Agent skill

Ra Qm Skills

by alirezarezvani in alirezarezvani/claude-skills

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…

MITAuto-check passedLegal & Compliance

Install Ra Qm Skills

skills CLI
$ npx skills add alirezarezvani/claude-skills --skill ra-qm-skills -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install alirezarezvani/claude-skills ra-qm-skills --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/ra-qm-team/skills/ra-qm-skills .claude/skills/ra-qm-skills && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
ra-qm-skills
GitHub stars
28k
Token cost
~833 tokens
SKILL.md length
223 words
Files
1
Skills in repo
342
Repo updated
First seen
Licence
MIT

At a glance

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…

  • A compliance request doesnt obviously match one skill and you need to pick the right one (e.g.
  • SKILL.md covers Routing table, Quick start and Rules
  • Calls python3
  • Prepare us for an ISO 13485 audit

What it does

Ra Qm Skills is an agent skill from alirezarezvani/claude-skills. 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').

Its SKILL.md is about 830 tokens, which your agent loads only when the skill is triggered. It is a single SKILL.md file with no bundled scripts.

It sits in Legal & Compliance, covering SOC 2 and security compliance, AI governance and Privacy and GDPR. The repository describes itself as: 380 Claude Code skills & agent skills & plugins (30+ Agents, 70+ custom commands, 380+ skills, customizable references, scripts)for Claude Code, Codex, Gemini CLI, Cursor, and 8… The licence is MIT.

When your agent uses it

  • A compliance request doesnt 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)

Example prompts

  • “t obviously match one skill and you need to pick the right one (e.g.,”
  • “is my AI system high-risk under the AI Act”
  • “/ra-qm-skills”

Requirements

  • Python 3

What it can do on your machine

Read from SKILL.md and the folder at commit 19392f7. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    Shell commands in SKILL.md call:

    • python3

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

Ra Qm Skills loads about 833 tokens when it runs. Until then it costs about 116 tokens; SKILL.md has 223 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~116
When it runs · the whole SKILL.md, loaded when a task matches
~833

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); files beside SKILL.md are not scanned.

SKILL.md

The full file from alirezarezvani/claude-skills at commit 19392f7, republished under its MIT licence (© alirezarezvani). 223 words, ~833 tokens.

Download SKILL.mdSave it as .claude/skills/ra-qm-skills/SKILL.md (or your agent's skills folder).
name
ra-qm-skills
description
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').
version
2.9.0
author
Alireza Rezvani
license
MIT
tags
regulatory, quality-management, iso-13485, mdr, fda, iso-27001, gdpr
agents
claude-code, codex-cli, openclaw

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 signalsSkillPath
Regulatory strategy, pathway selection, submissions planningregulatory-affairs-headskills/regulatory-affairs-head/
Management review, quality KPIs, QMR governancequality-manager-qmrskills/quality-manager-qmr/
ISO 13485 QMS implementation, process controlquality-manager-qms-iso13485skills/quality-manager-qms-iso13485/
ISO 14971 risk analysis, FMEA, risk filesrisk-management-specialistskills/risk-management-specialist/
Root cause analysis, corrective/preventive actionscapa-officerskills/capa-officer/
Document control, 21 CFR Part 11, DHF/DMR/DHRquality-documentation-managerskills/quality-documentation-manager/
ISO 13485 internal audits, NC classificationqms-audit-expertskills/qms-audit-expert/
ISO 27001 audit planning and executionisms-audit-expertskills/isms-audit-expert/
ISMS design, security risk assessmentinformation-security-manager-iso27001skills/information-security-manager-iso27001/
EU MDR classification, technical files, PSURmdr-745-specialistskills/mdr-745-specialist/
FDA 510(k)/PMA/De Novo, QMSRfda-consultant-specialistskills/fda-consultant-specialist/
GDPR/DSGVO, DPIA, data subject rightsgdpr-dsgvo-expertskills/gdpr-dsgvo-expert/
EU AI Act risk classification, obligationseu-ai-act-specialistskills/eu-ai-act-specialist/
ISO/IEC 42001 AI management systemiso42001-specialistskills/iso42001-specialist/
SOC 2 Type I/II readiness, trust criteriasoc2-complianceskills/soc2-compliance/

Quick start

bash
# Example: route a risk-analysis request
cat ra-qm-team/skills/risk-management-specialist/SKILL.md
python3 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).

© alirezarezvani, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

Just SKILL.md in ra-qm-team/skills/ra-qm-skills of alirezarezvani/claude-skills.

Open the folder on GitHubat commit 19392f7

Compare with similar skills

Ra Qm Skills next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.

Ra Qm Skills compared with similar skills
SkillStarsUsed inTokensAuto-checkLicenceRepo updated
Ra Qm Skills this skillalirezarezvani/claude-skills28k—~833Automated safety check: PassMIT
Policy OpaAgentSecOps/SecOpsAgentKit2201 repos~3.5kAutomated safety check: PassCustom licence
Implementing Complianceancoleman/ai-design-components525—~4kAutomated safety check: PassMIT
Security Compliance Compliance Checkaiskillstore/marketplace4338 repos~600Automated safety check: PassNone
Compliance Testingproffesor-for-testing/agentic-qe495—~1.8kAutomated safety check: PassMIT
Openrouter Compliance Reviewjeremylongshore/tons-of-skills-marketplace2.8k—~2.3kAutomated safety check: NotesMIT

Similar skills

  • Policy Opa

    AgentSecOps/SecOpsAgentKit

    Policy-as-code enforcement and compliance validation using Open Policy Agent (OPA).

