ISO13485

ReferencenumberISO13485:2003(E)©ISO2003INTERNATIONALSTANDARDISO13485Secondedition2003-07-15Medicaldevices—Qualitymanagementsystems—RequirementsforregulatorypurposesDispositifsmédicaux—Systèmesdemanagementdelaqualité—ExigencesàdesfinsréglementairesISO13485:2003(E)PDFdisclaimerThisPDFfilemaycontainembeddedtypefaces.InaccordancewithAdobe'slicensingpolicy,thisfilemaybeprintedorviewedbutshallnotbeeditedunlessthetypefaceswhichareembeddedarelicensedtoandinstalledonthecomputerperformingtheediting.Indownloadingthisfile,partiesacceptthereintheresponsibilityofnotinfringingAdobe'slicensingpolicy.TheISOCentralSecretariatacceptsnoliabilityinthisarea.AdobeisatrademarkofAdobeSystemsIncorporated.DetailsofthesoftwareproductsusedtocreatethisPDFfilecanbefoundintheGeneralInforelativetothefile;thePDF-creationparameterswereoptimizedforprinting.EverycarehasbeentakentoensurethatthefileissuitableforusebyISOmemberbodies.Intheunlikelyeventthataproblemrelatingtoitisfound,pleaseinformtheCentralSecretariatattheaddressgivenbelow.©ISO2003Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromeitherISOattheaddressbeloworISO'smemberbodyinthecountryoftherequester.ISOcopyrightofficeCasepostale56•[e-mail]©ISO2003—AllrightsreservedISO13485:2003(E)©ISO2003—AllrightsreservediiiContentsPageForeword............................................................................................................................................................iv0Introduction...........................................................................................................................................v0.1General...................................................................................................................................................v0.2Processapproach.................................................................................................................................v0.3Relationshipwithotherstandards.....................................................................................................vi0.4Compatibilitywithothermanagementsystems...............................................................................vi1Scope......................................................................................................................................................11.1General...................................................................................................................................................11.2Application.............................................................................................................................................12Normativereferences...........................................................................................................................23Termsanddefinitions...........................................................................................................................24Qualitymanagementsystem...............................................................................................................44.1Generalrequirements...........................................................................................................................44.2Documentationrequirements..............................................................................................................45Managementresponsibility..................................................................................................................65.1Managementcommitment....................................................................................................................65.2Customerfocus.....................................................................................................................................65.3Qualitypolicy.........................................................................................................................................65.4Planning.................................................................................................................................................75.5Responsibility,authorityandcommunication...................................................................................75.6Managementreview..............................................................................................................................86Resourcemanagement.........................................................................................................................86.1Provisionofresources.........................................................................................................................86.2Humanresources..........................................................................................................