GMP 제도가 의료기기산업의 경쟁력에 미치는 영향에 관한 연구
A Study on Competitiveness of Medical Device Industry by GMP System Certification.
- 주제(키워드) GMP
- 발행기관 아주대학교
- 지도교수 장중순
- 발행년도 2011
- 학위수여년월 2012. 2
- 학위명 석사
- 학과 및 전공 산업대학원 산업시스템공학과
- 실제URI http://www.dcollection.net/handler/ajou/000000012282
- 본문언어 한국어
- 저작권 아주대학교 논문은 저작권에 의해 보호받습니다.
초록/요약
2004년 의료기기법의 시행에 따라 2007년 5월 30일부로 국내 의료기기산업에도 일본, 캐나다, 유럽 등 의료기기 선진국과 같은 의무적 GMP 인증제도가 도입되었다. 경제발전과 인구의 고령화 등에 따라 삶의 질 향상을 위한 의료수요가 증가하면서 전문 의료인은 물론 일반 국민들이 사용하는 의료기기 또한 증가하고 있다. 의료기기의 사용대상은 정상인이 아닌 환자나 노약자 등으로 다른 공산품보다 더욱 강화된 안전성과 유효성의 확보가 필요하다. 또한 경제시장의 글로벌화에 따라 공정한 국제무역을 위해서 각 국가들은 WHO 및 GHTF 등의 국제기구를 통해 의료기기 관리제도를 국제적으로 조화시키는 작업을 추진하고있다. 국내 의료기기산업은 의료선진국에 비해 그 규모나 기술역량이 영세한 수준을 면하지 못하고 있는 것이 현실이다. 하지만 의료기기산업은 정부에서 차세대 육성산업으로 지정 및 육성하는 신성장 동력산업으로 수요와 관심이 증가하고 있는 산업이다. 이러한 산업적 특성 및 사회적 요구에 따라 의료기기산업의 경쟁력을 강화하고 선진관리체계의 구축을 위해 의무적으로 도입된 GMP 적합성 평가제도가 의료기기 제조업체의 경쟁력에 어떠한 영향을 미치고 있는지 연구하였다. GMP 제도는 2003년 의료기기법 제정 이전의 약사법 하에서 권장제도로 시행되었지만 그 당시의 GMP 품질시스템 요구사항은 국제규격과 정합도가 미흡했고 인증을 받은 기업도 메디슨과 솔고바이오메디칼 등 국내 의료기기산업의 선도업체라 할 수 있는 소수업체에 불과했다. 따라서 2004년 의료기기법의 시행에 따라 국제규격을 준용한 GMP 제도가 의무적으로 시행된 이후 GMP 인증을 받은 의료기기 제조업체를 대상으로 GMP 제도가 기업경쟁력에 미치는 영향을 연구하기 위해 GMP 적합 인정을 획득한 144개 업체의 설문조사결과를 분석하였다. 또한 국내 의료기기산업의 영세적 특성에 따라 그 영향이 상이한지도 조사하였다. 설문 응답결과는 평가요인에 따라 회귀분석 및 분산분석을 실시하였다. 통계분석결과 GMP 제도는 기업경쟁력에 정(+)적인 영향을 미치는 것으로 나타났다. 하지만 통합적으로 검증하였을 때는 품질과 기술경쟁력에는 유의한 영향을 미치지만 재무 및 영업경쟁력에는 그 영향이 미미한 것으로 나타났다. 또한 GMP 품질시스템의 요구사항 각 항목은 유의수준 0.05에서 기업경쟁력에 전반적으로 긍정적인 영향을 미치는 것으로 나타났다. 하지만 전체적인 관점에서는 경영자의 책임 및 제품실현 항목만이 기업의 경쟁력 향상에 유의한 영향을 미치고 품질시스템, 자원관리, 측정·분석 및 개선 항목은 그 영향력이 미미한 것으로 나타났다. 그리고 국내 의료기기 제조업체의 인원, 생산금액, 취급품목의 위험도와 품질관리체계에 따른 영향의 차이를 분석한 결과 이러한 기업의 규모나 특성에 관계없이 GMP 제도가 기업경쟁력에 미치는 영향이 유사하다는 연구가설이 검증되어 GMP 품질시스템 요구사항 및 인증제도는 업체의 규모나 특성에 따라 그 성과가 다르지 않다는 것을 확인하였다. 결론적으로 의료기기 GMP 제도는 의무적 인증제도임에도 불구하고 기업의 경쟁력 향상에 긍정적인 영향을 미치고 있는 것으로 분석되었다. 연구결과에 의하면 의료기기 GMP 제도는 의무적으로 적용해야 하는 제도적 문제가 아니라 기업이 경영성과의 개선을 위해 반드시 도입해야 하는 경영기법임을 보여주고 있다. GMP 제도는 비록 법적인 강제사항으로 도입되었지만 이를 통해 기업의 경쟁력을 강화하고 경영성과가 개선되도록 운용하는 것은 이제 의료기기 제조업체의 몫이다. GMP 제도를 주관하고 관리감독하는 식품의약품안전청에서도 규제를 위한 관리목적뿐만 아니라 국내 의료기기산업이 국제적인 경쟁력을 갖추도록 지원하고 육성하는 목적 또한 달성하도록 연구발전시켜야 할 것이다. 이제 국내 의료기기산업은 국제수준의 GMP 품질시스템 요구사항을 기반으로 품질경영시스템이 수립되어 있으므로 실질적인 실행과 유지·개선을 통해 국내 의료기기산업이 차세대 국가성장 동력산업으로 거듭나는 글로벌산업이 되길 바란다.
