ISO 9001：2015所有條文要求通用於任何規模大小、經營型態提供的產品和服務之組織；其以10個章節取代舊版8個章節，而過程導向與風險導向之作業或思維，在新版條文中佔有舉足輕重之地位。現在更促使管理者應有勇氣檢視與分析企業在經營管理所可能面對之風險。本研究以優貝克科技股份有限公司台灣分公司ISO9001：2015換證之實務經驗，進行探討與分享。

All the requirements of ISO 9001:2015 are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. It has ten clauses instead of eight 9001:2008. Process-oriented and risk-oriented acts have very important places in ISO 9001:2015. The managers are now strongly encouraged as an organization to use risk analysis in order to decide for yourself which challenges you see in the management of your business processes. In this study, we share the implementation experiences of a new version of ISO9001: 2015 certificated for ULVAC Taiwan Inc.