quality-manager-qms-iso13485
Pass
Audited by Gen Agent Trust Hub on Oct 24, 2026
Risk Level: SAFE
Full Analysis
- [INDIRECT_PROMPT_INJECTION]: The skill processes organizational quality management data, which creates a surface for indirect prompt injection. This is a functional requirement of the skill's purpose and is mitigated by the lack of dangerous capabilities (such as network access or file system modification) in the included scripts.
- [COMMAND_EXECUTION]: The skill includes a utility script,
qms_audit_checklist.py, designed to generate ISO 13485 audit checklists. The script uses only standard Python libraries and performs no sensitive operations beyond printing text to the console. - [EXTERNAL_DOWNLOADS]: The skill references regulatory guidelines from the official FDA domain (
fda.gov). These references are for informational purposes and target a well-known government service.
Audit Metadata