CEN-CENELEC approved EN 18286 on 12 July 2026. This is the harmonised standard that operationalises Article 17’s quality management system requirement for high-risk AI systems — the standard I described in an earlier piece as a deliberate architectural break from ISO 9001 and EN ISO/IEC 42001. That piece was written about the enquiry draft, because at the time the enquiry draft was all there was.
Following more than a thousand comments, a new consensus was hammered out during March in BSI’s London office. The resulting text was unanimously approved by national bodies in a Formal Vote (with some abstentions).
The enquiry draft ran 58 pages. The final text runs 51. Seven pages did not disappear at random!
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