ISO 9000系列品質保證制度診斷模式之研究

Abstract

ISO 9000 品質管理及品質保證系列標準，於1987年正式公佈以來對 於以出口為導向之我國經濟體制有極其重大的影響，ISO 9000在我國推動 動的整個發展趨勢由外銷廠商而到內銷廠商，亦由製造業而到服務業，儼 然成為各產業之生存發展之必要條件之一。 然而推行ISO 9000系列品 保制度有一定的過程模式，其中最重要的一個階段就是對目前品質系統進 行一全面性的診斷，以瞭解現有品質系統之狀況與ISO 9000標準所要求之 差距。本研究所探討的主題在ISO 9000系列標準的推動歷程而言，是屬於 最重要的一個步驟，本研究透過文獻整理與專家之訪談，針對ISO 9001標 準的內涵作一深入的探討，以瞭解ISO 9001標準之各品質要項的內涵與運 作原理以及ISO 9000系列標準評鑑的準則，進而建立ISO 9000的診斷模式 與診斷構面，並發展診斷的流程與相關的診斷輔助工具，以協助廠商掌握 並瞭解目前推動之進度與所面臨的問題，進而提出有效的解決方案以期能 順利通過未來之評鑑。 研究發現ISO 9000之診斷構面有『品質要項文 件化程度』與『品質文件執行程度』兩個主構面，每一構面由高、低兩個 程度所構成，所以廠商目前品質系統的狀況則依『ISO 9001診斷查檢表』 之內容，可區分為A、B、C及D等四種類型。本研究所選定之個案研究對象 ML公司，在運用本研究所診斷出來的結果與建議後，亦於1995年11月24日 正式通過ISO 9002驗證資格之登錄。 The ISO 9000, quality management and quality assurance starnard, was published in 1987 by the International Organization for Standardization. There are huge impact to the economics of Taiwan. The trend of promoting ISO 9000 were from exported company to imported corporation and from manufactory to service industry. However,there are some stages to implement ISO 9000 series standard. The most important stage in which was to take an overall diagnosis to quality system and to realize the gap between ISO 9000 standard and the quality system. This study attempted to realize the spirit of ISO 9000 standard quality clauses and how these clauses to process. Furtheremore, build the diagnosis model and diagnosis dimentions of ISO 9000. To develop the diagnosis procedure and diagnosis aided tools is to help the corporations handling and realizing the progress and the problems at present. Then propose the effective project to slove and pass the assement in future. The results of this thesis found that there are two dimen- tions in ISO 9000 diagnosis dimentions, one is the level of documentation of quality clauses and the other is the implementation level of quality documents. Every dimentions are composed by high and low level. Therefore the situation of quality system now devide into four categories, A,B,C and D. The object of the case study, the ML company, which was choosen by this thesis had passed ISO 9002 certification in 24, Nov, 1995 after adopted the results of diagnosis and the suggestions.