FprEN 18286 is structurally different from ISO 9001 and ISO/IEC 42001, and the difference is deliberate.

ISO 9001 and 42001 are organisation-centric. They follow Annex SL and organise everything around the management system. prEN 18286 is product-centric. It's organised directly around the thirteen QMS aspects in Article 17(1) of the AI Act.

That's because conformity assessment under the Act applies to specific high-risk AI systems, not to organisations. The CE mark attaches to the system. The QMS exists to ensure those systems comply.

Structure follows function. The function here is regulatory compliance demonstration, not organisational quality capability.