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The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process.
Table of Contents
Chapters cover: o Quality Standards in Research and Development o Building Blocks of the Design Control System o How to Approach Design Control o The Process of Research and Development o The Relationship Between ISO 9001 and Total Quality Management o Other Requirements of ISO 9001 in Research and Development o Audit and Certification o Beyond ISO 9001: Good Practices o Beyond ISO 9001: Regulatory Requirements o Conclusions
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