ISO 13485改訂の動向 - WEB PARK 2014
Contents
1.2. 8 3 8 3 1 5 A 9 lt 8 4
3. 4 1 3 QMS d b
4. 2 1SO 9000 2005 3 ISO 9000
5. a b c d e f g FDA QSR S 820 30 h 7 3 9 4 2 1 2 a j 7 4 7 4 1
6. a b c d e 7 8 5 2 0 x fhe a
7. TE 4 2 4 7 5 2 7 5 2 1 i
8. 0 1 1 1 2 1 1 1
9. c 2 a b UI 4 2 3 4 2 4 a b c d
10. 7 5 1 2 1 6 2 2 b 6 4 6 4 2 6 4 1
11. 4 2 4 4 1 4 QMS 4 1 5 2 2 7 4 2
12. gt 7 7 1 7 2 Z 2 7 7 2 2 Z 2 3 7 2 3 1 Z 2 3 2 7 7 1 4 IEC 62304 Normative Reference gt 7 2 7 2 1 2 A 5 c d
13. 30 3 3 9 3 10 3 3 12 i i 4
14. 26 2 di 0 I i A 7 SIn Wy 3 3 12 4 0 Ih 6 CE 2 8 1 3 0 AVE AE
15. 2 2 3 4 2 4 7 5 2 7 5 2 1 a 4 2 4 4
16. 7 4 1 3 4 2 4 7 5 7 5 1 7 5 1 1 7 5 1 2 7 5 1 2 1 7 5 1 2 2 7 5 1 2 3 7 5 1 3 7 5 2 7 5 2 1 7 5 7 5 3 7 5 3 1 7 5 3 2 7 5 3 2 1 7 5 3 2 2 7 5 3 3 7 5 4 7 5 5 7 5 1 7 5 1 1
17. OO O 1 2 7 3 4 2 2 a 7 3 6 7 8 4 2 2 a 1 2
18. 3 6 GHTF SG1 N55 3 3 7 3 8
19. f h TD 4 2 3 O 4 2 4
20. 7 5 4 4 2 4 aar EL L ud 7 A O 7 5 5 5 a 1
21. GHTF SG3N18 gt 6 ISO 13485 2 7 RN 8 EA 2 9 10
22. ISO 9001 2008 SO 9001 A ISO 9001 2008 1 2
23. b c d e f 4 8 5 3 o b c d
24. 5 FOX 2 5 7 3 6 gg AE F gt a 3 2 7 4 i 5 7 3 7
25. ISO DIS 13485 5 QMS 11 QMS IS013485 2003 ISO 13485 ISO 13485 QMS JIS Q 13485 IS ISO 13485 EN ISO 13485 3 Annex Z DIS QSR QSR 21CFR part820 ISO 13485 QSR
26. Ta 4 2 3 DO 0 e f PP 5 He TE i 5 es sw 24 7 5 1 2 7 5 1 2 1 a RR DR 80
27. 4 2 4 5 6 5 6 3 4 2 4 a b c Z d 6 6 1 6 2 6 2 1 6 2 2 6 3 6 4 6 2 6 2 1 a 2 nD
28. MDSAP QMS 6 ISO 9001 ISO 9001 2013 11 2014 3 CD DIS 2014 5 DIS 2014 10 10 2014 11 Dis 2015 FDIS 2015 IS ISO 9001 ISO13485 ISO 9001 ISO Annex SL ISO 13485 ISO 13485 Annex SL ISO 9001 ISO13485 QSR
29. e ERE 2 1 7 AE a N 7 2 3 7 2 3 1 _ a b c d Z 2 3 2 a EE c 9 7 7 3 Z 3 7 7
30. 1 3 1 active implantable medical device gt 3 2 active medical device CD 3 3 Authorized Representative M 3 4 clinical evaluation 3 5 complaint 3 6 distributor 3 7 advisary notice field safety notice 3 8 implantable medical deviece 3 9 mporter 2 3 10 labelling 3 77 __ life cycle 3 12 7 manufacturer 3 13 medical device GHTF 3 74 posr market surveillance 3 15 Eh erformance evaluation 3 76 _ risk 3 17 _ risk management 3 18 sterile medical device CD field safety corrective action 7egycg device software BK FF MM ore
31. d 0 e ON BR 7 7 Eg a b 6 4 1 2 a 6 4 1 2 b 7 5 1 2 2 4 2 4 7 5 1 2 3
32. 5 5 1 5 2 5 3 5 4 5 4 1 5 4 2 5 5 5 5 1 5 5 2 5 5 3 5 6 5 6 7 5 6 2 5 6 3 _ 5 5 5 6 1
