Ra Qm Skills

alirezarezvani/claude-skills/ra-qm-team/skills/ra-qm-skills

作者 alirezarezvani19392f7a0826MIT27K 个星标收录于 2026年10月8日更新于 2026年10月8日仓库5周前更新

Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act').

仅含说明Business & Finance

AI 生成的概览

将合规请求路由到 15 个内置监管与质量管理技能之一。

功能: 这是一个路由/索引技能，对应一个捆绑了 15 个监管事务与质量管理技能的插件，涵盖 ISO 13485、欧盟 MDR、FDA 申报、ISO 14971 风险、CAPA、文件控制、ISO 27001、ISO 42001、欧盟 AI 法案、GDPR、SOC 2 和审计等领域。它提供路由表，将请求信号匹配到具体技能及其路径，并指示加载该技能的 SKILL.md。它本身不附带任何工具，产出的是路由决策而非合规文件。
适用场景: 当合规请求无法明显对应某个内置技能、需要选择正确技能时使用，例如为 ISO 13485 审计做准备，或判断 AI 系统在 AI 法案下是否属于高风险。当多行路由同时匹配、需要先提出一个澄清问题时也适用。
运行要求: 本身不需要脚本或工具；需要能够访问捆绑的技能文件夹及其 SKILL.md 文件。输出为决策支持，最终合规判定交由指定的人工负责人。

Regulatory Affairs & Quality Management Skills — Router

This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under ra-qm-team/skills/). Each skill is self-contained.

Routing table

Match the request, then load ra-qm-team/skills/<skill>/SKILL.md. If multiple rows match, ask one clarifying question first.

Request signals	Skill	Path
Regulatory strategy, pathway selection, submissions planning	regulatory-affairs-head	`skills/regulatory-affairs-head/`
Management review, quality KPIs, QMR governance	quality-manager-qmr	`skills/quality-manager-qmr/`
ISO 13485 QMS implementation, process control	quality-manager-qms-iso13485	`skills/quality-manager-qms-iso13485/`
ISO 14971 risk analysis, FMEA, risk files	risk-management-specialist	`skills/risk-management-specialist/`
Root cause analysis, corrective/preventive actions	capa-officer	`skills/capa-officer/`
Document control, 21 CFR Part 11, DHF/DMR/DHR	quality-documentation-manager	`skills/quality-documentation-manager/`
ISO 13485 internal audits, NC classification	qms-audit-expert	`skills/qms-audit-expert/`
ISO 27001 audit planning and execution	isms-audit-expert	`skills/isms-audit-expert/`
ISMS design, security risk assessment	information-security-manager-iso27001	`skills/information-security-manager-iso27001/`
EU MDR classification, technical files, PSUR	mdr-745-specialist	`skills/mdr-745-specialist/`
FDA 510(k)/PMA/De Novo, QMSR	fda-consultant-specialist	`skills/fda-consultant-specialist/`
GDPR/DSGVO, DPIA, data subject rights	gdpr-dsgvo-expert	`skills/gdpr-dsgvo-expert/`
EU AI Act risk classification, obligations	eu-ai-act-specialist	`skills/eu-ai-act-specialist/`
ISO/IEC 42001 AI management system	iso42001-specialist	`skills/iso42001-specialist/`
SOC 2 Type I/II readiness, trust criteria	soc2-compliance	`skills/soc2-compliance/`

Quick start

bash

# Example: route a risk-analysis requestcat ra-qm-team/skills/risk-management-specialist/SKILL.mdpython3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help

# Example: route a risk-analysis requestcat ra-qm-team/skills/risk-management-specialist/SKILL.mdpython3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help

Rules

Route to exactly one skill, then follow that skill's workflow. This router ships no tools of its own.
All outputs are decision support: final compliance determinations route to the named human owner (QMR, DPO, regulatory counsel) — never auto-decide.
Verify regulatory citations against the current text (e.g., FDA QMSR effective 2026-02-02 replaced the legacy QSR subsections).

来源与署名

来源：alirezarezvani/claude-skills位于ra-qm-team/skills/ra-qm-skills提交19392f7

许可证： MIT

内容归原作者所有。SourceWeft 从公开仓库中收录这些内容。

举报或申请下架

Ra Qm Skills

Regulatory Affairs & Quality Management Skills — Router

Routing table

Quick start

Rules

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