Medical Device QMS & GMP（医械质量体系文档）

Generate and review medical-device GMP / ISO 13485 QMS documents: quality manual, procedure framework, process validation (IQ/OQ/PQ), reprocessing validation (clean-disinfect-sterilize-package for reusable devices), and sterilization qualification. Covers regulatory system-audit preparation. 生成与核查医疗器械 GMP/ISO 13485 质量体系文档：质量手册、程序文件框架、工艺验证（IQ/OQ/PQ）、复用器械再处理验证、灭菌确认，覆盖体系核查准备。

凡自治之物 · LGD 治理学 · 创造术家族 ｜ 评测协议：skill-quality-gate

English

Medical Device QMS/GMP Documents

The quality management system is the foundation of registration and production. This skill provides framework generation and review checklists for GMP/ISO 13485 system documents, focusing on process validation, reusable-device reprocessing validation, and sterilization qualification — high-frequency audit points.

When to use

• Generate/review GMP or ISO 13485 quality manuals, procedure frameworks, process validation (IQ/OQ/PQ), reprocessing validation, or sterilization qualification.
• Triggers: GMP, ISO 13485, process validation, IQ/OQ/PQ, reprocessing, sterilization, system audit.

How to use

• Writing-assistance skill, no scripts/; follow the seven-step process below.
• Rules/official links: see medical-device-reg-hub; after generation, self-check with medical-device-compliance-grader C5 dimension.

Workflow (7 steps)

1. Define system scope (design / procurement / production / inspection / after-sales).
2. Build quality manual + procedure framework per ISO 13485:2016.
3. Process validation: IQ/OQ/PQ for key processes.
4. Reprocessing validation (reusable devices): clean→disinfect→sterilize→package, confirm repeatable SAL.
5. Sterilization qualification per ISO 11135 (EO) / 11137 (irradiation) / 17665 (moist heat); sterile barrier per ISO 11607.
6. System-audit self-check → defect rectification ledger.
7. Self-check loop via medical-device-compliance-grader C5 dimension.

Key points

• Process validation is not one-time; key-process changes and equipment moves require re-qualification.
• Reusable-device IFU reprocessing must match the reprocessing validation conclusion.
• Sterilization status must be truthfully reflected on labels/IFU.
• Risk management (ISO 14971) runs through the system.

Boundary

Not legal/regulatory advice; follow the latest official releases. Inputs/outputs desensitized.

Evidence & safety

• Evidence: see bundled ATTESTATION.md / manifest.json / security_results.json.
• Version: 0.1.1; Security: local closed-loop, zero credentials, sensitive_hits=[] per bundled snapshot.

中文

医械质量体系 GMP 文档

质量体系是注册与生产的底座。本技能提供 GMP/ISO 13485 体系文档的框架生成与核查清单，重点覆盖工艺验证、复用器械再处理验证、灭菌确认——体系核查高频必查点。

何时用

• 需要生成与核查 GMP / ISO 13485 质量手册、程序文件框架、工艺验证、再处理验证、灭菌确认。
• 触发词：GMP、ISO 13485、工艺验证、IQ/OQ/PQ、再处理验证、灭菌确认、体系核查。

用法

• 编写辅助型技能，无 scripts/；按七步流程执行。
• 规则/官方链接走 medical-device-reg-hub；生成后用 medical-device-compliance-grader C5 维度自测。

使用流程（七步）

定体系范围 → 搭质量手册与程序框架（ISO 13485:2016）→ 关键工序 IQ/OQ/PQ → 复用器械清洗-消毒-灭菌-包装再处理验证 → 灭菌确认（ISO 11135/11137/17665，无菌屏障 ISO 11607）→ 体系核查自查与缺陷整改台账 → C5 维度自测闭环。

要点速查

工艺验证非一次性（变更/搬迁须再确认）；复用器械 IFU 再处理须与验证结论一致；灭菌状态须如实标注；风险管理（ISO 14971）贯穿体系。

注意事项

不构成法规意见，以监管机构最新发布为准；输入/输出去敏。

证据与安全声明

• 证据：见包内 ATTESTATION.md / manifest.json / security_results.json。
• 版本：0.1.1；安全：本地闭环、零凭据、sensitive_hits=[]。

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Ecosystem / 生态入口

This skill is one door of the LGD ecosystem — every entry below is publicly reachable. 本技能是 LGD 生态 的一个入口，下列地址均对公网可达。

• Ecosystem hub / 生态总入口: https://zhaoxinghua09-cell.github.io/lgd-hub/
• LGD theory (canonical) / 理论正本: https://github.com/zhaoxinghua09-cell/LGD
• Formal paper (DOI) / 形式化论文: https://doi.org/10.5281/zenodo.22456647
• Protocol & reference implementation / 协议与参考实现: https://github.com/zhaoxinghua09-cell/uibc-core
• Source of this skill / 本包源码: https://github.com/zhaoxinghua09-cell/agent-skills/tree/main/skills/medical-device-qms-gmp
• All published skills / 全部已发布技能: https://github.com/zhaoxinghua09-cell/agent-skills
• AI-readable index / AI 说明书: https://github.com/zhaoxinghua09-cell/agent-skills/tree/main/skills/medical-device-qms-gmp/llms.txt

Looking for something else? / 还想要别的？

Tell your AI assistant: "Find me an LGD skill that can " — the hub lists every published skill with a one-line purpose. 跟你的 AI 助手说一句「去 LGD 生态超市找能……的技能」，总入口按用途列全了所有已发布技能。