prEN 18286

The draft European standard for AI quality management systems under development by CEN-CENELEC JTC 21, intended to give presumption of conformity with Article 17 of the Regulation when published as a harmonised standard. Reached the public enquiry stage around October to November 2025 and is progressing toward formal vote; first AI Act standards estimated for 2026. Publication as a harmonised standard is the event that activates the Article 40 presumption of conformity for QMS documentation.

A draft harmonized standard developed by CEN and CENELEC through their Joint Technical Committee 21 (JTC 21), covering the AI Act's quality management system obligations (Article 17) and the technical documentation package (Annex IV). It entered public enquiry in 2025 and, as of the currency check for this program, targets delivery in the fourth quarter of 2026.

the CEN-CENELEC harmonized standard covering quality management practices, including the Annex IV technical documentation package, under the EU AI Act; it entered public enquiry in 2025 with delivery targeted for the fourth quarter of 2026. (see Topic 8.6)

The CEN-CENELEC draft standard for an AI Quality Management System for EU AI Act regulatory purposes, targeting presumption of conformity with Article 17 (QMS). Section 7.2 specifies competence requirements. Currently moving toward formal vote after public enquiry (late 2025); not yet published as a final harmonized standard as of June 2026. When finalized, likely to formalize evidence expectations for competence documentation.

The first AI quality management standard developed by CEN-CENELEC JTC 21 to provide presumption of conformity with Article 17 (quality management system); reached public enquiry stage around October to November 2025. Its unavailability by August 2026 was the primary rationale for the Omnibus delay.