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ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
- CUSTOMER
- ABOUT ICMC
- DOMESTIC RA
- GLOBAL RA
-
ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
ICMC NEWS & LIBRARY
ICMC (International Certification Management Center Co., Ltd.)
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(주)맥코이의 식약청(KFDA)의료기기 GMP(KGMP)인증 컨설팅을 진행함.
- Admin Hits:3039
- 2008-01-08 13:06:00
| 식약청(KFDA) 의료기기법에 따라 모든 기업은 의료기기 제조및 수입품질관리기준적합인정(GMP/GIP인정)을 받아야 제품판매를 할 수가 있습니다. 2008년 현재까지 KGMP인증 받지 못한 기업이 (주)해외인증경영센터-ICMC에 의뢰를 요청하고 있습니다. 최근 이온수기제품(식약청 의료기기 품목 및 등급분류기준에 따라 의료용품질생성기)을 생산하는 국내유명기업에 대하여 GMP컨설팅을 착수 하였습니다. 2008년에 식약청 의료기기 GMP심사시 요구사항중 위험관리(RISK MANAGEMENT)와 소프트웨어 밸리데이션(SOFT WARE VALIDATION)를 중점적으로 점검하고 있습니다. 의료기기 관련 기업들은 이 점을 특별히 유념하여 GMP준비를 하여야 합니다. |
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- Company : ICMC (International Certification Management Center Co., Ltd.)
- CEO : Bong Ju Kim
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