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Regulation watch · Explainer

ISO/IEC 42001: a management system for AI, explained

ISO/IEC 42001 is the first international standard for an AI management system. It does not tell you which AI to build. It asks you to run AI the way ISO 27001 asks you to run information security: with policy, risk assessment, controls, evidence and improvement. Agents that act generate exactly the evidence it asks for, if they are built to.

Author
elan1 regulation watch · Regulation and policy
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4 min read
Last reviewed
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What it is

ISO/IEC 42001:2023  (opens iso.org, external site), published in December 2023, specifies requirements for establishing, implementing, maintaining and improving an artificial intelligence management system. It applies to any organisation that develops, provides or uses AI, of any size. Unlike guidance documents, it is certifiable: an accredited certification body can audit an organisation against it.

How it is structured

The standard follows the harmonised structure shared by ISO management system standards, so organisations already certified to ISO/IEC 27001 or ISO 9001 will recognise it.

  • Clauses 4 to 10: context of the organisation, leadership, planning, support, operation, performance evaluation and improvement.
  • Planning includes an AI risk assessment, an AI risk treatment plan and an AI system impact assessment, which looks at consequences for individuals and society.
  • Annex A sets out reference controls across nine control objectives, from AI policy and internal organisation to data, the AI system life cycle, use of AI systems, and third-party relationships.
  • Annex B gives implementation guidance for those controls; Annexes C and D cover objectives, risk sources and use across domains.

As with ISO/IEC 27001, an organisation selects the controls that apply and records its choices in a statement of applicability, with the reasons for including or excluding each.

  • ISO/IEC 23894:2023 gives guidance on AI risk management.
  • ISO/IEC 42005:2025 gives guidance on AI system impact assessment.
  • ISO/IEC 42006:2025 sets requirements for bodies that audit and certify AI management systems.

What it asks of agents that act

The standard is technology-neutral, but several control areas land squarely on agents that change records.

  • Use of AI systems: defined objectives and processes for responsible use, including where a person must be involved.
  • AI system life cycle: documented requirements, verification and validation before deployment, and event logs during operation.
  • Information for interested parties: the ability to explain to users, customers and auditors what the system did.
  • Third-party relationships: clarity about responsibilities when AI components come from suppliers.

An auditor assessing these controls will ask for evidence. A policy that says "risky actions require approval" is a start; a record showing which actions were approved, by whom, under which rule version, is what makes the control demonstrable.

How elan1 maps to it (draft)

  • Operational controls as rules: elan1 Govern turns approval policy into rules evaluated before every agent action.
  • Evidence of operation: every action, allowed, approved or refused, leaves a signed, hash-chained record that can be exported for audit.
  • Verification before deployment: elan1 Work tests ERP changes against a copy of your data before they go live; elan1 Decide runs in shadow before any automation.
  • Supplier clarity: elan1 Run places each AI component behind a versioned contract, so third-party responsibilities are named.

elan1 is not certified to ISO/IEC 42001, and using elan1 does not make an organisation compliant. ISO/IEC 42001 certification is also not, on its own, conformity with the EU AI Act.

Key takeaways

  1. ISO/IEC 42001:2023 is a certifiable management system standard for organisations that develop, provide or use AI.
  2. It requires AI risk and impact assessments, selected Annex A controls and a statement of applicability.
  3. Auditors look for evidence of operation; a per-action record of approvals and refusals provides it.

Official sources

Last reviewed against the official text on . Not legal advice; take your counsel’s view before you act.

About the author

elan1 regulation watch

Regulation and policy

Regulation watch explains new AI rules in plain words for the people who answer for agents at work. Each explainer links to the official text and shows the date it was last checked against it. It is not legal advice; take your counsel's view before you act.

FAQs

Questions about ISO/IEC 42001

What is ISO/IEC 42001?

ISO/IEC 42001:2023, published in December 2023, is the first international standard for an AI management system. It sets requirements for how an organisation that develops, provides or uses AI runs it, with policy, risk assessment, controls, evidence and improvement, much as ISO/IEC 27001 does for information security.

Can an organisation be certified to ISO/IEC 42001?

Yes. Unlike guidance documents, ISO/IEC 42001 is certifiable: an accredited certification body can audit an organisation against it. ISO/IEC 42006:2025 sets requirements for the bodies that audit and certify AI management systems. elan1 is not certified to ISO/IEC 42001, and using elan1 does not make an organisation compliant.

How many controls are in ISO/IEC 42001 Annex A?

Annex A sets out 38 reference controls across 9 control objectives, from AI policy and internal organisation to data, the AI system life cycle, use of AI systems and third-party relationships. An organisation selects the controls that apply and records its choices, with the reasons, in a statement of applicability.

Does ISO/IEC 42001 certification mean EU AI Act compliance?

No. ISO/IEC 42001 certification shows that an organisation runs an AI management system to the standard. It is not, on its own, conformity with the EU AI Act, whose high-risk duties and deployer obligations are set separately in law. Take your counsel's view on how the two relate for each use of AI.

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