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Quality Manager Qms Iso13485
by
Alireza Rezvani
· GitHub ↗
· v2.1.1
· MIT-0
2083
Downloads
2
Stars
8
Active Installs
3
Versions
Install in OpenClaw
/install quality-manager-qms-iso13485
Description
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal aud...
Usage Guidance
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.
Capability Analysis
Type: OpenClaw Skill
Name: quality-manager-qms-iso13485
Version: 2.1.1
The skill bundle is a legitimate toolset for ISO 13485 Quality Management System (QMS) compliance. The included Python script, `scripts/qms_audit_checklist.py`, is a standalone utility that generates audit checklists from hardcoded data and does not perform any network, file system, or shell operations. The documentation in `SKILL.md` and the reference files provide relevant industry-standard templates and instructions without any evidence of prompt injection or malicious intent.
Capability Assessment
Purpose & 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.
How to Use
- Make sure OpenClaw is installed (local or Docker)
- Run the install command in chat:
/install quality-manager-qms-iso13485 - After installation, invoke the skill by name or use
/quality-manager-qms-iso13485 - Provide required inputs per the skill's parameter spec and get structured output
Version History
v2.1.1
v2.1.1: optimization, reference splits
v1.0.0
Initial release of the quality-manager-qms-iso13485 skill.
- Provides workflows and tools for implementing and maintaining an ISO 13485:2016-compliant Quality Management System for medical device organizations.
- Includes detailed guidance on QMS implementation, document control, internal audit, CAPA management, and certification support.
- Offers templates and best practices for process documentation, gap analysis, and audit planning.
- Supports key QMS processes such as management reviews, process validation, supplier qualification, and quality records management.
v0.1.0
Initial release — provides tools, workflows, and references for ISO 13485 Quality Management System implementation in medical device organizations.
- QMS implementation workflow from gap analysis to certification readiness
- Document control workflows, including numbering conventions and change control
- Internal audit planning and execution, with templates and auditor qualification criteria
- Detailed tables for required procedures, document types, and review schedules
- Coverage of key processes: CAPA, management review, process validation, supplier qualification
Metadata
Frequently Asked Questions
What is Quality Manager Qms Iso13485?
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal aud... It is an AI Agent Skill for Claude Code / OpenClaw, with 2083 downloads so far.
How do I install Quality Manager Qms Iso13485?
Run "/install quality-manager-qms-iso13485" in the OpenClaw or Claude Code chat to install it in one step — no extra setup required.
Is Quality Manager Qms Iso13485 free?
Yes, Quality Manager Qms Iso13485 is completely free, licensed under MIT-0. You can download, install and use it at no cost.
Which platforms does Quality Manager Qms Iso13485 support?
Quality Manager Qms Iso13485 is cross-platform and runs anywhere OpenClaw / Claude Code is available (cross-platform).
Who created Quality Manager Qms Iso13485?
It is built and maintained by Alireza Rezvani (@alirezarezvani); the current version is v2.1.1.
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