第4章 機器・体外診QMS省令 第1 制定の趣旨 1．
Contents
1. 0 000000 0 0 0 2 a t yo 1 1 1 ag 1 0000 92 0 000 00 15013485 2003 4 2 1 shall implemented o 5 o g Hoa g e E2. 00000000 15013485 2003 5 6 1 Management review O 00000000 5013485 2003 0 0 5 6 2 Review 0000000000 000 000000000 0 101 00000000 15013485 2003 5 6 3 Review output 000000000 0000 0000000 0 15013485 2003 6 1 Provision of resources 000000
3. producti lID L 000000000 LU 000000000 000000 0 15013485 2003 7 2 2 Review of requirements related to the 00000000 5013485 2003 7 2 3 Customer 0000000 015013485 2003 7 3 1 Design and development E ELE Hoo ao A oao aA ao A ao ao A ao A o ao A ao ao A ao A o ao aA ao ao A o ao aA ao ao A ao ao A ao ao A ao ao A 1 1 105 0000000 0 15013485 2003 7 3 2 Design development inputs 0000000 0 15013485 2003 7 3 3 Design and development outputs 000000000 0
4. 00 00000 00000 00000 1 o aA o t 0 000 00000000000 15013485 2003 0 00000000000 15013485 2003 00000 00000 000000000000 0 0 5013485 2003 top 000000000000 0 5 13485 2003 quality policy 87 lU UL 00000000000000 0 0 0 5013485 2003 quality management 5013485 2003 review 5013485 2003 resource 5013485 2003 infrastructure J o 000000000000 0 0 5013485 2003 traceablity 00 0000 00000000 15013485 2003 advis
5. 00000000 15013485 2003 6 2 1 Human resources O 0 0 0000000 0 15013485 2003 6 2 2 Competence awareness and 102 5013485 2003 6 3 Infrastructure 0 0 00 05013485 2003 associated utilities 0O 0 00000000000 a aA A oao aA 0 5013485 2003 6 4 Work environment 00000000 0000 00000000 0 0 2 05 5 5 o 2 a 2 ngo 2
6. SALO Sterility Assurance 1000 10 000000000000000000000000000 lI L 0 0000000 0000000 0000000 ogaao 15 5 Oga d Oga oga g E z 128 UU L LULU UL 129 oa oand o d ao od o od
7. o0520 o0 0g 115 00000000 15013485 2003 8 2 2 Internal 00000 00000 000 000000000 L 00000000 00000000 15013485 2003 8 2 3 Monitoring and measurement processes 000000000000 02 05 0200 g 05 5 g ooog ooog ooog ooog ooog ooog ooog ooog ooog ooog ooog ooog ooog ooog ooog ooog ooog 00000000 15013485 2003 8 2 4 Monitoring and measurement product 000 000 000 oaa 116 000000000 0 U implantable medical devices and implantable medical 1 00 DUUUUDUUDUDDUDDDUDUGUUUUUUDUUDUDUDUDUuUuu DUUUUDUDUUDUDUDDDUDUDUUUUUDUUDUUD
8. ao ao A o a A o a o a A o a A o a A oao lU UH 123 o o m o 1 O o o a mm Ao SAn El was o o m m o m m m o o O m g o coo o oOo o e Ei E o o m GE ER gt SER Il DY Fa gt o HAHH ES En S ERES o o m oo m oo o o o oo oo o oo ooo o o o oo o coocoo ooo oog aa o a ooo oao aaa cF ooo a aaa o ooo aaa aaa ooco
9. 0 0000 000 0000 000 0000000 0 15013485 2003 7 6 Control of monitoring and measuring devices 000000000000 ao ao ao ao a a oog oog oao aa A oao aa A oao aa A oao aa A oan aa A oo a A Genera 0000000000000 0000000 15013485 2003 8 1 Measurement analysis and improvement 0 5013485 2003 8 2 og og og og 5 og og og og og og 5 1 1 ao ao ao ao ao ao ao ao ao ao o o o E ao ao aA 000000 0 0000 0 0 0 E
10. H 110 coca a coa o0 o2 o0 goa t 50 2 m oof0g 2go20 02 02 2 mm 2 a 6 a a a a a L 0000000 0 15013485 2
11. 00000000 00000000 Ogo Oga d o m 0ga Ogag 1 o oag g m 5 ogag ooo ooo oog 5 UU L E EA o 130 00000 oog oo g oog oo H m oo H 2 oo H 5 p EN H O Hog Hog oO Oog oO oO o0 O oO o o o o coga o o ooga H La oooooocoog ng ng
12. S 2 Es m aaa a 2 2 5 L1 1 a 1 1 1 1 1 o D00 Oo o m oOo m m 20 oOo 50 g Ei 5 52052 O o 0 o o0 O0 p2 Ogo m o 2g H 0p 20 H O o0 g o H 202 a m 20 m ooo Haa aa aaa a IJ L g aaa a aa aa 0g ri q r g o O g 27 2 05 025 2 05 1 o aaa
