의료기기 제조 및 품질관리기준 ····························································· 1 제 1조 목적 ····································································································· 3 제 2조 정의 ··································································································· 11 제 3조 적용범위 ··························································································· 12 제 4조 적합성인정등 심사 구분 ······························································· 15 제 5조 적합성인정등 심사 기준 ······························································· 17 제 6조 적합성인정등 심사 방법 ······························································· 19 제 7조 적합성인정등 심사 신청 ······························································· 30 제 8조 적합성인정등 심사 절차 ······························································· 76 제 9조 적합인정서 유효기간 ····································································· 88 제10조 적합성인정서 재발급 등 ······························································· 89 제10조의2 적합인정서 반납 ······································································ 92 제11조 적합성인정등 심사 표시 ······························································· 94 제12조 품질관리심사기관 업무 ································································· 95 제13조 품질관리심사기관 지정 평가 ······················································· 96 제14조 품질관리심사기관 관리운영기준 등 ··········································· 97 제15조 보고 ··································································································· 99 제16조 품질관리심사기관에 대한 지도․점검 등 ·································· 100 제17조 품질책임자 교육실시기관 지정 신청 ······································ 101 제18조 품질책임자 교육실시기관 지정 평가 ······································ 102 제19조 품질책임자 교육실시기관 지정 공고 ······································ 103 제20조 교육내용 ························································································ 103
제21조 품질책임자 교육실시기관장의 준수사항 등 ·························· 104 제22조 품질책임자 교육실시기관에 대한 지도․점검 등 ·················· 105 제23조 규제의 재검토 ············································································ 106 [별표 1] 용어의 정의 ··············································································· 107 [별표 2] 의료기기 적합성인정등 기준 ················································· 115 1. 목 적 ································································································· 117 2. 적용범위 ····························································································· 118 3. 용어의 정의 ······················································································· 119 4. 품질경영시스템 ··················································································· 119 4.1 일반 요구사항 ················································································· 119 4.2 문서화 요구사항 ············································································· 133 5. 경영책임 ······························································································· 149 5.1 경영의지 ··························································································· 149 5.2 고객중심 ··························································································· 151 5.3 품질방침 ··························································································· 152 5.4 기획 ··································································································· 154 5.5 책임, 권한 및 의사소통 ································································ 157 5.6 경영검토 ··························································································· 161
6. 자원관리 ······························································································· 166 6.1 자원의 확보 ····················································································· 166 6.2 인적자원 ··························································································· 167 6.3 기반시설 ··························································································· 170 6.4 작업환경과 오염관리 ····································································· 172 7. 제품실현 ······························································································· 178 7.1 제품실현의 기획 ············································································· 178 7.2 고객 관련 프로세스 ······································································· 181 7.3 설계 및 개발 ··················································································· 185 7.4 구매 ··································································································· 212 7.5 생산 및 서비스 제공 ······································································ 222 7.6 모니터링 및 측정 장비의 관리 ···················································· 248 8. 측정, 분석 및 개선 ············································································ 251 8.1 일반 요구사항 ················································································· 251 8.2 모니터링 및 측정 ··········································································· 255 8.3 부적합 제품의 관리 ······································································· 269 8.4 데이터의 분석 ················································································· 277 8.5 개선 ··································································································· 282 9. 의료기기 적합성인정등 심사표 ······················································· 293
[별표 3] 의료기기 GMP 품목군 ···························································· 313 [별표 4] 적합성인정등 심사 주체 ························································· 321 [별표 5] 적합인정서 발급 및 관리 ······················································· 325 [별표 6] 적합성인정등 표시 ··································································· 329 [별표 7] 의료기기 품질관리심사기관 평가기준 ································· 333 [별표 8] 의료기기 품질관리심사기관 관리운영기준 ························· 341 [별표 9] 품질책임자 교육실시기관의 지정 기준 ······························· 351 ≪참고문헌≫ ································································································· 367