国外著名审核机构ISO13485的讲义.pptVIP

* 40 Competence. Certainty. Quality. ISO13485 ISO13485:2003 ISO9001 ü TüV SüD China ISO13485 TUV SüD China ISO13485—— 29 18 ISO/TC210 Quality management and corresponding general aspects for medical devices ANSI hwoehrle@ 17 ISO13485 2003 ISO13485 2003 TUV SüD China ISO13485—— 40 ISO13485 2003 TUV SüD China ISO13485—— 40 ISO13485 2003 27 2003 ISO13485 2003 ISO13485 2005 4 MHLW Ordinance No.169(2004) AIMDD MDD IVDD ISO13485 2003 TUV SüD China CE TUV SüD China J-GMP 1 — — ISO13485—— 40 ISO13485 2003 ISO13485——