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