iso13485-audit-prep

原文涵盖的主题

• /compliance-os:iso13485-audit-prep — ISO 13485 QMS Forcing Questions
• When to Run
• The Six QMS Questions
• 1. Pull three random DHFs. Are design verification + validation evidence complete?
• 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.

Command: /compliance-os:iso13485-audit-prep 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. 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 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 iso13485auditplaybook.md for the per-DHF checklist Verify traceability matrix from user needs through clinical evidence Second-most-cited finding area. Containment / correction / corrective action distinction documented Root cause analysis depth: 5 Why minimum Effectiveness verification = measurable evidence, not "we updated the procedure" Closure approved by appropriate authority Repeat CAPAs across products = systemic issue

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