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

Other Titles
 A Study on the Development and Effectiveness of ISO13485: 2016 Education Programs for Domestic Medical Device Manufacturers 
Authors
 이슬비  ;  강기호  ;  장원석  ;  권병주 
Citation
 품질경영학회지, Vol.50(3) : 503-515, 2022-09 
Journal Title
 품질경영학회지 
Issue Date
2022-09
Keywords
Medical Device ; Quality Management System ; GMP(Good Manufacturing Practice) ; ISO13485 ; Education Program
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.
Files in This Item:
T202205528.pdf Download
DOI
10.7469/JKSQM.2022.50.3.503
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Medical Engineering (의학공학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Byeong-Ju(권병주) ORCID logo https://orcid.org/0000-0001-9916-0546
Chang, Won Seok(장원석) ORCID logo https://orcid.org/0000-0002-4925-3549
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/192115
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