c) One way to demonstrate the effectiveness of corrective actions is that there is no
recurrence of problems or non-conformities.
Document and implement at least one formal technique for analyzing the root cause of the
problem. The evaluating group will verify that the technique of analysis of the root cause of
the problem has been correctly applied and that the corrective actions are appropriate for the
effects of the non-conformities found.
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The laboratory must have records of all activities performed for corrective actions whenever
there is a non-compliance derived from any source. [8.7.3]
Internal audits can be carried out both by an internal auditor and by an external auditor hired
for this purpose, and have different objectives to the evaluation of the ema.
The internal audit can not be replaced by external audits, such as those carried out by the
client, the ema, certification bodies, etc.
It should be clarified that the corrective actions derived from the non-conformities generated
from internal audits or from other sources may be in the process of attention at the time of
the on-site evaluation by the entity, for accreditation purposes it is an indispensable
requirement to close those not Conformities detected in internal audit or from other sources.
The assessment group will raise the non-conformities detected during the evaluation
b) Demonstrate that an internal audit is conducted at intervals of at least every twelve months,
including all the requirements of the laboratory management system.
c) Ensure that the evaluation of the implementation of the processes of the forensic unit
should include direct observation of the examination and tests done on site or in the laboratory
d) Include auditors or personnel who know the technical area.
Testifying activities in the intervention sites (applies when they have sampling)
The forensic unit must have a witnessing program to ensure that the people who work in the
organization have the competence that is required.
The factors that must be considered when deciding the approach that must be taken for the
examination of the place, include, but are not limited to:
The person making the testimony must have the appropriate competence.
• The testimony not only covers the procedural part of the work, but it must also go to the
depth of the technical competence of the personnel and their ability to make relevant
decisions in the place of intervention.
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The laboratory must maintain evidence that a review is conducted by the laboratory
management at planned intervals not exceeding twelve months. [8.9.1]
- Perform the review of the objectives of the management system and give a
conclusion on whether they are being met or not.
- Establish and document specific deadlines to perform the actions derived from the
review by management and evidence the monitoring provided by senior management
for compliance with them.
IDENTIFICATION OF CHANGES
Observations:
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Annex A
ACCREDITATION DISCIPLINES
FORENSIC SCIENCE LABORATORIES
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Risks to the impartiality of the laboratory are potential sources of biases that may compromise, or
may reasonably compromise, the laboratory's ability to make an unbiased decision. Risks originate
from various types of activities, relationships, and other circumstances. The laboratory should identify
the types of risks involved, analyze the effects of these risks and evaluate the potential impact on the
impartiality of the scope of laboratory activities.
The laboratory should have implemented safeguards that mitigate or eliminate the risks for
impartiality. Safeguards may include prohibitions, restrictions, disclosures, policy procedures,
practices, rules, rules, institutional arrangements, and environmental conditions. These should be
reviewed periodically to ensure its continued applicability.
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f. The establishment of sanctions, and the possibility of such actions by the accreditation entity
and others;
g. The legal responsibility faced by the laboratory.
h. The maintenance of a professional environment and a culture in the laboratory that supports
the behavior.
i. Policies, procedures, and practices directly related to maintaining the impartiality of laboratory
personnel;
j. The policies, procedures and practices for the hiring, training, promotion, and permanence of
the staff as well as the policies, procedures and practices on rewards that emphasize the
importance of impartiality, the potential risks posed by diverse circumstances that the
personnel in the laboratory that can cope, and the need for laboratory personnel to evaluate
their impartiality in relation to a specific client, after considering the existing safeguards to
mitigate or eliminate those risks.
