ISO/IEC 42001 guide
ISO 42001 Stage 1 and Stage 2 audit: what auditors check, day by day
Clause by clause: ISO/IEC 42001:2023 requirements: every clause explained →
What the certification body's auditor checks at the Stage 1 readiness review of your AI management system and at the Stage 2 audit, how a typical Stage 2 runs, which AI system trails are sampled, how findings are raised and who decides.
Key points
- An ISO 42001 Stage 1 and Stage 2 audit is the two-part initial audit an accredited certification body runs before it decides on your AIMS certificate. Stage 1 asks whether the system is ready to be audited; Stage 2 asks whether it works.
- At Stage 1 the auditor reads the design: scope, AI system inventory, AI policy, risk method, Statement of Applicability, impact assessments, internal audit and management review.
- At Stage 2 the auditor follows real AI systems through their life cycle, data, suppliers and monitoring, and checks that the controls you declared applicable operate.
- The audit team recommends; people at the certification body who did not audit you take the decision. Sterling does not certify.
Why an AIMS audit comes in two stages
ISO/IEC 17021-1, the standard every accredited certification body works to, requires the initial certification audit of any management system to run in two stages. For an artificial intelligence management system, ISO/IEC 42006:2025 adds further requirements on top of it for the bodies that audit and certify against ISO/IEC 42001.
Stage 1 confirms the foundations; Stage 2 tests the building. The wider route, from gap analysis to certificate, is set out in the ISO/IEC 42001 certification process guide, and how to select the body in choosing an ISO/IEC 42001 certification body.
Stage 1: the readiness review of your AIMS
Stage 1 is the certification body's readiness review. It is not Sterling's gap analysis and not the free online readiness check: the auditor records concerns but does not design your fixes. What the auditor asks for follows the Stage 1 objectives in ISO/IEC 17021-1, read against the text of ISO/IEC 42001.
| Stage 1 objective | What it means for an AIMS | Have ready |
|---|---|---|
| Review documented information | Scope under clause 4.3, AI policy under 5.2, risk criteria, the risk and impact assessment methods | Approved current versions, each with an owner |
| Obtain scope information | Which AI systems are covered, whether you develop, provide or use each, and the legal and contractual expectations about them | An AI system inventory that agrees with the scope statement |
| Review your understanding of the requirements | How AI risks are identified, analysed and evaluated; how AI objectives are tracked | Risk register, Statement of Applicability covering all 38 Annex A controls with justification, approved treatment plan |
| Evaluate site conditions and preparedness | Where development, deployment and oversight actually take place, including cloud and supplier environments | Access to the people and tools the auditor will need at Stage 2 |
| Agree Stage 2 resources and details | Which systems, teams and locations Stage 2 will sample | Diaries of system owners, data and engineering leads, procurement |
| Evaluate internal audits and management review | Whether the AIMS has checked itself before being checked | A completed internal audit report and management review minutes, not a plan |
Three points draw most of the auditor's attention. First, does the risk register agree with the Statement of Applicability, so that every control marked applicable answers an identified risk and every exclusion is justified? Second, is there an impact assessment for each system in scope, and have its results been considered in the risk assessment, as clause 6.1.4 requires? Third, has designated management approved the treatment plan and the acceptance of residual AI risk under clause 6.1.3?
The certification body must tell you in advance which Stage 1 activities it will carry out on site. Stage 1 ends with documented conclusions and any areas of concern that could become Stage 2 nonconformities.
The interval before Stage 2
The body sets the gap between the stages with your need to resolve those concerns in mind, and it may change the Stage 2 arrangements because of what it found. Close every concern with evidence rather than a promise. You receive the Stage 2 plan and the audit team's names beforehand.
Stage 2: implementation and effectiveness
Stage 2 evaluates whether the AIMS is implemented and effective across the scope. ISO/IEC 17021-1 requires it to cover conformity with all the requirements of the standard, performance monitoring against key objectives, legal and contractual compliance, operational control, internal audit and management review, and management responsibility for the policies. For ISO/IEC 42001 that means the auditor stops reading method documents and starts following systems.
- Life-cycle trails. One AI system is traced from its requirements and design records through verification and validation, deployment, operation and monitoring, and its event logs.
- Data trails. Where training and test data came from, how its quality and provenance were checked and how it was prepared.
- Reassessment on change. Clauses 8.2 and 8.4 require risk and impact assessments to be repeated at planned intervals or on significant change. A model retrained or replaced since Stage 1 is a natural test.
- Treatment effectiveness. Clause 8.3 asks you to verify that treatments worked; the auditor looks for that verification, not just the action.
- Third parties. For a supplied model or platform, how responsibilities were allocated and the component is controlled.
Effectiveness is the harder test. A completed impact assessment shows implementation. An impact assessment that changed a design decision, a deployment limit or the information given to users shows effectiveness. The questions auditors typically put to each role are gathered in our ISO/IEC 42001 audit questions guide.
