QMS Audit Expert

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

Clarify First

Before planning or executing the audit, confirm these inputs. If any is unknown or vague, ASK — do not assume:

• Audit purpose — internal scheduled audit, external/certification prep, or mock audit (sets the scope and formality)
• Processes/clauses in scope — which ISO 13485 clauses (drives the checklist and frequency)
• Risk level and prior findings per process — picks audit frequency and sample size

Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the audit plan.

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