Matrice de Conformite - Norme API q1

Instructions
Company: PleaseprovideaTier1(QualityManual)referenceand/oraTier2(Procedure/WorkInstruction)referencewhereeachrequirementhasbeenaddressedinyourQuality
ManagementSystemDocumentation.IfyouareapplyingforexclusionstoyourQMS,pleaseindicateExcludedintheTier1/Tier2boxesforeachrequirementbeing
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Reference:APISpecQ19thEd NOTE:AreasshadedinbluearenewAPISpecQ19thEditionrequirements.
Paragraph ISO9001:2008 Reference Requirement Tier1(QualityManual) Tier2(Procedure/WorkInstruction) Tier3(Procedure/WorkInstruction)
Number Reference DocumentNumber/ID,RevisionLevel, DocumentNumber/ID,RevisionLevel, DocumentNumber/ID,RevisionLevel,
DocumentDescription DocumentDescription DocumentDescription
4 QualityManagementSystemRequirements
4,1 QualityManagementSystem
4.1.1 4.1;4.1c;7.1; General Theorganizationshallestablish,document,implement,and
8.5.1 maintainatalltimesaqualitymanagementsystemforall
productsandservicingprovidedforuseinthepetroleumand
naturalgasindustry.Theorganizationshallmeasurethe
effectivenessandimproveuponthequalitymanagementsystem
inaccordancewiththerequirementsofthisspecification.
4.1.2 5.1b;5.3a;5.3b; QualityPolicy Theorganizationspolicyforitscommitmenttoqualityshallbe

5.3c;5.3d defined,documented,andapprovedbytopmanagement.The
organizationstopmanagementshallreviewthequalitypolicyto
ensurethatitisappropriatetotheorganization,isthebasisfor
thedevelopmentofqualityobjectives(see4.1.3),andis
communicated,understood,implemented,andmaintainedatall
relevantfunctionsandlevelswithintheorganization.Thepolicy
shallincludeacommitmenttocomplywithrequirementsand
continuallyimprovetheeffectivenessofthequalitymanagement
system.
4.1.3 5.1c;5.4.1;7.1a QualityObjectives Management,withapprovalfromtopmanagement,shallensure

thatqualityobjectives,includingthoseneededtomeetproduct
andcustomerrequirements,areestablishedatrelevantfunctions
andlevelswithintheorganization.Thequalityobjectivesshallbe
measurableandconsistentwiththequalitypolicy.
4.1.4 4.1a;7.1 Planning Managementshallensurethat:

a)criteriaandmethodsneededfortheoperationandcontrolof
allqualitymanagementsystemprocessesaredetermined,
managed,andeffective;and
5.4.2a b)planningofthequalitymanagementsystemiscarriedoutin
ordertomeettherequirementsofthisspecification.
4.1.5 Communication
APISpecQ19thEditionConformityMatrix Page1of30 FM186Rev2Effective7/16/2013

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4.1.5.1 5.5.3 Internal Managementshallensurethatappropriatecommunication

processesareestablishedwithintheorganizationandthe
effectivenessofthequalitymanagementsystemis
communicated.
5.1a Theorganizationshallestablishprocessestoensurethat:
a)importanceofmeetingcustomer,legal,andotherapplicable
requirementsiscommunicatedatrelevantfunctionswithinthe
organization;and
NRin9001* b)resultsofanalysisofdata(see6.3)arecommunicatedat
relevantlevelsandfunctionswithintheorganization.
4.1.5.2 5.2;7.2.3 External Theorganizationshalldetermineandimplementaprocessfor
communicatingwithexternalorganizations,includingcustomers,
toensurerequirementsareunderstoodthroughoutcontract
executionandproductrealization.Thecommunicationprocess
shalladdress:
7.2.3b a)executionofinquiries,contracts,ororderhandlingand
amendments(see5.1);
7.2.3a b)provisionofproductinformation,includingproduct
nonconformitiesidentifiedafterdeliverytothecustomer(see
5.10.4);
7.2.3c c)feedbackandcustomercomplaints(see6.2.1);and
NRin9001* d)whenrequiredbycontract,providinginformationrequiredby
productqualityplansandsubsequentchangestothoseplans(see
5.7.2).
4,2 ManagementResponsibility
4.2.1 4.1d;5.1;5.1e General Topmanagementshallensuretheavailabilityofresources
essentialtoestablish,implement,maintain,andimprovethe
qualitymanagementsystem.
Managementshallprovideevidenceofitscommitmenttothe
developmentandimplementationofthequalitymanagement
systemandcontinuallyimproveitseffectivenessby:
5.1c a)ensuringthatqualityobjectivesareestablishedincludingkey
performanceindicatorsforuseindataanalysis;and
5.1d b)conductingmanagementreviews(see6.5).

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4.2.2 5.5.1 Responsibilityand Responsibilities,authorities,andaccountabilitiesofpersonnel

Authority withinthescopeofthisdocumentshallbedefined,documented,
andcommunicatedthroughouttheorganization.
4,23 5.5.2 Management Topmanagementshallappointandmaintainamemberofthe

Representative organizationsmanagementwho,irrespectiveofother
responsibilities,shallhaveresponsibilityandauthoritythat
includes:
5.5.2a a)ensuringthatprocessesneededforthequalitymanagement
systemareestablished,implemented,andmaintained,
5.5.2b b)reportingtotopmanagementontheperformanceofthe
qualitymanagementsystemandanyneedforimprovement;
NRin9001* c)ensuringinitiationofaction(s)tominimizethelikelihoodofthe
occurrenceofnonconformities(see6.4.3);and
5.5.2c d)ensuringthepromotionofawarenessofcustomer
requirementsthroughouttheorganization.
4,3 OrganizationCapability
4.3.1 6.1;7.1b ProvisionofResources Theorganizationshalldetermineandallocatetheresources
neededtoimplement,maintain,andimprovetheeffectivenessof
theelementsofthequalitymanagementsystem.
4.3.2 HumanResources
4.3.2.1 6.2.2a;6.2.2b; General Theorganizationshallmaintainadocumentedprocedurefor
6.2.2c definingpersonnelcompetencyandidentifyingtraining
requirementsorotheractionstoachievethenecessary
competencyofpersonnelwhoseresponsibilitiesfallwithinthe
scopeofthequalitymanagementsystem.Theprocedureshall
includeprovisionsfordetermininganddocumentingthe
effectivenessofthetrainingorotheractionstakentowardthe
achievementofrequiredcompetency.
4.3.2.2 6.2.1 PersonnelCompetence Personnelshallbecompetentbasedontheappropriate

education,training,skills,andexperienceneededtomeet
productandcustomerrequirements.

