/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