AS9100D：2016新旧版本对照分析表英文版

9100:2016Clause,Related9100:2009Clause,ChangeSummary,ProcessImpacted,PersonResponsibleforGapAssessment,GapLevelandDifficultytoImplement(1Low-5High),OrganizationGapSummary,GapClosureDueDate,"Status:

-Pending

-Inwork

-Complete"

4Contextoftheorganization,1Scope,New...Title,,,,,,

4.1Understandingtheorganizationanditscontext,1.1General,New…externalandinternalissuesandstrategicdirection,,,,,,

4.2Understandingtheneedsandexpectationsofinterestedparties,1.1General,"New…interestedparties,effectorpotentialeffect",,,,,,

4.3Determiningthescopeofthequalitymanagementsystem,1.2Application,"New…exclusionsreplacedbyapplicability,externalandinternalissues,relevantinterestedparties",,,,,,

,4.2.2Qualitymanual,,,,,,,

4.4Qualitymanagementsystemanditsprocesses,4Qualitymanagementsystem,"New…Inputsrequiredandtheoutputsexpected,monitoring,measurements,performanceindicators,assignmentofresponsibilitiesandauthorities,risksandopportunities,documentedinformationforaqualitymanualorequivalent.",,,,,,

,4.1Generalrequirements,,,,,,,

5Leadership,5Managementresponsibility,Elevationofresponsibility,,,,,,

5.1Leadershipandcommitment,5.1Managementcommitment,Reworded…sameintent,,,,,,

5.1.1General,5.1Managementcommitment,"New…demonstrateleadership,accountability,compatiblewithcontextandstrategicdirectionoftheorganization,integrationofbusinessprocesses,achievesitsintendedresults,supportingpersons,promoting,supportingrelevantmanagementroles,NOTEonbusiness.",,,,,,

5.1.2Customerfocus,5.2Customerfocus,"New…statutoryandregulatory,conformityrisksandopportunitiesdetermined.",,,,,,

5.2Policy,5.3Qualitypolicy,Reworded…sameintent,,,,,,

5.2.1EstablishingtheQualityPolicy,5.3Qualitypolicy,"New…implementedandmaintain,supportsstrategicdirection",,,,,,

5.2.2CommunicatingtheQualityPolicy,5.3Qualitypolicy,"New…andapplied,availabletorelevantinterestedparties.",,,,,,

"5.3Organizationalroles,responsibilitiesandauthorities",5.5.1Responsibilityandauthority,"New…deliveringtheirintendedoutputs,opportunities.",,,,,,

,5.5.2Managementrepresentative,"New…addedmanagementrepresentative,assignedresponsibilities",,,,,,

,5.4.2Qualitymanagementsystemplanning,Nochange,,,,,,

6Planning,,,,,,,,

6.1Actionstoaddressrisksandopportunities,5.4.2Qualitymanagementsystemplanning,"New…riskandopportunities,achieveimprovement,structure,",,,,,,

,8.5.3Preventiveaction,"New…integrate,impactontheconformity,risk,opportunities",,,,,,

6.2Qualityobjectivesandplanningtoachievethem,5.4.1Qualityobjectives,"New…changefromtopmanagementtoorganization,relevanttoconformity,monitored,communicated,updated,maintaindocumentedinformation,whatwillbedone,resourcedrequired,whowillberesponsible,whenitwillbecompleted,howresultswillbeevaluated.",,,,,,

6.3Planningofchanges,5.4.2Qualitymanagementsystemplanning,"New…Purposeofthechangesandtheirpotentialconsequences,availabilityofresources,allocationorreallocateofresponsibilitiesandauthorities.",,,,,,

7Support,6Resourcemanagement,,,,,,,

7.1Resources,6Resourcemanagement,Reworded…sameintent,,,,,,

7.1.1General,6.1Provisionofresources,"New…capabilitiesof,andconstraintson,existinginternalresources,whatneededtobeobtainedfromexternalproviders.",,,,,,

7.1.2People,6.1Provisionofresources,Reworded…sameintent,,,,,,

7.1.3Infrastructure,6.3Infrastructure,Reworded…sameintent,,,,,,

7.1.4Environmentfortheoperationofprocesses,6.4Workenvironment,"New…operationoftheseprocesses,suitableenvironmentcanbeacombinationofhumanandphysicalfactors.",,,,,,

7.1.5Monitoringandmeasuringresources,7.6Controlofmonitoringandmeasuringequipment,Reworded…sameintent,,,,,,

7.1.5.1General,7.6Controlofmonitoringandmeasuringequipment,"New…resourcesneededtoensurevalidandreliableresults,Resources(e.g.equipment)",,,,,,

