iso-13485英文版教材

1、ReferencenumberISO13485:2003(E)©ISO2003INTERNATIONALSTANDARDISO13485Secondedition2003-07-15Medicaldevices—Qualitymanagementsystems—RequirementsforregulatorypurposesDispositifsmédicaux—Systèmesdemanagementdelaqualité—ExigencesàdesfinsréglementairesLicensedtoTUEVPRODUCTSERVICEGMBH/ELKEKUBSCHISOStoreorder#:550795/Downloaded:2003-07-09Singleuserlicenceonly,copyingandnetworkingprohibitedISO13485:2003(E)PDFdisclaimerThisPDFfilemaycontainembeddedtypefaces.InaccordancewithAdobe'slicensingpolicy,thisfil。

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3、ethatthefileissuitableforusebyISOmemberbodies.Intheunlikelyeventthataproblemrelatingtoitisfound,pleaseinformtheCentralSecretariatattheaddressgivenbelow.©ISO2003Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromeitherISOattheaddressbeloworISO'smemberbodyinthecountryoftherequester.ISOcopyrightofficeCasepostale56•CH-1211Geneva20Tel.+41227490111Fax+412。

4、27490947E-mailcopyright@iso.orgWeb©ISO2003—AllrightsreservedLicensedtoTUEVPRODUCTSERVICEGMBH/ELKEKUBSCHISOStoreorder#:550795/Downloaded:2003-07-09Singleuserlicenceonly,copyingandnetworkingprohibitedISO13485:2003(E)©ISO2003—AllrightsreservediiiContentsPageForeword............................................................................................................................................................iv0Introduction..................................................................。

5、.........................................................................v0.1General...................................................................................................................................................v0.2Processapproach.................................................................................................................................v0.3Relationshipwithotherstandards.......................................................................................。

6、..............vi0.4Compatibilitywithothermanagementsystems...............................................................................vi1Scope......................................................................................................................................................11.1General...................................................................................................................................................11.2Application................................。

7、.............................................................................................................12Normativereferences...........................................................................................................................23Termsanddefinitions...........................................................................................................................24Qualitymanagementsystem..............................................................................。

8、.................................44.1Generalrequirements...........................................................................................................................44.2Documentationrequirements..............................................................................................................45Managementresponsibility..................................................................................................................65.1Managementcommitment..................。

9、..................................................................................................65.2Customerfocus.....................................................................................................................................65.3Qualitypolicy.........................................................................................................................................65.4Planning......................................................................................。

10、...........................................................75.5Responsibility,authorityandcommunication...................................................................................75.6Managementreview..............................................................................................................................86Resourcemanagement..................................................................................................................。