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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.