Qms Audit Expert
v2.1.1ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for int...
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byAlireza Rezvani@alirezarezvani
MIT-0
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LicenseMIT-0 · Free to use, modify, and redistribute. No attribution required.
Security Scan
OpenClaw
Benign
high confidencePurpose & Capability
Name and description (ISO 13485 audit support) match the provided SKILL.md guidance, clause-by-clause references, and the included audit schedule optimizer script. Required resources (none) are appropriate for a documentation-plus-local-tool skill.
Instruction Scope
SKILL.md contains audit planning, execution, classification, and CAPA guidance only. Instructions do not tell the agent to read system credentials, arbitrary filesystem locations, or to transmit data to external endpoints; references are local files included in the package.
Install Mechanism
No install spec is present (instruction-only with a local Python script). There are no downloads or external package installs declared, so nothing is written to disk beyond existing files unless the agent runs the included script locally.
Credentials
The skill declares no required environment variables, credentials, or config paths. The SKILL.md and script do not access or expect secrets or unrelated service tokens.
Persistence & Privilege
always is false and the skill is user-invocable (normal). The skill does not request persistent system-wide configuration or elevated privileges and does not modify other skills.
Assessment
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.Like a lobster shell, security has layers — review code before you run it.
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License
MIT-0
Free to use, modify, and redistribute. No attribution required.