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NRin9001* Evidenceofthedeterminationofcompetenceofpersonnelshall
berecordedandmaintained(see4.5).
4.3.2.3 6.2.2 Trainingand Theorganizationshall:

NRin9001* Awareness a)provideforqualitymanagementsystemtrainingandjob
NRin9001* i i
b)ensurethatcustomerspecifiedtrainingand/orcustomer
providedtraining,whenrequired,isincludedinthetraining
program;
NRin9001* c)ensurethatthefrequencyandcontentoftrainingisidentified;
6.2.2d d)ensurethatitspersonnelareawareoftherelevanceand
importanceoftheiractivitiesandhowtheycontributetothe
achievementofthequalityobjectives;and
6.2.2e e)maintainappropriaterecordsofeducation,training,skills,and
experience(see4.5).
4.3.3 6.3;6.4 WorkEnvironment Theorganizationshalldetermine,provide,manage,andmaintain
theworkenvironmentneededtoachieveconformityapplicable
tothemanufactureoftheproduct.Workenvironmentshall
include:
6.3a a)buildings,workspace,andassociatedutilities;
6.3b b)processequipmentanditsmaintenance(bothhardwareand
software)(see5.7.8);
6.3c c)supportingservices(e.g.transport,communication,
informationsystems);and
6,4 d)conditionsunderwhichworkisperformedsuchasphysical,
environmentalorotherfactors.
4,4 DocumentRequirements
4.4.1 4.2.1 General Thequalitymanagementsystemdocumentationshallinclude:
4.2.1a a)statementsofqualitypolicyandqualityobjectives;
4.2.1b b)aqualitymanualthataddresseseachrequirementofthis
specificationandincludes:

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4.2.2a 1)thescopeofthequalitymanagementsystem,including
justificationforanyexclusionstospecificqualitymanagement
systemelements(seeSection1);
4.1b;4.2.2c 2)adescriptionofthesequenceandinteractionbetweenthe
processesofthequalitymanagementsystem;
NRin9001* 3)identificationofprocessesthatrequirevalidation(see5.7.1.5);
and
4.2.2b 4)referencetodocumentedproceduresthatcontrolthequality
managementsystemprocesses;
4.2.1c c)documentedproceduresestablishedforthequality
managementsystem;
4.2.1d;7.1b d)documentsandrecords,toensuretheeffectiveplanning,
operationandcontrolofitsprocesses,andcompliancewith
specifiedrequirements;and
NRin9001* e)identificationoflegal,andotherapplicablerequirementsto
whichtheorganizationclaimscompliancewhichareneededto
achieveproductconformity.
4.4.2 NRin9001* Procedures Allproceduresreferencedwithinthisspecificationshallbe
established,documented,implemented,andmaintainedfor
continuedsuitability.
4.4.3 4.2.3 ControlofDocuments Theorganizationshallmaintainadocumentedprocedureforthe
identification,distribution,andcontrolofdocumentsrequiredby
thequalitymanagementsystemandthisspecification,including
requireddocumentsofanoriginexternaltotheorganization.
4.2.3a;4.2.3b Theprocedureshallspecifyresponsibilitiesforapprovalandre
approvalandshallidentifythecontrolsneededtoensurethatthe
documentsrequiredbythequalitymanagementsystem,
includingrevisions,translationsandupdates:
4.2.3a;4.2.3b a)arereviewedandapprovedforadequacypriortoissueand
use,
4.2.3c b)identifychangesandrevisionstatus,
4.2.3e c)remainlegibleandreadilyidentifiable,and
4.2.3d d)areavailablewheretheactivityisbeingperformed.

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4.2.3f Documentsofexternaloriginshallbecontrolledtoensurethat
therelevantversionsareusedandmaintained.
4.2.3g Obsoletedocumentsshallberemovedfromallpointsofissueor
use,orotherwiseidentifiedtoensureagainstunintendeduseif
theyareretainedforanypurpose.
NRin9001* Procedures,workinstructionsandformsrequiredbythequality
managementsystemshallbecontrolled.
4.4.4 NRin9001* UseofExternal WhenAPIproductorotherexternalspecificationrequirements,
DocumentsinProduct includingaddenda,errata,andupdates,areusedinthedesignor
Realization manufactureoftheproduct,theorganizationshallmaintaina
documentedprocedurefortheintegrationoftheserequirements
intotheproductrealizationprocessandanyotheraffected
processes.
4,5 4.2.3;4.2.4 ControlofRecords Theorganizationshallmaintainadocumentedprocedureto
identifythecontrolsandresponsibilitiesneededforthe
identification,collection,storage,protection,retrieval,retention
time,anddispositionofrecords.
NRin9001* Records,includingthoseoriginatingfromoutsourcedactivities
(see5.6.1.6),shallbeestablishedandcontrolledtoprovide
evidenceofconformitytorequirementsandtheorganization's
qualitymanagementsystem.
4.2.4 Recordsshallremainlegible,identifiable,andretrievable.Records
shallberetainedforaminimumoffiveyearsorasrequiredby
customer,legal,andotherapplicablerequirements,whicheveris
longer.
5 ProductRealization
5,1 ContractReview
5.1.1 NRin9001* General Theorganizationshallmaintainadocumentedprocedureforthe
reviewofrequirementsrelatedtotheprovisionofproductsand
requiredservicing.
5.1.2 7.2.1 Determinationof Theorganizationshalldetermine:
7.2.1a Requirements a)requirementsspecifiedbythecustomer;
7.2.1c;7.2.1d b)legalandotherapplicablerequirements;and

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7.2.1b;7.2.2 c)requirementsnotstatedbythecustomerbutconsidered
necessarybytheorganizationfortheprovisionoftheproduct.
7.2.2 Wherethecustomerprovidesnodocumentedstatementofthe
requirements,thecustomerrequirementsshallbeconfirmedby
theorganizationandrecordsmaintained(see4.5).
5.1.3 7.2.2 Reviewof Theorganizationshallreviewtherequirementsrelatedto

Requirements provisionofproducts.Thisreviewshallbeconductedpriortothe
organizationscommitmenttodeliverproducttothecustomer
andshallensurethat:
7.2.2a a)requirementsareidentifiedanddocumented;
7.2.2b b)requirementsdifferingfromthosepreviouslyidentifiedare
resolved;and
7.2.2c c)theorganizationhasthecapabilitytomeetthedocumented
requirements.
7.2.2 Wherecontractrequirementsarechanged,theorganizationshall
ensurethatrelevantdocumentsareamendedandthatrelevant
personnelaremadeawareofthechangedrequirements.
7.2.2 Recordsoftheresultsofthereview,includingresultingactions,
shallbemaintained(see4.5).
5,2 7,1 Planning Theorganizationshallidentifyandplantheprocessesand
documentsneededforproductrealization.Planningofproduct
realizationshallbeconsistentwiththerequirementsoftheother
processesofthequalitymanagementsystem(see4.1.4).
7,1 Inplanning,theorganizationshalladdressthefollowing:
7.1b a)requiredresourcesandworkenvironmentmanagement(see
4.3);
7.1b b)productandcustomerspecifiedrequirements(see5.1);
NRin9001* c)legalandotherapplicablerequirements;
NRin9001* d)contingenciesbasedonriskassessment(see5.3and5.5);
7.1a e)designanddevelopmentrequirements(see5.4);

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7.1c f)requiredverification,validation,monitoring,measurement,
inspection,andtestactivitiesspecifictotheproductandthe
criteriaforproductacceptance;and
NRin9001* g)managementofchange(MOC)(see5.11);and
7.1d h)recordsneededtoprovideevidencethattheproduct
realizationprocessesmeetrequirements(see4.5).
NRin9001* Theoutputofplanningshallbedocumentedandupdatedas
changesoccur.
7,1 Theplansshallbemaintainedinastructuresuitableforthe
organizationsmethodofoperations.
5,3 NRin9001* RiskAssessmentand Theorganizationshallmaintainadocumentedprocedureto
Management identifyandcontrolriskassociatedwithimpactondeliveryand
qualityofproduct.Theprocedureshallidentifythetechniques,
toolsandtheirapplicationforriskidentification,assessment,and
mitigation.
NRin9001* Riskassessmentassociatedwithproductdeliveryshallinclude:
NRin9001* a)facility/equipmentavailabilityandmaintenance;and
NRin9001* b)supplierperformanceandmaterialavailability/supply.
NRin9001* Riskassessmentassociatedwithproductqualityshallinclude,as
applicable:
NRin9001* c)deliveryofnonconformingproduct(see5.10.1e);
NRin9001* d)availabilityofcompetentpersonnel.
NRin9001* Recordsofriskassessmentandmanagementincludingactions
takenshallbemaintained(see4.5).
5,4 DesignandDevelopment
5.4.1 NRin9001* Designand Theorganizationshallmaintainadocumentedproceduretoplan
DevelopmentPlanning andcontrolthedesignanddevelopmentoftheproduct.
7.3.1 Theprocedureshallidentify:
7.3.1 a)theplan(s),includingplanupdates,usedfordesign
development;
7.3.1a b)thedesignanddevelopmentstages;
7.3.1;7.3.1c c)theresources,responsibilities,authorities,andtheirinterfaces
toensureeffectivecommunication;

