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Slash command/iso13485-audit-prep
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/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.
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</> SKILL.md
iso13485-audit-prep.SKILL.md
---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
- 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
- Post-market clinical follow-up (PMCF) for MDR high-risk devices
- MDR reports per 21 CFR 803 for US-marketed devices (cross-check with cs-fda-qsr-auditor)
### 6. Where's the management review evidence covering all Clause 5.6 inputs?
**Annual minimum; semi-annual for mature programs.**
- Required inputs per Clause 5.6.2: audit results, customer feedback, process performance, product conformity, status of preventive + corrective actions, follow-up from prior reviews, changes that could affect QMS, recommendations for improvement, regulatory requirements
