ISO 13485 internal audit methodology for medical device quality management systems.
---name: "qms-audit-expert"description: "Use for ISO 13485 internal audits: planning the program, running an audit, classifying findings or preparing for an external audit. Optimizes the schedule with audit_schedule_optimizer.py."metadata: triggers: - ISO 13485 audit - internal audit - QMS audit - audit planning - nonconformity classification - CAPA verification - audit checklist - audit finding - external audit prep - audit schedule--- # QMS Audit Expert ISO 13485 internal audit methodology for medical device quality management systems. --- ## 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) --- ## Audit Planning Workflow Plan risk-based internal audit program: 1. List all QMS processes requiring audit2. Assign risk level to each process (High/Medium/Low)3. Review previous audit findings and trends4. Determine audit frequency by risk level5. Assign qualified auditors (verify independence)6. Create annual audit schedule7. Communicate schedule to process owners8. **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 Independence Verify auditor independence before assignment: - [ ] Auditor not responsible for area being audited- [ ] No direct reporting relationship to auditee- [ ] Not involved in recent activities under audit- [ ] Documented qualification for audit scope --- ## Audit Execution Conduct systematic internal audit: 1. Prepare audit plan (scope, criteria, schedule)2. Review relevant documentation before audit3. Conduct opening meeting with auditee4. Collect evidence (records, interviews, observation)5. Classify findings (Major/Minor/Observation)6. Conduct closing meeting with preliminary findings7. Prepare audit report within 5 business days8. **Validation:** All scope items covered, findings supported by evidence ### Evidence Collection | Method | Use For | Documentation ||--------|---------|---------------|| Document review | Procedures, records | Document number, version, date || Interview | Process understanding | Interviewee name, role, summary || Observation | Actual practice | What, where, when observed || Record trace | Process flow | Record IDs, dates, linkage | ### Audit Questions by Clause **Document Control (4.2):**- Show me the document master list- How do you control obsolete documents?- Show me evidence of document change approval **Design Control (7.3):**- Show me the Design History File for [product]- Who participates in design reviews?- Show me design input to output traceability **CAPA (8.5):**- Show me the CAPA log with open items- How do you determine root cause?- Show me effectiveness verification records See `references/iso13485-audit-guide.md` for complete question sets. ### Finding Documentation Document each finding with: ```Requirement: [Specific ISO 13485 clause or procedure]Evidence: [What was observed, reviewed, or heard]Gap: [How evidence fails to meet requirement]``` **Example:**```Requirement: ISO 13485:2016 Clause 7.6 requires calibrationat specified intervals. Evidence: Calibration records for pH meter (EQ-042) showlast calibration 2024-01-15. Calibration interval is12 months. Today is 2025-03-20. Gap: Equipment is 2 months overdue for calibration,representing a gap in calibration program execution.``` --- ## Nonconformity Management Classify and manage audit findings: 1. Evaluate finding against classification criteria2. Assign severity (Major/Minor/Observation)3. Document finding with objective evidence4. Communicate to process owner5. Initiate CAPA for Major/Minor findings6. Track to closure7. Verify effectiveness at follow-up8. **Validation:** Finding closed only after effective CAPA ### Classification Criteria | Category | Definition | CAPA Required | Timeline ||----------|------------|---------------|----------|| Major | Systematic failure or absence of element | Yes | 30 days || Minor | Isolated lapse or partial implementation | Recommended | 60 days || Observation | Improvement opportunity | Optional | As appropriate | ### Classification Decision ```Is required element absent or failed?├── Yes → Systematic (multiple instances)? → MAJOR│ └── No → Could affect product safety? → MAJOR│ └── No → MINOR└── No → Deviation from procedure? ├── Yes → Recurring? → MAJOR │ └── No → MINOR └── No → Improvement opportunity? → OBSERVATION``` ### CAPA Integration | Finding Severity | CAPA Depth | Verification ||------------------|------------|--------------|| Major | Full root cause analysis (5-Why, Fishbone) | Next audit or within 6 months || Minor | Immediate cause identification | Next scheduled audit || Observation | Not required | Noted at next audit | See `references/nonconformity-classification.md` for detailed guidance. --- ## External Audit Preparation Prepare for certification body or regulatory audit: 1. Complete all scheduled internal audits2. Verify all findings closed with effective CAPA3. Review documentation for currency and accuracy4. Conduct management review with audit as input5. Prepare facility and personnel6. Conduct mock audit (full scope)7. Brief personnel on audit protocol8. **Validation:** Mock audit findings addressed before external audit ### Pre-Audit Readiness Checklist **Documentation:**- [ ] Quality Manual current- [ ] Procedures reflect actual practice- [ ] Records complete and retrievable- [ ] Previous audit findings closed **Personnel:**- [ ] Key personnel available during audit- [ ] Subject matter experts identified- [ ] Personnel briefed on audit protocol- [ ] Escorts assigned **Facility:**- [ ] Work areas organized- [ ] Documents at point of use current- [ ] Equipment calibration status visible- [ ] Nonconforming product segregated ### Mock Audit Protocol 1. Use external auditor or qualified internal auditor2. Cover full scope of upcoming external audit3. Simulate actual audit conditions (timing, formality)4. Document findings as for real audit5. Address all Major and Minor findings before external audit6. Brief management on readiness status --- ## Reference Documentation ### ISO 13485 Audit Guide `references/iso13485-audit-guide.md` contains: - Clause-by-clause audit methodology- Sample audit questions for each clause- Evidence collection requirements- Common nonconformities by clause- Finding severity classification ### Nonconformity Classification `references/nonconformity-classification.md` contains: - Severity classification criteria and decision tree- Impact vs. occurrence matrix- CAPA integration requirements- Finding documentation templates- Closure requirements by severity --- ## Tools ### Audit Schedule Optimizer ```bash# Generate optimized audit schedulepython scripts/audit_schedule_optimizer.py --processes processes.json # Interactive modepython scripts/audit_schedule_optimizer.py --interactive # JSON output for integrationpython scripts/audit_schedule_optimizer.py --processes processes.json --output json``` Generates risk-based audit schedule considering:- Process risk level- Previous findings- Days since last audit- Criticality scores **Output includes:**- Prioritized audit schedule- Quarterly distribution- Overdue audit alerts- Resource recommendations ### Sample Process Input ```json{ "processes": [ { "name": "Design Control", "iso_clause": "7.3", "risk_level": "HIGH", "last_audit_date": "2024-06-15", "previous_findings": 2 }, { "name": "Document Control", "iso_clause": "4.2", "risk_level": "MEDIUM", "last_audit_date": "2024-09-01", "previous_findings": 0 } ]}``` --- ## Audit Program Metrics Track audit program effectiveness: | Metric | Target | Measurement ||--------|--------|-------------|| Schedule compliance | >90% | Audits completed on time || Finding closure rate | >95% | Findings closed by due date || Repeat findings | <10% | Same finding in consecutive audits || CAPA effectiveness | >90% | Verified effective at follow-up || Auditor utilization | 4 days/month | Audit days per qualified auditor | ## More in this skill Load these only when the task needs them. - [references/iso13485_audit_playbook.md](references/iso13485_audit_playbook.md) — ISO 13485:2016 Internal Audit Playbook