Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3)
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Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3)
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iso-13485-certification.SKILL.md
---name: iso-13485-certification
description: Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.
license: MIT license
metadata: {"version": "1.0", "skill-author": "K-Dense Inc."}
---# ISO 13485 Certification Documentation Assistant
## Overview
This skill helps medical device manufacturers prepare comprehensive documentation for ISO 13485:2016 certification. It provides tools, templates, references, and guidance to create, review, and gap-analyze all required Quality Management System (QMS) documentation.
**What this skill provides:**
- Gap analysis of existing documentation
- Templates for all mandatory documents
- Comprehensive requirements guidance
- Step-by-step documentation creation
- Identification of missing documentation
- Compliance checklists
**When to use this skill:**
- Starting ISO 13485 certification process
- Month 11-12: Management review and certification audit
### Scenario 2: Gap Analysis for Existing QMS
**User request:** "We have some procedures but don't know what we're missing for ISO 13485."
**Approach:**
1. **Run automated gap analysis:**
- Ask for document directory
- Run `scripts/gap_analyzer.py`
- Review automated findings
2. **Conduct detailed assessment:**
- Use comprehensive checklist for user's specific situation
- Go deeper than automated analysis
- Assess quality of existing documents, not just presence
3. **Provide prioritized gap list:**
- Missing mandatory procedures
- Incomplete procedures
- Quality issues with existing documents
- Missing records or forms
4. **Create remediation plan:**
- High priority: Safety-related, regulatory-required
- Medium priority: Core QMS processes
- Low priority: Improvement opportunities
### Scenario 3: Creating Specific Document
**User request:** "Help me create a CAPA procedure."
**Approach:**
1. **Explain requirements:**
- Read ISO 13485 Clauses 8.5.2 and 8.5.3 from references
- Explain what must be in CAPA procedure
- Provide examples of good CAPA processes
2. **Use template:**
- Start with CAPA procedure template
- Explain each section's purpose
- Show what needs customization
3. **Gather user-specific info:**
- How are CAPAs initiated in their organization?
- Who are the responsible parties?
- What prioritization criteria make sense?
- What RCA methods will they use?
- What are appropriate timeframes?
4. **Create customized procedure:**
- Replace all placeholders
- Adapt to user's processes
- Ensure completeness
5. **Add supporting materials:**
- CAPA request form
- RCA worksheets
- Action plan template
- Effectiveness verification checklist
### Scenario 4: Updating for Regulatory Changes
**User request:** "We need to update our QMS for FDA QMSR harmonization."
**Approach:**
1. **Explain changes:**
- FDA 21 CFR Part 820 harmonized with ISO 13485
- Now called QMSR (effective Feb 2, 2026)
- Key change: Medical Device File replaces DHF/DMR/DHR
2. **Review current documentation:**
- Identify documents referencing QSR
- Find separate DHF, DMR, DHR structures
- Check for ISO 13485 compliance gaps
3. **Update strategy:**
- Update references from QSR to QMSR
- Consolidate DHF/DMR/DHR into Medical Device Files
- Add any missing ISO 13485 requirements
- Maintain backward compatibility during transition
4. **Create transition plan:**
- Update Quality Manual
- Update MDF procedure
- Reorganize device history files
- Train personnel on changes
### Scenario 5: Preparing for Certification Audit
**User request:** "We have our documentation ready. How do we prepare for the certification audit?"
**Approach:**
1. **Conduct readiness assessment:**
- Use comprehensive gap analysis checklist
- Review all documentation for completeness
- Verify records exist for all required items
- Check for consistent implementation
2. **Pre-audit checklist:**
- [ ] All 31 procedures documented and approved
- [ ] Quality Manual complete with all required content
- [ ] Medical Device Files complete for all products
- [ ] Internal audit completed with findings addressed
- [ ] Management review completed
- [ ] Personnel trained on QMS procedures
- [ ] Records maintained per retention requirements
- [ ] CAPA system functional with effectiveness demonstrated
- [ ] Complaints system operational
3. **Conduct mock audit:**
- Use ISO 13485 requirements as audit criteria
- Sample records to verify consistent implementation
- Interview personnel to verify understanding
- Identify any non-conformances
4. **Address findings:**
- Correct any deficiencies
- Document corrections
- Verify effectiveness
5. **Final preparation:**
- Brief management and staff
- Prepare audit schedule
- Organize evidence and records
- Designate escorts and support personnel
## Best Practices
### Document Development
1. **Start at policy level, then add detail:**
- Quality Manual = policy level
- Procedures = what, who, when
- Work Instructions = detailed how-to
- Forms = data collection
2. **Maintain consistency:**
- Use same terminology throughout
- Cross-reference related documents
- Keep numbering scheme consistent
- Update all related documents together
3. **Write for your audience:**
- Clear, simple language
- Avoid jargon
- Define technical terms
- Provide examples where helpful
4. **Make procedures usable:**
- Action-oriented language
- Logical flow
- Clear responsibilities
- Realistic timeframes
### Exclusions
**When you can exclude:**
- Design and development (if contract manufacturer only)
- Installation (if product requires no installation)
- Servicing (if not offered)
- Sterilization (if non-sterile product)
**Justification requirements:**
- Must be in Quality Manual
- Must explain why excluded
- Cannot exclude if process performed
- Cannot affect ability to provide safe, effective devices
**Example good justification:**
> "Clause 7.3 Design and Development is excluded. ABC Company operates as a contract manufacturer and produces medical devices according to complete design specifications provided by customers. All design activities are performed by the customer and ABC Company has no responsibility for design inputs, outputs, verification, validation, or design changes."
