/iso-13485-certification

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:
    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
• Conducting gap analysis against ISO 13485
• Creating or updating QMS documentation
• Preparing for certification audit
• Transitioning from FDA QSR to QMSR
• Harmonizing with EU MDR requirements

Core Workflow

1. Assess Current State (Gap Analysis)

**When to start here:** User has existing documentation and needs to identify gaps

**Process:**

1. **Collect existing documentation:**

• Ask user to provide directory of current QMS documents
• Documents can be in any format (.txt, .md, .doc, .docx, .pdf)
• Include any procedures, manuals, work instructions, forms

2. **Run gap analysis script:**

   python scripts/gap_analyzer.py --docs-dir <path_to_docs> --output gap-report.json

3. **Review results:**

• Identify which of the 31 required procedures are present
• Identify missing key documents (Quality Manual, MDF, etc.)
• Calculate compliance percentage
• Prioritize missing documentation

4. **Present findings to user:**

• Summarize what exists
• Clearly list what's missing
• Provide prioritized action plan
• Estimate effort required

**Output:** Comprehensive gap analysis report with prioritized action items

2. Understand Requirements (Reference Consultation)

**When to use:** User needs to understand specific ISO 13485 requirements

**Available references:**

• `references/iso-13485-requirements.md` - Complete clause-by-clause breakdown
• `references/mandatory-documents.md` - All 31 required procedures explained
• `references/gap-analysis-checklist.md` - Detailed compliance checklist
• `references/quality-manual-guide.md` - How to create Quality Manual

**How to use:**

1. **For specific clause questions:**

• Read relevant section from `iso-13485-requirements.md`
• Explain requirements in plain language
• Provide practical examples

2. **For document requirements:**

• Consult `mandatory-documents.md`
• Explain what must be documented
• Clarify when documents are applicable vs. excludable

3. **For implementation guidance:**

• Use `quality-manual-guide.md` for policy-level documents
• Provide step-by-step creation process
• Show examples of good vs. poor implementation

**Key reference sections to know:**

• **Clause 4:** QMS requirements, documentation, risk management, software validation
• **Clause 5:** Management responsibility, quality policy, objectives, management review
• **Clause 6:** Resources, competence, training, infrastructure
• **Clause 7:** Product realization, design, purchasing, production, traceability
• **Clause 8:** Measurement, audits, CAPA, complaints, data analysis

3. Create Documentation (Template-Based Generation)

**When to use:** User needs to create specific QMS documents

**Available templates:**

• Quality Manual: `assets/templates/quality-manual-template.md`
• CAPA Procedure: `assets/templates/procedures/CAPA-procedure-template.md`
• Document Control: `assets/templates/procedures/document-control-procedure-template.md`

**Process for document creation:**

1. **Identify what needs to be created:**

• Based on gap analysis or user request
• Prioritize critical documents first (Quality Manual, CAPA, Complaints, Audits)

2. **Select appropriate template:**

• Use Quality Manual template for QM
• Use procedure templates as examples for SOPs
• Adapt structure to organization's needs

3. **Customize template with user-specific information:**

• Replace all placeholder text: [COMPANY NAME], [DATE], [NAME], etc.
• Tailor scope to user's actual operations
• Add or remove sections based on applicability
• Ensure consistency with organization's processes

4. **Key customization areas:**

• Company information and addresses
• Product types and classifications
• Applicable regulatory requirements
• Organization structure and responsibilities
• Actual processes and procedures
• Document numbering schemes
• Exclusions and justifications

5. **Validate completeness:**

• All required sections present
• All placeholders replaced
• Cross-references correct
• Approval sections complete

**Document creation priority order:**

**Phase 1 - Foundation (Critical):** 1. Quality Manual 2. Quality Policy and Objectives 3. Document Control procedure 4. Record Control procedure

**Phase 2 - Core Processes (High Priority):** 5. Corrective and Preventive Action (CAPA) 6. Complaint Handling 7. Internal Audit 8. Management Review 9. Risk Management

**Phase 3 - Product Realization (High Priority):** 10. Design and Development (if applicable) 11. Purchasing 12. Production a