qms-audit-expert

# QMS Audit Expert

ISO 13485 internal audit methodology for medical device quality management systems.

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## Table of Contents

- [Audit Planning Workflow](#audit-planning-workflow)
- [Audit Execution](#audit-execution)
- [Nonconformity Management](#nonconformity-management)
- [External Audit Preparation](#external-audit-preparation)
- [Reference Documentation](#reference-documentation)
- [Tools](#tools)

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## Audit Planning Workflow

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-Based Audit Frequency

| 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) |

### Audit Scope by Clause

| 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 verified |
| 7.3 | Design Control | Inputs, reviews, V&V, transfer, changes |
| 7.4 | Purchasing | Supplier evaluation, incoming inspection |
| 7.5 | Production | Work instructions, process validation, DHR |
| 7.6 | Calibration | Equipment list, calibration status, out-of-tolerance |
| 8.2.2 | Internal Audit | Schedule compliance, auditor independence |
| 8.3 | NC Product | Identification, segregation, disposition |
| 8.5 | CAPA | Root cause, implementation, effectiveness |

### Auditor Independe...