DeSain C, Vercimak C
Med Device Technol. 1994 Jan-Feb;5(1):28-30.
This article, which will be published in two parts, presents the basic principles of quality assurance and describes how they can be applied in a medical manufacturing environment. Although quality assurance standards in manufacturing will be harmonized one day, they will remain open to nationalistic interpretation. Thus, it is instructive to understand the differences between, as well as the similarities of, all perspectives. This article reflects an American approach to compliance, but by discussing the important elements and interrelations of a quality system, it will be useful to those operating in Europe and the US.
本文将分两部分发表，介绍质量保证的基本原则，并描述如何将这些原则应用于医疗制造环境。尽管制造业的质量保证标准终有一天会实现统一，但它们仍可能因国家主义的解读而存在差异。因此，了解所有观点之间的差异和相似之处具有启发性。本文反映了美国的合规方法，但通过讨论质量体系的重要要素和相互关系，对在欧洲和美国运营的企业也会有所帮助。
