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Quality Manager Qms Iso13485
作者
Alireza Rezvani
· GitHub ↗
· v2.1.1
· MIT-0
2083
总下载
2
收藏
8
当前安装
3
版本数
在 OpenClaw 中安装
/install quality-manager-qms-iso13485
功能描述
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal aud...
安全使用建议
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.
功能分析
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.
能力评估
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.
如何使用
- 确保已安装 OpenClaw（本地或 Docker 部署）
- 在对话框中输入安装命令：
/install quality-manager-qms-iso13485 - 安装完成后，直接呼叫该 Skill 的名称或使用
/quality-manager-qms-iso13485触发 - 根据 Skill 的参数说明提供必要输入，即可获得结构化输出
版本历史
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
元数据
常见问题
Quality Manager Qms Iso13485 是什么？
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal aud... 它是一个面向 Claude Code / OpenClaw 的 AI Agent Skill 插件，目前累计下载 2083 次。
如何安装 Quality Manager Qms Iso13485？
在 OpenClaw 或 Claude Code 对话框中运行命令「/install quality-manager-qms-iso13485」即可一键安装，无需额外配置。
Quality Manager Qms Iso13485 是免费的吗？
是的，Quality Manager Qms Iso13485 完全免费，采用 MIT-0 许可证，可自由下载、安装和使用。
Quality Manager Qms Iso13485 支持哪些平台？
Quality Manager Qms Iso13485 跨平台运行，可在任意部署了 OpenClaw / Claude Code 的环境中使用（cross-platform）。
谁开发了 Quality Manager Qms Iso13485？
由 Alireza Rezvani（@alirezarezvani）开发并维护，当前版本 v2.1.1。
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