[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill-0beb6925-5adb-470d-83bc-b7aae92d70c7":3,"$fDrembMhZ6lqwlIaO5RrT-4v6bOjhUUKw5kdVzePOq2k":43},{"id":4,"title":5,"description":6,"categoryId":7,"moduleId":8,"tags":9,"prompt":10,"icon":11,"source":12,"sourceUrl":13,"authorId":14,"authorName":15,"isPublic":16,"stars":17,"runs":18,"createdAt":19,"updatedAt":19,"module":20,"category":27,"packages":34},"0beb6925-5adb-470d-83bc-b7aae92d70c7","iso13485-audit-prep","ISO 13485 质量管理体系审核 6 个问题强制询问。设计控制+CAPA+上市后关注。在8.2.4内部审核、MDR\u002FFDA QSR 对齐审查或产品发布 DHF 关闭审核之前使用。","cat_coding_review","mod_coding","alirezarezvani,coding","---\nname: \"iso13485-audit-prep\"\ndescription: \"\u002Fcs:iso13485-audit-prep \u003Cscope> — ISO 13485 QMS audit 6-question forcing interrogation. Design controls + CAPA + post-market focused. Use before Clause 8.2.4 internal audit, MDR \u002F FDA QSR alignment review, or product-launch DHF closure audit.\"\n---\n\n# \u002Fcs:iso13485-audit-prep — ISO 13485 QMS Forcing Questions\n\n**Command:** `\u002Fcs:iso13485-audit-prep \u003Cscope>`\n\nThe ISO 13485 QMS auditor pressure-tests any medical-device QMS work. Six traceability-obsessed questions before any internal audit, MDR \u002F FDA QSR review, or product launch.\n\n## When to Run\n\n- Before annual Clause 8.2.4 internal audit\n- Before MDR \u002F FDA QSR alignment review (substantially harmonized post Feb 2026)\n- Before new-device commercial launch (DHF closure audit)\n- After significant CAPA closure event (effectiveness verification audit)\n- Post-recall event (root cause + corrective action audit)\n- Quarterly during regulatory submission preparation\n\n## The Six QMS Questions\n\n### 1. Pull three random DHFs. Are design verification + validation evidence complete?\n**Most-cited finding area.**\n- DHF must include: design plan + inputs + outputs + verification + validation + transfer + changes\n- Sample stratified by product class (I, IIa, IIb, III per MDR)\n- Reference `iso13485_audit_playbook.md` for the per-DHF checklist\n- Verify traceability matrix from user needs through clinical evidence\n\n### 2. Show me the last 5 CAPAs with effectiveness verification evidence.\n**Second-most-cited finding area.**\n- Containment \u002F correction \u002F corrective action distinction documented\n- Root cause analysis depth: 5 Why minimum\n- Effectiveness verification = measurable evidence, not \"we updated the procedure\"\n- Closure approved by appropriate authority\n- Repeat CAPAs across products = systemic issue trigger\n\n### 3. When was process validation (IQ\u002FOQ\u002FPQ) last revalidated?\n**Clause 7.5.6 — often stale.**\n- Initial validation at process introduction\n- Revalidation triggers: process change, equipment change, material change, periodic schedule\n- Trend monitoring (SPC) where statistical techniques apply per Clause 8.4\n- Cross-check with cs-fda-qsr-auditor for 21 CFR 820.75 alignment\n\n### 4. Show me the risk management file for the highest-risk product.\n**Clause 7.1 + ISO 14971:2019.**\n- Risk management plan exists per product\n- Hazard identification covers reasonable foreseeable misuse\n- Risk control hierarchy applied: inherent safety > protective measures > information for safety\n- Residual risk evaluated + accepted with rationale\n- Post-production information feeds back into RMF\n- For AI-enabled medical devices: layer ISO 42001 A.5 impact assessment on top\n\n### 5. Show me post-market surveillance evidence — last 6 months.\n**Clause 8.2.1 — high-stakes for MDR + FDA.**\n- Customer complaint log + investigation closure\n- Vigilance reports (serious incident \u002F FSCA) submitted per applicable regulation\n- Trend analysis evidence + management review input\n- Post-market clinical follow-up (PMCF) for MDR high-risk devices\n- MDR reports per 21 CFR 803 for US-marketed devices (cross-check with cs-fda-qsr-auditor)\n\n### 6. Where's the management review evidence covering all Clause 5.6 inputs?\n**Annual minimum; semi-annual for mature programs.**\n- 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\n- Outputs per Clause 5.6.3: improvement decisions, product requirement changes, resource needs\n- Integrated review across frameworks (per `multi_framework_audit_playbook.md`) preferred\n\n## Workflow\n\n```bash\n# 1. Audit programme optimization\npython ..\u002F..