국내 의료기기 제조업체의 ISO13485:2016 교육 프로그램 개발 및 교육 효과 연구
A Study on the Development and Effectiveness of ISO13485:2016 Education Programs for Domestic Medical Device Manufacturers
0
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
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.
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.
참고문헌 (19)
- 최익수, "한의약 의료기기 임상시험 교육 프로그램 개발을 위한 설문조사 연구", 대한한의학회지, 36(3), pp.84~97 (2015), 대한한의학회
- Ham Youngrin, "Development and Evaluation of Simulation Training Program Using High-fidelity patient simulator", PhD, pp.2009
- ISO, "ISO 9001:2015 Quality Management Systems - Requirements", International Organization for Standardization, ~ (2015)
- ISO, "ISO 13485:2016 Medical Devices - A Practical Guide", International Organization for Standardization, ~ (2016)
- 정영아, "ISO 국제표준의 비교 연구를 통한 국내 의료기기 GMP 제도의 효과적인 운영 방안", 품질경영학회지, 46(2), pp.211~224 (2018), 한국품질경영학회[DOI]
- 김희정, "Effects of Instructor's Communication Quality on Learning Flow and Satisfaction of Students: Targeting the Students(Parents) Participating in the Early Childhood Education Programs", 품질경영학회지, 43(2), pp.201~218 (2015), 한국품질경영학회[DOI]
- 김옥태, "조사원 교육 프로그램 개발 및 효율적 운영방안 연구", 인적자원개발연구, 16(1), pp.1~34 (2013), 한국인적자원개발학회
- Kim Youngsook, "December 2021 and annual automobile industry trends (provisional)", Ministry of Trade Industry and Energy, 1~ (2022)
- Biopharmaceutical Industry Trend Report. Chapter 3, "Korea Biomedicine Industry Association", Domestic biopharmaceutical market trends, 24~30 (2020)
- 2020 Medical Device Industry Analysis Report, "Korea Health Industry Development Institute", 1~91, pp.Own-Medical Device-2020-78 (2021)
- Lee Jonggu, "Development of Education Programs in HRPP System", Regulatory Research on Food, Drug and Cosmetic, 10(2), pp.141~153 (2015)
- Ministry of Food and Drug Safety, "Medical Device GMP Comprehensive Manual (Complaint Guide). 6 revision", 1~99 (2021)
- Ministry of Food and Drug Safety, "Statistics on medical device production and import", export performance in 2020. 10. Status of the top 10 production and import, pp.2021, 20~22
- Ministry of Food and Drug Safety, "Enforcement Rule of The Medical Devices Act -Regulations for Product Classification of Medical Device and Class by Product", ~ (2022)
- National Institute of Medical Device Safety Information, "Canadian Medical Device Product Certification Procedure – Medical Device Quality Control", 3~6 (2019)
- 2021 Medical Device Industry Trend Report. Part 2. 2021 Domestic and overseas medical device industry status, "National Institute of Medical Device Safety Information", 33~67 (2021)
- National Institute of Medical Device Safety Information, "Medical Device Regulatory Affair (RA) Expert -Good Manufacturing Practice (GMP)", pp.3~231 (2021), Joeunchaekchaoreum
- 백우현, "우리나라 GMP 변천사", 약 학 회 지, 59(1), pp.40~46 (2015), 대한약학회
- 유홍성, "창업인턴십교육 서비스 품질이 창업역량과 창업의지에 미치는 영향", 품질경영학회지, 44(4), pp.907~920 (2016), 한국품질경영학회[DOI]