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正式版ISO 13485-2016

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正式版 ISO 13485 2016
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©ISO2016MEDICALDEVICESQUALITYMANAGEMENTSYSTEMSREQUIREMENTSFORREGULATORYPURPOSESDISPOSITIFSMÉDICAUXSYSTÈMESDEMANAGEMENTDELAQUALITÉEXIGENCESÀDESFINSRÉGLEMENTAIRESINTERNATIONALSTANDARDISO13485THIRDEDITION20160301REFERENCENUMBERISO134852016EDOWNLOADFROMHTTP//BBSINFOEACHCOMDOWNLOADFROMHTTP//BBSINFOEACHCOMISO134852016EII©ISO2016–ALLRIGHTSRESERVEDCOPYRIGHTPROTECTEDDOCUMENT©ISO2016,PUBLISHEDINSWITZERLANDALLRIGHTSRESERVEDUNLESSOTHERWISESPECIFIED,NOPARTOFTHISPUBLICATIONMAYBEREPRODUCEDORUTILIZEDOTHERWISEINANYFORMORBYANYMEANS,ELECTRONICORMECHANICAL,INCLUDINGPHOTOCOPYING,ORPOSTINGONTHEINTERNETORANINTRANET,WITHOUTPRIORWRITTENPERMISSIONPERMISSIONCANBEREQUESTEDFROMEITHERISOATTHEADDRESSBELOWORISO’SMEMBERBODYINTHECOUNTRYOFTHEREQUESTERISOCOPYRIGHTOFFICECHDEBLANDONNET8CP401CH1214VERNIER,GENEVA,SWITZERLANDTEL41227490111FAX41227490947COPYRIGHTISOORGWWWISOORGDOWNLOADFROMHTTP//BBSINFOEACHCOMDOWNLOADFROMHTTP//BBSINFOEACHCOMISO134852016EFOREWORDVINTRODUCTIONVI1SCOPE12NORMATIVEREFERENCES13TERMSANDDEFINITIONS14QUALITYMANAGEMENTSYSTEM641GENERALREQUIREMENTS642DOCUMENTATIONREQUIREMENTS7421GENERAL7422QUALITYMANUAL7423MEDICALDEVICEFILE7424CONTROLOFDOCUMENTS8425CONTROLOFRECORDS85MANAGEMENTRESPONSIBILITY951MANAGEMENTCOMMITMENT952CUSTOMERFOCUS953QUALITYPOLICY954PLANNING9541QUALITYOBJECTIVES9542QUALITYMANAGEMENTSYSTEMPLANNING955RESPONSIBILITY,AUTHORITYANDCOMMUNICATION10551RESPONSIBILITYANDAUTHORITY10552MANAGEMENTREPRESENTATIVE10553INTERNALCOMMUNICATION1056MANAGEMENTREVIEW10561GENERAL10562REVIEWINPUT10563REVIEWOUTPUT116RESOURCEMANAGEMENT1161PROVISIONOFRESOURCES1162HUMANRESOURCES1163INFRASTRUCTURE1264WORKENVIRONMENTANDCONTAMINATIONCONTROL12641WORKENVIRONMENT12642CONTAMINATIONCONTROL127PRODUCTREALIZATION1271PLANNINGOFPRODUCTREALIZATION1272CUSTOMERRELATEDPROCESSES13721DETERMINATIONOFREQUIREMENTSRELATEDTOPRODUCT13722REVIEWOFREQUIREMENTSRELATEDTOPRODUCT13723COMMUNICATION1473DESIGNANDDEVELOPMENT14731GENERAL14732DESIGNANDDEVELOPMENTPLANNING14733DESIGNANDDEVELOPMENTINPUTS14734DESIGNANDDEVELOPMENTOUTPUTS15735DESIGNANDDEVELOPMENTREVIEW15736DESIGNANDDEVELOPMENTVERIFICATION15737DESIGNANDDEVELOPMENTVALIDATION15738DESIGNANDDEVELOPMENTTRANSFER16739CONTROLOFDESIGNANDDEVELOPMENTCHANGES167310DESIGNANDDEVELOPMENTFILES16©ISO2016–ALLRIGHTSRESERVEDIIICONTENTSPAGEDOWNLOADFROMHTTP//BBSINFOEACHCOMDOWNLOADFROMHTTP//BBSINFOEACHCOMISO134852016E74PURCHASING17741PURCHASINGPROCESS17742PURCHASINGINFORMATION17743VERIFICATIONOFPURCHASEDPRODUCT1775PRODUCTIONANDSERVICEPROVISION18751CONTROLOFPRODUCTIONANDSERVICEPROVISION18752CLEANLINESSOFPRODUCT18753INSTALLATIONACTIVITIES18754SERVICINGACTIVITIES19755PARTICULARREQUIREMENTSFORSTERILEMEDICALDEVICES19756VALIDATIONOFPROCESSESFORPRODUCTIONANDSERVICEPROVISION19757PARTICULARREQUIREMENTSFORVALIDATIONOFPROCESSESFORSTERILIZATIONANDSTERILEBARRIERSYSTEMS19758IDENTIFICATION20759TRACEABILITY207510CUSTOMERPROPERTY207511PRESERVATIONOFPRODUCT2076CONTROLOFMONITORINGANDMEASURINGEQUIPMENT218MEASUREMENT,ANALYSISANDIMPROVEMENT2281GENERAL2282MONITORINGANDMEASUREMENT22821FEEDBACK22822COMPLAINTHANDLING22823REPORTINGTOREGULATORYAUTHORITIES23824INTERNALAUDIT23825MONITORINGANDMEASUREMENTOFPROCESSES23826MONITORINGANDMEASUREMENTOFPRODUCT2383CONTROLOFNONCONFORMINGPRODUCT24831GENERAL24832ACTIONSINRESPONSETONONCONFORMINGPRODUCTDETECTEDBEFOREDELIVERY24833ACTIONSINRESPONSETONONCONFORMINGPRODUCTDETECTEDAFTERDELIVERY24834REWORK2484ANALYSISOFDATA2485IMPROVEMENT25851GENERAL25852CORRECTIVEACTION25853PREVENTIVEACTION25ANNEXAINFORMATIVECOMPARISONOFCONTENTBETWEENISO134852003ANDISO13485201627ANNEXBINFORMATIVECORRESPONDENCEBETWEENISO134852016ANDISO9001201530BIBLIOGRAPHY36IV©ISO2016–ALLRIGHTSRESERVEDDOWNLOADFROMHTTP//BBSINFOEACHCOMDOWNLOADFROMHTTP//BBSINFOEACHCOMISO134852016EFOREWORDISOTHEINTERNATIONALORGANIZATIONFORSTANDARDIZATIONISAWORLDWIDEFEDERATIONOFNATIONALSTANDARDSBODIESISOMEMBERBODIESTHEWORKOFPREPARINGINTERNATIONALSTANDARDSISNORMALLYCARRIEDOUTTHROUGHISOTECHNICALCOMMITTEESEACHMEMBERBODYINTERESTEDINASUBJECTFORWHICHATECHNICALCOMMITTEEHASBEENESTABLISHEDHASTHERIGHTTOBEREPRESENTEDONTHATCOMMITTEEINTERNATIONALORGANIZATIONS,GOVERNMENTALANDNONGOVERNMENTAL,INLIAISONWITHISO,ALSOTAKEPARTINTHEWORKISOCOLLABORATESCLOSELYWITHTHEINTERNATIONALELECTROTECHNICALCOMMISSIONIECONALLMATTERSOFELECTROTECHNICALSTANDARDIZATIONTHEPROCEDURESUSEDTODEVELOPTHISDOCUMENTANDTHOSEINTENDEDFORITSFURTHERMAINTENANCEAREDESCRIBEDINTHEISO/IECDIRECTIVES,PART1INPARTICULARTHEDIFFERENTAPPROVALCRITERIANEEDEDFORTHEDIFFERENTTYPESOFISODOCUMENTSSHOULDBENOTEDTHISDOCUMENTWASDRAFTEDINACCORDANCEWITHTHEEDITORIALRULESOFTHEISO/IECDIRECTIVES,PART2SEEWWWISOORG/DIRECTIVESATTENTIONISDRAWNTOTHEPOSSIBILITYTHATSOMEOFTHEELEMENTSOFTHISDOCUMENTMAYBETHESUBJECTOFPATENTRIGHTSISOSHALLNOTBEHELDRESPONSIBLEFORIDENTIFYINGANYORALLSUCHPATENTRIGHTSDETAILSOFANYPATENTRIGHTSIDENTIFIEDDURINGTHEDEVELOPMENTOFTHEDOCUMENTWILLBEINTHEINTRODUCTIONAND/ORONTHEISOLISTOFPATENTDECLARATIONSRECEIVEDSEEWWWISOORG/PATENTSANYTRADENAMEUSEDINTHISDOCUMENTISINFORMATIONGIVENFORTHECONVENIENCEOFUSERSANDDOESNOTCONSTITUTEANENDORSEMENTFORANEXPLANATIONONTHEMEANINGOFISOSPECIFICTERMSA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