Donawa M E
Donawa and Associates Ltd., Rome, Italy.
Med Device Technol. 1995 Jun;6(5):11-3.
The role and responsibility of management in implementing and maintaining a quality system is one of the most important elements of EN ISO 9001 and EN ISO 9002. Unless top management recognizes its quality-related responsibilities, it is virtually impossible for all levels of a company to implement and maintain a successful quality system. This article will discuss the management responsibility provisions of the 1994 quality system standards and point out the modifications that were made to the previous version of the standard.
管理层在实施和维护质量体系中的作用与职责是EN ISO 9001和EN ISO 9002最重要的要素之一。除非高层管理者认识到其与质量相关的职责，否则公司各级几乎不可能实施并维护一个成功的质量体系。本文将讨论1994版质量体系标准中的管理职责条款，并指出对该标准先前版本所做的修改。
