iso13485-audit-guide

Name: iso13485-audit-guide
Author: alirezarezvani

Clause-by-clause audit methodology with sample questions and common findings.

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# ISO 13485 Audit Guide

Clause-by-clause audit methodology with sample questions and common findings.

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## Table of Contents

- [Audit Approach](#audit-approach)
- [Clause 4: Quality Management System](#clause-4-quality-management-system)
- [Clause 5: Management Responsibility](#clause-5-management-responsibility)
- [Clause 6: Resource Management](#clause-6-resource-management)
- [Clause 7: Product Realization](#clause-7-product-realization)
- [Clause 8: Measurement and Improvement](#clause

How to Use

Recommended: Install to project (local)

mkdir -p .claude/skills
curl -o .claude/skills/iso13485-audit-guide.md \
  https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/ra-qm-team/qms-audit-expert/references/iso13485-audit-guide.md

Skill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.

Alternative: Clone full repo

git clone https://github.com/alirezarezvani/claude-skills

Then reference at ra-qm-team/qms-audit-expert/references/iso13485-audit-guide.md