Ra Qm Skills

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

作者 alirezarezvani19392f7a0826MIT27K 個星標收錄於 2026年10月8日更新於 2026年10月8日儲存庫5 週前更新

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').

僅含說明Business & Finance

AI 產生的概覽

將合規請求路由到 15 個內建監管與品質管理技能之一。

功能: 這是一個路由／索引技能，對應一個捆綁了 15 個監管事務與品質管理技能的外掛，涵蓋 ISO 13485、歐盟 MDR、FDA 送件、ISO 14971 風險、CAPA、文件管制、ISO 27001、ISO 42001、歐盟 AI 法案、GDPR、SOC 2 與稽核等領域。它提供路由表，將請求訊號對應到特定技能及其路徑，並指示載入該技能的 SKILL.md。它本身不附帶任何工具，產出的是路由決策而非合規文件。
適用情境: 當合規請求無法明顯對應某個內建技能、需要挑選正確技能時使用，例如為 ISO 13485 稽核做準備，或判斷 AI 系統在 AI 法案下是否屬於高風險。當多列路由同時符合、需要先提出一個釐清問題時也適用。
執行需求: 本身不需要指令碼或工具；需要能存取捆綁的技能資料夾及其 SKILL.md 檔案。輸出為決策支援，最終合規判定交由指定的人工負責人。

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).

來源與署名

來源：alirezarezvani/claude-skills位於ra-qm-team/skills/ra-qm-skills提交19392f7

授權條款： MIT

內容歸原作者所有。SourceWeft 從公開儲存庫中收錄這些內容。

檢舉或申請下架

Ra Qm Skills

Regulatory Affairs & Quality Management Skills — Router

Routing table

Quick start

Rules

來源與署名

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