1.3 KiB
1.3 KiB
RA/QM Skills — Codex CLI Instructions
When working on regulatory or quality management tasks, use the RA/QM skill system:
Routing
- Identify the domain: Regulatory (FDA/MDR), quality (ISO 13485), security (ISO 27001), or privacy (GDPR)
- Read the specialist SKILL.md for detailed instructions
Python Tools
All scripts in ra-qm-team/*/scripts/ are stdlib-only and CLI-first:
python3 ra-qm-team/risk-management-specialist/scripts/risk_matrix_calculator.py --help
python3 ra-qm-team/gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help
Key Skills by Task
| Task | Skill |
|---|---|
| FDA submissions | regulatory-affairs-head |
| EU MDR compliance | mdr-745-specialist |
| FDA 510(k)/PMA | fda-consultant-specialist |
| ISO 13485 QMS | quality-manager-qms-iso13485 |
| QMS governance | quality-manager-qmr |
| Risk management | risk-management-specialist |
| CAPA management | capa-officer |
| Document control | quality-documentation-manager |
| ISO 13485 audits | qms-audit-expert |
| ISO 27001 ISMS | information-security-manager-iso27001 |
| ISO 27001 audits | isms-audit-expert |
| GDPR compliance | gdpr-dsgvo-expert |
Rules
- Load only 1-2 skills per request — don't bulk-load
- Always verify outputs against current regulations