qms-audit-expert

原文涵盖的主题

• QMS Audit Expert
• Table of Contents
• Audit Planning Workflow
• Risk-Based Audit Frequency
• Audit Scope by Clause
• Auditor Independence
• Audit Execution
• Evidence Collection

ISO 13485 internal audit methodology for medical device quality management systems. -- Audit Planning Workflow Audit Execution Nonconformity Management External Audit Preparation Reference Documentation Tools -- Plan risk-based internal audit program: 1. List all QMS processes requiring audit 2. Assign risk level to each process (High/Medium/Low) 3. Review previous audit findings and trends 4. Determine audit frequency by risk level 5. Assign qualified auditors (verify independence) 6. Create annual audit schedule 7. Communicate schedule to process owners 8. Validation: All ISO 13485 clauses covered within cycle | Risk Level | Frequency | Criteria | |------------|-----------|----------| | High | Quarterly | Design control, CAPA, production validation | | Medium | Semi-annual | Purchasing, training, document control | | Low | Annual | Infrastructure, management review (if stable) | | Clause | Process | Focus Areas | |--------|---------|-------------| | 4.2 | Document Control | Document approval, distribution, obsolete control | | 5.6 | Management Review | Inputs complete, decisions documented, actions tracked | | 6.2 | Training | Competency defined, records complete, effectiveness v

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