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요약문 ····························································································· ⅰ
목차 ································································································· ⅲ
그림 차례 ························································································ ⅴ
표 차례 ···························································································· ⅵ
제1장 서론 ······················································································· 1
제1절 연구개요 ··············································································· 1
1. 연구의 필요성 ············································································ 1
2. 연구목적 ····················································································· 5
제2절 연구의 대상 및 범위 ·························································· 6
제3절 연구의 방법 및 구성 ·························································· 7
제2장 이론적 고찰 ········································································· 9
제1절 선행연구 조사 ····································································· 9
1. 의료기기 관련 선행연구 ·························································· 9
2. 품질경영과 경쟁력에 대한 선행연구 ··································· 15
제2절 의료기기 GMP 제도 고찰 ··············································· 22
1. 의료기기 GMP 제도의 개요 및 발전과정 ··························· 22
2. 국내 GMP 제도의 주요내용 ················································· 28
3. 국내 GMP 제도의 변화과정과 문제점 ································ 33
4. GMP 규격과 기타 품질경영시스템 규격 ···························· 36
제3절 문헌 및 선행연구 검토 결과 ··········································· 44
제3장 연구 설계 ··········································································· 45
제1절 연구모형 및 가설설정 ····················································· 45
1. 연구모형 ·················································································· 45
2. 가설 설정 ················································································· 48
제2절 변수의 조작적 정의 및 측정 ·········································· 55
1. 기업 경쟁력의 정의 및 측정 ················································· 55
2. GMP 품질시스템의 정의 및 측정 ········································ 57
3. 기업 형태의 정의 및 측정 ····················································· 59
제3절 표본설계와 분석방법 ······················································ 60
1. 표본의 설계 ············································································· 60
2. 자료수집 ·················································································· 60
3. 자료의 분석방법 ····································································· 61
제4장 자료 분석과 가설검증 ···················································· 62
제1절 표본기업의 현황 ······························································ 62
1. 표본기업의 일반현황 ····························································· 62
2. 표본기업의 품질관리체계 현황 ··········································· 64
제2절 신뢰성과 타당성 검증 ···················································· 72
1. 신뢰성 분석 ············································································ 72
2. 타당성 분석 ············································································ 75
제3절 가설검증 ·········································································· 78
1. GMP 인증 후 기업경쟁력 분석 현황 ································· 78
2. GMP 품질시스템과 기업경쟁력 ········································· 84
3. 의료기기산업의 특성과 GMP 품질시스템 ······················· 91
4. 의료기기산업의 특성과 기업경쟁력 ································· 95
5. 기업의 품질체계와 GMP 품질시스템 ······························· 98
6. 기업의 품질체계와 기업경쟁력 ········································ 102
제4절 연구결과 및 가설검증 요약 ········································ 106
1. GMP 제도가 경쟁력에 미치는 영향 ································ 106
2. GMP 요구사항과 경쟁력에 관한 연구가설 검증결과 ··· 107
제5장 결론 ················································································ 110
제1절 연구의 결과 ··································································· 110
제2절 연구의 전략적 의의 ······················································ 111
제3절 연구의 한계 및 향후 연구과제 ··································· 112
<참고문헌> ··············································································· 114
<설문지> ··················································································· 117
<감사의 글> ·············································································· 123
