Practical toolGlobalISO/IEC 42001

ISO/IEC 42001 AIMS Scope Decision Workflow

Run a repeatable scope decision from organisational context and interested-party requirements through AI activities, interfaces, external dependencies, boundary approval, and change review.

The output is a controlled AIMS scope statement supported by an AI inventory and responsibility map. A model list or legal role label alone does not define the boundary.

Author
Sorena AI
Published
May 9, 2026
Updated
Jul 25, 2026
Sections
5

Structured answer sets in this page tree.

Primary sources
1

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 25, 2026
Overview

Use this workflow when establishing the artificial intelligence management system and whenever acquisitions, new products, new AI uses, supplier changes, organisational restructuring, or changed interested-party requirements could alter the boundary. The output must be controlled documented information; ISO/IEC 42001 does not require certification or dictate one organisation-wide boundary.

Section 1

1. Establish the facts that determine the boundary

Start with the organisation's purpose, internal and external issues, intended AIMS results, relevant interested parties, and the requirements the AIMS will address. ISO/IEC 42001:2023 Clause 4.1 also requires the organisation to consider the intended purpose of the AI systems it develops, provides, or uses and to determine its roles in relation to those systems.

Build a factual map before drafting the scope: legal entities, business units, locations, products and services, AI systems, lifecycle activities, data and tooling resources, externally supplied services, customers, partners, and interfaces. Record both included and excluded activities and the reason for each decision.

The standard applies to organisations of any size that develop, provide, or use AI-based products or services. The organisation still chooses the boundaries and applicability of its own AIMS from its context and interested-party requirements; the scope is not automatically every model or every corporate activity. A narrow boundary can be valid, but it must not hide an interface, dependency, or applicable requirement that affects the AIMS's intended results.

  • Trigger: establish a new AIMS or review a proposed change that could alter its boundary.
  • Owner: assign an AIMS owner to coordinate facts from business, legal, risk, procurement, technical, and product owners.
  • Evidence: retain the context analysis, interested-party register, AI inventory, role and interface map, inclusion and exclusion rationale, and draft scope statement.
Section 2

2. Test inclusions, exclusions, and interfaces

For every proposed exclusion, ask whether the excluded activity affects the AIMS's intended results, supplies a resource or process used by an in-scope AI system, owns an applicable requirement, or controls an interface on which an in-scope activity depends. If it does, either include the activity or document how the interface, responsibility, information flow, control, and escalation route remain governed. An exclusion changes the boundary; it does not remove the dependency.

Separate the organisational AIMS boundary from a certification scope and from legal classifications. A certification body may certify a stated scope, while laws can assign different roles system by system. Neither replaces the Clause 4.3 decision about the management system's boundaries and applicability.

  • Include each AI lifecycle role the organisation actually performs, even when a supplier owns the underlying model.
  • Map customer, partner, supplier, and internal responsibilities at each boundary; an outsourced process can remain relevant to the AIMS.
  • Escalate exclusions that leave an applicable requirement, control, risk, resource, or decision authority without an owner.
Section 3

3. Approve and publish the controlled scope statement

Write the scope so a reader can identify the covered organisation, locations or functions, AI-related activities, products or services, and material boundaries. Keep the scope available as controlled documented information, with an owner, version, approval, effective date, and links to the evidence used.

Top management should confirm that the boundary is compatible with the AI policy and objectives, that responsibilities are assigned, and that resources exist to operate the AIMS. Approval does not make an unsupported exclusion valid; unresolved interfaces should return to the fact-finding step.

  • Decision: approve the proposed boundary, return it for defined revisions, or reject it with the unresolved requirement, interface, resource, or ownership gap recorded.
  • Approval record: identify the approver, decision date, unresolved assumptions, and required follow-up actions.
  • Downstream update: align the AI inventory, risk and impact assessment coverage, control ownership, internal-audit programme, and management-review inputs with the approved scope.
Section 4

4. Reopen the decision when the facts change

Embed a scope check in acquisition, product approval, procurement, deployment, significant-change, restructuring, and retirement workflows. Reopen the decision when an AI system, intended use, lifecycle role, supplier, customer allocation, jurisdiction, interested-party requirement, or organisational boundary changes.

If the boundary changes, revise the controlled scope and every dependent record. If it does not change, retain the review and the reason so the organisation can show that the trigger was considered.

  • Do not define scope from a stale model spreadsheet or an organisation chart alone.
  • Do not confuse outsourcing with exclusion; record who controls the supplier relationship and the dependent process.
  • Do not claim that an ISO/IEC 42001 scope determines compliance with a separate law or regulation.
Section 5

Completion criteria

The workflow is complete when the scope statement is controlled and understandable, each material inclusion and exclusion has a recorded rationale, boundary interfaces have owners, top management has approved the responsibilities and resources implied by the scope, and downstream AIMS records match the decision.

Set both a planned review date and event-driven triggers. Management review can then evaluate whether changes in context, interested-party needs, AIMS performance, audit results, risks, or opportunities require a new scope decision.

  • Controlled output: approved statement and decision record.
  • Aligned records: inventory, responsibilities, assessments, controls, audit coverage, and review agenda.
  • Open actions: named owner, due date, escalation route, and closure evidence.
Primary sources

References and citations

iso.org
Referenced sections
  • Clause 9.3 makes changes in internal and external issues and interested-party needs relevant management-review inputs, supporting planned and event-driven scope review.
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