Requisitos de documentação ISO 9001: 2015

Documentation requirements ISO 9001:2015

No HLS, 'informações documentadas' substitui os substantivos 'documentação' e 'registro' usados em

edições anteriores.

A partir do texto, é normalmente evidente quando “informação documentada” se refere a “registros”

como evidência da atividade / processo realizado e quando “informação de documentos” se refere a
como executar uma atividade / processo. Normalmente, a norma refere-se a “deve manter informações
documentadas” quando o significado é como executar uma atividade / processo e “deve reter
informações documentadas” quando o significado é manter evidência da atividade / processo executada.

Estes são os requisitos mínimos de documentação. As próprias organizações podem decidir que precisam
de informações documentadas adicionais.In the HLS ‘Documented information’ replaces both the nouns
‘documentation’ and ‘record’ used in prior editions.

From the text it is normally evident when “documented information” relates to “records” as evidence of
performed activity/process and when “documents information” relates to how to perform an activity/
process. Normally the standard refers to “shall maintain documented information” when the meaning is
how to perform an activity/process and “shall retain documented information” when the meaning is to
keep evidence of performed activity/process.

These are the minimum documentation requirements. Organizations themselves can decide that they
need additional documented information.

Clause Documentation requirement

4.3
(Scope) O escopo do sistema de gestão da qualidade da organização deve estar
disponível e ser mantido como informação documentada. O escopo deve
indicar os tipos de produtos e serviços cobertos e justificar qualquer
requisito desta Norma Internacional que a organização determine que não
seja aplicável ao escopo de seu sistema de gestão da qualidade.
The scope of the organization’s quality management system shall be
available and be maintained as documented information. The scope shall
state the types of products and services covered, and provide justification
for any requirement of this International Standard that the organization
determines is not applicable to the scope of its quality management
system.

4.4
(Sistema de gestão da
qualidade e seus
processosQuality
management system and
its processes)
5.2.2
(Comunicar a política da
qualidadeCommunicating
the quality policy)
4.4.2 Na medida do necessário, a organização deve:
a) manter informações documentadas para apoiar a operação de seus
processos;
b) reter informações documentadas para ter certeza de que os processos
estão sendo executados conforme o planejado.
4.4.2 To the extent necessary, the organization shall:
a) maintain documented information to support the operation of its
processes;
b) retain documented information to have confidence that the processes
are being carried out as planned.
5.2.2 A política da qualidade deve:
a) estar disponível como informação documentada;
b) ser comunicado, compreendido e aplicado dentro da organização;
c) estar disponível para as partes interessadas, conforme apropriado;
5.2.2 The quality policy shall:

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a) be available as documented information;

b) be communicated, understood and applied within the organization;
c) be available to interested parties, as appropriate;

6.2
(Objetivos da qualidade e
planejamento para alcançá-
losQuality objectives and
planning to achieve them)
A organização deve manter informações documentadas sobre os objetivos
da qualidade.
The organization shall maintain documented information on the quality
objectives.

7.1.5.1 A organização deve reter as informações documentadas apropriadas como

(Monitoramento e medição
de recursos -
GeralMonitoring and
measuring resources –
General)
evidência de adequação ao objetivo de monitorar e medir os dispositivos.
The organization shall retain appropriate documented information as
evidence of fitness for purpose of monitoring and measuring devices.

Quando a rastreabilidade da medição é um requisito ou é considerado pela

7.1.5.2 (Rastreabilidade da
mediçãoMeasurement
traceability)
organização uma parte essencial para proporcionar confiança na validade
dos resultados da medição, o equipamento de medição deve ser:
a) calibrado ou verificado, ou ambos, em intervalos especificados, ou antes
do uso, contra padrões de medição rastreáveis a padrões de medição
internacionais ou nacionais; quando não existirem tais padrões, a base
usada para calibração ou verificação será mantida como informação
documentada;
When measurement traceability is a requirement, or is considered by the
organization to be an essential part of providing confidence in the validity
of measurement results, measuring equipment shall be:

a) calibrated or verified, or both, at specified intervals, or prior to use,

against measurement standards traceable to international or national
measurement standards; when no such standards exist, the basis used for
calibration or verification shall be retained as documented information;

7.2
(CompetênciaCompetence) A organização deve:

d) reter as informações documentadas apropriadas como evidência de

competência.
The organization shall:

d) retain appropriate documented information as evidence of

competence.

