iso13485-audit-prep
/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.
Profile →npx skills add alirezarezvani/claude-skills --skill iso13485-audit-prep --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# /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 - Before annual Clause 8.2.4 internal audit - Before MDR / FDA QSR alignment review (substantially harmonized post Feb 2026) - Before new-device commercial launch (DHF closure audit) - After significant CAPA closure event (effectiveness verification audit) - Post-recall event (root cause + corrective action audit) - Quarterly during regulatory submission preparation ## The Six QMS Questions ### 1. Pull three random DHFs. Are design verification + validation evidence complete? **Most-cited finding area.** - DHF must include: design plan + inputs + outputs + verification + validation + transfer + changes - Sample stratified by product class (I, IIa, IIb, III per MDR) - Reference `iso13485_audit_playbook.md` for the per-DHF checklist - Verify traceability matrix from user needs through clinical evidence ### 2. Show me the last 5 CAPAs with effectiveness verification evidence. **Second-most-cite
- When to Run
- The Six QMS Questions
- 2. Show me the last 5 CAPAs with effectiveness verification evidence.
- 3. When was process validation (IQ/OQ/PQ) last revalidated?
- 4. Show me the risk management file for the highest-risk product.
- 5. Show me post-market surveillance evidence — last 6 months.
- 6. Where's the management review evidence covering all Clause 5.6 inputs?
- Workflow
- Output Format
- Routing
- Related
python ra-qm-team/skills/qms-audit-expert/scripts/audit_schedule_optimizer.py audit_scope.json python ../../skills/compliance-os/scripts/audit_simulator.py iso13485_scope.json Route to ra-qm-team/skills/capa-officer/ tools Route to ra-qm-team/skills/risk-management-specialist/ tools
What does the iso13485-audit-prep skill do?
/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.
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill iso13485-audit-prep --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.