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Korean Journal of Reproductive Medicine 2007;34(2):107-115.
Published online June 1, 2007.
Efficacy of ISO 9001: 2000 Quality Management System in Human Assisted Reproductive Technology Center.
Jin Hyun Jun, Yong Seog Park, Hyoung Song Lee, Soon Duk Kim, Son Hee Hwang, Su Kyoung Han, Jae Ho Kim, In Ok Song, Inn Soo Kang, Mi Kyoung Koong
Center for Reproductive Medicine & Infertility, Cheil general Hospital & Women's Healthcare Center, Kwandong University College of Medicine, Seoul, Korea.
Abstract
OBJECTIVE
A quality management system of international standardization organization (ISO) 9001:2000 has been proposed to properly evaluate and improve the quality of productions and services. The purpose of this article was to describe on successful introduction and application of the ISO system to human assisted reproductive technology (ART) center. METHODS: Center for reproductive medicine and infertility of Cheil General Hospital started the action for ISO 9001:2000 certification at January-2004. The ISO system of our center was monitored by measuring the customer satisfaction index and periodical internal and external audit. Reports of non-conformity described corrective and preventive actions for problems and occurrences that were not consistent with the standard process and operation of our center. Continuous management and improvement were performed on the project of customer dissatisfaction. RESULT: Our center has got the certification of ISO 9001:2000 for "Research and development of IVF-ET program for infertility treatment" from Korean Foundation for Quality at June-2004. The policy of ISO was "To establish the best center of reproductive medicine and infertility" and "To establish the best quality management system". We found 140 cases and 7 cases of non-conformity in internal and external audit for three years, respectively, and performed corrective action. CONCLUSION: Improvement of customer satisfaction, systemic documentation and transparency and efficacy of working procedure were achieved by application and operation of the ISO system to our center. This ISO system could be used as a basic institutional management system for the national guideline to the human ART center.
Key Words: ISO 9001:2000; Quality management system; Human ART center; Customer satisfaction index; Non-conformity


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