13. 5 i a esas Pa D mi 5 agoa agog ri mim i Fly Ei Es AA gga g g gogai d A gogan d A gga o A 1 1 89 00000000 15013485 2003 4 1 General requirements 0000000000 15013485 2003 3 aia Jr J J 0 Esa ki o ao El O goa 0000 0000000
14. oaa oanad 0000 0000 0000 0000 0 000 000 0 0 00000 0000000 0000000 136
15. lID L 000 o0 g o0 g gao oaa g ao 0o a a J a a Oo o 0000 0000000 90 0 0000000 5013485 2003 4 2 1 Documentation requirements o ooog ooog 23 nd oO 3 ao ao O o 1 1 1 1 91
16. 000 00000 15013485 2003 8 5 2 Corrective 00000000 00000 UUUIUUDUDUDUDUuuuuu 118 00000000 5013485 2003 8 5 3 Preventive 00000000 00000 119 0 000000000 ao A o a A 2 2 ULU Ul 0 oa E E a A Oo Oo m aa 5 05 2 0
17. m 1 000 6 1 1 OC ao o aA o o aa 1 0000000 85 00 0000 15 1 5 5 Ogg 5 gog oo H oo 0O oo Og 2 A Og o aA N man Og ao d Og ao d Og a n ao a aa oA d a 1 grg g mm g 1 e Es Es 5 86 000000000
18. l yg g lt ia e lsi 05 5 pO a CCI 103 15013485 2003 7 1 Planning of product realization 0 0 O Uu 0000000 0 15013485 2003 7 2 1 Determination of requirements related to the producti 104
19. y L Pa a m lU L 113 E 00000000 15013485 2003 7 5 3 3 Status 00000000 00000 0000000 0 15013485 2003 7 5 5 Preservation of 00000 00000000 15013485 2003 7 5 4 Customer property 000000 og og 1 1 g g g 1 114
20. 1 1 go 1 1 ao I rJ J Ez E oo ad o oaoa a 0 122
21. o LCP LCP a 1 E LLLP CECI LPP oa E zJ E o o 98 commitment 0000 15013485 2003 5 1 Management commitment 00000 15013485 2003 000000000000000 00 5 13485 2003 00000 0000000 0 15013485 2003 0 5 2 Customer 58 000000000060 00000000 15013485 2003 5 3 Quality policy O0 000000000 000 00000
22. 000000000 0 0 000 0000000 0 15013485 2003 7 3 4 Design and development 0 000000000 L 0000 lID L 106 00000000 15013485 2003 7 3 5 Design and development verification 15013485 2003 7 3 6 Design and development validation o o
23. 1 61 2292 E 112 00000 5013485 2003 7 5 3 1 Identification 000000000 0000 000 000 0000000000000 00000000 15013485 2003 7 5 3 21 Traceability o0 o0 oa o0 oa o0 o0 o0 o0 o0 o0 a 85 02 2 g o2 a g o e 00000000 15013485 2003 7 5 3 2 2 Particular requirements for active implantable medical devices and implantable medical 1 000000000 L gt 08 5 08
24. a ri 1 ET Onna m 124 o aA ao aA o ao aA oo aa A oo aa oon aa A CE oao aa A oao aa oao aa A 0 0 000000 000000 5 00000 0 0 0 0 000 0 125 ULU Ul o o o r o o o Oo Oo Oo o r o o 1 g 0o g ao ao ao ao ao ao
25. 0 0 108 lll 15013485 2003 7 5 1 Control of production and service 00000000 15013485 2003 7 4 3 Verification of purchased O DUUUDUBDUUDUDUDDDDUDUUUUUDUUDUBIBDDUDUUUUUUDUBUUUDDDUDDDUDUUuuun 000 000 aA ao ao aA EEEE ao A oao aA o a A ao A ao aA ao A E E E o a aA o ao A o a A aoa aA ao A oan aa g oao aa g m G m D oan aa g oao aa g m 0 D 00 oan aa d ao a d oaoa o oo ad o 1 11 109 00000000 15013485 2003 7 5 1 2 1 Cleanliness of product and contamination control 0000000000000 00000000 5013485 2003 7 5 1 2 2 Installation activities
26. o maaa o Z20200 a o 2o20 O0 Zoo oo oog 1 g oO ooog 1 g oO ono 05 1 g oO ogo 05 1 g o 0 1 05 55 Hog Fg Hog Fg Hog Fg H H H H H n R o H o m o 27 05 0 2 2 93 00000000 L 00000000N 000000000 Ullu H Wooo 0000 0000000 0000 00000000 15013485 2003 4 2 2 0000000000 LU 0 2 02 5 oaaao O 3 a m m 00000 94
27. 0000 000 0000000 0 15013485 2003 7 3 7 Control of design development changes o 107 15013485 2003 7 4 1 Purchasing process 0000 00000 1 1 1 000000000 ao ao ao ao ao ao ao ao lll L 0 000 000 000 ooon ooon ooon 0000000 013485 2003 7 4 2 Purchasing ULU UL 00000 000 00000 0 00000 0 0 0
