Qms Audit ExpertSAFE

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The instruction file, verbatim from the audited commit — this is the text the model reads, and the surface the audit's instruction layer examines. Quoted here so you can judge it without cloning anything.

---
name: "qms-audit-expert"
description: ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.
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 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 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 audit
3. Conduct opening meeting with auditee
4. Collect evidence (records, interviews, observation)
5. Classify findings (Major/Minor/Observation)
6. Conduct closing meeting with preliminary findings
7. Prepare audit report within 5 business days
8. **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 calibration
at specified intervals.

Evidence: Calibration records for pH meter (EQ-042) show
last calibration 2024-01-15. Calibration interval is
12 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 criteria
2. Assign severity (Major/Minor/Observation)
3. Document finding with objective evidence
4. Communicate to process owner
5. Initiate CAPA for Major/Minor findings
6. Track to closure
7. Verify effectiveness at follow-up
8. **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

SAFEgrade B · trust 89/100 Nothing in the source contradicts what it says it does. Grade A is reserved for packages that have also passed the behavioural sandbox.

What the source does

Filesystem

none-observed

Network

none-observed

Shell

none-observed

Dependencies

pinned

Secrets in source

none-found

Findings (1)

<key>k5Ey9KFlkqpj+SDkUw+5ED9lTA3En/qUi0zdrydUCH3kMWTE3Eh65NXnFCaxlY2omY2JHnlEoK7Li7oOEvM7eG5VPdcO/sFlMfoCRdnLYdepJ+uLzYwOWR8W4yQVve/clxVFTVRL4DFleKInGdpAxIbHZT2yi4ADAMENls1N1XSLojRuqXePXDeAT/4Mv4TTx0s

Gates applied: no_behavioural_pass.