3. Nature of safeguards:
Another way to describe safeguards is according to their nature. For example:
a. Preventive safeguards: for example, an induction program for newly hired personnel that
emphasizes the importance of impartiality
b. Safeguards related to the appearance of risks in specific circumstances: for example, the
prohibition of certain labor relations between the family members of the laboratory staff and
the clients of the laboratory;
c. Safeguards whose effect is to prevent infractions of other safeguards by punishing
offenders: for example, a zero-tolerance policy that allows the accreditation entity to
immediately suspend or withdraw accreditation;
d. Absolute prohibition: prohibiting the performance of laboratory activities depending on the
characteristics of the same.
e. The permission of the activity or relationship, but restricting its extension or its form:
preventing the participation of laboratory staff members of a responsible party for which said
personnel has participated in the preparation of a report on the test, sampling, measurement
or calibration done;
f. The permission of the activity or relationship, but requiring other policies or procedures to
eliminate or mitigate the risk: for example, allowing laboratory personnel to provide certain
types of training for a client;
g. The permission of the activity or the relationship but requiring the laboratory personnel to
disclose information about the management of the laboratory, for example, the disclosure of
the management of the laboratory on the nature of all their private relations provided by the
laboratory to the client, and any payment received from such relationships.
4. Management Considerations for Fairness In assessing the impartiality of its staff, the laboratory
may consider the following:
a. Pressures and other factors that could result in, or could reasonably be expected to result in,
biased decisions of laboratory activities: that is, risks to the impartiality of laboratory
personnel;
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b. Safeguards that can reduce or eliminate the effects of those pressures and other factors;
c. The importance of these pressures and other factors and the effectiveness of the safeguards;
d. The possibility that pressures and other factors, after considering the effectiveness of
safeguards, reach a level that compromises, or can be reasonably expected to be
compromised, the ability of laboratory personnel to make unbiased decisions during
laboratory activities.
The laboratory could assess the risk to impartiality by considering the types and significance of the
risks to the impartiality, types and effectiveness of the safeguards. This basic principle describes a
process by which the laboratory could identify and assess the level of risk for impartiality that comes
from diverse activities, relationships or other circumstances.
The level of risk for fairness can be expressed as a point on a continuous line that ranges from "no
risk to impartiality" to "maximum risk to fairness". The laboratory could assess the acceptable level of
risk for fairness. If unacceptable, the laboratory could decide what additional safeguards (including
prohibition) or combination of safeguards could reduce the risk to impartiality to an acceptably low
level of risk.
Table 1 describes a way to determine the acceptable level of risk for fairness.
There is no risk Remote risk for Average risk for High risk for Maximum risk for
to impartiality: It impartiality: impartiality: impartiality: impartiality. It is
is highly unlikely Objectivity is Objectivity may Objectivity is virtually certain
that objectivity is unlikely to be be compromised likely to be that objectivity is
compromised compromised compromised compromised
The laboratory The laboratory The laboratory The laboratory The services
has implemented has implemented has implemented has implemented cannot be
a process to a process to a process to a process to provided
assess the risk assess risk assess risk assess risk
Demonstrate the Demonstrate the Demonstrate the The services
objectivity of the objectivity of the objectivity of the cannot be
laboratory scope of scope of provided
laboratory laboratory
activities activities
Demonstrate the Demonstrate the The services
impartiality of the impartiality of the cannot be
results of the results of the provided
services services
provided provided
Demonstrate the The services
clear separation cannot be
of the different provided
legal entities in
the group that
provides the
services
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Given that there are certain factors in the environment in which the laboratory activities are carried
out (for example, that the test or calibration is paid by the client in all cases) the risk to impartiality
cannot always be completely eliminated. and, therefore, the laboratory always accepts some risk of
objectivity being compromised. However, in the presence of risks for impartiality, the laboratory
should consider that only a very low level of impartiality risk is acceptable.
Some risks to fairness may affect only certain people or groups within the laboratory and the
significance of some risks may be different for different groups or people.
To ensure that the risk to impartiality is at an acceptably low level, the laboratory could identify
individuals or groups affected differently by the risks to impartiality, and the significance of these risks.
Different types of safeguards may be appropriate for different groups and people depending on their
activities.
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