04 ISO13485：2003規格の解釈
Contents
1. aa a go Du n n LC DI 1 EJ 05 lt D D D 00000000000000000 Q0000000000000000000 31 LILI 000000000000000000000000000000000 0 LILI Q000000000000000000000000000000000 ee 0 000000000000000000000000000000000 0 0000000000000000000000000000000000 CERO SERIO LT EEA Ed Q00000000000000000 Q00000000000000000 000 02. 0 00000000000 000000000000 00000000000000000 150100121 00 000000000000000000000000000000 150100122111 0 00000000000000000000000 b 00000000 00000000000000 o 000000000000000000 dj 0000000000000000000000000000 000 00 00000000000000000000000 0 00 0000000000000000000000000000 000000000000000000000000000000 00000 0 00000000000000000000 00000000000 00000000000000000 4 2 4000 0 0000000000000000000000000000000 000000000000000000000000 0 00000000000000000000000000000 1 UUUUUUUUUUUUHUUUUUUUUUUHUUUUUIU 000 2U0000004100000000000000 000000000000000000000000000000000000000000000 0 000000000000000000000000000000000 000000000000000000000000000000000000 Q000000000000000000000000000000000 00000000000 0000000000 000000 0000000000 00000000000 000000000000000000000000000000000000000000000000000 Q000000000000000000
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10. 05 o Oo n 5 m 5 m o g m Do g 5 m D D g a 2 2 27 gt EJE mama lam lami i am og 1 a m 05 g o CGD ER es 52 20 gt o0 OOO m 2 Ea ET o D Oo na S ERE TEPE EEE 02 021 052 a SELE iman mmn ETE SEs Oqo
11. Ll 51 51 g 3 E E E O E 2 ET Iso 9001 20080 000 0000000000000 0000000000000 0000000000000 00000 x 0000 822 ISO 9001 2008 0 Q00 00000000000000000000000000000 J ISZ9911 QMS 00000000 00000000000000000000000 000 0 10 000 00 J1SZ9911 2 QMS0 0000 a 000000000000 0000000000 7100000 2009 500000 00000 200000000000 00000 0000000 000 0 0000000000000000000000000 1152991 0 5 0 0 b 000000000000000000000000000000 000 0 305000000 000 0000000000000000000000000000 00000 x 000000000000000000000000000000000 0000 00 00000 00000000000000000000000000000000 0000000000 000 00000000000000000000000000000 0000000000000 0000000600000 0000000000000 0000000000000000000 42400000000 0 0000000000000 0000000 00000000 0000000000 0000000000000 0000000 U Q0000000000000000000000000000000 Q00000 0000000000000 0000000000 8 5 2 00
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50. UUUUUUUUUUUUI 0000 70000000000000000000 0000000 422 8 888 8 UUUUUUUUUUUUUUUU 000 41 7000000000 00000 00000 UU 00000 07 00000000000 IJ000004040000040040004004400004004U RINE IRR IRR IRR IRR IR IRR IRIN UUUUUUUUUUUUUUUUUUUUUUUUUUUU OOO UU LOOOOOOOOOOOOOO0OOOO LOOOOOOOOOOOO 00000000000 0000000000 00000 00000 l j E LH L O A l 1 00000 x 60 0 0 15013485 1 000000000000 000000000000 000000 0000000000 QMS 000000 700000 300000000000 500000000000 00000000000 00 N oo lt 00000 0000000000000 0000000000000 0000000000000 0000000000000 2 0000 UUUUUUUUUUUUUUUUUUUUTIUUUUUUUUUNUI UUUUUUUUUUUUUUUUUUUUUUUUUUDUTIUUUI UUUUUUUUUUUUUUUUUUUUUUDUTIUUUUUUUNUI UUUUUUUUUUUUUUUID 150 9000 2008 0 00000000000 000000 00000 u 6150134850 0 0 0 01500 econo 20 2001000 0000000000000 00
51. ea 355 00 a Sco see nu N 200 2 5 Do nl 33 o 1 3 255 OOo o0 og SUO oN 355 5 E 5 5 G f m 3 Do GO 5 E Do Do s s og E OOo SS Do 28 75 0000000000 150 9001 2008 DDD 751 0000000000000 x 7 5 11 x 000 00000000000000 000000000000000 D00000000 00000000000000 000000000 a D00000000000000000 00000000000 b 10000000 0000000000000000000000 0000000000000 000000000000000000000000 000000000000 o 0000000000000 0000000000000 000000000000000 0000000 000000000 000 00000000000000000000 0000000000000 9 0000000000000000000000000000000 000000 0000000 000000000000 9 0000000000000000000000000 0000000 00000000000
52. u 00000000000000000000000000000 UUUUUUUUTUUUUUUUUUUUUUUUUUUUHUNI UUUUUUUUUD 423 000000000000000000000000000000 0000000000000 4 240000000000000000 0000 00000000000000 00000000 90000000 20000 4000000000000000000000000 bd 00000000000 000000000 O00000000000000000000000000 9100000000000 000000 000000000000 eq 0000000 0000000000000000000000 90000000000000000000000 00000000 Q000000000000 90000000000000000000000000000000 UUDTUUUUUUUUUUUUUUUUUUUUUUUUUHUNI UU UUUUUUUUUUUUUUUUUUUUUUUUUHUNUI UUUUUUUUUUUUUUUUUNI UUUUUUUUUUUUUUUUUUUUUUUUUUUDUUNI TJJIUUUUUUUUUUUUUUUUUUI UUUUUUUUUUUUUUUUUUUUUUUUUUUUUUI UUUDUUUUUUUI 42400000 UUUUUUUUUUUUUUUUUUUUUUUUUUUUUINI 0000 ISO 9001 2008 0 2000000000 EN 2 00000000000 00000 x 0000000000000 000000000000 00000000000 000000000000 000000000000 2 0000000000000 0000000000000 0 0 0000000000000 150 9001 20080000 aAD000000000000 000 0000000000000 x 1101111 2 O Im gO S00000045 200000000000000 0000000000000000000000000000000000 09 500000000000000000000000 00000 00000 000
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