    220 GitHub starsUsed in 1 repo~3.5k tokens
    Legal & ComplianceAuto-check passed
  • Implementing Compliance

    ancoleman/ai-design-components

    Implement and maintain compliance with SOC 2, HIPAA, PCI-DSS, and GDPR using unified control mapping, policy-as-code enforcement, and automated evidence collection.

    525 GitHub stars~4k tokensUpdated 10 mo ago
    Legal & ComplianceAuto-check passed
  • Security Compliance Compliance Check

    aiskillstore/marketplace

    You are a compliance expert specializing in regulatory requirements for software systems including GDPR, HIPAA, SOC2, PCI-DSS, and other industry standards.

    433 GitHub starsUsed in 8 repos~600 tokens
    Legal & ComplianceAuto-check passed
  • Compliance Testing

    proffesor-for-testing/agentic-qe

    Regulatory compliance testing for GDPR, CCPA, HIPAA, SOC2, PCI-DSS and industry-specific regulations.

    495 GitHub stars~1.8k tokensUpdated yesterday
    Legal & ComplianceAuto-check passed
  • Openrouter Compliance Review

    jeremylongshore/tons-of-skills-marketplace

    Review OpenRouter integration for regulatory compliance (SOC2, GDPR, HIPAA).

    2.8k GitHub stars~2.3k tokensUpdated yesterday
    Legal & ComplianceAuto-check: notes
  • Cometchat Compliance

    cometchat/cometchat-skills

    Data governance & compliance for CometChat — pick the data-residency region, satisfy GDPR/CCPA (right-to-erasure and data export), plan message retention & purge, and produce audit / eDiscovery…

    132 GitHub stars~1.7k tokensUpdated 5 days ago
    Legal & ComplianceAuto-check passed

More from alirezarezvani/claude-skills

All 342 skills in this repo
  • Agile Product Owner

    alirezarezvani/claude-skills

    Writes INVEST-checked user stories with acceptance criteria, splits epics, plans sprints from velocity and ranks the backlog with a weighted score.

    28k GitHub starsUsed in 3 repos~3.2k tokens
    Auto-check passed
  • Product Strategist

    alirezarezvani/claude-skills

    OKR cascade toolkit for product leaders: generates aligned company-to-team OKRs from five strategy types and scores how well they line up.

    28k GitHub starsUsed in 2 repos~1.8k tokens
    Auto-check passed
  • App Store Optimization

    alirezarezvani/claude-skills

    App Store Optimization (ASO) toolkit for researching keywords, analyzing competitor rankings, generating metadata suggestions, and improving app visibility on Apple App Store and Google Play Store.

    28k GitHub starsUsed in 1 repo~4.2k tokens
    Auto-check passed
  • AWS Solution Architect

    alirezarezvani/claude-skills

    Design AWS architectures for startups using serverless patterns and IaC templates.

    28k GitHub starsUsed in 1 repo~2.5k tokens
    Auto-check passed
  • Campaign Analytics

    alirezarezvani/claude-skills

    Calculates attribution, funnel and ROI figures for marketing campaigns with three Python scripts that need only the standard library.

    28k GitHub starsUsed in 1 repo~2.1k tokens
    Auto-check passed
  • Code to PRD

    alirezarezvani/claude-skills

    Reverse-engineers a frontend, backend or fullstack codebase into a product requirements document with per-page docs, an enum dictionary and an API inventory.

    28k GitHub starsUsed in 1 repo~4.9k tokens
    Auto-check passed

Questions about Ra Qm Skills

What does Ra Qm Skills do?

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…. Ra Qm Skills is an agent skill from alirezarezvani/claude-skills. 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).

When should I use Ra Qm Skills?

Ra Qm Skills fits situations like: A compliance request doesnt 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).

How do I install Ra Qm Skills in Claude Code?

Run `npx skills add alirezarezvani/claude-skills --skill ra-qm-skills -a claude-code`. Or copy the skill folder (ra-qm-team/skills/ra-qm-skills in alirezarezvani/claude-skills) into .claude/skills/ra-qm-skills in your project. Claude Code loads it when a task matches its description.

How do I install Ra Qm Skills in Codex?

Run `npx skills add alirezarezvani/claude-skills --skill ra-qm-skills -a codex`. Or copy the skill folder (ra-qm-team/skills/ra-qm-skills in alirezarezvani/claude-skills) into .agents/skills/ra-qm-skills in your project. Codex loads it when a task matches its description.

Can I use Ra Qm Skills in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add alirezarezvani/claude-skills --skill ra-qm-skills -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/ra-qm-skills, .gemini/skills/ra-qm-skills, .github/skills/ra-qm-skills and .opencode/skills/ra-qm-skills in your project.

What does Ra Qm Skills need to run?

Going by SKILL.md and its folder, Ra Qm Skills needs the command-line tools its instructions call (python3). Our summary lists: Python 3.

Does Ra Qm Skills access the network?

SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.

Is Ra Qm Skills safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. Review the folder before installing.

What licence does Ra Qm Skills use?

Ra Qm Skills is published under the MIT licence (declared in SKILL.md). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does Ra Qm Skills use?

About 833 tokens (SKILL.md is roughly 3.3k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full.

What are the alternatives to Ra Qm Skills?

Skills that share tags, products or a category with Ra Qm Skills: Policy Opa (AgentSecOps/SecOpsAgentKit, 220 stars), Implementing Compliance (ancoleman/ai-design-components, 525 stars), Security Compliance Compliance Check (aiskillstore/marketplace, 433 stars) and Compliance Testing (proffesor-for-testing/agentic-qe, 495 stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains Ra Qm Skills?

alirezarezvani (a GitHub user) maintains it in alirezarezvani/claude-skills, which has 27,938 GitHub stars. The repository holds 342 skills in this directory. The repository was last updated on August 30, 2026.

Source: alirezarezvani/claude-skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.