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7.3.1b d)thereview,verification,andvalidationactivitiesnecessaryto
completeeachdesignanddevelopmentstage;and
NRin9001* e)therequirementsforafinalreviewofthedesign(see5.4.5).
NRin9001* Whendesignanddevelopmentactivitiesareperformedat
differentlocationswithinthesameorganization,theprocedure
shallidentifythecontrolsrequiredtoensurethatthedesigns
meettherequirementsof5.4.
NRin9001* Whendesignanddevelopmentareoutsourced,theorganization
shallensurethesuppliermeetstherequirementsof5.6.1.6.
5.4.2 7.3.2 Designand Inputsshallbeidentifiedandreviewedforadequacy,

DevelopmentInputs completeness,andlackofconflict.
7.3.2a;7.3.2d Inputsshallincludefunctionalandtechnicalrequirements,and
thefollowing,asapplicable:
NRin9001* a)customerspecifiedrequirements(see5.1);
7.3.2d b)requirementsprovidedfromexternalsources,includingAPI
productspecifications;
7.3.2d c)environmentalandoperationalconditions;
NRin9001* d)methodology,assumptions,andformulaedocumentation;
7.3.2c e)historicalperformanceandotherinformationderivedfrom
previoussimilardesigns;
7.3.2b f)legalrequirements;and
NRin9001* g)resultsfromriskassessments(see5.3).
NRin9001* Recordsofdesigninputsshallbemaintained(see4.5).
5.4.3 7.3.3 Designand Outputsshallbedocumentedtoallowverificationagainstthe
DevelopmentOutputs designanddevelopmentinputrequirements.
7.3.3 Outputsshall:
7.3.3a a)meettheinputrequirementsfordesignanddevelopment;
7.3.3b b)provideappropriateinformationforpurchasing,production,
andservicing;
7.3.3c c)identifyorreferencedesignacceptancecriteria(DAC);

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NRin9001* d)includeidentificationof,orreferenceto,productsand/or
componentsdeemedcriticaltothedesign;
NRin9001* e)includeresultsofapplicablecalculations;and
7.3.3d f)specifythecharacteristicsoftheproductthatareessentialfor
itssafeandproperuse.
NRin9001* Recordsofdesignoutputsshallbemaintained(see4.5).
5.4.4 7.3.4 Designand Atsuitablestages,review(s)shallbeperformed:
7.3.4a DevelopmentReview a)toevaluatethesuitability,adequacy,andeffectivenessofthe
resultsofdesignanddevelopmentstagestomeetspecified
requirements;and
7.3.4b b)toidentifyanyproblemsandproposenecessaryactions.
7.3.4 Participantsinsuchreview(s)shallincluderepresentativesof
functionsconcernedwiththedesignanddevelopmentstage(s)
beingreviewed.
7.3.4 Recordsoftheresultsofthereview(s)andanynecessaryactions
5.4.5 7.3.5 Designand Toensurethatthedesignanddevelopmentoutputshavemetthe
Development designanddevelopmentinputrequirements,designand
VerificationandFinal developmentverificationandafinalreviewshallbeconducted
Review anddocumentedinaccordancewithplannedarrangements(see
5.4.1).
7.3.4;7.3.5 Recordsofdesignanddevelopmentverificationandthefinal
designreviewshallbemaintained(see4.5).
5.4.6 7.3.6 Designand Designanddevelopmentvalidationshallbeperformedin
Development accordancewithplannedarrangements(see5.4.1)toensurethat
Validationand theresultingproductiscapableofmeetingthespecified
Approval requirements.
7.3.6 Validationshallbecompletedpriortothedeliveryoftheproduct,
whenpossible.
NRin9001* Thecompleteddesignshallbeapprovedaftervalidation.
NRin9001* Competent(see4.3.2.2)individual(s)otherthanthepersonor
personswhodevelopedthedesignshallapprovethefinaldesign.

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7.3.6 Recordsofthedesignanddevelopmentvalidation,approval,and
anynecessaryactionsshallbemaintained(see4.5).
5.4.7 7.3.7 Designand Designanddevelopmentchangesshallbeidentified.Thechanges

DevelopmentChanges shallbereviewed,verifiedandvalidated,asappropriate,and
approvedbeforeimplementation.
7.3.7 Thereviewofdesignanddevelopmentchangesshallinclude
evaluationoftheeffectofthechangesonproductand/ortheir
constituentpartsalreadydelivered.
NRin9001* Designanddevelopmentchangesincludingchangestodesign
documents,shallrequirethesamecontrolsastheoriginaldesign
anddevelopment.
7.3.7 Recordsofdesignanddevelopmentchanges,reviewsofthose
changesandanynecessaryactionsshallbemaintained(see4.5).
5,5 Contingencyplanning
5.5.1 NRin9001* General Theorganizationshallmaintainadocumentedprocedurefor
contingencyplanningneededtoaddressriskassociatedwith
impactondeliveryandqualityofproduct.
NRin9001* Contingencyplanningshallbebasedonassessedrisks(see5.3)
andoutputshallbedocumentedandcommunicatedtothe
relevantpersonnel,andupdatedasrequired.
5.5.2 NRin9001* PlanningOutput Thecontingencyplanshallinclude,ataminimum:

NRin9001* a)actionsrequiredinresponsetosignificantriskscenariosto
mitigateeffectsofdisruptiveincidents;
NRin9001* b)identificationandassignmentofresponsibilitiesand
authorities;and
NRin9001* c)internalandexternalcommunicationcontrols(see4.1.5).
5,6 Purchasing
5.6.1 PurchaseControl
5.6.1.1 4.1;7.4.1 Procedure Theorganizationshallmaintainadocumentedprocedureto
ensurethatpurchasedproductsoroutsourcedactivitiesconform
tospecifiedrequirements.
Theprocedureshalladdress:

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NRin9001* a)determinationofthecriticalityoftheactivitiesorproductsas
theyareapplicabletoconformancetoproductorcustomer
specifications;
7.4.1 b)initialevaluationandselectionofsuppliersbasedontheir
abilitytosupplyproductsoractivitiesinaccordancewiththe
organizationsrequirements(see5.6.1.2and5.6.1.3);
NRin9001* c)typeandextentofcontrolappliedtothesupplierbasedonthe
criticalityoftheproductoractivity;
7.4.1 d)criteria,scope,frequency,andmethodsforreassessmentof
suppliers;
NRin9001* e)maintainingalistofapprovedsuppliersandscopeofapproval;
and
4,1 f)typeandextentofcontroltobeappliedtooutsourcedactivities
(see5.6.1.6).
5.6.1.2 NRin9001* InitialSupplier Forpurchaseofcriticalproducts,components,oractivities,the
EvaluationCritical criteriafortheinitialevaluationofsuppliersbytheorganization
Purchases shallbesitespecificforeachsupplierandshallincludethe
following:
NRin9001* a)verificationthatthesuppliersqualitymanagementsystem
conformstothequalitysystemrequirementsspecifiedfor
suppliersbytheorganization;and
NRin9001* b)assessmentofthesuppliertoensureitscapabilitytomeetthe
organizationspurchasingrequirementsby:
NRin9001* i.performinganonsiteevaluationofrelevantactivities;or
NRin9001* ii.performingfirstarticleinspectiontoensureconformanceto
statedrequirements;or
NRin9001* iii.Identifyinghowthesuppliedproductconformstostated
requirementswhenlimitedbyproprietary,legaland/or
contractualarrangements.
5.6.1.3 NRin9001* InitialSupplier Forpurchaseofnoncriticalproducts,components,oractivities
EvaluationNoncritical thatimpactproductrealizationorthefinalproduct,thecriteria
Purchases forevaluationofsuppliersbytheorganizationshallmeetthe
requirementsof5.6.1.2orsatisfyoneormoreofthefollowing:

