Journal of Korean Society of Industrial and Systems Engineering (산업경영시스템학회지)

Society of Korea Industrial and System Engineering (한국산업경영시스템학회)
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The Impact of ISO 13485 on the Performance of Korean Medical Device Manufacturers

ISO 13485 인증 시스템이 경영성과에 미치는 영향 분석 : 국내 의료기기 제조업을 대상으로

  • Kim, Chung-Yeon (Department of Industrial Management Engineering, Konkuk University) ;
  • Ko, Sung-Seok (Department of Industrial Engineering, Konkuk University) ;
  • Han, Yong-Hee (Department of Entrepreneurship and Small Business, Soongsil University)
  • 김충연 (건국대학교 산업경영학과) ;
  • 고성석 (건국대학교 산업공학과) ;
  • 한용희 (숭실대학교 벤처중소기업학과)
  • Received : 2017.10.07
  • Accepted : 2018.01.19
  • Published : 2018.03.31
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Abstract

This paper investigated relationship among internal as well as external motive to receive the ISO 13485 certification, countermeasure to the certification examination, active reception/execution level of the certification, and operational as well as financial performance of the medical device related enterprises in South Korea which received and are maintaining the ISO 13485 certification. SEM (structural equation model) and related analyses using AMOS 21.0 and SPSS 21.0 have been applied to verify the hypotheses of the research. Result of the research showed that internal as well as external motive for certification positively(+) affects active reception/execution level of the certification as well as countermeasure to the certification examination. The reception/execution level of the certification also positively(+) affects on the operational as well as financial performance of the certified enterprises. However, countermeasure to the certification examination was found out to negatively(-) affects the active reception/execution level of the certification and we can interpret that relatively more countermeasure to the certification examination burdens the employees of the enterprise, causing them to be less active on the reception/execution level of the certification. This research found that an enterprise's operational/financial performance improves when an enterprise introduces the ISO 13485 certification standard spontaneously on the purpose of improving its system and the certification system is applied to the enterprise actively, not passively. This research emphasizes the need to recognize the difference of the level of active reception implication among members of an enterprise according to the motive of introduction of the certification system.

Keywords

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