GOST R 54421-2011 Guidelines for regulatory auditing of quality management systems of medical device manufacturers Part 1 General requirements《医疗设备制造商的质量管理体系的常规审核指南 第1部分 通用要求》.pdf

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1、 1 GHTF/SG4/N28R4:2008Guidelines for regulatory auditing of quality management systemsof medical device manufacturers Part 1: General requirements(MOD) 544212011(GHTF/SG4/N28R4:2008) 27 2002 . 184- , 1.02004 . 1 , 42 436 - 3 28 2011 . 352-4 (Global Harmonization Task Force GHTF) - . 1. (GHTF/SG4/N28

2、R4:2008 Guidelines for regulatoryauditing of quality management systems of medical device manufacturers Part 1: General requirements) , - ( 3.1, 3.15, 3.17), , - . 3 4 , , 1.02004, , 1 . - . GHTF . - () -, 5 - , - . () . - , , 2012 , - - II 5442120111 12 13 24 , 34.1 34.2 44.3 , 44.4 .45 .55.1 55.2

3、.55.3 .56 .56.1 56.2 56.3 .67 .77.1 77.2 .77.3 -.97.4 , 117.5 .137.6 .147.7 .197.8 .19 () GHTF/SG4/N28R4:2008 . 1. 20 () GHTF/SG4/N28R4:2008 . 1. 21 () , .22 544212011III - . 1. (GHTF) , - . , - . , 13485, - ( ), , , -. - . /-, , , , :- - ( );- , , - ;- ( ) - , . .IV 544212011 1 Guidelines for regul

4、atory auditing of quality management systems of medical device manufacturers.Part 1. General requirements 201301011 , - , , - . , -, , . , - , .2 : 548812011 . 3. (GHTF/SG4/N33R16:2007, MOD) 548822011 . 2. (GHTF/SG4/N30R20:2006, MOD) 90002008 . ( 9000:2008, IDT) 134852004 . . - ( 13485:2003, IDT) /

5、170212008 . , (/ 17021:2006, IDT) 190112003 / ( 19011:2002, IDT) - - , 1 - , , . (), - () . -, , , , .1 544212011(GHTF/SG4/N28R4:2008)3 :3.1 () (audit): , - ( 9000; 3.9.1). - - .3.2 (audit criteria): , , ( 9000; 3.9.3). (. 9000; 3.9.4).3.3 (audit evidence): , , ( 9000; 3.9.4). / - .3.4 () (audit fin

6、dings): - ( 9000; 3.9.5). .3.5 (audit language): (), () - .3.6 (audit program): , - ( 9000; 3.9.2). , -, .3.7 (auditee): , , . / . 9000, 3.9.8, -, .3.8 , (auditing organization): , - -.3.9 (auditor): , , - , . 9000, 3.9.9, , .3.10 ( ) (compliance): -.3.11 (conformity): ( 9000; 3.6.1).3.12 (establish): (), ( ) .2 544212011 13485 (-, ), - .3.13 (lead auditor): , - ( 9000; 3.9.10, 1).3.14 (manufacturer): , -, , / , / -, , . - (, , ). , . , - , .3.15 (nonconformity): ( 9000; 3.6.2). (, ).3.16 (objective evidence): , - ,

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