推行ISO 9001:2015 品質管理系統之關鍵成功因素探討- 以濾心製造業 E公司為例

眾所周知產品品質是企業重要的競爭力之一。為了因應全球化需求的變遷，如何建立品質管理系統以強化組織的流程，是製造相關產業努力的方向。現今許多企業將品質管理系統導入在生產技術層面上，以確保原物料及生產製程的管制都是持續被監控的，並達成產品的信賴度以符合客戶需求。ISO 9001自發行，1994年第一次執行並接受驗證之後，近23年間已經成為全球品質管理方面的基礎語言，在全世界180多個國家中，已超過250萬家企業或組織單位取得ISO 9001品質管理系統驗證證書。企業的營運重點在於以顧客需求為導向，滿足顧客品質需求，本研究藉由Kano Model與IPA的方法並探討，收集國內、外專家與學者所提出之ISO 9000系列驗證導入動機，加以整理歸納出推行之ISO 9001：2015品質管理系統關鍵成功因素，來了解所面臨外在環境因素之機會與威脅，以增加個案公司在濾心產業上的競爭優勢。

關鍵字

ISO 9001:2015 ；二維品質模式；重要－表現程度分析法；關鍵成功因素

並列摘要

As we know product quality is one of the important competitiveness of enterprises. In order to cope with the changing needs of globalization, how to establish a quality management system to strengthen the organization's processes is the direction for the efforts of related industries. Today, Many companies import quality management systems into the production technology to ensure that raw materials and manufacturing process are under control and continuously monitored and reach product reliability to meet customer needs. ISO 9001 has been the language of global QM for almost 23 years since it was first published and validated in 1994. And there are over 2.5 million organizations has been achieved ISO 9001 and get Quality Management System Certification in more than 180 countries around the world. The key point for the operation of the enterprise is customer oriented to meet customer quality requirements. This research collecting the motivation of ISO 9000 series validation which were introduced by domestic and foreign experts and scholars. Then applying Kano Model and IPA methods to explore and summary the key success factors of ISO 9001: 2015 quality management system implemented. Thus the individua filtration industry companies could understand and facing the opportunities and threats from external environmental, then it can increase and enhance the competitive advantages.