7.5.1 O sistema de gestão da qualidade da organização deve incluir:

(Informações
documentadas - a) informações documentadas exigidas por esta Norma Internacional;
GeralDocumented
information - General) b) informações documentadas determinadas pela organização como
necessárias para a eficácia do sistema de gestão da qualidade.

NOTA A extensão das informações documentadas para um sistema de

gerenciamento da qualidade pode diferir de uma organização para outra
devido a:

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8.1
(Planejamento e controle
operacionalOperational
planning and control)
8.2.3
(Revisão de requisitos para
produtos e serviçosReview
of requirements for
products and services)
8.3.2
(Planejamento de design e
desenvolvimentoDesign
and development planning)
Requisitos de documentação ISO 9001: 2015 Updated October 1st 2015
- o tamanho da organização e seu tipo de atividades, processos, produtos
e serviços;
- a complexidade dos processos e suas interações;
- a competência das pessoas.
The organization’s quality management system shall include:
a) documented information required by this International Standard;
b) documented information determined by the organization as being
necessary for the effectiveness of the quality management system.
NOTE The extent of documented information for a quality management
system can differ from one organization to another due to:
- the size of organization and its type of activities, processes,
products and services;
- the complexity of processes and their interactions;
- the competence of persons.
e) determinar, manter e reter informações documentadas na extensão
necessária
1) ter confiança de que os processos foram realizados conforme o
planejado;
e) 2) demonstrar conformidade de produtos e serviços com seus
requisitos.determining, maintaining and retaining documented
information to the extent necessary
1) to have confidence that the processes have been carried out as
planned;
2) to demonstrate conformity of products and services to their
requirements.
8.2.3.2 A organização deve reter informações documentadas,
conforme aplicável:
a) nos resultados da revisão;
b) em quaisquer novos requisitos para os produtos e
serviços.8.2.3.2 The organization shall retain documented
information, as applicable:
on the results of the review;
on any new requirements for the products and services.
Ao determinar os estágios e controles de design e desenvolvimento, a
organização deve considerar:
j) as informações documentadas necessárias para demonstrar que os
requisitos de design e desenvolvimento foram atendidos.
In determining the stages and controls for design and development, the
organization shall consider:
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8.3.3
(Entradas de design e
desenvolvimentoDesign
and development inputs)
8.3.4
(Controle de projeto e
desenvolvimentoDesign
and development control)
8.3.5
(Saída de design e
desenvolvimentoDesign
and development output)
8.3.6
(Alterações de design e
desenvolvimentoDesign
and development changes)
8.4
(Controle de produtos e
serviços externos
fornecidos -
8.4.1 GeralControl of
external provided products
and services -
8.4.1 General)
8.5.1
(Controle de produção e
prestação de
serviçosControl of
production and service
provision)
Requisitos de documentação ISO 9001: 2015 Updated October 1st 2015
j) the documented information needed to demonstrate that design
and development requirements have been met.
A organização deve reter informações documentadas sobre entradas de
design e desenvolvimento.
The organization shall retain documented information on design and
development inputs.
A organização deve aplicar controles ao processo de design e
desenvolvimento para garantir que:
f) informações documentadas dessas atividades são mantidas
The organization shall apply controls to the design and development
process to ensure that:
f) documented information of these activities is retained
A organização deve reter informações documentadas sobre os resultados
do projeto e desenvolvimento.
The organization shall retain documented information on the design and
development outputs.
A organização deve reter informações documentadas sobre:
a) mudanças de design e desenvolvimento;
b) os resultados das revisões;
c) a autorização das alterações;
The organization shall retain documented information on:
a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse impacts.
A organização deve reter informações documentadas dos resultados
dessas atividades e de quaisquer ações necessárias decorrentes das
avaliações.The organization shall retain documented information of the
results of these activities and any necessary actions arising from the
evaluations.
As condições controladas devem incluir, conforme aplicável:
a) a disponibilidade de informações documentadas que definem:
1) as características dos produtos a serem produzidos, os serviços a serem
prestados ou as atividades a serem executadas;
2) os resultados a serem alcançados;
Controlled conditions shall include, as applicable:
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8.5.2 (identificação e
rastreabilidadeIdentificatio
n and traceability)
8.5.3
(Propriedade pertencente a
clientes ou fornecedores
externosProperty belonging
to customers or external
providers)
8.5.6
(Controle de
mudançasControl of
changes)
8.6
(Liberação de bens e
serviçosRelease of goods
and services)
8.7.2
(Controle de saídas não
conformesControl of
nonconforming outputs)
Requisitos de documentação ISO 9001: 2015 Updated October 1st 2015
a) the availability of documented information that defines:
1) the characteristics of the products to be produced, the
services to be provided, or the activities to be performed;
2) the results to be achieved;
A organização deve controlar a identificação exclusiva dos resultados
quando a rastreabilidade é um requisito e reter as informações
documentadas necessárias para permitir a rastreabilidade.
The organization shall control the unique identification of the outputs when
traceability is a requirement, and shall retain the documented information
necessary to enable traceability.
Quando a propriedade de um cliente ou fornecedor externo for perdida,
danificada ou considerada inadequada para uso, a organização deve
relatar isso ao cliente ou fornecedor externo e reter informações
documentadas sobre o que ocorreu.
When the property of a customer or external provider is lost, damaged or
otherwise found to be unsuitable for use, the organization shall report this
to the customer or external provider and retain documented information
on what has occurred.
A organização deve reter informações documentadas que descrevem os
resultados da revisão das alterações, a (s) pessoa (s) que a autorizou e
quaisquer ações necessárias decorrentes da revisão.
The organization shall retain documented information describing the
results of the review of changes, the person(s) authorizing the change,
and any necessary actions arising from the review.
A organização deve reter informações documentadas sobre o lançamento
de produtos e serviços. As informações documentadas devem incluir:
a) evidência de conformidade com os critérios de aceitação;
b) rastreabilidade para a pessoa que autoriza a liberação.
The organization shall retain documented information on the release of
products and services. The documented information shall include:
a) evidence of conformity with the acceptance criteria;
b) traceability to the person(s) authorizing the release.
A organização deve reter informações documentadas que:
a) descreve a não conformidade;
b) descreve as ações tomadas;
c) descreve quaisquer concessões obtidas;
d) identifica a autoridade que decide a ação em relação à não
conformidade.
The organization shall retain documented information that:
describes the nonconformity;
describes the actions taken;
describes any concessions obtained;
identifies the authority deciding the action in respect of the
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nonconformity.

