GOST R 54882-2011 Guidelines for regulatory auditing of quality management systems of medical device manufacturers Part 2 Regulatory auditing strategy《医疗设备制造商质量管理系统的监管审计指南 第2部分 监管审.pdf

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1、 2 GHTF/SG4/N30R20:2008Guidelines for regulatory auditing of quality management systems of medical devicemanufacturers Part 2: Regulatory auditing strategy(MOD) 548822011(GHTF/SG4/N30R20:2008) 27 2002 . 184- , 1.02004 . 1 - , 42 436 - 3 13 2011 . 1189-4 (Global Harmonization Task Force GHTF) -. 2. (

2、GHTF/SG4/N30R20:2008 Guidelines for regulatory auditing of qualitymanagement systems of medical device manufacturers Part 2: Regulatory auditing strategy) - , (- 3.1; 3.3; 3.7), , . 4 , - , 1.02004, , 1 . , - 1.02004 ( ). - A. GHTF . - () -, . 2010 ., , GHTF, , - , 5 - , - . () . - , , 2012 , - - II

3、 5488220111 12 13 24 34.1 34.2 .34.3 .44.4 .54.5 54.6 .54.7 - 74.8 85 .85.1 95.2 .95.3 .115.4 115.5 125.6 .135.7 .145.8 , .14 () 15 () , 17 () 13485:2003 21 CFR, 820 .18 D () 22 () .23 A () GHTF/SG4/N30R20:2006 . 2. .24 () GHTF/SG4/N30R20:2006 . 2. .25 D () , .26 27 548822011III - . 2. (GHTF) , - .

4、, - . - . - , :- , ;- - , , , ;- ;- , , , - ;- , ;- , . - :- , ;- , , - ;- , -;- , , , - . , , -, - , .IV 548822011 2 Guidelines for regulatory auditing of quality management systems of medical device manufacturers.Part 2. Regulatory auditing strategy 201301011 , - (. 13485). -, , -, , , , . , , - .

5、 , , , , . , , 54421, , - GHTF SG4 , . , .2 : 40.0032008 . . 90012008( 9001:2008) 539182010 . - (GHTF/SG3/N15R8:2005, IDT) 544212011 . 1. (GHTF/SG4/N28R4:2008, MOD) 90002008 . ( 9000:2008, IDT) 134852004 . . - ( 13485:2003, IDT) / 149692007 . . - 13485:2003 (/ 14969:2004, IDT)1 548822011(GHTF/SG4/N3

6、0R20:2008) 149712010 . - ( 14971:2007, IDT) / 170212008 . , - (/ 17021:2006, IDT) 190112003 / ( 19011:2002, IDT) - - , 1 - , , . (), - () . -, , , , .3 :3.1 () (audit): , - - ( 9000; 3.9.1).3.2 (regulatory audit): - . -.3.3 (audit criteria): , , ( 9000; 3.9.3).3.4 (audit evidence): , , ( 9000, 3.9.4). / - .3.5 , (auditing organization): , - -.3.6 (establish): (), ( ) . 13485 (-, ), - .3.7 (medical device): - .3.8 (process): -, ( 9000, 3.4.1).3.9 (residual risk): , - ( 14971, 2.15).3.10 (risk management): , , ,

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