Column: Standards Outlook: Corrective and Preventive Action In Medical Device Manufacturing
Column: Standards Outlook: Corrective and Preventive Action In Medical Device Manufacturing
ISO 9000 made more rigorous to ensure a robust system
- Publication:
- Quality Progress
- Date:
- November 2001
- Issue:
- Volume 34 Issue 11
- Pages:
- pp. 75-80
- Author(s):
- Schnoll, Les
- Organization(s):
- Gliatech Inc.,
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Abstract
(Pages 75-76, 79-82)
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[Abstract taken from article.]
21 CFR (Code of Federal Regulations) 820 was revised in 1995 to more closely resemble ISO 9001:1994, and what had been known as "Good Manufacturing Practices" became a Quality System Regulation (QSR).One crucial element was the need for a system to monitor the effectiveness of actions implemented to resolve past or potential nonconforming conditions. The requirements for this subsystem, known as corrective and preventive action (CAPA), are identified in 21 CFR 820.100. The purpose, scope, procedures, and assigment of responsibilities for CAPA are discussed.
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