iso13485： 2016標(biāo)準(zhǔn)（en版）醫(yī)療器械

1、© ISO 2016Medical devices — Quality management systems — Requirements for regulatory purposesDispositifs médicaux — Systèmes de management de la qualité — ???????????????????????????????????INTERNA

2、TIONAL STANDARD ISO 13485Third edition 2016-03-01Reference number ISO 13485:2016(E)????????Disp ?????? ???ISO 13485:2016(E)Foreword .......................................................................................

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

4、......................................................................................................................................................................vi1 Scope ...........................................

5、......................................................................................................................................................................................12 Normative references .............

6、.........................................................................................................................................................................1?? ????????????????????? .........................

7、............................................................................................................................................................14 Quality management system .................................

8、...................................................................................................................................6 4.1 General requirements .............................................................

9、.......................................................................................................... 6 4.2 Documentation requirements................................................................................

10、.................................................................... 7 4.2.1 General.......................................................................................................................................

11、............................................... 7 ?????? ?????????????? ....................................................................................................................................................

12、.............. 7 ?????? ??????????????????? ..........................................................................................................................................................7 4.2.4 Control of do

13、cuments ..................................................................................................................................................8 4.2.5 Control of records ......................................

14、.....................................................................................................................85 Management responsibility .........................................................................

15、.............................................................................................9 5.1 Management commitment .................................................................................................

16、........................................................... 9 5.2 Customer focus ..........................................................................................................................................

17、............................................. 9 ???? ?????????????? .......................................................................................................................................................

18、..................................... 9 5.4 Planning ......................................................................................................................................................................

19、.................................. 9 ?????? ?????????????????? ............................................................................................................................................................9

20、 ?????? ?????????????????????????????????? ......................................................................................................... 9 ???? ??????????????????????????????????????????? ...................

21、.......................................................................................10 ?????? ???????????????????????????? ..............................................................................................

22、................................10 5.5.2 Management representative ...............................................................................................................................10 5.5.3 Internal commu

23、nication .........................................................................................................................................10 5.6 Management review ...............................................

24、.........................................................................................................................10 5.6.1 General..................................................................................

25、.................................................................................................10 5.6.2 Review input ...................................................................................................

26、..................................................................10 5.6.3 Review output ..................................................................................................................................

27、...............................116 Resource management ...................................................................................................................................................................

28、.............11 6.1 Provision of resources ...................................................................................................................................................................11 6.2 Human

29、 resources ...............................................................................................................................................................................11 6.3 Infrastructure ..........

30、..............................................................................................................................................................................12 6.4 Work environment and contamination con

31、trol .......................................................................................................12 6.4.1 Work environment ....................................................................................

32、..................................................................12 6.4.2 Contamination control .........................................................................................................................

33、....................127 Product realization ...............................................................................................................................................................................

34、..........12 7.1 Planning of product realization .............................................................................................................................................12 7.2 Customer-related proc

35、esses .....................................................................................................................................................13 7.2.1 Determination of requirements related to product ....

36、....................................................................13 7.2.2 Review of requirements related to product ..........................................................................................13 7.2.3

37、Communication ..............................................................................................................................................................14 7.3 Design and development ................

38、.............................................................................................................................................14 7.3.1 General..............................................................

39、.....................................................................................................................14 7.3.2 Design and development planning ............................................................

40、....................................................14 7.3.3 Design and development inputs ......................................................................................................................14 7.3.4

41、Design and development outputs ..................................................................................................................15 7.3.5 Design and development review ..................................

42、...................................................................................15 ?????? ??????????????????????????????????? ...........................................................................................

43、..............15 7.3.7 Design and development validation .............................................................................................................15 7.3.8 Design and development transfer .........

44、.........................................................................................................16 7.3.9 Control of design and development changes ..............................................................

45、..........................16 ??????? ???????????????????????????? ............................................................................................................................16© ISO 2016 – All right

46、s reserved iiiContents Page??????????Quality Qua 4.1 4.1 Ge4.2 .2 Docu D 4.2.1 4 ????? ?????? ????? ??? ??4.2.4 4.2 Contro Cont4.2.5 2.5 Control o Conagement responsibility nt responsibilitManagement commitme agement c

47、ommit tomer focus omer focus .......................... ......???????? ????????...................................... ................................................................................ .....................

48、..................???????????????? ???????????? ................... ..............???????????????????? ??????????????????????????????????????? ???????????????? ??????????????????? ?????????????? ........... ..representat

49、ive epresentative................... ..............unication ication.................................... ........................................................................................ ..........................

50、.................................................. ...................................................................................... ..................................................................................

51、... ................................................................ ................................................................................... ........................................................... .......

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53、................................ ......................................................................................... .............................................................................................. ..

54、............................................................................................... ................................................................................... ........................................