Conformity Assessment Procedure

Purpose

This procedure establishes the step-by-step process for conducting conformity assessments of high-risk AI systems in compliance with EU AI Act Articles 43 (Conformity Assessment), 47 (EU Declaration of Conformity), and 48 (CE Marking). The procedure ensures that AI systems meet all applicable requirements before being placed on the market or put into service. The conformity assessment demonstrates that the AI system: - Complies with all mandatory requirements of the EU AI Act - Has undergone appropriate technical and quality management system evaluation - Is safe and respects fundamental rights - Can be legally placed on the EU market with the CE marking

Applies To

• All high-risk AI systems as defined in EU AI Act Annex III
• AI systems intended to be used as safety components of products covered by EU harmonization legislation
• AI systems requiring third-party conformity assessment per Article 43(1)
• Biometric identification systems (third-party assessment mandatory only when harmonised standards/common specifications not applied)
• Providers placing high-risk AI systems on the EU market
• Providers putting high-risk AI systems into service under their own name or trademark

Does Not Apply To

• Minimal-risk AI systems (no conformity assessment required)
• Limited-risk AI systems (transparency obligations only, covered by Transparency & User Information Procedure (PROC-AI-TRANS-001))
• AI systems subject to internal control only (Annex VI) without notified body involvement
• Third-party AI systems procured as-is (deployer obligations covered by AI Deployment Procedure (PROC-AI-DEPLOY-001))