제 1조 목적 ··········································································································· 1
제 2조 정의 ··········································································································· 4
제 3조 적용범위 ··································································································· 5
제 4조 적합성인정등 기준 ················································································· 6
제 5조 적합성인정등 구분 ················································································· 8
제 6조 적합성인정등 심사 ················································································· 9
제 7조 적합성인정등 신청 ··············································································· 17
제 8조 적합성인정등 절차 ··············································································· 28
제 9조 적합인정서 유효기간 ··········································································· 32
제10조 적합인정서 재발급 등 ········································································· 33
제11조 적합성인정등 표시 ··············································································· 35
제12조 품질관리심사기관 업무 ······································································· 35
제13조 품질관리심사기관 지정 평가 ····························································· 36
제14조 품질관리심사기관 관리운영기준 등 ················································· 37
제15조 보고 ········································································································· 39
제16조 품질관리심사기관에 대한 지도․점검 등 ······································ 40
제17조 품질책임자 교육실시기관 지정 기준 ··············································· 40
제18조 품질책임자 교육실시기관 지정 평가 ··············································· 41
제19조 품질책임자 교육실시기관 지정 공고 ··············································· 42
제20조 교육내용 ································································································· 42
제21조 품질책임자 교육실시기관장의 준수사항 등 ··································· 43
제22조 품질책임자 교육실시기관에 대한 지도․점검 등 ······················ 44
제23조 규제의 재검토 ····················································································· 44
[별표 1] 용어의 정의 ························································································ 45
[별표 2] 의료기기 적합성인정등 기준 등 ·················································· 52
1. 목 적 ········································································································· 52
2. 적용 범위 ··································································································· 53
3. 인용규격 및 용어의 정의 ······································································· 54
4. 품질경영 시스템 ························································································· 55
4.1 일반 요구사항 ·························································································· 55
4.2 문서화 요구사항 ······················································································ 60
5. 경영책임 ······································································································· 75
5.1 경영의지 ···································································································· 75
5.2 고객중심 ···································································································· 77
5.3 품질방침 ···································································································· 78
5.4 기획 ············································································································ 79
5.5 책임과 권한 및 의사소통 ······································································ 81
5.6 경영검토 ···································································································· 86
6. 자원관리 ······································································································· 91
6.1 자원의 확보 ······························································································ 91
6.2 인적 자원 ·································································································· 94
6.3 기반시설 ···································································································· 97
6.4 작업환경 ·································································································· 100
7. 제품실현 ····································································································· 106
7.1 제품실현의 기획 ···················································································· 106
7.2 고객 관련 프로세스 ·············································································· 113
7.3 설계 및 개발 ·························································································· 118
7.4 구매 ·········································································································· 138
7.5 생산 및 서비스 제공 ············································································ 146
7.6 모니터링 및 측정 장비의 관리 ·························································· 186
8. 측정, 분석 및 개선 ·················································································· 191
8.1 일반 요구사항 ························································································ 191
8.2 모니터링 및 측정 ·················································································· 192
8.3 부적합 제품의 관리 ·············································································· 206
8.4 데이터의 분석 ························································································ 211
8.5 개선 ·········································································································· 213
[참고 1] 의료기기 GMP 시정 및 예방조치 항목심사 지침 ··············· 221
[참고 2] GMP 관련 가이드라인 현황 ····················································· 263
[별표 3] 의료기기 GMP 품목군 ·································································· 281
[별표 4] 적합성인정등 심사 주체 ································································ 286
[별표 5] 적합인정서 발급 및 관리 ······························································ 287
[별표 6] 적합인정등 표시 ·············································································· 289
[별표 7] 의료기기 품질관리심사기관 평가기준 ········································ 290
[별표 8] 의료기기 품질관리심사기관 관리운영기준 ································ 296
[별표 9] 품질책임자 교육실시기관의 지정 기준 ······································ 303
≪별첨자료≫ ·································································································· 312
1. 체외진단용 의료기기 위험관리 지침 ISO 14971 Appendix H(번역본)
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