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ISO/IEC 42001:2023 — scope and certification

ISO 42001 is a management-system standard. Auditors test how you govern AI over time, not whether a single document exists on audit day. This page covers the two artefacts that anchor every certification audit — the AIMS scope statement under Clause 4.3 and the Statement of Applicability — and walks through the Stage 1 / Stage 2 / surveillance / recertification cycle.

Quick decision

  • You need to write the AIMS scope statement → Clause 4.3. Anchor it in your role under 4.1 and the interested parties under 4.2. Cover organisational functions, AI systems, and lifecycle stages.
  • You need to decide which Annex A controls apply → build the Statement of Applicability from the AI risk and impact assessments (6.1.2 / 6.1.4). Annex A is informative; the SoA documents the selection.
  • You are preparing for Stage 1 → focus on documentation completeness: scope, AI policy, risk and impact records, SoA, internal-audit programme, management-review minutes.
  • You are preparing for Stage 2 → focus on operational evidence: control execution records, decisions, supplier evidence, corrective actions, surveillance signals.
  • You already operate ISO 27001 → the Annex SL clauses (4–10) are shared; the AIMS-specific additions (5.2 AI policy, 6.1.2/3/4 risk + impact, Annex A AI lifecycle controls) sit on top of the existing ISMS.

TL;DR

  • Scope (Clause 4.3) names organisational functions, AI systems and lifecycle stages — anchored in the organisation's role (Clause 4.1) and interested parties (4.2).
  • Statement of Applicability records which Annex A reference controls the organisation has selected, the justification, the implementation status. ISO 42001 Annex A is informative — selection is risk-driven.
  • Stage 1 = documentation review by an accredited certification body. Stage 2 = operational evidence audit. Surveillance annually for two years. Recertification at month 36.
  • AI impact assessment (Clause 6.1.4) is the AIMS analogue to the EU AI Act Article 27 FRIA — distinct from the AI risk assessment (6.1.2) which looks at organisational risks.
  • The constraint on time-to-certification is the evidence window — the AIMS has to run long enough for auditors to see real records of internal audit, management review and continual improvement.

Primary source

ISO/IEC 42001:2023Information technology — Artificial intelligence — Management system, Clauses 4.1, 4.2, 4.3, 6.1.2, 6.1.3, 6.1.4, 9.2, 9.3. Available via the ISO Online Browsing Platform. © ISO.

Scope you can defend (Clause 4.3)

In ISO work, scoping is not a formality — it is the contract with the auditor. The Stage 2 sampling plan flows from the scope statement.

A defensible AIMS scope statement is:

  • Specific — names what is included and explicitly what is excluded. "All AI systems developed or operated by Division X" is verifiable; "AI systems in the organisation" is not.
  • Role-anchored — references the organisation's role under Clause 4.1. The scope of a provider-role AIMS differs from a deployer-role AIMS; both can be in scope simultaneously when relevant.
  • Operational — names accountable functions and which processes apply.
  • Reviewable — describes how scope changes are approved and recorded (typically through the management review under Clause 9.3).

Practical questions to anchor the scope:

  • Which AI systems (and which lifecycle stages) are inside the AIMS?
  • Which organisational functions are in scope — product, platform, vendor management, risk, legal?
  • Which third parties materially affect the AI systems — model providers, data providers, hosting and compute providers, downstream integrators?
  • Which markets and stakeholders drive the obligations and risk tolerance the AIMS responds to?

Most teams structure the scope into an organisation-level AIMS layer (policy, roles, internal audit, shared controls) plus per-AI-system execution (controls, evidence, monitoring per system). That structure maps cleanly onto Modulos's OFF + MFF project pair (see Operationalizing in Modulos).

Statement of Applicability — the Annex A selection record

ISO 42001 Annex A is informative, not normative. The organisation selects which Annex A control objectives apply based on the AI risk and impact assessments under Clauses 6.1.2 / 6.1.3 / 6.1.4 and documents the selection in a Statement of Applicability.

A workable SoA captures, per control objective:

  • inclusion / exclusion decision — applied, partially applied, or excluded;
  • justification — the risk or impact that drove inclusion, or the explicit reason for exclusion;
  • implementation status — implemented, in progress, planned;
  • responsible function — who owns operation of the control;
  • evidence reference — where the operational evidence is recorded.

