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- ひとお なかきむら
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1 ISO9001QMS
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4 I 1. 2 EBMEvidence Based Medicine 1
5 TQM To err is a human Don Berwick 7 7 5% 2
6 R&D 2. ISO 9000 ISO 9000 ISO ISO 9001 ISO 9001 ISO 9000 ISO 9001 ISO
7 ISO 9001 ISO 9001 (1995) ISO
8 II
9 Fact Control ( ) PDCA Plan Do Check Act ( ) PDCA PDCA C 6
10 Plan do check action 4 1 Plan Do Check Action : : ( ) 23 Plan Action Check Do 2 7
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15 A A
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20 / / Software Hardware Environment Liveware 8 SHEL SHEL SHEL 17
21 SHEL 1 Soft 2 Hard SHEL
22
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25 ISO9000 ISO ISO ISO ISO9001 ISO ISO9001 ISO
26 ISO9001 peer evaluation 1 2 ISO QC QC 1 QC QC
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