**Example poor justification:**
> "We don't do design." (Too brief, doesn't explain why or demonstrate no impact)
### Common Mistakes to Avoid
1. **Copying ISO 13485 text verbatim**
- Write in your own words
- Describe YOUR processes
- Make it actionable for your organization
2. **Making procedures too detailed**
- Procedures should be stable
- Excessive detail belongs in work instructions
- Balance guidance with flexibility
3. **Creating documents in isolation**
- Ensure consistency across QMS
- Cross-reference related documents
- Build on previously created documents
4. **Forgetting records**
- Every procedure should specify records
- Define retention requirements
- Ensure records actually maintained
5. **Inadequate approval**
- Quality Manual must be signed by top management
- All procedures must be properly approved
- Train staff before documents become effective
## Resources
### scripts/
- `gap_analyzer.py` - Automated tool to analyze existing documentation and identify gaps against ISO 13485 requirements
### references/
- `iso-13485-requirements.md` - Complete breakdown of ISO 13485:2016 requirements clause by clause
- `mandatory-documents.md` - Detailed list of all 31 required procedures plus other mandatory documents
- `gap-analysis-checklist.md` - Comprehensive checklist for detailed gap assessment
- `quality-manual-guide.md` - Step-by-step guide for creating a compliant Quality Manual
### assets/templates/
- `quality-manual-template.md` - Complete template for Quality Manual with all required sections
- `procedures/CAPA-procedure-template.md` - Example CAPA procedure following best practices
- `procedures/document-control-procedure-template.md` - Example document control procedure
## Quick Reference
### The 31 Required Documented Procedures
1. Risk Management (4.1.5)
2. Software Validation (4.1.6)
3. Control of Documents (4.2.4)
4. Control of Records (4.2.5)
5. Internal Communication (5.5.3)
6. Management Review (5.6.1)
7. Human Resources/Competence (6.2)
8. Infrastructure Maintenance (6.3) - when applicable
9. Contamination Control (6.4.2) - when applicable
10. Customer Communication (7.2.3)
11. Design and Development (7.3.1-10) - when applicable
12. Purchasing (7.4.1)
13. Verification of Purchased Product (7.4.3)
14. Production Control (7.5.1)
15. Product Cleanliness (7.5.2) - when applicable
16. Installation (7.5.3) - when applicable
17. Servicing (7.5.4) - when applicable
18. Process Validation (7.5.6) - when applicable
19. Sterilization Validation (7.5.7) - when applicable
20. Product Identification (7.5.8)
21. Traceability (7.5.9)
22. Customer Property (7.5.10) - when applicable
23. Preservation of Product (7.5.11)
24. Control of M&M Equipment (7.6)
25. Feedback (8.2.1)
26. Complaint Handling (8.2.2)
27. Regulatory Reporting (8.2.3)
28. Internal Audit (8.2.4)
29. Process Monitoring (8.2.5)
30. Product Monitoring (8.2.6)
31. Control of Nonconforming Product (8.3)
32. Corrective Action (8.5.2)
33. Preventive Action (8.5.3)
*(Note: Traditional count is "31 procedures" though list shows more because some are conditional)*
### Key Regulatory Requirements
**FDA (United States):**
- 21 CFR Part 820 (now QMSR) - harmonized with ISO 13485 as of Feb 2026
- Device classification determines requirements
- Establishment registration and device listing required
**EU (European Union):**
- MDR 2017/745 (Medical Devices Regulation)
- IVDR 2017/746 (In Vitro Diagnostic Regulation)
- Technical documentation requirements
- CE marking requirements
**Canada:**
- Canadian Medical Devices Regulations (SOR/98-282)
- Device classification system
- Medical Device Establishment License (MDEL)
**Other Regions:**
- Australia TGA, Japan PMDA, China NMPA, etc.
- Often require or recognize ISO 13485 certification
### Document Retention
**Minimum retention:** Lifetime of medical device as defined by organization
**Typical retention periods:**
- Design documents: Life of device + 5-10 years
- Manufacturing records: Life of device
- Complaint records: Life of device + 5-10 years
- CAPA records: 5-10 years minimum
- Calibration records: Retention period of equipment + 1 calibration cycle
**Always comply with applicable regulatory requirements which may specify longer periods.**
---
## Getting Started
**First-time users should:**
1. Read `references/iso-13485-requirements.md` to understand the standard
2. If you have existing documentation, run gap analysis script
3. Create Quality Manual using template and guide
4. Develop procedures in priority order
5. Use comprehensive checklist for final validation
**For specific tasks:**
- Creating Quality Manual → See Section 4 and use quality-manual-guide.md
- Creating CAPA procedure → See Section 4 and use CAPA template
- Gap analysis → See Section 1 and 5
- Understanding requirements → See Section 2
**Need help?** Start by describing your situation: what stage you're at, what you have, and what you need to create.
