medical-qms-tools

name: medical-qms-tools description: 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.

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

1. Treat this as documentation and process support, not legal or certification advice.
2. Ask what standard, jurisdiction, and product class the user is targeting before drafting requirements.
3. Distinguish mandatory procedures from organization-specific implementations.
4. Preserve traceability: requirement, procedure, record, owner, revision, and evidence.
5. Flag missing risk-management and post-market processes explicitly.

Core Workflow

1. Inventory current documents and records.
2. Build a clause-to-document matrix.
3. Mark each item as present, partial, missing, or out of date.
4. Prioritize critical gaps first:
   • document control
   • training and competence
   • CAPA
   • complaint handling
   • supplier controls
   • design controls
   • risk management
5. 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.