A typical Stage 2 for an AIMS, day by day
The certification body sets the audit time from your scope, the AI systems within it, headcount and locations, under its accreditation rules. The table below is an illustration only: three days, one auditor, one office, cloud tooling reviewed on screen. Your audit plan decides the real order.
| When | What happens | Who is needed | What is sampled |
|---|---|---|---|
| Day 1, start | Opening meeting: plan, scope and changes since Stage 1 confirmed | Top management, AIMS lead, guides | The plan; closure of Stage 1 concerns |
| Day 1, rest | Leadership, context, AI policy, objectives, risk criteria, management review | Senior sponsor, AIMS lead, risk owners | Objectives and results, review minutes, approval of residual risk |
| Day 2, morning | A developed or provided AI system, end to end | System owner, engineering, data lead | Requirements, design and validation records, data provenance, deployment approval, logs |
| Day 2, afternoon | A used or supplier-provided AI system; procurement and contracts | Business owner, procurement, legal | Supplier agreements, allocated responsibilities, intended-use limits, user information |
| Day 3, morning | Reassessments, incidents, competence, internal audit, corrective action | AIMS lead, HR, internal auditors | Impact assessments redone after change, incident records, training evidence, audit reports |
| Day 3, afternoon | Auditor prepares conclusions; closing meeting | Management and system owners | Findings, grading, deadlines and recommendation |
Leadership usually comes first because the AI policy and objectives frame every later question. The auditor picks samples from lists you supply, so keep the inventory current up to the morning of the audit.
How findings are raised and who decides
A nonconformity is written against a specific requirement of ISO/IEC 42001, with a statement of what is wrong and the objective evidence. The auditor discusses it with you to confirm the facts; that is the moment to produce a record the auditor has not seen. The auditor may not suggest the cause or the remedy, which protects the impartiality of the audit. Findings are graded as major, where the system's capability to achieve its intended results is affected, or minor, where it is not; opportunities for improvement are noted separately where the scheme allows.
At the closing meeting you hear the conclusions and the recommendation, and you are told that the evidence came from a sample, how findings affect certification and the deadline for your correction and corrective action plan. Competent people at the certification body who were not on the audit then decide. Every major nonconformity must be corrected, with its corrective action accepted and verified, before a certificate can be issued; plans for minor ones must be accepted. Grading and closure are covered in our ISO/IEC 42001 nonconformities guide, and the surveillance that follows in the surveillance and recertification guide.
How Sterling prepares you for both stages
A Stage 1 with no surprises, and system owners who can walk the auditor through their own AI.
Before the certification body arrives, Sterling's expert and experienced consultants run the internal audit and management review with your team, test the scope, inventory, risk register, Statement of Applicability and impact assessments against the Stage 1 objectives, and rehearse the system trails with the people who own them. Every finding we raise is closed with evidence first. Records sit in Effivity, included with the engagement at no additional cost, so any sample the auditor asks for is found in seconds. We ensure successful certification for our clients. Both stages, and the certification decision, rest with your independent, accredited certification body; Sterling does not certify.
Book a free discovery callISO 42001 Stage 1 and Stage 2 audits: questions buyers ask
How long is the gap between ISO 42001 Stage 1 and Stage 2?
It depends on the concerns Stage 1 raises and the certification body's diary. The body must allow time for you to resolve them, so a few weeks is common; a long delay risks parts of Stage 1 being repeated.
Will the Stage 2 auditor test our AI models for accuracy or bias?
No. The auditor tests your management system, not the model: whether you set requirements, validated the system against them, monitored it and acted on what you found. Your own validation and monitoring records are the evidence.
Can the ISO 42001 Stage 1 audit be done remotely?
Partly, where the certification body's procedures and accreditation rules on remote auditing allow. The body tells you in advance which Stage 1 activities will be on site; much of an AIMS lives in cloud tools, but people and premises are still part of the review.
What if we retrain or replace a model between Stage 1 and Stage 2?
Tell the certification body and treat it as a significant change: repeat the risk and impact assessments, update the Statement of Applicability if controls change and keep the records. Handled that way, the change becomes good evidence at Stage 2.
Can Stage 2 be combined with our ISO/IEC 27001 surveillance audit?
Often, if the same body is accredited for both standards and plans a combined audit. Shared elements such as document control, internal audit and management review are then examined once, but AIMS-specific trails still need their own time.
More ISO/IEC 42001 guides
Every guide in the ISO/IEC 42001 series is written for one question and links back to the hub for the whole picture.
- AI system impact assessment, with ISO/IEC 42005
- ISO/IEC 42001 Annex A: the 38 controls explained
- ISO/IEC 42001 certification process, step by step
- ISO/IEC 42001 certification cost: what moves the price
- ISO/IEC 27001 to ISO/IEC 42001: extending an ISMS into an AIMS
- ISO/IEC 42001 requirements explained, clause by clause
- ISO 42001 for retail and e-commerce
- ISO 42001 scope
- ISO 42001 certification in Singapore and South East Asia
- ISO 42001 for start-ups and small AI teams
- ISO 42001 surveillance audit and recertification
- ISO 42001 for software companies
Keep exploring
Explore more about ISO/IEC 42001
Watch a video on how to implement ISO 42001 here.
Watch a video on ISO 42001 requirements here.
ISO/IEC 42001 resources
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