This guide to the new standard helps clarify changes in presentation, terminology, format, and requirements. Explains the meaning and intent of requirements and discusses them as they relate to product categories, identifying key changes from the 1994 standard. Icons note new changes, definitions, typical audit items to appraise compliance with requirements, and considerations for documentation. Includes the text of ISO/DIS 9001:2000. Tsiakals is a medical device technical expert and a founding member of the ISO Medical Device Quality Committee. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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