意見 意見に対する考え方 第一章総則 定義の条項を設けていただきたい
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1. 00000000000000000000000000000000000000 0000000000000N00 0000000 G6w4O0000000 000000000000000000000000000000000000 0000000000M6U00 00000P0mM000000006M0000 O 0 101050 13485 2003 00000000000000000000U0000000000 0000000000000000000000U0 00 0000000000000000000000U0 00 JO ODOOOOOUODODODOOOOUDIU 1000000000000000000000 000000000000000 0109 OOOOOOODOODODODOODOODOO2. 000000000 0 000 JOD00 000000000 DO 00000000000 001000000 0 0 000 0000 0000000000 LU O O DDI DI 4010000000 0 0 000 0000000 p0m10000000 0 0 000 IODODODDDD0 000 poo0 0 man00000000 P0 M000000 00000 oO El
3. OUMUOUUOUUUUUUUU 000000000 0 000 IOUUOUOUOUUUUUU material O0 00000000 0010000000 0 0 000 Odd 00000 mn 000 15013485 2003 000000 0000000000000 corno 0000000 I LI I LU DO 00 000000 00000000000000000000000000000000000 00000000000000000000000000 000 0000 TD ISO13485 20031 reference 10000000MO00
4. 0000000000 000 0000000000 000 JBQBBD00 00000000 0000000000000 0 0000000000000 000 000000000000 0000000000 0000 10000000000 000 00000000 0 0 000 1S013485 2003 0 000000 IOOUMUOUUOUUU I 00 M00000 00000 000000 000000 00 NHOUMWOOW 00000000 0 0 000 0000000000 El oO CI E MN000000O0OO0O0OO 0000000000000M0NM00MUO0I0 0000000000
5. JODO 0000000000 00000000 00000000000 O0000000 Oo00000000000M6M0000000000 00000600000000 UDIUDUUDDUDUDDDDUDDUDUDDDDUUDDDUUDUDDDDUD ODOOMODOODOODOUDOOO JOOGODOOUODOOUODODOODOUODODOODOUODONUODODOUODODODOOODO 100000000000000000000000000000000U0 00000000000000600000000000000000U00010 00000000000000000000000000000000000 1000000000000000000000000 100000000000000000000000000 000000 DI Co CI Co Ea E mm oO oO H E oO oO 10000000000000U000 0000 000000000000000000000000000000 DO d0000 0000000000000 0000 JOQODOOD 000000000000 JAOdODDOD 00000000000
6. DoODO DD PO00000 CI 5 E al ODO0MoD00000000 000000 00 000000 1000000000600 0000000000000 PP Mo00000 000000 DO0000 0000000000000 000000000000 II UDDUDD 00 0000000000000 000000000000 000600M60UO0000000 0 0 0 O 15013485 20037 00000000000 000000000000 O 1 013485 2003 0 0000000000000 0000000000 80000 000000000 100000000000000000000 100000000000000000000000000000000 00 10000000 00000000000 0 0000000000000 000000000 000000000 40000000000 0 000 pg00000000 0 0 0 0000 00 mno0000000000000 JOODOO0 0000000 M00000 JODODO
7. 000000000000000000000000000000000000 000000000000U0 000000000000000PE00000000000000000 0000000000000 0 100000000000000000000000000000000000 10000000000 O00000 0000000000000 00000000 00000000 00000000000000 JOB 000000000 ru 0000000000000 00000000 2080000000 00 0000 134859 0000000000000 0000 1000000000000000 10000000 GMPO 000 000000000 00000000000 000000000000 000 DODD0O0D000000000 0000000000000 000 10000000000000000000000000000 0000000000000000000000000000 Bo JOdDOO DD 000 0000000000100 JOBOD DO DDD 00 0000000000100 100M6M000000000 000000 1000000000000000000000 000 00 050 13485 20039 0 0 0 UDUUIUDDDDDUDDDOTDD UDUIUUDDDDDOD 10000000000 000 O0 Un Ir Ii nu Uu I I 000000000000 J0000000000000 EH CI Co Co Cy J0000000000DODU Me Co Co Co CI CI Co CI
