Medical QMS Tools
Use this skill for structured quality-system documentation work in regulated medical settings.
Typical triggers:
- gap-assess existing QMS documentation
- prepare or review Quality Manual, SOP, CAPA, complaint, audit, or training records
- map documents to ISO 13485 or FDA QMSR requirements
- define traceability across design inputs, verification, validation, and risk controls
- prepare audit-readiness checklists for device or diagnostic programs
Working Rules
- Treat this as documentation and process support, not legal or certification advice.
- Ask what standard, jurisdiction, and product class the user is targeting before drafting requirements.
- Distinguish mandatory procedures from organization-specific implementations.
- Preserve traceability: requirement, procedure, record, owner, revision, and evidence.
- Flag missing risk-management and post-market processes explicitly.
Core Workflow
- Inventory current documents and records.
- Build a clause-to-document matrix.
- Mark each item as present, partial, missing, or out of date.
- Prioritize critical gaps first:
- document control
- training and competence
- CAPA
- complaint handling
- supplier controls
- design controls
- risk management
- Draft remediation plan with owners, dependencies, and evidence artifacts.
Key Surfaces To Cover
Always check whether the user has adequate documentation for:
- scope and Quality Manual
- document and record control
- management review
- training and competence
- design and development planning
- design inputs, outputs, verification, validation, and transfer
- supplier qualification and purchasing controls
- production and process validation where relevant
- traceability and labeling
- complaint handling and vigilance
- CAPA and internal audit
- risk management linkage to design and post-market feedback
Output Expectations
Good outputs usually include:
- clause or requirement matrix
- missing-document list
- prioritized remediation plan
- draft document skeletons or SOP outlines
- audit-readiness checklist
Related Skills
For clinical-study protocols and reporting workflows, activate clinical-research-tools.
For medical datasets and operational analysis artifacts, activate medical-data-tools.
1---2name: medical-qms-tools3description: Medical quality-system and documentation workflow guide for ISO 13485, FDA QMSR, design controls, risk management, CAPA, document control, supplier qualification, complaint handling, and audit preparation. Use when the user asks to plan, review, or gap-assess medical-device or diagnostic quality documentation without asking for legal determinations or regulatory guarantees.4---56# Medical QMS Tools78Use this skill for structured quality-system documentation work in regulated medical settings.910Typical triggers:11- gap-assess existing QMS documentation12- prepare or review Quality Manual, SOP, CAPA, complaint, audit, or training records13- map documents to ISO 13485 or FDA QMSR requirements14- define traceability across design inputs, verification, validation, and risk controls15- prepare audit-readiness checklists for device or diagnostic programs1617## Working Rules18191. Treat this as documentation and process support, not legal or certification advice.202. Ask what standard, jurisdiction, and product class the user is targeting before drafting requirements.213. Distinguish mandatory procedures from organization-specific implementations.224. Preserve traceability: requirement, procedure, record, owner, revision, and evidence.235. Flag missing risk-management and post-market processes explicitly.2425## Core Workflow26271. Inventory current documents and records.282. Build a clause-to-document matrix.293. Mark each item as present, partial, missing, or out of date.304. Prioritize critical gaps first:31 - document control32 - training and competence33 - CAPA34 - complaint handling35 - supplier controls36 - design controls37 - risk management385. Draft remediation plan with owners, dependencies, and evidence artifacts.3940## Key Surfaces To Cover4142Always check whether the user has adequate documentation for:43- scope and Quality Manual44- document and record control45- management review46- training and competence47- design and development planning48- design inputs, outputs, verification, validation, and transfer49- supplier qualification and purchasing controls50- production and process validation where relevant51- traceability and labeling52- complaint handling and vigilance53- CAPA and internal audit54- risk management linkage to design and post-market feedback5556## Output Expectations5758Good outputs usually include:59- clause or requirement matrix60- missing-document list61- prioritized remediation plan62- draft document skeletons or SOP outlines63- audit-readiness checklist6465## Related Skills6667For clinical-study protocols and reporting workflows, activate `clinical-research-tools`.68For medical datasets and operational analysis artifacts, activate `medical-data-tools`.
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