qms-audit-expert - ISO 13485 Internal Audit Expert for Medical Device QMS
Provides ISO 13485 internal audit methodology, nonconformity management, CAPA verification, and external audit preparation for medical device QMS.
Tags
Updated: 2026-09-21Capabilities
What this skill does
- Plan risk-based internal audit programs
- Conduct systematic internal QMS audits
- Classify and manage audit nonconformities
- Prepare for external certification audits
- Generate optimized audit schedules
Inputs
- Process risk data JSON file
- ISO 13485 QMS documentation and records
Outputs
- Optimized audit schedule JSON report
- Audit report and finding documentation
Requirements
- Python environment