8. 000000000000000 000000000000000 1000000000 0 000 200000000 00000 100006m0000000 15013485 2003 0 0 0000 IDDU I I I I I II 00 0000000 OOUUOUUUUUUUOUUU 1000000000000 DOOWW 00600000 100000000000000 10000000 000000000000000 Il UU In un If appropriate O O LII 0 1S013485 20037 0000000 OOU 00000 00000
9. 010Pm00m 00060000 100000000000000000000000000000000000 00000000000000 00000000000000400000000000000000000 0000000000000 1000000000000600000000000006000000C4A 0 0 00 000000 00 0 ITITHIDIUDUIDUUDn 000 00000000000 00000000000 0000000000000 0000000000 M0000 0000000000000 1000000000 00000000000000000000000 0000000U0000000 000000000000000000000000000000000000000960000000U 0000 cW40000000000000000000000000 00000000000000000040000000000000000 II UI DID 0000 UDDUUDDIUDDUDDUDDDUUDDDUUDUDUDDDDDODDD 00000000000000000000000 00 00 DODdg00 0000000 00000000000 000 JO 000000000000 00000000000 0000 000000000000000000V0 00 JOOGOOOODODOO 00000000 0 000000 IA
10. 1000000600000000000000000000 10000 180000 00 0 0 00 0 OSO 134850 0000000000000000 4000000000000 0 III 000000 000000690MO00000000000 000000000000000 00080000000 ODOO00 0000000 M0 000000 0000000000000 000 0000000000 M00000000
11. J0000000000000 000000000000000 UDDIUDIUUUDUUDDD 000000000000 000000 DOVODgODODODODO NOOWUUUU p0mM00000000 0000 100000000 P0M00000000 000 Co Co Co Co CI E E oO Co CI oO El l l
12. IHOUUVOUUMUMOOO0 0000000000000000000000000000000000 nUDDDIDUDDUDUDD JOOGOOOUODODOUODODODUOD OO 10000000000000 0 0 0 OSO 13485 200390 0 O 20000U00000 10000000000000000e 10000000000000000000000000000000000 000000000000U00 0000000000 ODd00b 000000000000 0o0p000000000 00000 000 00000 000000000000 0000000000000 ODOd 000000000 000000000000 0000000000 000000 000000000060000MO0O0D00D 0008 00000 015013485720030 0 00 00 00 Note 0 00 Design Transfer O 00 000000000000 000000000000000000
13. 0000000000 000 100000000000000 2000000000000 0 E E A a Co 5 IW II UI UI DI IU UU I UL EU I I UU I Uu Uu Uu Ui 0A I DN 00000000000000 000000 13485 2003 and to evaluate if improvement of the effectiveness of the quality management system can be made OMOODODOOODOOODOUDGODIU 100000000000000096M00000000000000000 IOOUUUUUOQUUUUWU In ODO nn ni Ii LD O00 00000000000 OD000000000000 0000000000000 00010000000 0 0 000 0000000000 001000000 0 0 000
14. 10000000000000000 1000000000000000000000000000 UIDDUIUDDDUUUDDUDDUUDDUD 10000000000 000 DODODD o 000000 00 000000000000 0000 00010000000 0 0 000 II Un I Uu 000000 000 0000001000000 JOB BDO000000 000 100000000 00000 00 1000 10000000000 000 oOgo0 0000000000 0000000000000 00
15. 0000000 pod00 00000 M00000 0000000000 DOOd0 0000000000 00000 Mm Cy oO Cy Cy 1000000000 El H 8 H O A El 00000000000 00000000000 0000000000 00000000000000000000 OOOO 000 0000000000000 000000000000 000000000000000000 00 2000000000 00000000000 0000000000000000000000000000 00 JPp00000 0000000000000 0000000000000 10000 000000000000000O00000 O ID I DU I I Ii I I Ui MUUUOUUOUUUUU0U 1000 000000000 00
