GOST R 55748-2013 Guidelines for regulatory auditing of quality management systems of medical device manufacturers Part 4 Multiple site auditing《医疗设备制造商质量管理系统的监管审核指南 第4部分 多个现场审计》.pdf

1、 55748 2013 4 GHTF/SG4/N83:2010 Guidelines for regulatory auditing of quality management systems of medical device manufacturers Part 4: Multiple Site Auditing (MOD) 2014 557482013 II 1 - , 4 2 436 - 3 8 2013 . 1494- 4 - (Global Harmonization Task Force GHTF) GHTF/SG4/N83:2010 - . 4. - (GHTF/SG4/N83

2、:2010 Guidelines for Regulatory Auditing of Quality Management Sys-tems of Medical Device Manufacturers Part 4: Multiple Site Auditing) 3 4 , , 1.0, , 1. - . GHTF - . - , -, . 5 1.02012 ( 8). ( 1 ) , -. () - . , (gost.ru) , 2014 , - 557482013 III -, . - 54882. - : - - ; - ; - , - . : - - ; - ; - - .

3、 55748 2013 1 4 Guidelines for regulatory auditing of quality management systems of medical device manufacturers. Part 4 Multiple site auditing 2015 01 01 1 , , , , - (. 3.5) , . , , . - . (. 557472013 (GHTF/SG4/N84:2010). , - , , . 2 : 544212011 - . 1. - (GHTF/SG4/N28R4:2008, MOD) 548822011 . 2. (G

4、HTF/SG4/N30R20:2008, MOD) 548812011 . 3. - (GHTF/SG4/N33R16:2007, MOD) 557472013 (GHTF/SG4/N84:2010) - . 5. GHTF/SG1/N055:2009 / , - , / - , 1 , - , , . -, , - (). -, , , , , . 557482013 2 , , , , - . 3 : 3.1 (audit program): , - (- ISO 90002011, .3.9.2). , -, . 3.2 (centralized function): -, , ( ).

5、 3.3 (common function): , - , . 3.4 (lead site): , - -. - , . - . 3.5 (manufacturer): , -, , / , / , GHTF/SG1/N055. 3.6 (manufacturer with multiple sites): , . 3.7 (site): ( ), - . 3.8 (overall lead auditor): , ( ISO 90002011, .3.9.10, 1). 4 - , - , - . - . . 544212011 ( 7) 548822011 (.4.3, 4.6 5),

6、. 557482013 3 1 - (4) - (4.1) (4.2) (5.3) (5) (5.1) (5.1.1) (5.1.2) (5.1.3) (5.2) (5.3) (6) (7) (5.1.4) 557482013 4 4.1 - , - . (. 544212011, .7.1 7.6.2). . (. 544212011, .7.1). 4.1.1 : - . ; - , - ; - - , , , , , , . . 544212011, .7.1.1. 4.1.2 : - , ; - , - . . 544212011, .7.6.2.2. 4.2 , , , : - , , -, ; - , -; - (), () ; - . ( ), , , , : - ; - , ; - ; - ( ); - ; - ; - ; - ; -