qms-audit-expert

ISO 13485 internal audit methodology for medical device quality management systems. Plan risk-based internal audit program: Verify auditor independence before assignment: Conduct systematic internal audit: Document Control (4.2): Design Control (7.3): CAPA (8.5): See references/iso13485-audit-guide.md for complete question sets. Document each finding with: Example: Classify and manage audit findings: See references/nonconformity-classification.md for detailed guidance. Prepare for certification body or regulatory audit: Documentation: Personnel: Facility: references/iso13485-audit-guide.md contains: references/nonconformity-classification.md contains: Generates risk-based audit schedule considering: Output includes: Track audit program effectiveness: - Audit Planning Workflow - Audit Execution - Nonconformity Management - External Audit Preparation - Reference Documentation - Tools - List all QMS processes requiring audit - Assign risk level to each process (High/Medium/Low) - Review previous audit findings and trends - Determine audit frequency by risk level - Assign qualified auditors (verify independence) - Create annual audit schedule - Communicate schedule to process owners - Validation: All ISO 13485 clauses covered within cycle - Prepare audit plan (scope, criteria, schedule) - Review relevant documentation before audit - Conduct opening meeting with auditee - Collect...