quality-manager-qms-iso13485
Pass
Audited by Gen Agent Trust Hub on Jul 18, 2026
Risk Level: SAFE
Full Analysis
- [SAFE]: The skill consists of ISO 13485 regulatory reference material, documentation templates (SKILL.md, references/iso13485-clause-requirements.md, references/qms-process-templates.md), and a helper script.
- [SAFE]: The Python script
scripts/qms_audit_checklist.pyis a utility to format and print audit checklists based on predefined dictionaries. It uses only Python standard libraries (argparse,json,sys,datetime) and contains no network operations, file system writes, or dynamic code execution (eval/exec). - [SAFE]: No prompt injection patterns, data exfiltration vectors, or obfuscated content were detected across the skill files.
- [SAFE]: The skill focuses on professional QMS workflows without requiring excessive privileges or external dependencies.
Audit Metadata