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NRin9001* a)verificationthatthesuppliersqualitymanagementsystem
conformstothequalitysystemrequirementsspecifiedfor
suppliersbytheorganization;or
NRin9001* b)assessmentofthesuppliertomeettheorganizations
purchasingrequirements;or
NRin9001* c)assessmentoftheproductupondeliveryoractivityupon
completion.
5.6.1.4 NRin9001* SupplierReevaluation Forreevaluationofallsuppliers(criticalandnoncritical),the
requirementsof5.6.1.3shallapply.
5.6.1.5 7.4.1 SupplierEvaluation Recordsoftheresultsofallevaluationsandanynecessaryactions
Records arisingfromtheevaluationsshallbemaintained(see4.5).
5.6.1.6 4,1 Outsourcing Whereanorganizationchoosestooutsourceanyactivitywithin

thescopeofitsqualitymanagementsystem,theorganization
shallensurethatallapplicableelementsofitsquality
managementsystemaresatisfiedandshallmaintain
responsibilityforproductconformancetospecifiedrequirements,
includingapplicableAPIproductspecifications,associatedwith
productrealization.
NRin9001* Recordsofoutsourcedactivitiesshallbemaintained(see4.5).
5.6.2 7.4.2 PurchasingInformation Theorganizationshallensuretheadequacyofspecified

purchasinginformationpriortotheircommunicationtothe
supplier.
7.4.2 Purchasinginformationprovidedtothesuppliershallbe
documentedandadequatelydescribetheproductoractivityto
bepurchased,
7.4.2a includingacceptancecriteria,andwhereappropriate:
7.4.2a a)requirementsforapprovalofsuppliersprocedures,processes,
andequipment;
NRin9001* b)applicableversionofspecifications,drawings,process
requirements,inspectioninstructions,traceability,andother
relevanttechnicaldata;
7.4.2b c)requirementsforqualificationofsupplierspersonnel;and
7.4.2c d)qualitymanagementsystemrequirements.
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5.6.3 NRin9001* Verificaionof Theorganizationshallmaintainadocumentedprocedureforthe

PurchasedProductsor verificationorotheractivitiesnecessaryforensuringthat
Activities purchasedproductsoractivitiesmeetspecifiedpurchase
requirements.
7.4.3 Wheretheorganizationoritscustomerintendstoperform
verificationatthesupplierspremises,theorganizationshallstate
theintendedverificationarrangementsandmethodofproduct
releaseinthepurchasinginformation.
7.4.3 Theorganizationshallensureandprovideevidencethat
purchasedproductsandactivitiesconformtospecified
requirements.
NRin9001* Theorganizationshallmaintainrecordsofverificationactivities
(see4.5).
5,7 ProductionandServicingProvision
5.7.1 ControlofProductionandServicing
5.7.1.1 NRin9001* Production Theorganizationshallmaintainadocumentedprocedurethat
describescontrolsassociatedwiththeproductionofproducts.
Theprocedureshalladdressthefollowing:
7.5.1a a)theavailabilityofinformationthatdescribesthecharacteristics
oftheproduct;
NRin9001* b)implementationoftheproductqualityplan,whenapplicable
(see5.7.2);
NRin9001* c)ensuringdesignrequirementsandrelatedchangesare
satisfied,whenapplicable(see5.4);
7.5.1c;7.5.1d d)theavailabilityanduseofsuitableproduction,testing,
monitoring,andmeasurementequipment;
7.5.1b e)theavailabilityofworkinstructions,whenapplicable;
NRin9001* f)processcontroldocuments(see5.7.1.3);
7.5.1e g)theimplementationofmonitoringandmeasurementactivities;
and
7.5.1f h)theimplementationofproductrelease(see5.9),including
applicabledeliveryandpostdeliveryactivities.
5.7.1.2 NRin9001* Servicing Theorganizationshallmaintainadocumentedprocedurethat
describescontrolsassociatedwiththeservicing(see3.1.21)of
products.Theprocedureshalladdressthefollowing:

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7.5.1a a)reviewandimplementationoftheorganizations,customer
specific,productservicing,andotherservicingrequirements;
7.5.1c;7.5.1d b)theavailabilityanduseofsuitableservicing,testing,
monitoring,andmeasurementequipment;
7.5.1b c)theavailabilityofworkinstructions,whenapplicable;
NRin9001* d)ensuringidentificationandtraceabilityrequirementsare
maintainedthroughouttheservicingprocess;
7.5.1e e)theimplementationofmonitoringandmeasurementactivities;
and
NRin9001* f)processcontroldocuments(see5.7.1.3),and
7.5.1f g)requirementsforreleaseoftheproductthatwasserviced(see
5.9).
5.7.1.3 NRin9001* ProcessControl Processcontrolsshallbedocumentedinroutings,travelers,
Documents checklists,processsheets,orequivalentcontrolsrequiredbythe
organizationandshallincluderequirementsforverifying
conformancewithapplicableproductqualityplans(see5.7.2),
APIproductspecifications,customerrequirementsand/orother
applicableproductstandards/codes.Theprocesscontrol
documentsshallincludeorreferenceinstructions,workmanship
andacceptancecriteriaforprocesses,tests,inspections,and
requiredcustomersinspectionholdorwitnesspoints.
5.7.1.4 NRin9001* ProductRealization Theorganizationshalldevelopandmaintaindocumentationthat

Capability includesbutisnotlimitedtoproductrealizationplans(see5.2)
Documentation andrecordsofreview/verification,validation,monitoring,
measurement,inspectionandtestactivities,includingcriteriafor
productacceptancethatdemonstratesthecapabilityofthe
organizationtosatisfyspecifiedproductand/orservicing
requirements.

