Journal of Korean Society for Quality Management (품질경영학회지)

Korean Society for Quality Management (한국품질경영학회)
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A Study on the Development and Effectiveness of ISO13485:2016 Education Programs for Domestic Medical Device Manufacturers

국내 의료기기 제조업체의 ISO13485:2016 교육 프로그램 개발 및 교육 효과 연구

  • Lee, Seul-Bi (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Kang, Giho (Siemens Healthineers Ltd.) ;
  • Jang, Wonseuk (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Kwon, Byeong-Ju (Department of Medical Device Engineering and Management, Yonsei University College of Medicine)
  • 이슬비 (연세대학교 의과대학 의료기기산업학과) ;
  • 강기호 (지멘스헬시니어스(주)) ;
  • 장원석 (연세대학교 의과대학 의료기기산업학과) ;
  • 권병주 (연세대학교 의과대학 의료기기산업학과)
  • Received : 2022.08.01
  • Accepted : 2022.09.02
  • Published : 2022.09.30
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Abstract

Purpose: As ISO 13485 was revised in 2016, the domestic GMP (Good Manufacturing Practice) system was also revised and implemented in 2019. However, there are many problems in the domestic medical device industry because most of the small and medium-sized enterprises lack human and material resources. Accordingly, this study was conducted to provide education programs for domestic medical device companies to induce information provision and improve the company's quality management ability. Methods: First, analyze existing education. Second, based on the revised GMP system, a survey paper was produced to investigate difficulties and problems experienced by companies. Third, a two-week survey was conducted on domestic medical device manufacturers, and a total of 77 companies responded to this survey. Fourth, educational program development was conducted based on the results of the survey. Results and Conclusion: The developed education program consists of a total of five sessions. In this study, the educational program developed by grasping the needs of the company through a survey consists of a total of five sessions. The first session consisted of theoretical education and the second to fifth sessions of practical education. Through the education program developed in this study, it is expected to contribute to the overall development of medical device quality by establishing a domestic medical device manufacturing environment that secures the safety and performance of domestic medical device companies.

Keywords

Acknowledgement

이 논문은 2021년도 식품의약품안전처 '최신 의료기기 품질관리 국제기준 도입을 위한 기술지원'사업 추진 시 수행된 연구임

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