過程導向與風險管理之實務研究:ISO9001:2015為例

The Practical Study of the Process-oriented and Risk Management: A Case for ISO 9001: 2015

韓慧林1、韓榮姿2、錢怡岑3
H. L. Hai1, B. Han2 and Y. T. Chien3

1實踐大學資訊管理系
2國防部資源司
3楠梓電子公司品管部


摘要

國際標準組織是由各國標準化團體組成的世界性聯合會,制定國際標準工作通常由ISO的技術委員會執行。品質管理系統的導入是組織的策略決定,可幫助提升組織整體績效並為永續發展提供了一個堅實的基礎。本研究以顧問輔導新版ISO9001:2015認證之實務經驗,透過作業風險管理及過程流程圖,提供一套6個步驟之評估與管理標準作業模式,做為執行與認證之參考。

關鍵字:過程方法、作業風險管理、ISO9001品質管理系統。

ABSTRACT

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. The work of preparing International Standards is normally executed through ISO technical committees. Each member body interested in a subject where technical committees have been established has the right to be represented on that committee. The quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. In this study, we use the counseling practice experience of a new version of ISO9001: 2015 certificated. Finally, we apply operational risk management and process flow diagram to provide a “six-step” standard operation procedure as the reference to evaluation and management for ISO9001 certificated or implementation.

Keywords: Process Approach; Operational Risk Management; ISO9001 Quality Management System