Agent skill · data analytics · alirezarezvani
iso13485-audit-prep
Use for /compliance-os:iso13485-audit-prep, or before an ISO 13485 internal audit or DHF closure.
Why this skill is useful
Adds specific audit preparation workflows and domain knowledge for ISO 13485 compliance that the AI wouldn't reliably generate on its own.
What it needs
Requires python installed locally. About 3k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.
What this skill does
/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 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 iso13485auditplaybook.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-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 trigger 3. When was process validation (IQ/OQ/PQ) last revalidated? Clause 7.5.6 — often stale. Initial validation at process introduction Revalidation triggers: process change, equipment change, material change, periodic schedule Trend monitoring (SPC) where statistical techniques apply per Clause 8.4 Cross-check with cs-fda-qsr-auditor for 21 CFR 820.75 alignment 4. Show me the risk management file for the highest-risk product. Clause 7.1 + ISO 14971:2019. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/iso13485-audit-prep--588260