JantonioFC /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.mdfor 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.
- Risk management plan exists per product
- Hazard identification covers reasonable foreseeable misuse
- Risk control hierarchy applied: inherent safety > protective measures > information for safety
- Residual risk evaluated + accepted with rationale
- Post-production information feeds back into RMF
- For AI-enabled medical devices: layer ISO 42001 A.5 impact assessment on top
5. Show me post-market surveillance evidence — last 6 months.
Clause 8.2.1 — high-stakes for MDR + FDA.
- Customer complaint log + investigation closure
- Vigilance reports (serious incident / FSCA) submitted per applicable regulation
- Trend analysis evidence + management review input
- 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
- Outputs per Clause 5.6.3: improvement decisions, product requirement changes, resource needs
- Integrated review across frameworks (per
multi_framework_audit_playbook.md) preferred
Workflow
# 1. Audit programme optimization
python ../../ra-qm-team/skills/qms-audit-expert/scripts/audit_schedule_optimizer.py audit_scope.json
# 2. Mock audit for readiness check
python ../../skills/compliance-os/scripts/audit_simulator.py iso13485_scope.json
# 3. CAPA system review
# Route to ra-qm-team/skills/capa-officer/ tools
# 4. Risk management file review
# Route to ra-qm-team/skills/risk-management-specialist/ tools
Output Format
# ISO 13485 Audit Prep: <scope>
**Date:** YYYY-MM-DD
## The Decision Being Made
[programme-plan | DHF-closure | CAPA-health | post-market-trend | pre-cert | MDR-FDA-alignment]
## Design Control Status (sampled DHFs)
- DHFs sampled: <list product IDs>
- Verification evidence: pass/fail per DHF
- Validation evidence: pass/fail per DHF
- Clinical evidence (per MDR Annex XIV / FDA 510(k)): pass/fail
- Traceability matrix complete: yes/no per DHF
## CAPA Health
- CAPAs sampled: N
- Root cause analysis depth: adequate/inadequate per CAPA
- Effectiveness verification: complete/incomplete per CAPA
- Aging CAPAs > 90 days: N
- Repeat issues across products: <list>
## Process Validation Status
- Validations on schedule: %
- Stale validations (> 12 months since revalidation): <list>
- Statistical techniques applied per Clause 8.4: yes/no
## Risk Management File Status
- Sampled product RMFs: <list>
- Post-production updates in last 12 months: <count per product>
- Residual risk acceptance signed: yes/no
## Post-Market Surveillance
- Complaint trending: stable/rising
- MDR / vigilance reports filed timely: %
- PMCF on schedule (where required): yes/no
## Management Review Status
- Last review date: YYYY-MM-DD
- Required Clause 5.6.2 inputs present: yes/no
- Open action items past due: N
## Cross-Framework Impact
- EU MDR alignment: clean / gaps in <list>
- FDA QSR alignment (post-Feb 2026): substantially harmonized; FDA-specific overlays per cs-fda-qsr-auditor
- ISO 42001 AIMS overlay (if AI-enabled device): pass/fail per Annex A
## Verdict
🟢 READY | 🟡 CLOSE-DHF-GAPS-FIRST | 🔴 NOT-READY
## Top 3 Actions
[3 concrete next steps with owner + corrective-action timeline]
Routing
/cs:compliance-readiness— for multi-framework view/cs:fda-qsr-audit-prep— for FDA-specific overlay/cs:aims-audit— for AI-enabled medical device ISO 42001 layer/cs:gdpr-audit-prep— for personal-data overlap (clinical data, customer data)/cs:cpo-review— for executive product strategy decisions/cs:decide— to log the verdict
Related
- Agent:
cs-cqm-iso13485 - Skill:
qms-audit-expert - Playbook: iso13485_audit_playbook.md
- Adjacent:
../fda-qsr-audit-prep/,../aims-audit/,../compliance-readiness/
Version: 1.0.0