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 required procedures are present vs. missing. The script checks the 26 always-applicable documented procedures (it omits the conditional "when applicable" ones — design, installation, servicing, sterilization, etc. — to avoid false-negative gaps); the full set is "31" by convention. See references/quick-reference.md for the full list and counting note.
   • Identify missing key documents (Quality Manual, MDF, etc.)
   • Calculate compliance percentage (reported against the 26 procedures the script tracks)
   • Prioritize missing documentation, including any conditional procedures that apply to this manufacturer

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

Follow the full creation process, priority order (Phases 1-6), and per-document deep dives (Quality Manual, SOPs, CAPA, Medical Device Files) in references/document-creation-guide.md. That guide also covers the detailed clause-by-clause comprehensive gap analysis.

Routing Guidance

• Gap analysis (existing docs) → Core Workflow Step 1; run scripts/gap_analyzer.py. Detailed clause-by-clause assessment: references/document-creation-guide.md.
• Understanding a clause/requirement → Core Workflow Step 2; read references/iso-13485-requirements.md and references/mandatory-documents.md.
• Creating a Quality Manual / SOP / CAPA / MDF → references/document-creation-guide.md + the matching template in assets/templates/.
• Matching a user situation to an approach (startup from scratch, existing-QMS gap, single document, QMSR transition, audit prep) → references/common-scenarios.md.
• Writing-quality, exclusions, mistakes to avoid → references/best-practices.md.
• The 31 procedures, regulatory requirements by region, retention periods → references/quick-reference.md.

References Index

• references/iso-13485-requirements.md — complete ISO 13485:2016 breakdown, clause by clause.
• references/mandatory-documents.md — all 31 required procedures plus other mandatory documents, explained.
• references/gap-analysis-checklist.md — comprehensive compliance checklist.
• references/quality-manual-guide.md — step-by-step guide for a compliant Quality Manual.
• references/document-creation-guide.md — full document-creation process, priority order, and per-document deep dives (QM, SOPs, CAPA, MDF, detailed gap analysis).
• references/common-scenarios.md — worked approaches for the five most common user situations.
• references/best-practices.md — document-development best practices, exclusion rules and examples, common mistakes.
• references/quick-reference.md — the 31 procedures, regulatory requirements by region, document retention periods.

scripts/

• gap_analyzer.py — automated tool to analyze existing documentation and identify gaps against ISO 13485 requirements.

assets/templates/

• quality-manual-template.md, procedures/CAPA-procedure-template.md, procedures/document-control-procedure-template.md.

Getting Started

First-time users should:

1. Read references/iso-13485-requirements.md to understand the standard.
2. If you have existing documentation, run the gap analysis script (Core Workflow Step 1).
3. Create the Quality Manual using the template and references/document-creation-guide.md.
4. Develop procedures in priority order (see the guide).
5. Use references/gap-analysis-checklist.md for final validation.

Need help? Start by describing your situation: what stage you're at, what you have, and what you need to create — then route via the guidance above.