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5.7.1.5 7.5.2 ValidationofProcesses Theorganizationshallvalidateprocessesforproductionand

forProductionand servicingwheretheresultingoutputcannotbeverifiedby
Servicing subsequentmonitoringormeasurementandasaconsequence,
deficienciesbecomeapparentonlyaftertheproductisinuseor
theservicinghasbeendelivered.Validationshalldemonstratethe
abilityoftheseprocessestoachieveplannedresults.
NRin9001* Whereanorganizationchoosestooutsourceaprocessthat
requiresvalidation,theorganizationshallrequirethatthe
supplierconformtotheserequirements(see5.6.1.6).
7.5.2 Theorganizationshallmaintainadocumentedprocedureto
addressmethodsforreviewandapprovaloftheprocesses
including:
7.5.2b a)requiredequipment;
7.5.2b b)qualificationofpersonnel;
7.5.2c c)useofspecificmethods,includingidentifiedoperating
parameters;
7.5.2a d)identificationofacceptancecriteria;
7.5.2d e)requirementsforrecords(see4.5);and
7.5.2e f)revalidation.
NRin9001* Theorganizationshallvalidatethoseprocessesidentifiedbythe
applicableproductspecificationasrequiringvalidation.Ifthese
processesarenotidentified,orthereisnoproductspecification
involved,theprocessesrequiringvalidationshallinclude,asa
minimum,nondestructiveexamination,welding,andheat
treating,ifapplicabletotheproduct.
5.7.2 NRin9001* ProductQualityPlans Whenrequiredbycontract,theorganizationshalldevelopa

productqualityplanthatspecifiestheprocessesofthequality
managementsystem(includingtheproductrealizationprocesses)
andtheresourcestobeappliedtoaproduct.
NRin9001* Theproductqualityplanrequiredbycontractshalladdresseach
ofthefollowingasaminimum:
NRin9001* a)descriptionoftheproducttobemanufactured;

Instructions
Date:
NRin9001* b)requiredprocessesanddocumentation,includingrequired
inspections,tests,andrecords,forconformancewith
requirements;
NRin9001* c)identificationandreferencetocontrolofoutsourcedactivities;
NRin9001* d)identificationofeachprocedure,specificationorother
documentreferencedorusedineachactivity;and
NRin9001* e)identificationoftherequiredhold,witness,monitorand
documentreviewpoints.
NRin9001* Theseproductqualityplansandanyrevisionstothemshallbe
documentedandapprovedbytheorganizationtoensure
customerrequirementsaremet.Theseproductqualityplansand
anyrevisionsshallbecommunicatedtothecustomer.
5.7.3 7.5.3 Identificationand Theorganizationshallmaintainadocumentedprocedurefor
Traceability identificationandtraceabilitywhiletheproductisundercontrol
oftheorganizationasrequiredbytheorganization,thecustomer,
andtheapplicableproductspecifications,throughouttheproduct
realizationprocess,includingapplicabledeliveryandpostdelivery
activities.
NRin9001* Theprocedureshallincluderequirementsformaintenanceor
replacementofidentificationand/ortraceabilitymarks.
7.5.3 Records(see4.5)ofidentificationandtraceabilityshallbe
maintained.
5.7.4 NRin9001* Product Theorganizationshallmaintainadocumentedprocedureforthe
Inspection/TestStatus identificationofproductinspectionand/orteststatusthroughout
theproductrealizationprocesswhichindicatestheconformityor
nonconformityofproductwithrespecttoinspectionsand/or
testsperformed.
NRin9001* Theorganizationshallensurethatonlyproductthatmeets
requirementsor
8.3b isauthorizedunderconcession(see5.10.3),isreleased.

Instructions
Date:
5.7.5 7.5.4 CustomerSupplied Theorganizationshallmaintainadocumentedprocedureforthe

Property identification,verification,safeguarding,preservation,
maintenance,andcontrolofcustomersuppliedproperty,
includingintellectualpropertyanddata,whileundercontrolof
theorganization.
7.5.4 Theprocedureshallincluderequirementsforreportingtothe
customeranyloss,damage,orunsuitabilityforuseofcustomer
suppliedproperty.
7.5.4 Recordsforthecontrolanddispositionofcustomersupplied
propertyshallbemaintained(see4.5).
5.7.6 PreservationofProduct
5.7.6.1 NRin9001* General Theorganizationshallmaintainadocumentedprocedure
describingthemethodsusedtopreservetheproductand
constituentpartsthroughoutproductrealizationanddeliveryto
theintendeddestinationinordertomaintainconformityto
requirements.Asapplicable,preservationshallinclude
identificationandtraceabilitymarks,transportation,handling,
packaging,andprotection.
5.7.6.2 NRin9001* Storageand Theprocedureshallidentifytherequirementsforstorageand
Assessment assessment.
NRin9001* Theorganizationshallusedesignatedstorageareasorstock
roomstopreventdamageordeteriorationofproduct,pending
useordelivery.
NRin9001* Inordertodetectdeterioration,theconditionofproductor
constituentpartsinstockshallbeassessedatspecifiedintervals
identifiedbytheprocedure.
NRin9001* Theintervalshallbeappropriatetotheproductsorconstituent
partsbeingassessed.
NRin9001* Recordsoftheresultsofassessmentsshallbemaintained(see
4.5).
5.7.7 InspectionandTesting
5.7.7.1 NRin9001* General Theorganizationshallmaintainadocumentedprocedurefor
inspectionandtestingtoverifythatproductrequirementshave
beenmet.

Instructions
Date:
8.2.4 Theprocedureshallincluderequirementsforinprocessandfinal
inspectionandtesting.Recordsofrequiredinspectionandtesting
shallbemaintainedperdocumentedprocedures(see4.5).
5.7.7.2 8.2.4 InprocessInspection Theorganizationshallinspectandtesttheproductatplanned

andTesting stagesasrequiredbytheproductqualityplan(see5.7.2),process
controldocuments(see5.7.1.3),and/ordocumentedprocedures.
Evidenceofconformitywiththeacceptancecriteriashallbe
maintained.
5.7.7.3 NRin9001* FinalInspectionand Theorganizationshallperformallfinalinspectionandtestingin
Testing accordancewiththeproductqualityplan(see5.7.2)and/or
documentedprocedurestovalidateanddocumentconformityof
thefinishedproducttothespecifiedrequirements.
NRin9001* Personnelotherthanthosewhoperformedordirectlysupervised
theproductionoftheproductshallperformfinalacceptance
inspectionatplannedstagesoftheproductrealizationprocess.
5.7.8 NRin9001* Preventative Theorganizationshallmaintainadocumentedprocedureforthe
Maintenance establishmentofpreventivemaintenanceforequipmentusedin
productrealization.Theprocedureshallidentifyrequirements
for:
NRin9001* a)typeofequipmenttobemaintained;
NRin9001* b)frequency;and
NRin9001* c)responsiblepersonnel.
NRin9001* Recordsofpreventivemaintenanceshallbemaintained(see4.5).
5,8 7,6 ControlofTesting, Theorganizationshalldeterminethetesting,monitoring,and

Measuringand measurementrequirementsandtheassociatedequipment
MonitoringEquipment neededtoprovideevidenceofconformitytothoserequirements.
forProductConformity
NRin9001* Theorganizationshallmaintainadocumentedprocedureinorder
toensurethattesting,measurement,andmonitoringequipment
iscalibratedandmaintainedandthattheequipmentisusedina
mannerthatisconsistentwithmonitoringandmeasurement
requirements.

