Qms Audit Expert

ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for int...

This skill appears coherent and appropriate for ISO 13485 internal-audit support. Before use: (1) inspect any input files you pass to the optimizer (processes.json) to avoid leaking sensitive production or patient data; (2) if you run the Python script in a production environment, run it in a controlled environment (no unexpected network mounts) and review the code (it appears local and non-networking); (3) treat audit findings and CAPA guidance as advisory—confirm regulatory/legal interpretations with your QA/regulatory lead. No credentials or network endpoints are requested by the skill.

Type: OpenClaw Skill Name: qms-audit-expert Version: 2.1.1 The skill bundle provides a legitimate framework for ISO 13485 medical device QMS auditing, including detailed methodology and templates. The included Python utility, 'scripts/audit_schedule_optimizer.py', is a standard scheduling tool that uses risk-based logic to prioritize audits without any suspicious network, file system, or shell execution capabilities. No evidence of prompt injection, data exfiltration, or malicious intent was found across the documentation or code.