ISO13485 2016 & ISO9001 2015 标准对照表

MatrixbetweenISO13485:2016&ISO9001:2015ISO13485:2016ISO9001:20154Qualitymanagementsystem4Contextoftheorganization4.1Generalrequirements4.1Understandingtheorganizationanditscontext4.2Understandingtheneedsandexpectationsofinterestedparties4.4Qualitymanagementsystemanditsprocesses8.4Controlofexternallyprovidedprocesses,productsandservices4.2Documentationrequirements7.5Documentedinformation4.2.1General7.5.1General4.2.2Qualitymanual4.2.3Medicaldevicefile4.3Determiningthescopeofthequalitymanagementsystem7.5.1General4.4Qualitymanagementsystemanditsprocesses4.2.4Controlofdocuments7.5.2Creatingandupdating7.5.3ControlofdocumentedInformation4.2.5Controlofrecords7.5.2Creatingandupdating7.5.3ControlofdocumentedInformation5Managementresponsibility5Leadership5.1Managementcommitment5.1Leadershipandcommitment5.1.1General5.2Customerfocus5.1.2Customerfocus5.3Qualitypolicy5.2Policy5.2.1EstablishingtheQualitypolicy5.2.2CommunicatingtheQualitypolicy5.4Planning6Planning5.4.1Qualityobjectives6.2Qualityobjectivesandplanningtoachievethem5.4.2Qualitymanagementsystemplanning5.3Organizationalroles,responsibilitiesandauthorities6.1Actionstoaddressrisksandopportunities6.3Planningofchanges5.5Responsibility,authorityandcommunication5Leadership5.5.1Responsibilityandauthority5.3Organizationalroles,responsibilitiesandauthorities5.5.2Managementrepresentative5.3Organizationalroles,responsibilitiesandauthorities5.5.3Internalcommunication7.4Communication5.6Managementreview4.1Understandingtheorganizationanditscontext4.2Understandingtheneedsandexpectationsofinterestedparties9.3Managementreview5.6.1General9.3.1General5.6.2Reviewinput9.3.2Managementreviewinputs9.3.1General5.6.3Reviewoutput9.3.3Managementreviewoutputs6Resourcemanagement7Support6.1Provisionofresources7.1Resources7.1.1General7.1.2People6.2Humanresources7.2Competence6.2Humanresources7.2Competence6.2Humanresources7.2Competence7.3Awareness6.3Infrastructure7.1.3Infrastructure6.4Workenvironmentandcontaminationcontrol6.4.1Workenvironment7.1.4EnvironmentfortheoperationofprocessesISO13485:2016ISO9001:20156.4.2Contaminationcontrol7Productrealization8Operation7.1Planningofproductrealization6.1Actionstoaddressrisksandopportunities8.1Operationalplanningandcontrol7.1.6Organizationalknowledge7.2Customer-relatedprocesses8.2Requirementsforproductsandservices7.2.1Determinationofrequirementsrelatedtotheproduct8.2.2Determiningtherequirementsrelatedforproductsandservices7.2.2Reviewofrequirementsrelatedtotheproduct8.2.3Reviewofrequirementsrelatedforproductsandservices8.2.4Changestorequirementsforproductsandservices7.2.3Customercommunication8.2.1Customercommunication7.3Designanddevelopment7.3.1General8.3Designanddevelopmentofproductsandservices7.3.2Designanddevelopmentplanning8.3.1General8.3.2Designanddevelopmentplanning7.3.3Designanddevelopmentinputs8.3.3Designanddevelopmentinputs7.3.4Designanddevelopmentoutputs8.3.5Designanddevelopmentoutputs7.3.5Designanddevelopmentreview8.3.4Designanddevelopmentcontrols7.3.6Designanddevelopmentverification8.3.4Designanddevelopmentcontrols7.3.7Designanddevelopmentvalidation7.3.8Designanddevelopmenttransfer8.3.4Designanddevelopmentcontrols7.3.9Controlofdesignanddevelopmentchanges7.3.10Designanddevelopmentfiles8.3.6Designanddevelopmentchanges7.4Purchasing8.4Controlofexternallyprovidedprocesses,productsandservices7.4.1Purchasingprocess8.4Controlofexternallyprovidedprocesses,productsandservices8.4.1General8.4.2Typeandextentofcontrol7.4.2Purchasinginformation8.4.3Informationforexternalproviders7.4.3Verificationofpurchasedproduct8.4.2Typeandextentofcontrol8.4.3Informationforexternalproviders7.5ProductionandServiceprovision8.5Productionandserviceprovision7.5.1Controlofproductionandserviceprovision7.5.2Cleanlinessofproduct7.5.3Installationactivities7.5.4Servicingactivities7.5.5Particularrequirementsforsterilemedicaldevices8.5.1Controlofproductionandserviceprovision8.5.6Controlofchanges7.5.6Validationofprocessesforproductionandserviceprovision7.5.7Particularrequirementsforvalidationofprocessesforsterilizationandsterilebarriersystems8.5.1Controlofproductionandserviceprovision7.5.8Identification7.5.9Traceability8.5.2Identificationandtraceability7.5.10Customerproperty8.5.3Propertybelongingtocustomersorexternalproviders7.5.11Preservationofproduct8.5.4Preservation7.6Controlofmonitoringandmeasuringequipment7.1.5Monitoringandmeasuringresources7.1.5.1General7.1.5.2Measurementtraceability8Measurement,analysisandimprovement9Performanceevaluation8.1General9.1.1General8.2Monitoringandmeasurement9.1Monitoring,measurement,analysisandevaluation8.2.1Feedback8.5.5Post-deliveryactivitiesISO13485:2016ISO9001:20158.2.2Complainthandling8.2.3Reportingtoregulatoryauthorities9.1.2Customersatisfaction8.2.4Internalaudit9.2Internalaudit8.2.5Monitoringandmeasurementofprocesses9.1.1General8.2.6Monitoringandmeasurementofproduct8.6Releaseofproductsandservices8.3Controlofnonconformingproduct8.3.1General8.3.2Actionsinresponsetononconformingproductdetectedbeforedelivery8.3.3Actionsinresponsetononconformingproductd