Instructions
Date:
7,6 Theprocedureshallincluderequirementsforthespecific
equipmenttypethataddresses:
7.6c a)uniqueidentifier;
7.6a b)calibrationstatus;
7.6a;7.6b c)equipmenttraceabilitytointernationalornational
measurementstandards;wherenosuchstandardsexist,thebasis
usedforcalibrationorverificationshallberecorded(see4.5);
NRin9001* d)frequencyofcalibration,atspecificintervalsorpriortouse
NRin9001* e)calibrationorverificationmethod,includingadjustmentsand
readjustments,asnecessary;
7,6 f)acceptancecriteria;
7,6 g)controlofequipmentidentifiedasoutofcalibrationinorderto
preventunintendeduse;and
7,6 h)whentheequipmentisfoundtobeoutofcalibration,an
assessmentofthevalidityofpreviousmeasurementsandactions
tobetakenontheequipmentandproduct,includingmaintaining
recordsandevidenceofnotificationtothecustomer(see4.1.5.2)
ifsuspectproducthasbeenshipped.
7,6 Testing,measuring,monitoringequipmentshall:
NRin9001* 1)becalibratedorverified,orboth,againstmeasurement
standards,
NRin9001* 2)havethecalibrationstatusidentifiablebytheuserforthe
activitiesbeingperformedatalltimes;
7.6d 3)besafeguardedfromadjustmentsthatwouldinvalidatethe
measurementresultorthecalibrationstatus;
7.6e 4)beprotectedfromdamageanddeteriorationduringhandling,
maintenanceandstorage;and
NRin9001* 5)beusedunderenvironmentalconditionsthataresuitablefor
thecalibrations,inspections,measurementsandtestsbeing
carriedout.
7,6 Whenusedinthetesting,monitoring,ormeasurementof
specifiedrequirements,theabilityofcomputersoftwareto
satisfytheintendedapplicationshallbeconfirmedpriortoinitial
useandreconfirmedasnecessary.
Instructions
Date:
NRin9001* Whentheequipmentisprovidedfromasourceexternaltothe
organization,includingthirdparty,proprietary,employeeand
customerownedequipment,theorganizationshallverifythatthe
equipmentissuitableandprovideevidenceofconformitytothe
requirementsofthissection.
NRin9001* Theorganizationshallmaintainaregistryoftherequiredtesting,
measurement,andmonitoringequipmentusedtodetermine
productconformitytorequirementsthatincludesaunique
identification,specifictoeachpieceofequipment.
7,6 Recordsoftheresultsofcalibrationandverificationshallbe
maintained(see4.5).
5,9 NRin9001* ProductRelease Theorganizationshallmaintainadocumentedprocedureto
ensurereleaseofproducttothecustomershallnotproceeduntil
theplannedarrangements(see5.7)havebeensatisfactorily
completed,unlessotherwiseapprovedbyarelevantauthority
and,
8.2.4 whereapplicable,bythecustomer.
8.2.4 Recordsshallbemaintainedtoenableidentificationofthe
individualreleasingtheproduct(see4.5).
5.10 ControlofNonconformingProduct
5.10.1 8,3 General Theorganizationshallmaintain(a)documentedprocedure(s)to
identifythecontrolsandrelatedresponsibilitiesandauthorities
foraddressingnonconformingproduct.
8,3 Theprocedureforaddressingnonconformingproductidentified
duringproductrealizationshallincludecontrolsfor:
8,3 a)productidentificationtopreventunintendeduseordelivery;
8.3a b)addressingthedetectednonconformity(see5.10.2);
8.3c c)takingactiontoprecludeitsoriginalintendeduseordelivery;
and
8.3b d)authorizingitsuse,releaseoracceptanceunderconcessionby
relevantauthorityand,whereapplicable,bythecustomer(see
8,3 Theprocedureforaddressingnonconformingproductidentified
afterdeliveryshallincludecontrolsfor:
Instructions
Date:
NRin9001* 1)identifying,documentingandreportingnonconformancesor
productfailureidentifiedafterdelivery;
NRin9001* 2)ensuringtheanalysisofproductnonconformanceorfailure,
providedtheproductordocumentedevidencesupportingthe
nonconformityisavailabletofacilitatethedeterminationofthe
cause(see6.4.2);
8.3d 3)takingactionappropriatetotheeffects,orpotentialeffects,of
thenonconformancewhennonconformingproductisdetected
afterdelivery.
5.10.2 NRin9001* Nonconforming Theorganizationshalladdressnonconformingproductby
Product performingoneormoreofthefollowing:
NRin9001* a)repairorreworkwithsubsequentinspectiontomeetspecified
requirements;
NRin9001* b)regradeforalternativeapplications;
NRin9001* c)releaseunderconcession(see5.10.3);and/or
NRin9001* d)rejectorscrap.
5.10.3 NRin9001* ReleaseorAcceptance Theevaluationandreleaseunderconcessionofnonconforming
ofNonconforming productthatdoesnotsatisfymanufacturingacceptancecriteria
ProductunderMACor (MAC)shallbepermittedwhentheorganizationsrelevant
DACConcession authorityandthecustomer(whereapplicable)haveauthorized
thereleaseprovidedthat:
NRin9001* a)productscontinuetosatisfytheapplicableDACand/or
customercriteria;or
NRin9001* b)theviolatedMACarecategorizedasunnecessarytosatisfythe
applicableDACand/orcustomercriteria;or
NRin9001* c)theDACarechangedandtheproductssatisfytherevisedDAC
andassociatedMACrequirements.
5.10.4 NRin9001* CustomerNotification Theorganizationshallnotifycustomersofproductnot
conformingtoDACorcontractrequirementsthathasbeen
delivered.Theorganizationshallmaintainrecordsofsuch
notifications(see4.5).
5.10.5 8,3 Records Recordsofthenatureofnonconformitiesandanysubsequent
actionstaken,includingconcessionsobtained,shallbe
maintained(see4.5).
5,11 ManagementofChange(MOC)
Instructions
Date:
5.11.1 NRin9001* General Theorganizationshallmaintainaprocessformanagementof

change(MOC).
5.4.2b Theorganizationshallensurethattheintegrityofthequality
managementsystemismaintainedwhenchangestothequality
managementsystemareplannedandimplemented.
NRin9001* Forthemanagementofchange,theorganizationshallidentify
thepotentialrisks(see5.3)associatedwiththechangeandany
requiredapprovalspriortotheintroductionofsuchchanges.
NRin9001* TheorganizationshallmaintainrecordsofMOCactivities(see
4.5).
5.11.2 NRin9001* MOCImplementation TheorganizationshallusetheMOCprocessforanyofthe
followingthatmaynegativelyimpactthequalityoftheproduct:
NRin9001* a)changesintheorganizationalstructure(see4.3.2)
NRin9001* b)changesinkeyoressentialpersonnel(see4.3.2);
NRin9001* c)changesincriticalsuppliers(see5.6.1);
NRin9001* d)changestothemanagementsystemprocedures,including
changesresultingfromcorrectiveandpreventiveactions(see
6.4);
5.11.3 NRin9001* MOCnotification Theorganizationshallnotifyrelevantpersonnel,includingthe
customerwhenrequiredbycontract,ofthechangeandresidual
ornewriskduetochangesthathaveeitherbeeninitiatedbythe
organizationorrequestedbythecustomer.
6 QualityManagementSystemMonitoring,Measurement,Analysis,andImprovement
6,1 4.1c;8.1b;8.1c; General Theorganizationshallplanandimplementthemonitoring,
8.5.1 measurement,analysis,andimprovementprocessesneededto
ensureconformityofthequalitymanagementsystemtothe
requirementsofthisspecificationandtocontinuallyimprovethe
effectivenessofthequalitymanagementsystem.
8,1 Qualitymanagementsystemmonitoring,measurement,analysis,
andimprovementshallincludedeterminationofapplicable
methods,includingtechniquesfortheanalysisofdata,andthe
extentoftheiruse.

