qms-audit-expert - ISO 13485 internal audit expert for medical device QMS
Provides ISO 13485 internal audit methodology, nonconformity classification, CAPA verification, and audit schedule optimization.
Tags
Updated: 2026-09-22Capabilities
Typical Inputs
Typical Outputs
What this skill does
- Plan risk-based internal audits
- Conduct systematic audit execution
- Classify nonconformity severity levels
- Verify CAPA implementation effectiveness
- Prepare external audit readiness
- Optimize audit program schedules
Inputs
- QMS process data JSON
- ISO 13485 quality records
- Audit finding logs
Outputs
- Audit plans and reports
- Nonconformity classification records
- Optimized audit schedule JSON
- Audit program metrics
Requirements
- Python runtime environment