Conformity Assessment

Conformity assessment is the formal process of demonstrating that a high-risk AI system meets the requirements of the EU AI Act before being placed on the market or put into service.

What is Conformity Assessment?

Conformity assessment for high-risk AI involves technical documentation (Annex IV), risk management, data and data governance evidence, testing records, human-oversight design, accuracy and robustness measurement, cybersecurity controls, and a quality management system. Most high-risk systems can self-assess; some require notified body involvement. The output is a CE marking and an EU declaration of conformity.

How does Conformity Assessment apply to enterprise AI?

Enterprises building or procuring high-risk AI need a conformity assessment plan from day one. The artefacts overlap heavily with ISO 42001 and ISO 27001 evidence and can be produced once and reused.