ISO/IEC 42001 under AI Act Art. 40

Confers no presumption of conformity with the AI Act. Article 40(1) attaches the presumption only to harmonised standards whose references are published in the Official Journal, and no reference has been published for the AI Act. EN 18286:2026, the European standard written for the Article 17 quality management system, was published by CEN-CENELEC in July 2026 but is not cited in the Official Journal either.

Invalidation trigger

A harmonised standard covering the requirement is cited in the Official Journal; EN 18286:2026 is the first candidate.

Sources

1. [1]Regulation (EU) 2024/1689 (AI Act), consolidated text of 27 July 2026, Art. 40(1) · retrieved 2026-09-17 · https://eur-lex.europa.eu/eli/reg/2024/1689/2026-07-27/eng
2. [2]European Commission, Standardisation of the AI Act, standards referenced in the Official Journal after Commission assessment; prEN 18286 entered public enquiry on 30 October 2025 · retrieved 2026-09-17 · https://digital-strategy.ec.europa.eu/en/policies/ai-act-standardisation
3. [3]CEN-CENELEC, EN 18286 in the Spotlight (31 July 2026), EN 18286:2026 published · retrieved 2026-09-17 · https://www.cencenelec.eu/news-events/news/2026/en-in-the-spotlight/2026-07-30-ai-quality-management/

Confidence

medium

Jurisdiction

European Union · coverage drafting

Permanent URL

/effect/european-union/ai-act-40/iso-42001