iso-13485-certification

What it does

Guides users through preparing ISO 13485:2016 QMS documentation and readiness for certification. Provides gap analysis, templates for mandatory documents (e.g., Quality Manual, CAPA, Document Control), reference materials, and a step-by-step process to create and customize documents, assess requirements, and manage Medical Device Files.

How it works

1. Assess Current State (Gap Analysis): Collect user documents in any format, run a gap analysis script via python scripts/gap_analyzer.py --docs-dir <path_to_docs> --output gap-report.json, review results to identify which of the 31 required procedures are present, determine missing items (e.g., Quality Manual, MDF), compute compliance percentage, and present a prioritized action plan with an output gap analysis report.
2. Understand Requirements (Reference Consultation): Access references including references/iso-13485-requirements.md, references/mandatory-documents.md, references/gap-analysis-checklist.md, and references/quality-manual-guide.md to explain clause-based requirements, document necessities, and implementation guidance.
3. Create Documentation (Template-Based Generation): Use templates for Quality Manual (assets/templates/quality-manual-template.md), CAPA (assets/templates/procedures/CAPA-procedure-template.md), and Document Control (assets/templates/procedures/document-control-procedure-template.md). Identify needed documents, prioritize creation (Quality Manual, CAPA, Complaints, Audits), customize templates by replacing placeholders with organization-specific information, ensure scope and exclusions are justified, and validate completeness (section requirements, cross-references, approvals).
4. Develop Specific Documents: For Quality Manual, follow the guide in references/quality-manual-guide.md, gather organizational data (legal name, addresses, product types, scope, exclusions), and ensure the Quality Manual references all 31 procedures (Appendix A) and includes process maps and an organization chart. For CAPA, read relevant ISO clauses, use the CAPA template, customize prioritization criteria, root cause analysis methods, and add attachments (CAPA Request Form, Root Cause Analysis Worksheet, Action Plan Template, Effectiveness Verification Checklist). For Medical Device Files (MDF), create a structure per device type/family and collect required elements with traceability.
5. Conduct Comprehensive Gap Analysis: Use references/gap-analysis-checklist.md to perform clause-by-clause evaluation, mark statuses (Compliant, Partial, Non-compliant, N/A), summarize compliance by clause, and generate a prioritized action plan with owners and target dates. Produce a final gap analysis checklist, a summary report with compliance percentages, and a timeline.

When to use it

• 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

What it can touch

• Templates and templates-based document generation assets at assets/templates/... for Quality Manual, CAPA, and Document Control
• Provided references and gap-analysis scripts location (e.g., scripts/gap_analyzer.py)
• Output artifacts: gap reports, completed templates, and documentation skeletons

Caveats

• Requires user-provided existing documentation for gap analysis
• Outcomes depend on user data and alignment with ISO 13485 clauses
• Does not guarantee certification; focuses on documentation readiness and gap closure per described workflow