The Governance Framework
EU AI Act Requires
ISO 42001 provides the conformity assessment framework for EU AI Act High Risk AI obligations. Gap assessment, implementation and pre-certification audit pathway.
ISO 42001 Satisfies EU AI Act Conformity Assessment Requirements
The EU AI Act requires a conformity assessment for all High Risk AI systems before August 2026. ISO 42001:2023 — the AI Management System standard — provides the governance framework that satisfies this requirement for organisations in pharma, medical devices, financial services and technology.
For pharma and medical device organisations, ISO 42001 aligns directly with EU GMP Annex 22 and GAMP 5 AI Guide obligations — meaning a single implementation satisfies all three frameworks simultaneously.
Current state assessment against all ISO 42001 clauses + Annex A controls + EU AI Act obligations.
AI policy, risk register, governance structure, Annex A controls, monitoring programme, and conformity assessment package.
Internal audit against ISO 42001 requirements. Management review. Certification body audit readiness verification.
- Pharma manufacturers using AI in batch release or PV
- Medical device companies with AI/SaMD products
- Technology organisations selling AI to regulated industries
- Financial services firms using credit or insurance AI
- Any organisation with High Risk AI under the EU AI Act