QMS Audit Expert

Table of Contents

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

Audit Planning Workflow

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

• 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

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

• Show me the document master list
• How do you control obsolete documents?
• Show me evidence of document change approval

• Show me the Design History File for [product]
• Who participates in design reviews?
• Show me design input to output traceability

• Show me the CAPA log with open items
• How do you determine root cause?
• Show me effectiveness verification records

references/iso13485-audit-guide.md

Finding Documentation

Requirement: [Specific ISO 13485 clause or procedure]
Evidence: [What was observed, reviewed, or heard]
Gap: [How evidence fails to meet requirement]

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

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

references/nonconformity-classification.md

External Audit Preparation

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

• Quality Manual current
• Procedures reflect actual practice
• Records complete and retrievable
• Previous audit findings closed

• Key personnel available during audit
• Subject matter experts identified
• Personnel briefed on audit protocol
• Escorts assigned

• 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

• Process risk level
• Previous findings
• Days since last audit
• Criticality scores

• 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