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ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal aud...

综合技能

作者:Alireza Rezvani @alirezarezvani

许可证:MIT-0

MIT-0 ·免费使用、修改和重新分发。无需归因。

版本:v2.1.1

统计:⭐ 1 · 1.7k · 6 current installs · 6 all-time installs

1

安装量(当前) 6

🛡 VirusTotal :良性 · OpenClaw :良性

Package:alirezarezvani/quality-manager-qms-iso13485

安全扫描(ClawHub)

  • VirusTotal :良性
  • OpenClaw :良性

OpenClaw 评估

The skill's files and runtime instructions align with its stated purpose (ISO 13485 QMS guidance and audit checklist generation); it does not request unrelated credentials, installs, or external network access.

目的

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.

说明范围

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).

安装机制

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.

证书

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.

持久

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.

综合结论

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 appropr…

安装(复制给龙虾 AI)

将下方整段复制到龙虾中文库对话中,由龙虾按 SKILL.md 完成安装。

请把本段交给龙虾中文库(龙虾 AI)执行:为本机安装 OpenClaw 技能「Quality Manager Qms Iso13485」。简介:ISO 13485 Quality Management System implementation and maintenance for medical …。
请 fetch 以下地址读取 SKILL.md 并按文档完成安装:https://raw.githubusercontent.com/openclaw/skills/refs/heads/main/skills/alirezarezvani/quality-manager-qms-iso13485/SKILL.md
(来源:yingzhi8.cn 技能库)

SKILL.md

打开原始 SKILL.md(GitHub raw)

暂无本地缓存内容,可在后台执行详情同步。