Quality Manager Qms Iso13485
v2.1.1ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal aud...
⭐ 2· 2k·8 current·8 all-time
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
The name/description (ISO 13485 QMS implementation, document control, internal audit, CAPA) match the included SKILL.md, reference templates, and the qms_audit_checklist.py script. All required artifacts (templates, clause guidance, an audit checklist generator) are appropriate and proportionate to the stated purpose.
Instruction Scope
SKILL.md provides step-by-step QMS workflows and explicitly references the bundled templates; it does not instruct the agent to read unrelated system files, access secret environment variables, or transmit data to external endpoints. The guidance is scoped to QMS tasks (gap analysis, document control, audits, CAPA).
Install Mechanism
There is no install spec (instruction-only skill) and only a small Python utility is included. The script is local, requires a standard Python runtime and uses standard libraries; no external downloads or archive extraction are present.
Credentials
The skill declares no required environment variables, binaries, or credentials. The content and code do not access secrets or unrelated services, so the requested environment access is minimal and proportionate.
Persistence & Privilege
always is false and the skill is user-invocable. It does not request elevated or persistent platform privileges and does not modify other skills' configuration. Autonomous invocation is allowed by platform default but not combined with other concerning factors here.
Assessment
This skill appears coherent and appropriate for ISO 13485 QMS guidance. Before installing: (1) review the included Python script if you plan to execute it in your environment—it uses only standard libraries and has no network calls; (2) ensure templates and procedures are adapted to your organization and reviewed by your regulatory/quality leads; (3) don't feed real patient data or confidential device records into tools unless you have appropriate handling/retention controls; (4) confirm license/usage terms with the skill author if you need to redistribute or embed the templates. If you want higher assurance, ask the author for provenance (source/homepage) or a signed release artifact.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.