33. 2 2 e 4 2 4 4 ISO 13485 AM ISO DIS 13485 ISO DIS 13485 ISO TC 210 ISO 13485 ISO DIS 13485 ISO FDIS 13485 1SO FDIS 2 1SO 13485 2015 6 6 20 7 10 7 20 2014 9 2014 2015 2015 ISO 13485 ISO 13485 QMS ISO TC 210 ISO TC 210 es 210 WG1 QMS OMS 1 ARCB QMS 2 QMS QMS ISO 13485
34. ISO 9001 MS 19 20 3 ISO DIS 13485 0 0 1 0 2 0 3 0 4 0 0 1
35. 4 7 7 5 5 1 AR ld Party 8 4 8 8 1 8 2 8 2 1 8 2 1 1 8 2 7 2 8 2 7 3 8 2 7 2 8 2 2 8 2 3 8 2 4 8 2 4 1 8 2 4 2 8 8 3 8 3 7 _ 8 3 2 8 3 3
36. 5 Ef ER ER OR RR ER NR 3 3 13 GHTF SG1 N071 2012 3 nl 3 14 u 3 15
37. 2 ii 4 b 0 c 7 4 4 1 6 QMS 4 1 6
38. Z 2 7 7 DKE Z 2 7 2 Z 4 7 3 7 4 2 7 4 3 7 4 1 7 4 1 7 4 1 1 O 7 4 2 7 4 1 2
39. 4 1 6 QMS 4 1 1 4 PR USK A AHWP WG3 QMS IS0 13485 2003 WWW http www ahwp info e Guidance on the Quality Management System for Medical Device Distributor 4 1 2 QMS
40. 4 2 3 4 2 4 4 2 4 2 1 4 2 1 1 4 2 3 3 6 1 2 a b c d OO ODO VW 4 2 4 2 1 4 2 1 2 4 2 3
41. a EA ISO 80002 2 CD FDA QSR S 820 70 i 4 2 4 2 1 4 2 1 1 2 2 7 2 4 2 2
42. 8 3 4 8 3 5 8 4 8 5 8 5 1 8 5 2 8 5 3 PMUM 8 2 1 8 2 1 1 EA ee a o 8 2 1 2
43. 3 16 ISO 14971 2007 3 17 ISO 14971 2007 3 3 18 IO 4 4 1 2 QMS 3 QMS Ye 4 1 1 Document establish implement maintain Role Manufacturer Distributor Authorized Representative Importer 4 1 2 4 1 4 4 1 5
44. 0 11 12 ISO 13485 3 13 14 GHTF GHTF SG3 N99 10 Edition 2 15 16 PR 17 EN ISO 13485 2012 Annex ZA ZB ZC EN ISO 13485 2012 Annex ZA ZB ZC ISO 13485 4 18 ISO 9001 ISO 9001 2008
45. 6 4 6 4 1 6 4 1 1 6 4 1 2 a b ISO 14644 4 O 6 4 6 4 1 3 4 2 4
46. 7 3 2 7 3 3 7 3 4 Z 3 5 7 Z 3 6 7 Z 3 7 7 7 3 8 7 3 1 a 8 b c d e f 7 3 5 0
47. clinical evaluation 3 3 1 3 2 3 3 3 3 4 3 3 5
48. 2 4 TY 7 5 2 2 4 2 3 Y ISO 11607 7 5 3 7 5 3 1 O 7 5 3 2 7 5 3 2 1 4 2 4
49. 2014 2 20 amp 2014 7 20 DIS 2014 9 ISO TC 210 WG1 DIS FDIS DIS WG _ 6 2 ISO 13485 ISO 13485 MSS Annex SL ISO 9001 Annex SL MSS ISO 9001 Annex SL ISO 9001 2008 QMS ISO 13485 1 QMS gt QMS QMS
50. ISO 13485 ISO DIS 13485 ISO TC 210 WG1 Mn A w MN bP ISO 13485 ISO 13485 ISO DIS 13485 ISO 9001 1 ISO 13485 ISO 13485 1 2011 4 Malvern WG1 2011 10 2012 3 2012 10 2013 3 2013 10 2014 2 Alexandria TC210 NWIP London WG1 WD1 Santa Rosa WG1 WD2 ITC210 CD CD DIS DIS ISO 13485 2 CD 2013 5 10 CD 2013 8 10 31 1 10 16 1 4 ISO DIS 13485 201X amp
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