Conformity Based on an Assessment of the Quality Management System and an Assessment of the Technical Documentation
Conformity assessment involving a notified body
Overview
Defines the conformity assessment route involving a notified body that evaluates both the provider's quality management system and the technical documentation for each AI system. This is the more rigorous conformity path, required for certain high-risk AI systems (particularly those in Annex III areas 1, 6, 7, and 8).
1. Conformity based on an assessment of the quality management system and an assessment of the technical documentation is the conformity assessment procedure based on points 2 to 5.