\u002Fra-qm-team\u002Fskills\u002Fqms-audit-expert\u002Fscripts\u002Faudit_schedule_optimizer.py audit_scope.json\n\n# 2. Mock audit for readiness check\npython ..\u002F..\u002Fskills\u002Fcompliance-os\u002Fscripts\u002Faudit_simulator.py iso13485_scope.json\n\n# 3. CAPA system review\n# Route to ra-qm-team\u002Fskills\u002Fcapa-officer\u002F tools\n\n# 4. Risk management file review\n# Route to ra-qm-team\u002Fskills\u002Frisk-management-specialist\u002F tools\n```\n\n## Output Format\n\n```markdown\n# ISO 13485 Audit Prep: \u003Cscope>\n**Date:** YYYY-MM-DD\n\n## The Decision Being Made\n[programme-plan | DHF-closure | CAPA-health | post-market-trend | pre-cert | MDR-FDA-alignment]\n\n## Design Control Status (sampled DHFs)\n- DHFs sampled: \u003Clist product IDs>\n- Verification evidence: pass\u002Ffail per DHF\n- Validation evidence: pass\u002Ffail per DHF\n- Clinical evidence (per MDR Annex XIV \u002F FDA 510(k)): pass\u002Ffail\n- Traceability matrix complete: yes\u002Fno per DHF\n\n## CAPA Health\n- CAPAs sampled: N\n- Root cause analysis depth: adequate\u002Finadequate per CAPA\n- Effectiveness verification: complete\u002Fincomplete per CAPA\n- Aging CAPAs > 90 days: N\n- Repeat issues across products: \u003Clist>\n\n## Process Validation Status\n- Validations on schedule: %\n- Stale validations (> 12 months since revalidation): \u003Clist>\n- Statistical techniques applied per Clause 8.4: yes\u002Fno\n\n## Risk Management File Status\n- Sampled product RMFs: \u003Clist>\n- Post-production updates in last 12 months: \u003Ccount per product>\n- Residual risk acceptance signed: yes\u002Fno\n\n## Post-Market Surveillance\n- Complaint trending: stable\u002Frising\n- MDR \u002F vigilance reports filed timely: %\n- PMCF on schedule (where required): yes\u002Fno\n\n## Management Review Status\n- Last review date: YYYY-MM-DD\n- Required Clause 5.6.2 inputs present: yes\u002Fno\n- Open action items past due: N\n\n## Cross-Framework Impact\n- EU MDR alignment: clean \u002F gaps in \u003Clist>\n- FDA QSR alignment (post-Feb 2026): substantially harmonized; FDA-specific overlays per cs-fda-qsr-auditor\n- ISO 42001 AIMS overlay (if AI-enabled device): pass\u002Ffail per Annex A\n\n## Verdict\n🟢 READY | 🟡 CLOSE-DHF-GAPS-FIRST | 🔴 NOT-READY\n\n## Top 3 Actions\n[3 concrete next steps with owner + corrective-action timeline]\n```\n\n## Routing\n\n- `\u002Fcs:compliance-readiness` — for multi-framework view\n- `\u002Fcs:fda-qsr-audit-prep` — for FDA-specific overlay\n- `\u002Fcs:aims-audit` — for AI-enabled medical device ISO 42001 layer\n- `\u002Fcs:gdpr-audit-prep` — for personal-data overlap (clinical data, customer data)\n- `\u002Fcs:cpo-review` — for executive product strategy decisions\n- `\u002Fcs:decide` — to log the verdict\n\n## Related\n\n- Agent: [`cs-cqm-iso13485`](..\u002F..\u002Fagents\u002Fcs-cqm-iso13485.md)\n- Skill: [`qms-audit-expert`](..\u002F..\u002F..\u002Fra-qm-team\u002Fskills\u002Fqms-audit-expert\u002FSKILL.md)\n- Playbook: [iso13485_audit_playbook.md](..\u002F..\u002F..\u002Fra-qm-team\u002Fskills\u002Fqms-audit-expert\u002Freferences\u002Fiso13485_audit_playbook.md)\n- Adjacent: `..\u002Ffda-qsr-audit-prep\u002F`, `..\u002Faims-audit\u002F`, `..\u002Fcompliance-readiness\u002F`\n\n---\n\n**Version:** 1.0.0\n","","imported","https:\u002F\u002Fgithub.com\u002Falirezarezvani\u002Fclaude-skills","user_system_seed","SkillOPIC",true,56,391,"2026-05-16 13:52:49",{"id":8,"name":21,"slug":22,"icon":23,"description":24,"sort":25,"createdAt":26},"编程开发","coding","mdi-code-braces","代码生成、调试、审查，提升开发效率",2,"2026-05-16 12:53:40",{"id":7,"name":28,"slug":29,"icon":30,"description":31,"moduleId":8,"sort":32,"skillCount":33,"createdAt":26},"代码审查","review","mdi-magnify-scan","代码质量分析、安全审查",4,145,[35],{"id":36,"skillId":4,"version":37,"fileName":38,"fileSize":39,"filePath":40,"fileHash":41,"manifest":42,"createdAt":19},"f7c57428-9148-489e-aca0-4702f4b14c5d","1.0.0","iso13485-audit-prep.zip",2966,"uploads\u002Fskills\u002F0beb6925-5adb-470d-83bc-b7aae92d70c7\u002Fiso13485-audit-prep.zip","4e95f97517c2e91ed8525b3b0bdc78b388447d85c635a3b0faf2baa2cba26d04","[{\"path\":\"SKILL.md\",\"isDirectory\":false,\"size\":6691}]",{"code":44,"message":45,"data":46},200,"success",{"items":47,"stats":48,"page":51},[],{"averageRating":49,"totalRatings":49,"ratingCounts":50},0,[49,49,49,49,49],{"limit":52,"offset":49,"hasMore":53,"nextOffset":52,"ratedOnly":16},15,false]