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International (certifiable standard)

ISO/IEC 42001 AI Management System Testing Guide

ISO/IEC 42001 is the first certifiable management system standard for AI. It does not tell you which metrics to use; it requires that you define AI objectives, assess risks and impacts, verify and validate systems against defined criteria, keep records and improve. Auditors look for evaluation that is planned, repeated and acted on.

Reviewed by Nandini Joshi, Head of Regulatory Science · updated 1 Nov 2026
ISO/IEC 42001
Instrument
ISO/IEC 42001:2023 Artificial intelligence: Management system
Primary citation
ISO/IEC 42001:2023, clauses 6.1, 8 and 9 and Annex A controls A.6.2.4, A.6.2.6 and A.6.2.8
Authority
ISO/IEC JTC 1/SC 42; certification by accredited certification bodies
Status
As of November 2026: ISO/IEC 42001:2023 (published December 2023) is the current edition, and accredited certification is available. It is referenced alongside the NIST AI RMF in procurement and state law discussions; ISO/IEC 42006 sets requirements for bodies that audit and certify against it.
Cross-verticalHealthcareFinTechLegalInsuranceLife Sciences

Statutory requirements

  1. 01

    AI risk assessment and treatment

    Clauses 6.1.2 and 6.1.3

    The organization defines and applies an AI risk assessment process that identifies risks that could prevent achieving its AI objectives, analyzes their consequences and likelihood, and evaluates them against risk criteria. Risk treatment selects controls, compares them with Annex A to make sure nothing necessary is omitted, and produces a Statement of Applicability.

  2. 02

    AI system impact assessment

    Clause 6.1.4 and Annex A.5

    A separate process assesses potential consequences of AI systems for individuals, groups and societies, considering the technical and societal context. For a clinical or credit agent, the impact assessment is where harms to patients or applicants are named, and those harms should map to test suites.

  3. 03

    Verification and validation

    Annex A.6.2.4

    Annex A expects the organization to define and document verification and validation measures for the AI system and to specify criteria for their use, as part of a documented lifecycle that also covers requirements, design, deployment, operation and monitoring. Evaluation criteria set in advance and evidence that each release met them is what an auditor samples.

  4. 04

    Operation, monitoring and event logs

    Annex A.6.2.6 and A.6.2.8

    Controls cover operation and monitoring of AI systems, including repairs, updates and support, and determining at which lifecycle phases event logging is enabled. For agents, trajectory logs are the natural event record, and their retention and access policies belong in the AIMS.

  5. 05

    Data quality, monitoring, internal audit and improvement

    Annex A.7.4; clauses 9.1, 9.2, 9.3 and 10

    The standard requires data quality requirements for data used in AI systems, monitoring and measurement of the management system's performance, internal audits at planned intervals, management review, and corrective action on nonconformities. A recurring regression suite with tracked failures is direct evidence for clauses 9 and 10.

Evaluation methodologies

Objective-to-metric traceability

Write AI objectives that can be measured (for example zero unverified identity actions, contraindication recall at or above 0.97) and link each to an evaluation suite and threshold. Auditors follow the chain from objective to evidence.

Release gating as a documented V&V procedure

Describe the CI gate as the verification and validation procedure: what runs on each change, thresholds, who can override and how overrides are recorded. Then show the gate's history for the audit period.

Impact-driven test design

For each harm in the impact assessment, design a suite that would detect it. Missing coverage is a finding waiting to happen; documented rationale for untested harms is acceptable.

Nonconformity handling

Treat a failed gate or a production incident traced to a missed test as a nonconformity: root cause, correction, new test case added to the golden set, and verification that the fix holds.

Testing artifacts to retain

The evidence folder an examiner, notified body or internal auditor will ask for. GONATURELLE compliance reports export most of it from signed runs.

evidence/iso-iec-42001/7 items
  • 01AI policy, objectives and Statement of Applicability
  • 02AI risk assessment and AI system impact assessment records
  • 03Verification and validation procedure with acceptance criteria
  • 04Gate history for the audit period, including overrides and approvals
  • 05Event log policy and sample trajectory logs
  • 06Data quality requirements for evaluation and training data
  • 07Internal audit reports, management review minutes and corrective actions

GONATURELLE assertion rules

Each assertion maps to a requirement above. Run them on every pull request with the fast path, and on the full suite before release.

iso42001_vv_gate.py
from gonaturelle import EvalSuite, TrajectoryTester, assertions as A
from gonaturelle.governance import Objectives

objectives = Objectives.load('aims/objectives.yaml')  # OBJ-03, OBJ-07 ...

suite = EvalSuite.load('insurance/coverage-exclusions')
results = suite.evaluate(agent=coverage_agent, max_concurrency=10)

# A.6.2.4: criteria defined in advance, linked to AI objectives
results.assert_tool_schema_valid()
results.assert_metric('exclusion_recall', min=objectives['OBJ-03'].threshold)
TrajectoryTester(results).assert_order('fetch_policy_form', 'cite_exclusion')
results.assert_all([A.cites_only(source='policy_forms/'), A.judge(rubric='coverage-reasoning-v2', threshold=0.88)])

# A.6.2.8: event logs retained per policy
results.assert_logs_retained(policy='aims/log_policy.yaml')

# Clause 10: failed cases become nonconformities with owners
results.failures().open_nonconformities(project='AIMS', assignee='coverage-ai-team')
results.export_report('iso42001', path='aims/vv_evidence.json', sign=True)

Audit checklist

ISO/IEC 42001 readiness0/10

ISO/IEC 42001 testing questions

Does ISO/IEC 42001 certification prove our AI is safe?

No. Certification shows the management system meets the standard's requirements. It does not certify the performance of any individual model, and GONATURELLE does not issue certifications. This guide is not legal advice.

We already hold ISO/IEC 27001. How much carries over?

The management system structure (context, leadership, planning, support, operation, evaluation, improvement) is shared, so document control, internal audit and management review processes extend naturally. AI risk and impact assessments and the Annex A AI controls are new work.

What evidence do auditors sample most?

Typically the link from AI objectives to verification criteria, a sample of releases showing criteria were applied, and how failures were handled. Signed run manifests make that sampling quick.

Run ISO/IEC 42001 assertions in CI.

Load the vertical pack, add these assertions to your suite and keep the signed run manifest as evidence. 14-day free production trial, no card.