7.1.5.2Measurementtraceability,7.6Controlofmonitoringandmeasuringequipment,"New…traceability,confidenceinthevalidityofmeasurement",,,,,,

7.1.6Organizationalknowledge,,New…allnewrequirements,,,,,,

7.2Competence,6.2.1General,New…skillsreplacedwithcompetence,,,,,,

,"6.2.2Competence,trainingandawareness","New…performance,effectiveness,newNOTEforconsideringperiodicreviews",,,,,,

7.3Awareness,"6.2.2Competence,trainingandawareness","New…effectiveness,benefitsofimprovedperformance,implicationofnotconforming,contributiontoproductorserviceconformity,contributiontoproductsafety,importanceofethicalbehavior.",,,,,,

7.4Communication,5.5.3Internalcommunication,"New…externalcommunicationswhatitwillcommunicate,whentocommunicate,whomtocommunicate,howtocommunicate,newNOTE",,,,,,

7.5Documentedinformation,4.2Documentationrequirements,Reworded…sameintent,,,,,,

7.5.1General,4.2.1General,Reworded…sameintent,,,,,,

7.5.2Creatingandupdating,4.2.3Controlofdocuments,Reworded…sameintent,,,,,,

,4.2.4Controlofrecords,Reworded…sameintent,,,,,,

7.5.3ControlofdocumentedInformation,4.2.3Controlofdocuments,New…Suitableforuseandadequatelyprotected.,,,,,,

,4.2.4Controlofrecords,"New…dataprotectiondefinedtoprotectfromloss,unauthorizedchanges,unintendedalteration,corruption,physicaldamage...",,,,,,

8Operation,7Productrealization,Reworded…sameintent,,,,,,

8.1Operationalplanningandcontrol,7.1Planningofproductrealization,"New…productobsolescence,FODprevention,achieveconformityandon-timedelivery,engagingrepresentativesofaffectedorganizationfunctions,determiningtheproductstobeobtainedfromExternalProviders,preventdeliveryofNCMtraining,additionofNOTEontimephasedeventsperformedinaparticularsequence,andimpactsandriskstobemanaged.",,,,,,

8.1.1Operationriskmanagement,7.1.2RiskManagement,New…AdditionofNOTEs,,,,,,

8.1.2Configurationmanagement,7.1.3ConfigurationManagement,"New…Controlproductidentityandtraceability,ensuredocumentedinformationisconsistentwiththeactualattributesoftheproductsandservices.",,,,,,

8.1.3Productsafety,,New,,,,,,

8.1.4Preventionofcounterfeitproducts,,New,,,,,,

8.2Requirementsforproductsandservices,7.2Customer-relatedprocesses,New…Title,,,,,,

8.2.1Customercommunication,7.2.3Customercommunication,New…contingencyactions,,,,,,

8.2.2Determiningtherequirementsforproductsandservices,7.2.1Determinationofrequirementsrelatedtotheproduct,New…meettheclaims,,,,,,

8.2.3Reviewtherequirementsforproductsandservices,7.2.2Reviewofrequirementsrelatedtotheproduct,New…coordinatedwithapplicablefunctionsandifunabletomeetcustomerrequirementsthennegotiateamutuallyacceptablerequirementwiththecustomer.,,,,,,

8.2.4Changestorequirementsforproductsandservices,7.2.2Reviewofrequirementsrelatedtotheproduct,Reworded…sameintent,,,,,,

8.3Designanddevelopmentofproductsandservices,7.3.1Designanddevelopmentplanning,Reworded…sameintent,,,,,,

8.3.1General,7.3.1Designanddevelopmentplanning,New…planandcontrolthedesignanddevelopmentofproduct.,,,,,,

8.3.2Designanddevelopmentplanning,7.3.1Designanddevelopmentplanning,"New…Nature,durationandcomplexityofthedesignanddevelopmentactivity,needforinvolvementofcustomerandusersinthedesignanddevelopmentprocess,requirementsforsubsequentprovisionofproductsandservices.",,,,,,

8.3.3Designanddevelopmentinputs,7.3.2Designanddevelopmentinputs,"New…standardsorcodesofpracticethattheorganizationhascommittedtoimplement,potentialconsequencesoffailure,potentialconsequencesofobsolescence.",,,,,,

8.3.4Designanddevelopmentcontrols,7.3.4Designanddevelopmentreview,New…controlstothedesignanddevelopmentprocess.,,,,,,

,7.3.5Designanddevelopmentverification,New…linkagetoclause7.1.5,,,,,,

,7.3.6Designanddevelopmentvalidation,Reworded…sameintent,,,,,,

8.3.5Designanddevelopmentoutputs,7.3.3Designanddevelopmentoutputs,New…D&Doutputsareapprovedbyauthorizedperson(s)priortorlease.New...NOTEonmaintainingdatatoachieveconformingproductorserviceandtechnicaldataandrepairschemesforoperatingandmaintainingtheproduct.,,,,,,

