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iso13485-audit-prep
Use for /compliance-os:iso13485-audit-prep, or before an ISO 13485 internal audit or DHF closure.
compliance-os/skills/iso13485-audit-prep/SKILL.md
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# /compliance-os:iso13485-audit-prep — ISO 13485 QMS Forcing Questions
**Command:** `/compliance-os: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