由於國內醫療環境的改變,醫療院所無不致力於經營管理的求新求變,以期降低成本並提高品質與效益。ISO 9000系列品質管理標準初版於1987年發行以來,已逐漸成為全球各國品質管理共同認定的準則。國內醫療院所通過ISO 9002認證首見於壢新醫院,至今約有15家醫院陸續通過認證,應用仍不普遍。 國際標準組織(ISO)於2000年12月正式公布新版ISO 9000系列標準,使其更容易為醫療服務業所使用。國際醫院評鑑聯合會(Joint Commission International Accreditation)亦於2000年出版了國際評鑑標準手冊(International Accreditation Standards Manual),並由國內財團法人醫院評鑑暨醫療品質策進會轉譯出版“國際評鑑標準對照表”。本文旨在闡述新版ISO 9000系列標準的要求,並與JCIA國際評鑑標準手冊比較其品管觀念之異同,以期國內醫療院所能應用此兩種標準於品質管理上,或作為將來修訂國內醫院評鑑標準之參考。
Due to the medical environment is changing in Taiwan, medical organizations make efforts in improving their management in order to get lower cost and better quality and benefit. Since the ISO 9000 series were published firstly in 1987, these standards have become the quality management criteria in all over the world. In Taiwan, the first ISO 9002 certified medical organization is Li Shin Hospital and more or less 15 Hospitals are certified continually until now, so the ISO certification is still not common in medical organizations. The International Organization for Standardization (ISO) published ISO 9000 series reversion in Dec. 2000. The Joint Commission International Accreditation (JCIA) published International Accreditation Standards Manual and it was translated to Chinese version by Taiwan Joint Commission on Hospital Accreditation (TJCHA) in the same time. This article is to expound the requirements of ISO 9000 series reversion and make a comparison between the quality management concepts of these two standards, then finally attempt to propose applying these two standards in hospital quality management or refer for reviewing Taiwan Hospital Accreditation Standard in the future.