本简明、用户友好的指南帮助新手和经验丰富的质量从业者理解和实施ISO 13485和13488的要求，这两个标准分别基于ISO 9001和9002。该手册概述了ISO 9000系列标准的当前背景，并深入了解了预期的200年版本，概述了ISO 9000系列标准，并解释了与医疗器械行业相关的质量保证要求的强制性；并提供使用标准的指导。为此，它包括来自各种来源的摘录，以及ISO 9001:1994和ISO 13485:96的完整文本。

This concise, user-friendly guide help novice and experienced quality practitioners to understand and implement the requirements of ISO 13485 and 13488, which are based on ISO 9001 and 9002, respectively. The handbook outlines the current background of the ISO 9000 family of standards and gives an insight into the anticipated Year 200 versions, presents an overview of ISO 9000 family of standards, and explains the mandatory nature of quality assurance requirements related to the medical device industry; and provides guidance on using the standards. To do so, it includes excerpts from various sources, along with the complete text of ISO 9001:1994 and ISO 13485:96.