28. 05 05 1 1 131 lID L 0000 132 00000000 DUDUDUDUDUBUUUUUUUUDUDUDUDUDUDUUUuU 0 0000 0000 0000 0000
29. 000 00000 15013485 2003 5 4 4 Quality objectives H 0000 lU L 0 0000000 15013485 2003 5 4 2 Quality management system 99 000 0000000 0 5013485 2003 5 5 1 Responsibility and authority O 000 000000000 0000 0000000 0 5013485 2003 5 5 2 Management representative 0 O 000 16 18485 2003 U J management representative 5013485 2003 5 5 3 Internal 00000 100
30. A LP PLP CP CD LP LP EE IPE LIP nnd a0 A TJ E E E E E E agaa qaa qaaaa aaa qaaaqaaaaaaaaaaaaana nnd a0 A LP LPD PE CIP LCP nmi n0 A agaa aqaga qaaaaaaq qaaqaaaaaaaaaaqaaaaa ndn A agaa aqaga aaaaaaq qaaqaaaaa aaaaaaaaaa nnn A E EJ E EJ EJ E agaa qaa aaaa aaa qaaq qaaaqaaaaaannaanaaaana nnd nad A agaa qaa qaaa aaa qaaqaaaaa aaaaaaaaqaaa nnd nad A 1 d oaoa 1 1 oaoa A 0000000 00000000 A oA A 97 1 1 ENE 1 A ao aA oao aa A a aA oao aa A ao ao A oon aa A oao aa A oonan aa A oao aa oonan aa A
31. 0000000 0000 21 2 2 H Fili 1 S Ei 5 1 1 oga 105 ao g O ad a 2 a Ei ET E AHOA Ho SAHARAN ooooogo 0 COgo oo oooog Ll Ogoooonno LT En 1 d
32. 00000 00 15013485 2003 4 2 3 Control of 2 1 1 1 o A Ea E Ed EJ E 1 1 aoaaa 1 aaan aoaaa o a aA agaaa qaa qaaaa aaoaaaqaaaaannanid 1 1 E E E E l gt l J E ao a aA LCD DP PP ao ao A LC LP PP EP ao A LP LP LP A LP PLP P Ez E EA A 80 E r A aaa qaaaaa qoana
33. ao A oao 1 EEE E E oo aa A aoao E E oonan aa A oonan aa A 1 P zJ E EJ E LP PCP lU UL 000 000 0000 0000 0000 0000000 5013485 2003 4 2 4 Control 96 0000000 1 1 ao aA o o o a A oa aaqaa qaa qaaaanoannidi o o
34. o o ao ao A ao a aA ao ao A ao ao A a ao A EJ E mm ao ao og og onang onang E E E J onang onang onang onang onang oag oag oag oa g oag o0 g 126 00000 00000 0 0 O L O g O g 5021 0 O g O g 0 0 Og 020 0 0 1 o o a 10501 o a 150 127 00000000000 0000
35. 000 00000000000 00 00000 r r 5 e Papa zi 52 aG TTS PS a si mm 202 05 7 o a Ogag 1957 e gt 131 Ela 0 80 84 g a 2
36. 003 7 5 1 2 3 Servicing 5 o0 o g o g og oag oaan oag 00000000 15013485 2003 7 5 1 3 Particular requirements for sterile medical devices 111 0000000 15013485 2003 7 5 2 1 Validation of processes for production and service provision General 00 00000 000 000 00000 000 00000000 15013485 2003 7 5 2 2 Particular requirements for sterile medical devices o o
37. 133 UU L UDUUUUUUUUUUUDDUDUDUUU Ullu Ul UU l 00000000 0 134 0000000 o 00 o0 a o m 7 0O o O 7 o o o o o r ao a lU UU 00000 000000000 0 0000000 000000 135 o000 1 5
38. 2 05 aa 05 05 a a 52 05 a a 02 05 a a 2 05 aa 052 05 a a 52 5 a a 05 a a a a ag a a a a a A m E oo o H 5 H 5 H o o o o o o o o o o o o ooo oo 120 0000 oao on g on g EE on g ao ao ao
39. JUUDUDUD L 00000000 5013485 2003 8 2 4 2 Particular requirements for active 0000000 0 15013485 2003 8 3 Control of nonconforming 00000000 117 0000000 0 15013485 2003 8 4 Analysis 1 0 000000000 000 00000000 15013485 2003 8 5 1 Improvement 0000 000000000000 0 lU Ul lID LU d o 000 000
40. ao mimp oag ENEG EErEE e agian 121 1 oo HA o og 1 o Hano 5 g co r0p0004 02 02 5 0 g 02 02 5 02 02 5 g 02 2 02 02 2 02 L LIP LIPE
41. naaaaaannarnnnmnr nnmn na A oo Oga Ogo 00G Es a 65 o0 o0 5 oono 0 QO D O0 a O0 oa L E LCP E 95 EE E E E 8 T E E PCP E A
42. ory notices 000 oao oaa E oa oaa oaa oaa oa oa oaa oaa oaa aoao A 1 1 1 ria 2 1 gm gm oo 0 g 0 aa a aa a a a a a aa a a aa a 5 n 1 1 1 88 o PJ E E 1 oad gg oaod g oaod o a a Ad
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