ISO 13485 QMS Forcing Questions
This skill pressure-tests a medical-device QMS with six traceability-obsessed questions covering design controls, CAPA, process validation, risk management, post-market surveillance, and management review. It produces a structured audit prep report with a readiness verdict and top actions.
✨ What it does
- Checks design verification and validation evidence in sampled DHFs
- Reviews last 5 CAPAs for effectiveness verification and root cause depth
- Verifies process validation (IQ/OQ/PQ) revalidation status
- Assesses risk management files per ISO 14971:2019
- Evaluates post-market surveillance evidence and vigilance reporting
- Confirms management review covers all Clause 5.6 inputs
🎯 When to use it
- Before an annual Clause 8.2.4 internal audit
- Before MDR / FDA QSR alignment review
- Before a new-device commercial launch (DHF closure audit)
- After a significant CAPA closure event or recall
- Quarterly during regulatory submission preparation
🚀 How to use
Trigger: /cs:iso13485-audit-prep
Trigger with the slash command /cs:iso13485-audit-prep <scope> where scope is the audit context (e.g., product launch, internal audit). The skill expects you to provide the scope and will guide you through six questions, producing a report. Example prompts:
/cs:iso13485-audit-prep DHF-closure for Product X
/cs:iso13485-audit-prep annual internal audit
📄 Output: A markdown audit prep report with status sections, a readiness verdict (READY / CLOSE-DHF-GAPS-FIRST / NOT-READY), and top 3 actions.
📦 Add this skill to Claude Code
# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills
# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/compliance-os/skills/iso13485-audit-prep .claude/skills/iso13485-audit-prepSkill source: compliance-os/skills/iso13485-audit-prep/SKILL.md
⚠️ Good to know
Requires access to DHFs, CAPA records, validation documentation, risk files, and post-market data; assumes integration with related skills for FDA QSR and AI-specific overlays.
❓ FAQ
What are the six questions?
The six questions cover DHF design verification/validation, CAPA effectiveness, process validation revalidation, risk management files, post-market surveillance, and management review inputs.
How often should management review occur?
At least annually, but semi-annual for mature programs.
What does the verdict indicate?
The verdict is READY, CLOSE-DHF-GAPS-FIRST, or NOT-READY, summarizing overall audit readiness.
🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.