QMS Audit Expert

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

Table of Contents

• Audit Planning Workflow
• Audit Execution
• Nonconformity Management
• External Audit Preparation
• Reference Documentation
• 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

Audit Scope by Clause

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

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

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

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

See

references/nonconformity-classification.md

External Audit Preparation

Prepare for certification body or regulatory audit:

1. Complete all scheduled internal audits
2. Verify all findings closed with effective CAPA
3. Review documentation for currency and accuracy
4. Conduct management review with audit as input
5. Prepare facility and personnel
6. Conduct mock audit (full scope)
7. Brief personnel on audit protocol
8. 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 auditor
2. Cover full scope of upcoming external audit
3. Simulate actual audit conditions (timing, formality)
4. Document findings as for real audit
5. Address all Major and Minor findings before external audit
6. Brief management on readiness status

Reference Documentation

ISO 13485 Audit Guide

references/iso13485-audit-guide.md

• 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

• Severity classification criteria and decision tree
• Impact vs. occurrence matrix
• CAPA integration requirements
• Finding documentation templates
• Closure requirements by severity

Tools

Audit Schedule Optimizer

# Generate optimized audit schedule
python scripts/audit_schedule_optimizer.py --processes processes.json

# Interactive mode
python scripts/audit_schedule_optimizer.py --interactive

# JSON output for integration
python 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

{
  "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:

Troubleshooting

last_audit_date

risk_level

criticality_score

processes.json

YYYY-MM-DD

last_audit_date

--processes processes.json

--interactive

Success Criteria

• Annual audit schedule covers 100% of ISO 13485 clauses with risk-based frequency (quarterly for high-risk, semi-annual for medium, annual for low)
• Schedule compliance rate exceeds 90% (audits completed on time vs. planned)
• All Major findings result in full root cause analysis CAPA initiated within 30 days and verified effective within 6 months
• Finding closure rate exceeds 95% by due date, with no overdue Major findings at any point
• Repeat finding rate below 10% across consecutive audit cycles, demonstrating effective corrective actions
• Auditor independence verified and documented for every audit assignment (no self-auditing of own work area)
• Mock audit conducted before every external certification or surveillance audit with all Major and Minor findings resolved

Scope & Limitations

In Scope:

• ISO 13485:2016 internal audit planning, scheduling, and execution
• Risk-based audit frequency optimization
• Nonconformity classification (Major/Minor/Observation) with decision tree
• CAPA integration for audit findings
• External audit preparation and mock audit protocols
• Audit program metrics and effectiveness tracking

Out of Scope:

• External audit execution (this skill supports preparation for and response to external audits, not conducting them)
• Regulatory inspection management (FDA, Notified Body inspections have jurisdiction-specific protocols beyond internal audit scope)
• Detailed CAPA root cause analysis methodology (use capa-officer skill for 5-Why, Fishbone, FTA, FMEA)
• ISO 19011 auditor certification or training program administration
• Technical product testing or process validation
• QMSR-specific audit checklist generation (use quality-manager-qms-iso13485 for QMSR gap analysis)

Integration Points

Tool Reference

audit_schedule_optimizer.py

Generates risk-based audit schedules optimized by process risk, findings history, and time since last audit.

--processes

--interactive

name

iso_clause

risk_level

last_audit_date

previous_findings

criticality_score

--interactive

--output

json