iso-13485-certification

Files (10)

• SKILL.md
• CAPA-procedure-template.md · assets/templates/procedures/
• document-control-procedure-template.md · assets/templates/procedures/
• quality-manual-template.md · assets/templates/
• gap-analysis-checklist.md · references/
• iso-13485-requirements.md · references/
• mandatory-documents.md · references/
• quality-manual-guide.md · references/
• gap_analyzer.cpython-313.pyc · scripts/__pycache__/
• gap_analyzer.py · scripts/

SKILL.md (first lines)

# 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:**
   ```bash
   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

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