Instructions
Date:
6,2 Monitoring,Measuring,andImproving
6.2.1 6.1b;8.2.1 CustomerSatisfaction Theorganizationshallmaintainadocumentedprocedureto
measurecustomersatisfaction.
8.2.1 Theprocedureshalladdressthefrequencyofmeasurement,
obtainingcustomerfeedback,keyperformanceindicators(KPIs),
andotherinformationthattheorganizationusestodetermine
whethertheorganizationhassatisfiedcustomersinmeeting
identifiedrequirements.
NRin9001* Recordsoftheresultsofcustomersatisfactioninformationshall
bemaintained(see4.5).
6.2.2 InternalAudit
6.2.2.1 8.2.2 General Theorganizationshallmaintainadocumentedprocedureto
defineresponsibilitiesforplanning,conducting,anddocumenting
internalaudits.
8.2.2a;8.2.2b Auditsshallverifythatthequalitymanagementsystemis
effectivelyimplementedandmaintained,andconformstothe
requirementsofthisspecification.
8.2.2 Theplanningofinternalauditsshalltakeintoconsiderationthe
resultsofpreviousauditsandcriticalityoftheprocessbeing
8.2.2 di d
Theorganizationshallidentifytheauditcriteria,scope,
frequency,andmethods
NRin9001* toensurethatallprocessesofthequalitymanagementsystem
claimingconformitytotherequirementsofthisdocumentare
auditedatleasteverytwelvemonths.
NRin9001* Outsourcedactivitiesthatimpactthequalityoftheproductand
thatareperformedattheorganizationsfacilityshallbeincluded
aspartoftheinternalauditoftheorganization.
6.2.2.2 8.2.2 Performanceof Auditsshallbeperformedbycompetentpersonnel(see4.3.2.2)
InternalAudit independentofthosewhoperformedordirectlysupervisedthe
activitybeingauditedtoensureobjectivityandimpartialityofthe
auditprocess.
8.2.2 Recordsoftheauditsshallprovideobjectiveevidencethatthe
qualitymanagementsystemisimplementedandmaintained(see
4.5).

Instructions
Date:
NRin9001* Allprocessesofthequalitymanagementsystemrequiredtomeet
thisspecificationshallbeauditedpriortoclaimingconformance
totherequirementsofthisspecification.
6.2.2.3 8.2.2 AuditReviewand Theorganizationshallidentifyresponsetimesforaddressing
Closure detectednonconformities.
8.2.2 Themanagementresponsiblefortheareabeingauditedshall
ensurethatanynecessarycorrectionsandcorrectiveactions
followtherequirementsof6.4.2.
5.6.2a Theresultsofinternalauditsandthestatusofcorrectiveactions
shallbereportedinthemanagementreview(see6.5).
8.2.2 Recordsofinternalauditsshallbemaintained(see4.5).
6.2.3 4.1e;4.1f;8.2.3 ProcessEvaluation Theorganizationshallapplysuitableevaluationmethodsto

demonstratetheabilityofthequalitymanagementsystem
processestoachieveplannedresults,includingconformityto
productrequirements.
8.2.3 Whenplannedresultsarenotachieved,correctionandcorrective
actionshallbetaken(see6.4.2),asappropriate.
6,3 AnalysisofData
6,3 4.1c Theorganizationshallmaintainadocumentedprocedureforthe
identification,collection,andanalysisofdatatodemonstratethe
suitabilityandeffectivenessofthequalitymanagementsystem.
8,4 Theanalysisshallincludedatageneratedfrommonitoringand
measurement,internalaudits(see6.2.2),managementreviews
(see6.5),andotherrelevantsources.
Thedataanalysisoutputshallprovideinformationrelatingto:
8.4a a)customersatisfaction(see6.2.1);
8.4b b)conformitytoproductrequirements;

Instructions
Date:
NRin9001* c)nonconformitiesandproductfailuresidentifiedafterdelivery
oruse,providedtheproductordocumentedevidenceisavailable
tofacilitatethedeterminationofthecause(see5.10);
8.4c d)characteristicsandtrendsofprocessesandproductsincluding
opportunitiesforpreventiveaction(see6.4.3);
8.4d e)supplierperformance(see5.6);and
NRin9001* f)qualityobjectives(see4.1.3).
8,4 Theorganizationshallusedatatoevaluatewherecontinual
improvementoftheeffectivenessofthequalitymanagement
systemcanbemade.
6,4 Improvement
6.4.1 8.5.1 General Theorganizationshallcontinuallyimprovetheeffectivenessof
thequalitymanagementsystemthroughtheuseofthequality
policy,qualityobjectives,auditresults,analysisofdata,corrective
andpreventiveactions,andmanagementreview.
6.4.2 8.5.2 CorrectiveAction Theorganizationshallmaintainadocumentedprocedureto

correctnonconformitiesandtotakecorrectiveactions,both
internallyandwithinthesupplychain,toeliminatethecausesof
anonconformityinordertominimizethelikelihoodofits
recurrence.
8.5.2 Correctiveactionsshallbeappropriatetotheeffect(s)ofthe
nonconformityencountered.
8.5.2 Theprocedureshallidentifyrequirementsfor:
8.5.2a a)reviewingaprocessnonconformity(includingcustomer
complaints);
8.5.2c;8.5.2d b)determineandimplementcorrections;
8.5.2b;8.5.2d c)identifyingtherootcauseofthenonconformityandevaluating
theneedforcorrectiveactions;
8.5.2d d)implementingcorrectiveactiontoreducethelikelihoodthata
nonconformityrecurs;
NRin9001* e)identifyingthetimeframeandresponsibleperson(s)for
addressingcorrectionsandcorrectiveaction;

Instructions
Date:
8.5.2f f)verificationoftheeffectivenessofthecorrectionsand
correctiveactiontaken;and
NRin9001* g)MOC(see5.11)whenthecorrectiveactionsrequirenewor
changedcontrolswithinthequalitymanagementsystem.
8.5.2e Recordsoftheactivitiesforcontrolofanonconformingprocess
NRin9001* Recordsshallidentifytheactivitiesperformedtoverify
effectivenessofthecorrectiveactionstaken.
6.4.3 8.5.3 PreventiveAction Theorganizationshallmaintainadocumentedprocedureto
determineandimplementpreventiveactions,bothinternallyand
withinthesupplychain,toeliminatethecausesofpotential
nonconformitiesinordertominimizethelikelihoodoftheir
occurrence.
8.5.3 Preventiveactionsshallbeappropriatetotheeffect(s)ofthe
potentialproblems.
8.5.3 Theprocedureshallidentifyrequirementsfor:
8.5.3c a)Identifyingopportunitiesforimprovements;
8.5.3a b)identifyingapotentialnonconformityanditspotential
cause(s);
8.5.3b c)evaluatingtheneedforpreventiveaction,includingany
immediateorshorttermactionrequired,topreventoccurrence
ofanonconformity;
NRin9001* d)identifyingthetimeframeandresponsibleperson(s)for
implementingapreventiveaction;
8.5.3e e)reviewingtheeffectivenessofthepreventiveactiontaken;
and
NRin9001* f)MOC(see5.11)whenthepreventiveactionrequirenewor
changedcontrolswithinthequalitymanagementsystem.
8.5.3d Recordsoftheactivitiesforcontrolofpotentialprocess
nonconformitiesshallbemaintained(see4.5).
6,5 ManagementReview

Instructions
Date:
6.5.1 5.6.1;5.1d General Theorganizationsqualitymanagementsystemshallbereviewed

atleasteverytwelvemonthsbytheorganizationsmanagement
toevaluatethequalitymanagementsystemscontinuing
suitability,adequacy,andeffectiveness.
5.6.1;5.3e Thisreviewshallincludeassessingopportunitiesforimprovement
andtheneedforchangestothequalitymanagementsystem,
includingthequalitypolicyandqualityobjectives.
6.5.2 5.6.2 InputRequirements Theinputtomanagementreviewshallinclude,asaminimum:
5.6.2e a)effectivenessofactionsresultingfrompreviousmanagement
reviews;
5.6.2a b)resultsofaudits(see6.2.2);
5.6.2f c)changesthatcouldaffectthequalitymanagementsystem,
includingchangestolegalandotherapplicablerequirements
(suchasindustrystandards);
5.6.2b d)analysisofcustomersatisfaction,includingcustomerfeedback
(see6.2.1);
NRin9001* e)processperformance(see6.2.3and6.3d);
NRin9001* f)resultsofriskassessment(see5.3);
5.6.2d g)statusofcorrectiveandpreventiveactions(see6.4.2and
6.4.3);
NRin9001* h)analysisofsupplierperformance(see5.6);
5.6.2c i)reviewoftheanalysisofproductconformity,including
nonconformitiesidentifiedafterdeliveryoruse(see5.10);and
5.6.2g i)recommendationsforimprovement.
6.5.3 5.6.3a OutputRequirements Theoutputfromthemanagementreviewshallincludea
summaryassessmentoftheeffectivenessofthequality
managementsystem.
5.6.3 Theassessmentshallinclude:
5.6.3a anyrequiredchanges(see5.11)totheprocessesandany
decisionsandactions;
5.6.3c requiredresources,

