Conformity based on an assessment of the quality management system and an assessment of the technical documentation

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.

The approved quality management system for the design, development and testing of AI systems pursuant to Article 17 shall be examined in accordance with point 3 and shall be subject to surveillance as specified in point 5. The technical documentation of the AI system shall be examined in accordance with point 4.

3.1.

(a) the name and address of the provider and, if the application is lodged by an authorised representative, also their name and address;

(b) the list of AI systems covered under the same quality management system;

(c) the technical documentation for each AI system covered under the same quality management system;

(d) the documentation concerning the quality management system which shall cover all the aspects listed under Article 17;

(e) a description of the procedures in place to ensure that the quality management system remains adequate and effective;

(f) a written declaration that the same application has not been lodged with any other notified body.

3.2.

3.3.

3.4.

4.1.

4.2.

(a) the name and address of the provider;

(b) a written declaration that the same application has not been lodged with any other notified body;

(c) the technical documentation referred to in Annex IV.

4.3.

4.4.

4.5.

4.6.

4.7.

5.1.

5.2.

5.3.