Skills

quality-manager-qms-iso13485

quality-manager-qms-iso13485 is a skill in alirezarezvani/claude-skills, last changed 20 Oct 2026. It can bundle scripts. Our pattern check flagged nothing at commit 5434623 on 26 Oct 2026.

Pattern check: nothing flagged · commit 5434623 · 26 Oct 2026

Install
From the author
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.
Licence
MIT
Repo stars
28.8k
Folder last changed
20 Oct 2026 (opens in a new tab)
Publisher
alirezarezvani
Files
4 files
Checked
5434623 (opens in a new tab) · 26 Oct 2026

Install

Each tab says whether it installs commit 5434623, the one we checked, or the latest version.

No tab for your agent? Use Any agent for OpenCode, Goose, Windsurf (Devin Desktop), Zed, Roo Code, Factory Droid, Junie, Amp and Antigravity, and Claude Code for Cline. Kiro needs the folder copied by hand.

Pinned to commit 5434623, the one we checked.

From your project's root folder:

tmp="$(mktemp -d)" &&
  git clone -q --depth 1 --filter=blob:none --no-checkout https://github.com/alirezarezvani/claude-skills.git "$tmp" &&
  git -C "$tmp" fetch -q --depth 1 origin 5434623a788ec3105d238328cfe554e1e2242ff7 &&
  git -C "$tmp" sparse-checkout set -- ra-qm-team/skills/quality-manager-qms-iso13485 &&
  git -C "$tmp" checkout -q 5434623a788ec3105d238328cfe554e1e2242ff7 &&
  mkdir -p .claude/skills &&
  mkdir .claude/skills/quality-manager-qms-iso13485 &&
  cp -R "$tmp"/ra-qm-team/skills/quality-manager-qms-iso13485/. .claude/skills/quality-manager-qms-iso13485/ &&
  rm -rf "$tmp"

If Claude Code was already running and this created the skills folder, run /reload-skills.

Or install the ra-qm-skills plugin it ships in. Installs the latest version, not the one we checked. Installs everything in the plugin, including any hooks, MCP servers and scripts our check doesn't cover.

claude plugin marketplace add alirezarezvani/claude-skills --scope project &&
  claude plugin install ra-qm-skills@claude-code-skills --scope project
Claude Code docs (opens in a new tab)

What it can touch

From the files and frontmatter at commit 5434623. This is how much a skill can do, not whether it is risky.

What it can touch: Scripts or outside hosts

  • Bundles scripts

    The folder holds code files the agent may run.

Pattern check

Pattern check: nothing flagged · commit 5434623 · 26 Oct 2026

We checked every text file in this skill, at commit 5434623 on 26 Oct 2026, against 45 published patterns such as download-and-run commands, hidden text and credential access. We don't run the skill, we don't read the web pages it points to, and we can't judge everything its instructions might lead an agent to do. In published tests, pattern checks like this one missed most malicious skills. Read the skill before you install it — especially anything it asks you to download or run.

How the check worksReport an incorrect finding

Format check

Each agent reads SKILL.md a little differently. We check the file against each one's published rules; we don't run the skill in any agent.

  • Agent Skills specPasses with warnings

    The open format from agentskills.io, held to what the strictest agents enforce, so one folder loads everywhere.

    • Warning

      metadata values should be text; triggers (a list) is not. The spec's validator turns them into text; other readers may not. O4

      Fix: Quote each value, for example version: "1.0".

    • Warning

      Paths that may not work once the skill is installed: line 436: ../quality-manager-qmr/ (outside the skill folder), line 437: ../capa-officer/ (outside the skill folder), line 438: ../qms-audit-expert/ (outside the skill folder), line 439: ../quality-documentation-manager/ (outside the skill folder) and line 440: ../risk-management-specialist/ (outside the skill folder). B6

      Fix: Use forward-slash paths relative to SKILL.md, and copy shared files into the skill.

    • Note

      There is no license field, so readers can't tell whether they may reuse the skill. O2

      Fix: Add license: with an SPDX name such as MIT or Apache-2.0, or the name of a bundled licence file.

  • Claude CodePasses with warnings

    Claude Code reads its own extra fields, ignores unknown ones, and still loads a skill whose frontmatter is broken, without its fields.

    • Warning

      Paths that may not work once the skill is installed: line 436: ../quality-manager-qmr/ (outside the skill folder), line 437: ../capa-officer/ (outside the skill folder), line 438: ../qms-audit-expert/ (outside the skill folder), line 439: ../quality-documentation-manager/ (outside the skill folder) and line 440: ../risk-management-specialist/ (outside the skill folder). B6

      Fix: Use forward-slash paths relative to SKILL.md, and copy shared files into the skill.

  • Claude apps & API uploadPasses with warnings

    Uploading to claude.ai or the Claude API, or packaging with Anthropic's script, accepts only the six spec fields and stops on anything else.

    • Warning

      Paths that may not work once the skill is installed: line 436: ../quality-manager-qmr/ (outside the skill folder), line 437: ../capa-officer/ (outside the skill folder), line 438: ../qms-audit-expert/ (outside the skill folder), line 439: ../quality-documentation-manager/ (outside the skill folder) and line 440: ../risk-management-specialist/ (outside the skill folder). B6

      Fix: Use forward-slash paths relative to SKILL.md, and copy shared files into the skill.

    • Note

      The description is 546 characters. The claude.ai Help Center says 200 at most, though Anthropic's API docs and validator allow 1,024. D4

      Fix: If the claude.ai upload refuses it, trim the description to 200 characters.

    • Note

      metadata values should be text; triggers (a list) is not. The spec defines metadata as text to text. O4

      Fix: Quote each value, for example version: "1.0".

  • OpenAI (Codex & API)Passes with warnings

    Codex finds SKILL.md by its exact name and needs a description; OpenAI's Skills API checks the frontmatter against the spec and caps uploads.

    • Warning

      metadata values should be text; triggers (a list) is not. OpenAI's upload follows the spec's text-to-text rule. O4

      Fix: Quote each value, for example version: "1.0".

    • Warning

      Paths that may not work once the skill is installed: line 436: ../quality-manager-qmr/ (outside the skill folder), line 437: ../capa-officer/ (outside the skill folder), line 438: ../qms-audit-expert/ (outside the skill folder), line 439: ../quality-documentation-manager/ (outside the skill folder) and line 440: ../risk-management-specialist/ (outside the skill folder). B6

      Fix: Use forward-slash paths relative to SKILL.md, and copy shared files into the skill.

  • VS Code & CopilotPasses with warnings

    VS Code reads skills one folder below .github/skills, .claude/skills or .agents/skills and falls back to the folder name when the name is missing or differs; GitHub's Copilot docs require the exact name SKILL.md.

    • Warning

      Paths that may not work once the skill is installed: line 436: ../quality-manager-qmr/ (outside the skill folder), line 437: ../capa-officer/ (outside the skill folder), line 438: ../qms-audit-expert/ (outside the skill folder), line 439: ../quality-documentation-manager/ (outside the skill folder) and line 440: ../risk-management-specialist/ (outside the skill folder). B6

      Fix: Use forward-slash paths relative to SKILL.md, and copy shared files into the skill.

SKILL.md

Files

4 files

PathSize
SKILL.md (opens in a new tab)17.5 KB
references/iso13485-clause-requirements.md (opens in a new tab)23.1 KB
references/qms-process-templates.md (opens in a new tab)19.5 KB
scripts/qms_audit_checklist.py (opens in a new tab)29.5 KB

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