ASQ H0965

This book provides essential information regarding the new FDA regulation for medical devices andinternational quality system requirements (ISO 9001 and ISO/DIS 13485). Icons quickly establish thedifferences and relationship between FDA regulation, the ISO 9001 standard, FDA guidance, and the Global Harmonization Task Force (GHTF) guidance. In addition, the end of each subsection includes blank pages for your notes. This book allows manufacturers to establish a single quality system that satisfies world requirements. Benefits * Understand the differences between the new FDA requirements and the 1978 FDA requirements. * Save time by using the comparison chart rather than referring to separate documents. CONTENTSGeneral Provisions/Quality System Requirements/Design Controls/Document Controls/Purchasing Controls/Identification and Traceability/Production and Process Controls/Acceptance Activities/Nonconforming Product/Corrective and Preventive Action/Labeling and Packaging Control/Handling, Storage, Distribution, and Installation/Records/Servicing/Statistical Techniques/Comparison Chart

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