The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
ASQC Quality Press, 1997 - Law - 210 pages
This book provides essential information regarding the new FDA regulation for medical devices and international quality system requirements (ISO 9001 and ISO/DIS 13485:1996). Icons quickly establish the differences 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.
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SUBPART A General Provisions
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820 ANSI/ISO/ASQC 820 Good Manufacturing acceptance activities ALS0 SEE ISO/DIS American National Standard and/or applicable appropriate components Corrective and preventive Critical devices defined design and development design changes design control Design output design process design review Design validation design verification DEVICE MASTER RECORD documented procedures effective establish and maintain evaluation fault tree analysis FDA believes FDA GUIDANCE FDA QUALITY SYSTEM functions GHTF GUIDANCE identify implementation individual(s inspection and testing installation internal audits labeling maintain documented proce maintain procedures Management review management with executive manufacturer shall establish medical devices ments nonconforming product original CGMP packaging packaging and labeling performance personnel preventive action process control product or service Purchasing data quality assurance Quality planning quality policy quality records quality system regulation QUALITY SYSTEM REGULATION–1996 quality system requirements review and approval specifications specified requirements storage subcontractors supplier shall establish System Regulation 1996 tion traceability