quality-manager-qms-iso13485
Pass
Audited by Gen Agent Trust Hub on Sep 4, 2026
Risk Level: SAFENO_CODE
Full Analysis
- [SAFE]: The skill provides structured guidance and templates for medical device quality management compliance. Analysis of the instructions and scripts shows adherence to standard industry practices.
- [COMMAND_EXECUTION]: The skill includes a Python script
scripts/qms_audit_checklist.py. Technical review of this script confirms it is a benign utility that uses the standard library (argparse,json,sys,datetime) to generate text or JSON audit checklists based on a hardcoded mapping of ISO clauses. It does not perform network operations, file system writes, or execute external commands. - [NO_CODE]: Other than the checklist generator script, the skill consists entirely of markdown documentation and reference templates for QMS processes like CAPA, Internal Audits, and Supplier Qualification.
- [DATA_EXPOSURE_AND_EXFILTRATION]: The skill does not access sensitive local file paths (such as credentials or SSH keys) nor does it perform any network requests to external domains. Documentation mentions standard regulatory records (e.g., Device History Records) but only in the context of compliance templates.
- [PROMPT_INJECTION]: No patterns of instruction override, safety filter bypass, or adversarial role-play were found in the markdown content. The instructions are consistently framed within the domain of quality management.
Audit Metadata