Iso 13485 Certification

1. Run an automated gap analysis (end-to-end)

1) (Optional) Create and activate a virtual environment

python -m venv .venv source .venv/bin/activate

macOS/Linux

.venv\Scripts\activate # Windows PowerShell

2) Run the gap analyzer against your existing QMS document folder

python scripts/gap_analyzer.py
--docs-dir ./my-qms-docs
--output ./gap-report.json

3) Review the output

cat ./gap-report.json 2) Use the references and templates to draft core documents A typical workflow after generating gap-report.json : Read ISO clause guidance: references/iso-13485-requirements.md Confirm mandatory documents and applicability: references/mandatory-documents.md Draft/update the Quality Manual: assets/templates/quality-manual-template.md Guidance: references/quality-manual-guide.md Draft priority procedures (examples): assets/templates/procedures/document-control-procedure-template.md assets/templates/procedures/CAPA-procedure-template.md Perform a detailed checklist-based assessment: references/gap-analysis-checklist.md Implementation Details

1. Gap analysis logic (practical model) The gap analysis workflow is designed to answer: Existence : Do required documents/procedures appear to exist in the provided document set? Coverage : Which ISO 13485 clauses and mandatory procedures are addressed? Prioritization : What should be created/updated first to reduce audit risk? Typical inputs A directory containing QMS documentation (e.g., .md , .txt , .docx , .pdf ), including manuals, SOPs, work instructions, and forms. Typical outputs A machine-readable report (e.g., gap-report.json ) that can be summarized into: Present vs. missing procedures/documents Clause coverage estimates A prioritized action list (Critical/High/Medium/Low)
2. ISO 13485 documentation structure (recommended hierarchy) Level 1 : Quality Manual (policy-level mapping to Clauses 4–8) Level 2 : Procedures / SOPs (who/what/when; stable process requirements) Level 3 : Work Instructions (how-to steps; task-level detail) Level 4 : Forms / Records (evidence of implementation) This skill emphasizes writing procedures that define what must be done and who is responsible , while keeping detailed step-by-step instructions in work instructions.
3. Quality Manual requirements (key checkpoints) When drafting with assets/templates/quality-manual-template.md and references/quality-manual-guide.md , ensure: The manual includes required content aligned to ISO 13485 Clause 4.2.2 . The scope is explicit and any exclusions are justified (only where permitted and not impacting safety/effectiveness). The manual references the supporting procedures and describes process interactions (e.g., a process map). Approval/signature expectations are met (top management ownership of policy-level commitments).
4. Medical Device File (MDF) content model (Clause 4.2.3) For each device type/family, the MDF should consolidate or reference: Device description and intended use Labeling and IFU specifications Product and manufacturing specifications Purchasing/manufacturing/servicing procedures (as applicable) Monitoring and measurement procedures Installation requirements (if applicable) Risk management documentation Verification and validation evidence Design and development documentation (if applicable) This structure supports ISO 13485 expectations and aligns with FDA QMSR’s direction toward consolidated device documentation.
5. Procedure customization parameters (what must be decided) When generating SOPs from templates (e.g., CAPA, document control), the organization must define: Roles and responsibilities (role-based, not person-based) Triggers and inputs (complaints, audit findings, nonconformities, feedback) Timeframes (triage, investigation, closure, effectiveness checks) Decision criteria (severity, risk, escalation thresholds) Records and retention (what evidence is kept and for how long) Interfaces (how CAPA links to complaints, audits, risk management, change control)
6. Mandatory procedures list (reference-driven) Use references/mandatory-documents.md as the source of truth for: Which procedures are required vs. conditional (“if applicable”) How to justify non-applicability What evidence/records each procedure should produce For detailed clause interpretation, use references/iso-13485-requirements.md .