Individual skill
iso-certification
A toolkit for preparing ISO 13485:2016 certification documentation for medical device QMS. Use when you need to perform a documentation gap analysis, draft or update a Quality Manual, create required procedures/work instructions, build Medical Device Files (MDF), interpret ISO 13485 clauses, or identify missing documents for certification (often triggered by ISO 13485, QMS certification, FDA QMSR, EU MDR, or quality system documentation requests).
scientific-skills/Other/iso-13485-certification/SKILL.md
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SKILL.mdcore · 7,142 bytesSKILL.mdcore · 7,142 bytesSKILL.mdcore · 7,142 bytesSKILL.mdcore · 7,142 bytesassets/templates/procedures/CAPA-procedure-template.mddoc · 15,979 bytesassets/templates/procedures/document-control-procedure-template.mddoc · 19,740 bytesassets/templates/quality-manual-template.mddoc · 21,291 bytesiso-13485-certification_audit_result_v1.jsonasset · 12,482 bytesreferences/gap-analysis-checklist.mddoc · 28,837 bytesreferences/iso-13485-requirements.mddoc · 26,981 bytesreferences/mandatory-documents.mddoc · 22,634 bytesreferences/quality-manual-guide.mddoc · 27,294 bytesscripts/gap_analyzer.pyruns · 15,969 bytes
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> **Source**: [https://github.com/aipoch/medical-research-skills](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.