8.3.6Designanddevelopmentchanges,7.3.7Controlofdesignanddevelopmentchanges,New…processwithcriteriafornotifyingcustomers,,,,,,

"8.4Controlofexternallyprovidedprocesses,productsandservices",7.4.1Purchasingprocess,New…Titleandterminology,,,,,,

8.4.1General,7.4.1Purchasingprocess,"New…controlstotheirsub-tiersuppliers,conformityandon-timedeliveryperformancecriteria.",,,,,,

8.4.2Typeandextentofcontrol,7.4.1Purchasingprocess,New…effectivenessofcontrols,,,,,,

,7.4.3Verificationofpurchasedproduct,"Reworded…sameintentNew…effectivenessofcontrols,highrisksuppliers,counterfeitparts,productionpartapprovalprocess,periodicallymonitor,periodicallymonitorsupplierdelegations,processtoevaluatetestreports,rawmaterialtestreportaccuracy",,,,,,

8.4.3Informationforexternalproviders,7.4.2Purchasinginformation,"New…requirementforqualificationofcompetence,supplierawarenessoftheircontributionstoproductorserviceconformity,contributiontoproductsafety,andimportanceofethicalbehavior.",,,,,,

,7.4.3Verificationofpurchasedproduct,Reworded…sameintent,,,,,,

8.5Productionandserviceprovision,7.5Productionandserviceprovision,Nochange,,,,,,

8.5.1Controlofproductionandserviceprovision,7.5.1Controlofproductionandserviceprovision,"New…resultstobeachieved,servicestobeprovided,infrastructure,environment,periodicrevalidation,actionstopreventhumanerror",,,,,,

,7.5.2Validationofprocessesforproductionandserviceprovision,Reworded…sameintent,,,,,,

"8.5.1.1Controlofequipment,toolsandsoftwareprograms","7.5.1.3ControlofProductionEquipment,ToolsandSoftwarePrograms",Reworded…sameintent,,,,,,

8.5.1.2Validationandcontrolofspecialprocesses,7.5.2Validationandcontrolofspecialprocesses,Reworded…sameintent.ISO9001:2008textaddedbackin.,,,,,,

8.5.1.3Productionprocessverification,7.5.1.1Productionprocessverification,New…OutlineshowProductionProcessVerificationisdifferentandnotonlyFAI.,,,,,,

8.5.2Identificationandtraceability,7.5.3Identificationandtraceability,"New…outputs,conformity,requiredconfiguration",,,,,,

8.5.3Propertybelongingtocustomersorexternalproviders,7.5.4Customerproperty,Reworded…sameintent,,,,,,

8.5.4Preservation,7.5.5Preservationofproduct,"New…toextentnecessary,changefromShallstatementtoNOTE,preservationofoutputs.",,,,,,

8.5.5Post-deliveryactivities,7.5.1Controlofproductionandserviceprovision,Reworded…sameintent,,,,,,

,7.5.1.4Post-deliverysupport,"New…consider…,statutoryandregulatory,undesirablecircumstances,nature,useandintendedlifetime,customerrequirements,customerfeedback,newexamples,product/customersupport.",,,,,,

8.5.6Controlofchanges,7.3.7ControlofDesignandDevelopmentChanges,Reworded…sameintent,,,,,,

8.6Releaseofproductsandservices,7.4.3Verificationofpurchasedproduct,Reworded…sameintent,,,,,,

,8.2.4Monitoringandmeasurementofproduct,Reworded…sameintent,,,,,,

8.7Controlofnonconformingoutputs,8.3Controlofnonconformingproduct,"New…segregation,counterfeitorsuspectcounterfeit.Requirementfornonconformitycontrolprocessmaintainedasdocumentedinformation",,,,,,

9Performanceevaluation,"8Measurement,analysisandimprovement",Reworded…sameintent,,,,,,

"9.1Monitoring,measurement,analysisandevaluation","8Measurement,analysisandimprovement",Reworded…sameintent,,,,,,

9.1.1General,8.1General,Reworded…sameintent,,,,,,

,8.2.3MonitoringandMeasurementProcesses,Reworded…sameintent,,,,,,

9.1.2Customersatisfaction,8.2.1Customersatisfaction,New…customerperceptions,,,,,,

9.1.3Analysisandevaluation,8.4Analysisofdata,"New…planningimplementedeffectively,effectivenessofactionstaken-risksandopportunities,performanceofexternalproviders,newNOTE",,,,,,

9.2Internalaudit,8.2.2Internalaudit,"New…NewandexpandedNOTEs,changesimpactingtheorganization,impartialitycoversauditi