Unlike ISO/IEC 27001 (where Annex A is normative and the SoA is mandatory under Clause 6.1.3 d), ISO 42001 frames Annex A as a reference set. In practice every accredited certification audit expects an SoA-equivalent record — the standard is risk-driven, and the SoA is how the organisation demonstrates that the risk assessment actually drove control selection.

Go deeper: Annex A and informative annexes.

The certification audit cycle

The most important pattern: auditors sample operational reality (records, decisions, evidence) — not just the existence of policy documents. The AIMS has to operate, not just be written.

What auditors typically test

  • AI governance scope, AI policy and AI objectives are defined and current (Clauses 4.3, 5.2, 6.2).
  • Responsibilities and oversight are assigned and operating, not just defined (Clause 5.3, Annex A.3).
  • AI risks are assessed, treated and re-assessed as systems change (Clauses 6.1.2 / 6.1.3, 8.2 / 8.3).
  • AI impact assessments exist for in-scope systems and influence decisions (Clause 6.1.4, Annex A.5).
  • Annex A controls in the SoA are actually executed — evidence exists, not just policy.
  • Findings from internal audit (9.2) feed corrective actions (10.2) and continual improvement (10.1).
  • Management review (9.3) inputs and outputs are recorded, including resourcing decisions.

The questions auditors ask themselves: Is this AIMS conformant with the standard? and Is it effective in achieving its objectives? Both have to be answered with operational evidence.

How to operationalise scope + SoA in Modulos

Modulos models the AIMS scope + SoA against the OFF-10 / MFF-10 framework templates (clause-aligned ISO 42001) or OFF-7 / MFF-7 (legacy). The scope statement, Statement of Applicability and audit artefacts live as evidence on the relevant ORF / MRF requirements:

Requirement (OFF-10 / MFF-10)DescriptionISO 42001 clause
ORF-164Determining the scope of the AI management system4.3
ORF-165AI management system4.4
ORF-167AI Policy5.2
ORF-170AI risk assessment6.1.2
ORF-171AI risk treatment6.1.3
ORF-172AI system impact assessment6.1.4
ORF-184 / ORF-185Internal audit + audit programme9.2.1 / 9.2.2
ORF-186 / ORF-187 / ORF-188Management review (process, inputs, outputs)9.3.1 / 9.3.2 / 9.3.3
ORF-189 / ORF-190Continual improvement + nonconformity and corrective action10.1 / 10.2

The Statement of Applicability is recorded as control-level evidence on the Annex A requirements (ORF-191ORF-194 for areas A.2–A.5 on OFF-10; corresponding ORF / MRF for the lifecycle and data controls). Modulos does not provide a dedicated SoA workflow surface — the SoA artefact is owner-authored and stored as evidence with versioning.

Freeze scope before generating audit packs

Exports are point-in-time snapshots. Freeze scope (and any framework-template version changes) before generating audit packs, so findings stay comparable across the surveillance cycle.

Cross-framework mapping (preview)

ISO 42001 elementAdjacent framework
Clause 4.3 AIMS scopeISO 27001 Clause 4.3 ISMS scope; EU AI Act Article 16 + Article 26 role-tagged obligations
Statement of Applicability (Annex A informative)ISO 27001 Statement of Applicability (Annex A normative); EU AI Act Annex IV technical documentation
Clause 6.1.4 AI impact assessmentEU AI Act Article 27 FRIA; algorithmic-impact-assessment frameworks
Stage 1 / Stage 2 / surveillance cycleISO 27001 certification cycle (identical); ISO 9001 certification cycle
Internal audit (Clause 9.2)ISO 27001 Clause 9.2; ISO 9001 Clause 9.2
Management review (Clause 9.3)ISO 27001 Clause 9.3; shared management-system process

Source attribution

ISO/IEC 42001:2023Information technology — Artificial intelligence — Management system, Clauses 4.1, 4.2, 4.3, 5.2, 5.3, 6.1.2, 6.1.3, 6.1.4, 9.2, 9.3, 10.1, 10.2 + Annex A.2–A.10. © ISO/IEC. Available via the ISO Online Browsing Platform.

Disclaimer

This page is for general informational purposes and does not constitute legal or certification advice.