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iso13485-audit-prep

/cs:iso13485-audit-prep - ISO 13485 QMS audit 6-question forcing interrogation. Design controls + CAPA + post-market focused. Use before Clause 8.2.4 internal audit, MDR / FDA QSR alignment review, or product-launch DHF closure…

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What it does and how to use it

A skill that teaches Claude Code to do general tasks well. It is packaged knowledge the model uses whenever it is relevant.

  1. Install the skill (command above).
  2. In Claude Code, describe what you need - the skill turns on by itself when the context fits.
  3. No commands to memorize: you talk in plain language and the skill does the rest.

Install (Claude Code)

mkdir -p .claude/skills/alirezarezvani-claude-skills__iso13485-audit-prep && curl -fsSL https://doutorai.pt/data/lib/skills__alirezarezvani-claude-skills__iso13485-audit-prep.md -o .claude/skills/alirezarezvani-claude-skills__iso13485-audit-prep/SKILL.md

Paste this command into the terminal, in your project folder, and the component installs automatically.

Content

---
name: "iso13485-audit-prep"
description: "/cs:iso13485-audit-prep <scope> - ISO 13485 QMS audit 6-question forcing interrogation. Design controls + CAPA + post-market focused. Use before Clause 8.2.4 internal audit, MDR / FDA QSR alignment review, or product-launch DHF closure audit."
---

# /cs:iso13485-audit-prep - ISO 13485 QMS Forcing Questions

**Command:** `/cs:iso13485-audit-prep <scope>`

The ISO 13485 QMS auditor pressure-tests any medical-device QMS work. Six traceability-obsessed questions before any internal audit, MDR / FDA QSR review, or product launch.

## When to Run

- Bef

- 🔒 Full content on the Pro plan (€7.99/month) -

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