正式版iso 13485-2016

1、?ISO2016Medicaldevices—Qualitymanagementsystems—RequirementsfregulatypurposesDispositifsmdicaux—Systmesdemanagementdelaqualit—ExigencesdesfinsrglementairesINTERNATIONALSTARDISO13485Thirdedition20160301ReferencenumberISO1

2、3485:2016(E)DownloadFrom:bbs.DownloadFrom:bbs.ISO13485:2016(E)Fewd..........................................................................................................................................................

3、................................................................................vIntroduction...............................................................................................................................

4、.................................................................................................vi1Scope...................................................................................................................

5、..............................................................................................................12Nmativereferences...........................................................................................

6、...........................................................................................13Termsdefinitions...............................................................................................................

7、......................................................................14Qualitymanagementsystem.............................................................................................................................

8、.......................................64.1Generalrequirements..............................................................................................................................................................

9、.........64.2Documentationrequirements....................................................................................................................................................74.2.1General.....................

10、.................................................................................................................................................................74.2.2Qualitymanual........................................

11、..........................................................................................................................74.2.3Medicaldevicefile...........................................................................

12、...............................................................................74.2.4Controlofdocuments.....................................................................................................................

13、.............................84.2.5Controlofrecds...........................................................................................................................................................85Managementresp

14、onsibility......................................................................................................................................................................95.1Managementcommitment....................

15、........................................................................................................................................95.2Customerfocus...................................................................

16、....................................................................................................................95.3Qualitypolicy.......................................................................................

17、.....................................................................................................95.4Planning...........................................................................................................

18、.............................................................................................95.4.1Qualityobjectives........................................................................................................

19、....................................................95.4.2Qualitymanagementsystemplanning.........................................................................................................95.5Responsibilityauthityc

20、ommunication..........................................................................................................105.5.1Responsibilityauthity..........................................................................

21、....................................................105.5.2Managementrepresentative...............................................................................................................................105.5.3Int

22、ernalcommunication.........................................................................................................................................105.6Managementreview............................................

23、............................................................................................................................105.6.1General..................................................................................

24、.................................................................................................105.6.2Reviewinput.........................................................................................................

25、............................................................105.6.3Reviewoutput.............................................................................................................................................

26、....................116Resourcemanagement................................................................................................................................................................................116

27、.1Provisionofresources...................................................................................................................................................................116.2Humanresources................

28、...............................................................................................................................................................116.3Infrastructure..........................................

29、..............................................................................................................................................126.4Wkenvironmentcontaminationcontrol........................................

30、...............................................................126.4.1Wkenvironment.........................................................................................................................................

31、.............126.4.2Contaminationcontrol.............................................................................................................................................127Productrealization..................

32、.......................................................................................................................................................................127.1Planningofproductrealization....................

33、.........................................................................................................................127.2Customerrelatedprocesses......................................................................

34、...............................................................................137.2.1Determinationofrequirementsrelatedtoproduct........................................................................137.2.2Reviewofrequ

35、irementsrelatedtoproduct..........................................................................................137.2.3Communication......................................................................................

36、........................................................................147.3Designdevelopment..............................................................................................................................

37、...............................147.3.1General...............................................................................................................................................................................

38、....147.3.2Designdevelopmentplanning................................................................................................................147.3.3Designdevelopmentinputs..........................................

39、............................................................................147.3.4Designdevelopmentoutputs.................................................................................................................

40、.157.3.5Designdevelopmentreview.....................................................................................................................157.3.6Designdevelopmentverification....................................

41、.....................................................................157.3.7Designdevelopmentvalidation.............................................................................................................157.3.8D

42、esigndevelopmenttransfer..................................................................................................................167.3.9Controlofdesigndevelopmentchanges..........................................

43、..............................................167.3.10Designdevelopmentfiles............................................................................................................................16?ISO2016–Allrights