Performs a six-question forcing interrogation of an ISO 13485 Quality Management System, focusing on Design History Files (DHF), CAPA effectiveness, process validation, risk management, post-market surveillance, and management review. It generates a structured audit-readiness report with a verdict and prioritized corrective actions.
Say it in your own words; the assistant finds this recipe by itself. Examples:
Use this skill when preparing for an ISO 13485 internal audit, specifically before Clause 8.2.4 reviews or annual audits. It is also appropriate for assessing readiness before MDR/FDA QSR alignment reviews, product launch DHF closure audits, or after significant CAPA or recall events. It is ideal for teams needing a structured, evidence-based check of their QMS documentation and traceability.
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.
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.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 trigger
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
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
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)
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
# 1. Audit programme optimization
python ${CLAUDE_PLUGIN_ROOT}/vendor/ra-qm-team/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 ${CLAUDE_PLUGIN_ROOT}/vendor/ra-qm-team/capa-officer/ tools
# 4. Risk management file review
# Route to ${CLAUDE_PLUGIN_ROOT}/vendor/ra-qm-team/risk-management-specialist/ tools
# 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]
/compliance-os:compliance-readiness — for multi-framework view/compliance-os:fda-qsr-audit-prep — for FDA-specific overlay/compliance-os:aims-audit — for AI-enabled medical device ISO 42001 layer/compliance-os:gdpr-audit-prep — for personal-data overlap (clinical data, customer data)/c-level-agents:cpo-review — for executive product strategy decisions/c-level-agents:decide — to log the verdictcs-cqm-iso13485qms-audit-expert../fda-qsr-audit-prep/, ../aims-audit/, ../compliance-readiness/Version: 1.0.0
LICENSESKILL.mdVendored from alirezarezvani/claude-skills, commit 27cfcd0fb0a4, path compliance-os/skills/iso13485-audit-prep, licence MIT. The upstream licence file ships inside the skill.