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GOST R 55747-2013 Guidelines for regulatory auditing of quality management systems of medical device manufacturers Part 5 Audits of manufacturer control of suppliers《医疗设备制造商质量管理系统的.pdf

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1、 55747 2013 5 GHTF/SG4/N84:2010 Guidelines for regulatory auditing of quality management systems of medical device manufacturers - Part 5: Audits of Manufacturer Control of Suppliers (MOD) 2014 (GHTF/SG4/N84:2010) 557472013 II 1 - , 4 2 436 - 3 8 2013 . 1493- 4 - (Global Harmonization Task Force GHT

2、F) GHTF/SG4/N84:2010 - . 5. (GHTF/SG4/N84:2010 Guidelines for regulatory auditing of quality management systems of medical device manufacturers Part 5: Audits of Manufacturer Control of Suppliers) . 3 , , 1.0, , 1 - . - . GHTF - . - -, . 5 1.02012 ( 8). ( 1 ) , -. () - . , (gost.ru) , 2014 , - 55747

3、2013 III , - - . - . 544212011 - -. 1. 548822011 - . 2. . , 3 GHTF/SG3/N17 - . . , - . - - -. , , - - (). , , , , ( ) . , - . 557472013(GHTF/SG4/N84:2010) 1 5 Guidelines for regulatory auditing of quality management systems of medical device manufacturers. Part 5. Audits of Manufacturer Control of S

4、uppliers 2015 01 01 1 - . - 54421 54882. , , . . 2 : 54422011 - . 1. - (GHTF/SG4/N28R4:2008, MOD) 548822011 . 2. (GHTF/SG4/N30R20:2008, MOD) 548812011 . 3. - (GHTF/SG4/N33R16:2007, MOD) 557482013 (GHTF/SG4/N83:2010) - . 4. ISO 90002011 . ISO 134852011 . . - , 1 , - , , . -, , - (). -, , , , , . , ,

5、 , - . 557472013 2 3 : 3.1 (supplier): , . ( ISO 9000, 3.3.6) : , , , , . 1 . 2 . , , - . , -. , , 55748. - . 3.2 (manufacturer): , / , , / . (GHTF/SG1/N055) , , , - . 3.3 (critical supplier): , , - , . , - , , , . , , , - , . 4 4.1 -. 54882, GHTF/SG3/N17/2008. , , , , , - (. 4.2). -, -, / . , , ,

6、 , , , - ( ), . , (, ). 1, 55748. ) , ( ISO 13485, .7.4.1): 557472013 3 1) ;2) ;b) , - ( ISO 13485, .7.4.1): 1) ; 2) ; 3) ; 4) ; c) , , , - . ( ISO 13485, .7.4.2). , , : 1) , ; 2) ;3) ;4) , ;d) , ( ISO 13485, .7.4.1): 1) ;2) ( ) (, , - , , .); 3) ;4) ;5) ;e) , ( ISO 13485, .7.4.1): 1) ;2) ;3) . . 4.2 54421, .7.4.4. . . : a) ;b) , , -; : 1) ;2) ;3);4) , -

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