Implementing a quality system, part I

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.