Apr 20
ISO 13485 Documentation Lifecycle Explained
The ISO 13485 Documentation Lifecycle focuses on controlled document management within a medical device QMS. It defines how documents are created, reviewed, approved, and updated to ensure accuracy and regulatory compliance. Proper version control and distribution prevent the use of outdated information and support consistent quality system performance. These structured procedures help maintain traceability, audit readiness, and compliance with ISO requirements.
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Introduction The ISO 13485 documentation lifecycle defines how documents are created, reviewed, approved, controlled, updated, and archived
