360 Secure SkillHub
360 安全技能中心

medical-device-qms-gmp

以提示词方式提供医疗器械 GMP/ISO 13485 质量体系文档的框架生成与核查清单，按七步流程覆盖体系范围界定、质量手册与程序框架、关键工序 IQ/OQ/PQ、复用器械再处理验证、灭菌确认及体系核查自查与缺陷整改。属编写辅助型技能，无脚本、无凭据、本地闭环。

zhaoxinghua09-cell
zhaoxinghua09-cell
热度 40.68
最近更新 2026-10-17 07:19:13
分类：知识依赖：纯提示词应用场景：报告撰写 / 法律文档 / 模板 / 校对润色

安装技能

复制下面的话术发给你的 Agent，它会通过 secure-skills 检索并安装该技能。

执行命令安装此 skill： npx secure-skills-cli add medical-device-qms-gmp
Metadata
name
medical-device-qms-gmp
title
Medical Device QMS/GMP Documents
display_name
医械质量体系GMP文档
display_name_en
Medical Device QMS/GMP Documents
description
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）、再处理验证、灭菌确认。覆盖体系核查准备。
description_zh
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。
description_en
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.
version
0.1.1
author
SynomosAI
category
knowledge-management
tags
["medical-device-qms-gmp","医疗器械","GMP","ISO 13485","质量体系","工艺验证"]
license
MIT
platforms
["windows","macos","linux"]
platform_compatibility
["windows","macos","linux"]
slug
medical-device-qms-gmp
classification
{"skillhub":["medical-device","quality","regulatory"],"iso_25010":["Maintainability"]}
read_when
["需要生成/核查 GMP 或 ISO 13485 质量手册与程序文件框架","需要做工艺验证（IQ/OQ/PQ）、复用器械再处理验证、灭菌确认方案","体系核查（飞检/稽核）前准备与缺陷整改台账"]
ai_protocol
true
spec
usk/1.0
interface
{"type":"prompt","entry_point":"SKILL.md","runtime":"none","call_pattern":"prompt"}
input_schema
{"args":{"type":"string","description":"CLI arguments per skill usage","required":false}}
output_schema
{"stdout":"structured result (JSON IR)","exit_code":"rc=0 ok / rc=1 warning / rc=2 bad input"}
capabilities
["medical-devices","qms","gmp","regulatory"]
permissions
{"network":false,"filesystem":false,"subprocess":false}
requirements
{"python_packages":[],"min_python":"3.8"}
changelog
0.1.1: Bilingual rewrite (EN-first) + read_when/classification; legacy author/copyright/platform refs neutralized; 0.1.0 initial upload (USK v3 injected round2)

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=[]。