在全球化的強烈需求下，取得品質管理國際認證，與全世界共用一套可執行的一致化標準，得以在國際貿易上與全球接軌，是企業近年來的一個大趨勢。 而ISO9001品質管理系統(Quality Management System, QMS)歷經1994年版以品質保證為宗旨轉換為2000年版的品質管理(經營)系統，它不斷的調整整體經濟對於品質的需求以及產銷走向，來迎合時代變遷所需品質管理的改革及創新，並符合企業經營的目的。 製造業在ISO的驗證稽核架構下，檢測出的不合格，加以矯正作業及預防措施之宣告，而得以通過認證。本文所做的研究目的在於透過351廠次，1413件實證資料的分析，提出製造業品質管理改善之方法與重點，藉以達成企業快速認證之方向，並避免一般常見的管理作業缺失。 本研究以驗證稽核之不合格報告，經由整理、分類、統計及分析，做為欲申請或已通過認證之企業，或強化或維護其品質管理系統之依據。 研究結果顯示，為了永續經營，長保競爭優勢，企業要不斷的進行規劃，管控所有的流程，時時檢核整個管理體系，確實做好矯正作業及預防措施，並將所有潛在的不合格因素排除，真正去體現P-D-C-A的精神。 Globalization is needed strongly more and more for enterprises, therefore acquire an international certification of quality management and to contact with all the countries all over the world is becoming a mega-trend. ISO9001 Quality Management System amended from edition 1994 to edition 2000, from Quality Assurance System into Quality Management System has adjusted the need of quality system and production-marketing tendency in the integral economic environment and help the enterprises to reach the creation and renovation purposes to meet challenges of competition. Under the structure of Certification Audit of ISO9001:2000, manufacturing industries has been verified with unconformities by external audit and through corrective actions on these unconformities, the enterprises finally attain the certification of ISO9001:2000. In order to get a faster way to obtain an certification and avoid to spend time to correct the unconformities from quality management system, enterprises has to follow the result of this study, which has offered the key points and methods of improvement in quality management system through the collecting, clarifying any analysis of 351 companies, 1413 cases of audited reports. The result of this study showed an enterprise wants to own its competition power and to operate continuously, it should have to the plan continuously, control all the process every minute, check the whole management system frequently, to complete all the corrective action actually, eliminate all the elements of potential unconformities, and finally to undergo a real practice of P-D-C-A cycle.
