自「斷層掃描用正子放射同位素調製作業要點」於民國92年年底公告迄今，已過了8個年頭，由於該要點
主要依據美國藥典第<823>章節並參考當時國內現狀修編而來，因此較為強調規範各項作業的基準，對於
品質管理系統的著墨甚少。2009年底，美國FDA依據21CFR212法規制訂並公告Guidance-PET Drugs CGMP ，明訂各生產設施應建立品質保證(qualityassurance)系統之要求。因應衛生署要求及此國際趨勢，三軍總醫院正子中心亦開始著手建立品質管理系統。因受編制人力、專業背景等主客觀因素影響，晶質管理系統建立過程中實際面臨不少困難及相當大之壓力。
本文章將依本中心過去之經驗，分享品質管理系統建立過程中主要的步驟、遭遇的困難與適行的解決方法。
其中包括，品質管理系統流程、管理組織架構、文件組織架構之建立，品質管理(稽核)條文之擬訂及品
質稽核作業之執行。
在建立品質管理系統的過程中，實際上也讓我們深刻了解，若僅僅思索如何建立完善的管理系統、編寫
妥善的標準文件、或增加品質稽核作業之強度與頻率，其成效勢必不如根本提升作業人員的品質觀念，
觀念的提升才是品質系統能否成功的關鍵，這也是品質管理系統建立後的下一個挑戰。

The "Directions of PET Radioisotopes Compounding" have been announced by the Department of Health (DOH)， Taiwan， R.O.C.since 2003. As most of them were modified from the General Chapter <823> in the current version of United States Pharmacopoeia (USP)， more emphasis were put on the compounding process of PET drugs per se and their standardized procedures while less details of pertinent quality assurance system were addressed. Now that USA FDA has been developing CGMP regulations for PET drugs under the Code of Federal Regulations Title 21 (21 CFR) Part 212， the PET drug production facilities are demanded to have quality assurance function. In order to comply with that trend and， meanwhile， fulfill the requirements of the Taiwan DOH， our PET center attempted to establish a quality management system (QMS). However， due to the small-sized manpower with limited professional backgrounds of our staffs， and other affecting factors， we actually encountered quite a lot of difficulties and stress through the process.ln this article， the experiences to initiate our QMS based on IS09001 :1994 will be shared and those major steps， including the layout of flow of QMS， establishment of mini-organization of management， structuring the documents with interim quality audit standard and implementation of quality audit work. Additionally， the problem-solving process will be further discussed. Throughout the entire QMS establishment， we learn that the conceptual improvement plays a more pivotal role than simply generating management system， standard procedures or intense and frequent audit works. Indeed， how to break ∞nceptboundaries for most professionals to abide with a QMS is the next challenge.