9.1
(Monitoramento, medição, A organização deve reter as informações documentadas apropriadas como
análise e avaliação -9.1.1 evidência dos resultados.The organization shall retain appropriate
GeralMonitoring, documented information as evidence of the results.
measurement, analysis and
evaluation -9.1.1 General)

9.2 9.2.2 A organização deve:

(Auditoria internaInternal
Audit) f) reter informações documentadas como evidência da implementação do
programa de auditoria e dos resultados da auditoria.
9.2.2 The organization shall:

f) retain documented information as evidence of the implementation

of the audit programme and the audit results.

9.3.3 (Revisão de A organização deve reter informações documentadas como evidência dos
gerenciamentoManagement resultados das análises críticas pela gerência.The organization shall retain
review) documented information as evidence of the results of management
reviews.

10.2 (Não conformidade e

ação 10.2.2 A organização deve reter informações documentadas como
corretivaNonconformity evidência de:
and corrective action)
a) a natureza das não-conformidades e quaisquer ações
subsequentes tomadas;
b) os resultados de qualquer ação corretiva.
10.2.2 The organization shall retain documented information as
evidence of:

the nature of the nonconformities and any subsequent actions

taken;

the results of any corrective action.

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Furthermore, the new standard in several places uses the wording “shall determine”. What does this
mean? Annex A.3 of ISO 14001:2015 explains “The change from “identify” to “determine” is intended to
harmonize wih the standardized management system terminology. The word “determine” implies a
discovery process that results in knowledge.”
There is no explicit “documentation” requirement, but where “determine” is used the organization
should at least be able to demonstrate and give confidence of completeness and control of such
activities/processes.

4.1
(Understanding
the organization The organization shall determine external and internal issues that are relevant to its
and its context) purpose and its strategic direction and that affect its ability to achieve the intended
result(s) of its quality management system.

4.2
(Understanding Due to their impact or potential impact on the organisation’s ability to consistently
the needs and provide products and services that meet customer and applicable statutory and
expectations of regulatory requirements, the organization shall determine:
interested
parties) the interested parties that are relevant to the quality management system;

the requirements of these interested parties that are relevant to the quality
management system.

4.3
(Scope) The organization shall determine the boundaries and applicability of the quality
management system to establish its scope.

