iso-certification

Source: https://github.com/aipoch/medical-research-skills

When to Use

Use this skill in any of the following situations:

1. Starting ISO 13485 implementation and you need a structured documentation set (Quality Manual, procedures, records, templates).
2. Assessing an existing QMS and you want a gap analysis against ISO 13485:2016 requirements and mandatory documentation.
3. Preparing for a certification audit and you need readiness checks, evidence mapping, and prioritized remediation actions.
4. Creating or updating specific SOPs (e.g., CAPA, complaint handling, internal audit, document/record control) using consistent templates.
5. Transitioning or harmonizing with regulations (e.g., FDA QMSR alignment, EU MDR documentation expectations) and you need to reorganize device documentation (e.g., MDF).

Key Features

• Automated documentation gap analysis via scripts/gap_analyzer.py to detect missing/covered QMS documents.
• Clause-by-clause ISO 13485 reference guidance using references/iso-13485-requirements.md.
• Mandatory documentation mapping (procedures and required documents) using references/mandatory-documents.md.
• Comprehensive audit-style checklist for detailed assessments using references/gap-analysis-checklist.md.
• Template-based document generation for Quality Manual and key procedures under assets/templates/.
• Medical Device File (MDF) guidance aligned to ISO 13485 Clause 4.2.3 and FDA QMSR harmonization concepts.