經濟貿易全球化使得國際市場上的競爭加劇，企業為滿足顧客需求並拓展市場，均紛紛推動ISO 9001品質系統驗證，藉由取得ISO 9001驗證增加企業的附加價值。利用ISO 9001品質管理系統作為組織品質活動的根基，以擴展其它持續改善活動，並提高顧客滿意度。回顧以往研究與ISO 9001相關文獻，主要在探討ISO品質管理系統推動的動機、成功關鍵因素、效益與組織績效，對於執行ISO 9001系統驗證的驗證機構其角色與影響卻鮮少有進一步的討論。為了解驗證機構對組織品質管理系統推動與持續改進的影響，本研究以品質管理系統八大構面為基礎，探討驗證機構之稽核品質與驗證機構對組織品質管理系統推動的關聯性。
本研究歸納相關文獻資料，並以問卷調查方式對高雄地區經濟部加工出口區廠商進行調查，探討第三方驗證稽核對組織品質管理系統推動與持續改善效益的關聯性。研究共計發出問卷215份，回收問卷103份，回收率47.9%。研究結果發現驗證機構通過認證單位認證與否對組織品質系統推行八大構面中之「依事實決策」具有顯著影響。驗證機構受認證單位監督主要可透過此機制有效監控驗證機構的運作，以確保品質系統的稽核品質。ISO 9001品質管理系統的立意主要是希望組織藉由P-D-C-A管理循環不斷進行持續改進，以提升各項品質活動績效，並以滿足顧客需求為最終目的。驗證機構除了應依ISO 9001條文要求進行稽核，同時也必須鑑別、評估這些改善活動的有效性，方能彰顯組織品質管理系統的運作。驗證機構受認證單位之監督，對組織品質管理系統的推行與運作是具有正向的幫助，主要可透過此機制有效監控驗證機構的運作，以確保組織品質系統的稽核品質。另外，組織特性對企業在品質活動成效上也具不同程度之影響。研究發現，不同管理制度之下組織之品質活動績效於「領導」構面具有影響；組織規模大小對企業在品質管理系統運作實施也具差異，其中以「人員參與」及「系統導向管理」具有顯著影響。

The competition of international market increases dramatically due to globalization. In order to satisfy the customers and extend the market share, businesses intend to acquire the ISO (International Standard of Organization) certificate as the driving force for continual improvement. For the ISO 9001 QMS implementation, its benefits and motivations, the critical success factors, how far the quality performance is improved had been discussed in depth, however, the audit effectiveness of ISO 9001 certification bodies was rarely mentioned. The main idea of this study is to explore the audit effectiveness of the certification bodies and whether the businesses can obtain long-term improvement through the QMS audit of the certification bodies.
Previous studies and literatures were reviewed to construct the research framework and a questionnaire that is based on the eight principles of quality management system was developed. The questionnaires surveyed the businesses located in the Export Processing Zone (Kaohsiung area). A total of 215 questionnaires were distributed and 103 of the questionnaires had been returned, the return rate was 47.9%.
The purpose of ISO 9001 quality management system is to improve and maintain the quality performance through the PDCA cycle with continual improvement and meeting the customers’ requirements being the long term goal. Certification bodies should not only check organization’s regular business practices but also must verify the effectiveness of the corrective and improvement measures. Result of this study showed the certification bodies under the monitoring of the accreditation bodies can achieve significant positive influences with “Factual Approach to Decision Making” of the eight principles. Also, management style from different nationality showed significant effect with “Leadership”; furthermore, the number of employees show a variation between SEM sector and large sector and got significant effect with “Involvement of People” and “System Approach to Management”. With the study result we conclude that certification bodies supervised by accreditation bodies showed the positive benefits to the organization of ISO 9001 certified, through this mechanism the audit effectiveness of certification bodies can be monitored as well.

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網站部份
1. International Organizational for Standard. http://www.iso.org/iso/home.htm
2. International Accreditation Forum. http://www.iaf.nu/
3. 財團法人全國認證基金會. http://service.taftw.org.tw/tafweb/index.aspx