Instructions
Date:
5.6.2b andimprovementtoproductsinmeetingcustomerrequirements
(see5.11).
5.6.1 Topmanagementshallreviewandapprovetheoutputof
managementreviews.
5.6.1 Managementreviewsshallbedocumentedandrecordsofthese
reviewsshallbemaintained(see4.5).
AnnexA UseofAPIMonogrambyLicensees
A.4 NRin9001* QualityManagement AnorganizationapplyingtheAPIMonogramtoproductsshall
SystemRequirements develop,maintain,andoperateatalltimesaqualitymanagement
systemconformingtoAPIQ1.
A.5 NRin9001* Controlofthe EachlicenseeshallcontroltheapplicationandremovaloftheAPI

Applicationand Monograminaccordancewiththefollowing:
NRin9001* RemovaloftheAPI a)ProductsthatdonotconformtoAPIspecifiedrequirements
Monogram shallnotbeartheAPIMonogram.
NRin9001* b)EachlicenseeshalldevelopandmaintainanAPIMonogram
markingprocedurethatdocumentsthemarking/monogramming
requirementsspecifiedbythisannexandanyapplicableAPI
productspecification(s)and/orstandard(s).
NRin9001* Themarkingprocedureshall:
NRin9001* 1)definetheauthorityresponsibleforapplicationandremovalof
theAPIMonogram;
NRin9001* 2)definethemethod(s)usedtoapplytheMonogram;
NRin9001* 3)identifythelocationontheproductwheretheAPIMonogram
istobeapplied;
NRin9001* 4)requiretheapplicationofthelicensee'slicensenumberand
dateofmanufactureoftheproductinconjunctionwiththeuseof
theAPIMonogram;
NRin9001* 5)requirethatthedateofmanufacture,ataminimum,betwo
digitsrepresentingthemonthandtwodigitsrepresentingthe
year(e.g.0512forMay2012)unlessotherwisestipulatedinthe
applicableAPIproductspecification(s)orstandard(s);and

Instructions
Date:
NRin9001* 6)requireapplicationoftheadditionalAPIproduct
specification(s)and/orstandard(s)markingrequirements,as
applicable.
NRin9001* c)OnlyanAPIlicenseeshallapplytheAPIMonogramandits
designatedlicensenumbertoAPImonogrammableproducts.
NRin9001* d)TheAPIMonogramlicense,whenissued,issitespecificand
subsequentlytheAPIMonogramshallonlybeappliedatthatsite
specificlicensedfacilitylocation.
NRin9001* e)TheAPIMonogrammaybeappliedatanytimeappropriate
duringtheproductionprocessbutshallberemovedin
accordancewiththelicenseesAPIMonogrammarkingprocedure
iftheproductissubsequentlyfoundtobeoutofconformance
withanyoftherequirementsoftheapplicableAPIproduct
specification(s)and/orstandard(s)andAPIMonogramProgram.
A.6 NRin9001* DesignPackage Eachlicenseeand/orapplicantforlicensingshallmaintaina

Requirements currentdesignpackageforalloftheapplicableproductsthatfall
underthescopeofeachMonogramlicense.Thedesignpackage
informationshallprovideobjectiveevidencethattheproduct
designmeetstherequirementsoftheapplicableandmost
currentAPIproductspecification(s).Thedesignpackage(s)shall
bemadeavailableduringAPIauditsofthefacility.
Inspecificinstances,theexclusionofdesignactivitiesisallowed
undertheMonogramProgram,asdetailedinAdvisory#6.
*NoRequirementinISO9001:2008
I hereby declare that <insert Company Name> has implemented a quality management system that conforms to all applicable requirements of API Spec Q1, 9 th Edition as described in this document.
Signed by:
Name
Title
Date

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Instructions

4.1.2 5.1b;5.3a;5.3b; QualityPolicy Theorganizationspolicyforitscommitmenttoqualityshallbe

4.1.3 5.1c;5.4.1;7.1a QualityObjectives Management,withapprovalfromtopmanagement,shallensure

4.1.4 4.1a;7.1 Planning Managementshallensurethat:

APISpecQ19thEditionConformityMatrix Page1of30 FM186Rev2Effective7/16/2013

4.1.5.1 5.5.3 Internal Managementshallensurethatappropriatecommunication

APISpecQ19thEditionConformityMatrix Page2of30 FM186Rev2Effective7/16/2013

4.2.2 5.5.1 Responsibilityand Responsibilities,authorities,andaccountabilitiesofpersonnel

4,23 5.5.2 Management Topmanagementshallappointandmaintainamemberofthe

4.3.2.2 6.2.1 PersonnelCompetence Personnelshallbecompetentbasedontheappropriate

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4.3.2.3 6.2.2 Trainingand Theorganizationshall:

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5.1.3 7.2.2 Reviewof Theorganizationshallreviewtherequirementsrelatedto

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5.4.2 7.3.2 Designand Inputsshallbeidentifiedandreviewedforadequacy,

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5.4.7 7.3.7 Designand Designanddevelopmentchangesshallbeidentified.Thechanges

5.5.2 NRin9001* PlanningOutput Thecontingencyplanshallinclude,ataminimum:

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5.6.1.6 4,1 Outsourcing Whereanorganizationchoosestooutsourceanyactivitywithin

5.6.2 7.4.2 PurchasingInformation Theorganizationshallensuretheadequacyofspecified

5.6.3 NRin9001* Verificaionof Theorganizationshallmaintainadocumentedprocedureforthe

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5.7.1.4 NRin9001* ProductRealization Theorganizationshalldevelopandmaintaindocumentationthat

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5.7.1.5 7.5.2 ValidationofProcesses Theorganizationshallvalidateprocessesforproductionand

5.7.2 NRin9001* ProductQualityPlans Whenrequiredbycontract,theorganizationshalldevelopa

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5.7.5 7.5.4 CustomerSupplied Theorganizationshallmaintainadocumentedprocedureforthe

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5.7.7.2 8.2.4 InprocessInspection Theorganizationshallinspectandtesttheproductatplanned

5,8 7,6 ControlofTesting, Theorganizationshalldeterminethetesting,monitoring,and

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5.11.1 NRin9001* General Theorganizationshallmaintainaprocessformanagementof

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6.2.3 4.1e;4.1f;8.2.3 ProcessEvaluation Theorganizationshallapplysuitableevaluationmethodsto

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6.4.2 8.5.2 CorrectiveAction Theorganizationshallmaintainadocumentedprocedureto

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6.5.1 5.6.1;5.1d General Theorganizationsqualitymanagementsystemshallbereviewed

6.5.2 5.6.2 InputRequirements Theinputtomanagementreviewshallinclude,asaminimum:

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A.5 NRin9001* Controlofthe EachlicenseeshallcontroltheapplicationandremovaloftheAPI

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A.6 NRin9001* DesignPackage Eachlicenseeand/orapplicantforlicensingshallmaintaina

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