Self-Assessment – Annex VI
Internal Control (Annex VI)
The self-assessment is the standard conformity assessment procedure for high-risk AI systems (where no third-party assessment is required).
Step 1: QMS Verification
Confirmation that the QMS (Art. 17) is implemented and meets the requirements.
Step 2: Technical Documentation
Verification that the technical documentation (Art. 11, Annex IV) is complete and up to date.
Step 3: Conformity Check
Systematic check against all requirements of Art. 8–15:
| Requirement | Checked | Conforming | Remark |
|---|---|---|---|
| Risk Management System (Art. 9) | ☐ | ☐ | |
| Data Governance (Art. 10) | ☐ | ☐ | |
| Technical Documentation (Art. 11) | ☐ | ☐ | |
| Record-Keeping (Art. 12) | ☐ | ☐ | |
| Transparency (Art. 13) | ☐ | ☐ | |
| Human Oversight (Art. 14) | ☐ | ☐ | |
| Accuracy, Robustness, Cybersecurity (Art. 15) | ☐ | ☐ |
Step 4: EU Declaration of Conformity
Upon successful self-assessment: issue the EU Declaration of Conformity (Art. 47).
Step 5: CE Marking
Affix the CE marking (Art. 48).
Step 6: Registration
Register in the EU database (Art. 49).