Journal of Korean Society for Quality Management (품질경영학회지)

Korean Society for Quality Management (한국품질경영학회)
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Comparative Study of ISO Standards for an Effective Implementation of the Domestic Medical Device GMP System

ISO 국제표준의 비교 연구를 통한 국내 의료기기 GMP 제도의 효과적인 운영 방안

  • Jung, Young A (Dept. of Management of Technology, Graduate School, Pukyong National University) ;
  • Kim, Young Jin (Dept. of Technology Management, Graduate School of MOT, Pukyong National University)
  • 정영아 (부경대학교 일반대학원 기술경영협동과정) ;
  • 김영진 (부경대학교 기술경영전문대학원 기술경영학과)
  • Received : 2018.03.21
  • Accepted : 2018.04.23
  • Published : 2018.06.30
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Abstract

Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.

Keywords

References

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