quality-manager-qms-iso13485
Pass
Audited by Gen Agent Trust Hub on Sep 14, 2026
Risk Level: SAFE
Full Analysis
- [SAFE]: The skill is primarily composed of instructional markdown and structured templates for medical device quality management compliance. No security risks were identified in the instructional content.
- [COMMAND_EXECUTION]: The skill includes a Python script (
scripts/qms_audit_checklist.py) used to generate audit checklists from a hardcoded database of ISO 13485 requirements. The script uses only standard library modules (argparse,json,sys,datetime) and contains no network operations, file writing, or subprocess spawning logic. - [INDIRECT_PROMPT_INJECTION]: The skill provides templates for processing organizational data (audits, CAPAs, supplier evaluations). While these are ingestion points for external data, the skill does not possess high-risk capabilities (like network exfiltration or arbitrary code execution) that would make this surface exploitable. The script and markdown utilize clear boundaries for data presentation.
- [EXTERNAL_DOWNLOADS]: The documentation references official regulatory resources (fda.gov) for compliance verification. These references are documented neutrally as they point to well-known government services.
Audit Metadata