16. og D0O000000M00 2000000000000 000 ODO po 00000000 0M0M000000000000 00000 m000d000 0000000000 000600000000000 40000000000 0 00 OUUODUUWUUWUOOUUWMOUUMUUUUUUUUUUUUUUU P000000000000 0 DO00 0000000000000 M00000000000000000 modo 0d00d00tmPmMn000000 100000000000000 00000000000 00000 10000 0 O DISO 13485 2003 the activities outside the organization JAO000000000 0 00 0000000000 000 00000006MO0OO0O0O0 DODODDODD 0000 00000000000 10000000000 000 00000 000000000
17. 0000 000000000O000U0 0000 0006000000000 000 1000 MOUUUWMOW U I I NANA II II I UD 1 00000000000000000000060000000000 mm mm a gt O DO 000000 00000000 000000000U0O000 0 00000000 000000000 m0000mo0000000
18. J 000M6M000000U0 Co PO O O O work instructions 07100000 Owork 00060000 0000000 instructions OO O O O 0 0150 9001 22000 O O 0 0 I II DD instructions I O O0 O I UE 00000000000 1 0 0000 1000000000000000000000000000000 0092 Dworkinstructions 70000 10000060000M0000000000 0000000 0000000 IIUnnuununuuunuuunugnnnnnunnnnuununoutnm 00000000000000000000000000000000 Co E E E 10000000000000000 0109 J000060U00000 JODDOOD 0000000000000 IL I 4 UD UD UI I I Ui I I EL J100000000
19. 0000000000 I Ui ru I I UD II O DI DO 0 CU ED O DI OI UI bold 000000000000000000 00000000000000 P0 M000000 00000 100000 000000000000000000M0MO0OO0O0O000 000000000000 000000000000000000000000000000 We 01000000000000000000000000000000 000 1000000000000000000000000000000U0000 100000000000U000000000000 dq00 000000000000 000 0000000000 l p400000000000000 UD 00000 400000000000 0000000000 po00000000000 0000 DD 00000 0000 0000000000000 JOQdD0 00000000000 000 000000000 018 cause the medical device 100000
20. 00040000000 0000 000 M0000000000 0000150000000 0000 00matan1 O0 0 0 0 0000 0 0m 0O O 00M6M000000000000000000000U00U000 IOOUUUUUUU 0000000 000000000000 100000000000 00000 00000000000000000 Po0000000000000 40000000000 0000000 0000000000 000000000 000000000000 00000 00000000000 0000000 go 0000000000000 0000000000000 00000 1000000000000000000 01 15013485 20037 0 U JOUDODODODOO 00000000000000000000 J0000000000 o 00000000000 0000000000 1000000 00000mM0000000
21. B ODO 000000 00000000000 M0 M000 OD0000000000 00000000 0000000 15013485070 00000000 JOOMOODOOODUODODOUD 0000000000 O 0000 top management ID DDI 00000000 DOO0Mo0o00000 customer 00000 0000000000000 2000000 000000000 00000000000000000 0 000000000000U0000000000U0 000 00000000000000 0000 15013485 NOTE GMPOO O 0 O 00000000000000000000000000000000000 100000000000000000000000000000000 00 po000
22. Co CI CI CI Co E gt aa o A DI E DI Co CI Co Co Co ou 100000000000000 0000000 0000 ISO13485 2003 D 0 customer 00000000000M6M LD 1000000000M6O000 000000000 00 0 00 10000000 00 00000 000 JOOOODOUOOOUODODUD DD O UU DI DID UI 0000 DODOOD ODO 000000 00000000000000 LU LIU UI I I gt l I UL UU UI I I 000000
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