4.4
(Quality The organization shall determine the processes needed for the quality management
management system and their application throughout the organization and shall:
system and its
processes) determine the inputs required and the outputs expected from these processes;

determine the sequence and interaction of these processes;

determine and apply the criteriaand methods (including monitoring, measurements

and related performance indicators) needed to ensure the effective operation and
control of these processes;

determine the resources needed and ensure their availability;

assign the responsibilities and authorities for these processes;

address the risks and opportunities as determined in accordance with the

requirements of 6.1;

evaluate these processes and any needed to ensure that these processes achieve
their intended results;

improve the processes and the quality management system.

6.1
(Actions to 6.1.1 When planning for the quality management system, the organization shall
address risks consider the issues referred to in 4.1 and the requirements referred to in 4.2 and
and determine the risks and opportunities that need to be addressed to:
opportunities)
give assurance that the quality management system can achieve its intended
result(s);
enhance desirable effects;

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prevent, or reduce, undesired effects;

achieve improvement.

6.2
(Quality 6.2.2 When planning how to achieve its quality objectives, the organization shall
objectives and determine:
planning to
achieve them) what will be done,

what resources will be required,

who will be responsible,

when it will be completed, and

how the results will be evaluated.

7.1
(Resources - The organization shall determine and provide the resources needed for the
7.1.1 General) establishment, implementation, maintenance and continual improvement of the
quality management system.

7.1.2
(People) The organization shall determine and provide the persons necessary for the effective
implementation of its quality management system and for the operation and control
of its processes.

7.1.3
(Infrastructure) The organization shall determine, provide and maintain the infrastructure necessary
for the operation of its processes to achieve conformity of products and services.

7.1.4
(Environment for The organization shall determine, provide and maintain the environment necessary
the operation of for the operation of its processes and to achieve conformity of products and services.
processes)

7.1.5
(Monitoring and The organization shall determine and provide the resources needed to ensure valid
measuring and reliable results when monitoring or measuring is used to verify the conformity of
resources) products and services to requirements.

The organization shall determine if the validity of previous measurement results have
been adversely affected when measuring equipment is found to be unfit for its
intended purpose and shall take appropriate action as necessary.

7.1.6
(Organisational The organization shall determine the knowledge necessary for the operation of its
knowledge) processes and to chief conformity of products and services.

When addressing changing needs and trends, the organization shall consider its
current knowledge and determine how to acquire or access any necessary additional
knowledge and required updates.

7.2
(Competence) The organization shall:

determine the necessary competence of person(s) doing work under its control that
affects the performance and effectiveness of the quality management system;

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7.4 The organization shall determine the internal and external communications relevant
(Communication) to the quality management system including:

on what it will communicate,

when to communicate,

with whom to communicate,

how to communicate

who communicates.

8.3.3
(Design and The organization shall determine requirements essential for the specific type of
development products and services being designed and developed. The organization shall
inputs) consider:

functional and performance requirements;

information derived from previous similar design and development activities;

statutory and regulatory requirements;

standards or codes of practice that the organization has committed to implement;

potential consequences of failure due to the nature of the products and services.

8.4
Control of The organization shall determine the controls to be applied to externally provided
externally processes, products and services when:
provided
processes, products and services from external providers are intended for incorporation into the
products and organization’s own products and services;
services - products and services are provided directly to the customer(s) by external providers
8.4.1 General) on behalf of the organization;
a process, or part of a process, is provided by an external provider as a result of a
decision by the organization.

The organization shall determine and apply criteria for the evaluation, selection,
monitoring of performance, and re-evaluation of external providers, based on their
ability to provide processes or products and services in accordance with
requirements.

8.4.2
(Type and extent The organization shall:
of control)
determine the verification, or other activities, necessary to ensure that the externally
provided processes, products and services meet requirements.

9.1
(Monitoring, The organization shall determine:
measurement,
analysis and what needs to be monitored and measured;
evaluation -
9.1.1 General) the methods for monitoring, measurement, analysis and evaluation needed to ensure
valid results;

when the monitoring and measuring shall be performed;

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when the results from monitoring and measurement shall be analysed and evaluated.

9.1.2
(Customer The organization shall monitor customers’ perceptions of the degree to which their
satisfaction) needs and expectations have been fulfilled. The organization shall determine the
methods for obtaining, monitoring and reviewing this information.

10
(Improvement - The organization shall determine and select opportunities for improvement and
10.1 General) implement necessary actions to meet customer requirements and enhance customer
satisfaction.

Requisitos de documentação ISO 9001: 2015 Updated October 1st 2015