ISO/IEC 42001 guide
Effivity ISO 42001: how the software runs your AI management system, from inventory to audit
Clause by clause: ISO/IEC 42001:2023 requirements: every clause explained →
Effivity, Sterling's ISO and GRC software, is used in 50+ countries and included with every consulting engagement at no additional cost. This guide maps an ISO/IEC 42001 AIMS to its modules, shows what is configured at the start and what the auditor sees.
Key points
- Effivity runs an ISO/IEC 42001 AI management system in one place: the AI system inventory, the risk register and treatment plan, the impact assessments, the Statement of Applicability, training, audits and corrective actions.
- Most of the AIMS sits in Effivity's standard management-system modules; the AI-specific records, such as the inventory and the impact assessment form, are registers configured for your organisation at the start.
- Sterling works in Effivity from the first workshop. It is included with the engagement, at no additional cost, and is used in 50+ countries.
- The software holds evidence and prompts reassessment when systems change. It does not assess risk for you, and it does not certify: an independent, accredited certification body decides.
What an AIMS auditor looks for when the system runs in software
An ISO/IEC 42001 auditor does not test the tool. They test whether three mechanisms work together: the AI risk assessment, the risk treatment with its Statement of Applicability, and the impact assessment for each AI system. The quickest test is to follow one system from your inventory. Who owns it? Which risks were identified for it, and what treatment was chosen? Does the Statement of Applicability agree with that treatment? When the model was last retrained, was the impact assessment looked at again?
Where these records live in separate spreadsheets and slide decks, that trail usually breaks at the first change. The inventory lists a system the risk register has never heard of, or the impact assessment still describes the version from a year ago. Clauses 8.2 and 8.4 expect both assessments to be repeated at planned intervals or when significant change happens, so a stale record is a finding, not a formality.
Running the AIMS in Effivity means the inventory entry, the risks, the controls, the impact assessment and the reviews are held in one system with owners, dates and version history. The auditor pulls a thread and your system owner shows them the whole chain.
Effivity ISO 42001 modules: clauses 4 to 10 and Annex A
The table shows where each part of the AIMS is kept and the record it leaves behind. Module names follow Effivity's own; where no dedicated module exists for an AI-specific requirement, the record is a register or form configured during set-up.
| What ISO/IEC 42001 needs | Where it lives in Effivity | Evidence produced |
|---|---|---|
| Clause 4: context, interested parties and scope | The context module | Issues (including the climate-change decision), parties' expectations about AI, the scope statement |
| Clause 4 and A.4: the AI systems in scope | AI system inventory, a register configured for you | Each system with its owner, your role (developer, provider or user), data and computing resources |
| Clause 5, 6.2 and A.2: AI policy and objectives | Policy & Objectives | The approved AI policy, its review, AI objectives and their progress |
| Clauses 6.1.2, 6.1.3, 8.2 and 8.3: risk assessment and treatment | Risk Management | Risks per system rated against your criteria, treatment decisions, the approved plan and accepted residual risk |
| Clause 6.1.3: Statement of Applicability | Statement of Applicability (SOA), configured with the Annex A controls | All 38 controls with inclusion or exclusion justified and implementation status |
| Clauses 6.1.4, 8.4 and A.5: impact assessment | Impact assessment form, configured for you | One assessment per system, dated, reviewed after change and linked to its risks |
| Clause 7 and A.3: roles, competence and awareness | HR | Competence for people who design, deploy and oversee AI; training and its effectiveness |
| Clause 7: documented information | Documented Information | Versions, approvals and change history for policies, procedures and technical documentation |
| Clause 8 and A.10: suppliers and third-party models | Purchase | Supplier evaluation against your AI requirements and agreed responsibilities |
| A.8: AI incidents and their communication | Incident Management | Each incident with assessment, response, cause and who was informed |
| Clause 9: internal audit and management review | Internal Audit; Management Review | Audit schedule, plans, reports and findings; minutes, decisions and actions |
| Clause 10: nonconformity and corrective action | Non-Conformance | Correction, root cause, corrective action, effectiveness check and closure |
A worked trace: a retrained screening model
A recruitment firm uses a CV-screening model supplied by a vendor. The vendor announces a retrained version. The system owner logs the change against the system in the inventory, which flags that the risk and impact assessments are due for review. The impact assessment is revisited with the HR lead: does the new training data change who could be disadvantaged? One new risk is added to the register, a control for pre-deployment validation is confirmed in the treatment plan, and the supplier record is updated with the vendor's release notes. When the auditor samples that system, the dates line up: change, reassessment, treatment, approval.
What is configured at the start of a Sterling engagement
Effivity is set up in the first weeks, while the gap analysis is under way, so the workshops write straight into the system rather than into documents that are typed up later.
- The inventory first. The AI system register is built with the functions that own each system, including tools bought in, so scope and ownership are visible before any assessment starts.
- Your risk criteria. Likelihood, consequence and acceptance levels are set in Risk Management so that repeated assessments give consistent, comparable results, as clause 6.1.2 asks.
- The impact assessment form. Its fields follow your method: intended use, foreseeable misuse, the individuals, groups and societies affected, and the jurisdictions involved. AI system impact assessment, with ISO/IEC 42005 covers the method itself.
- Roles and reminders. System owners, approvers and reviewers are named, and review dates are set so reassessments surface before they fall overdue.
- The project plan. Milestones from the gap analysis are tracked with owners, so management sees progress directly.
How risks are identified and treated is explained in ISO/IEC 42001 AI risk assessment and treatment, with ISO/IEC 23894; this guide deals only with where the results are kept.
AI systems that keep changing
Models are retrained, data sources altered and vendor versions replaced, so an AIMS that records only the state at certification ages within months.
In Effivity each change is logged against the system it affects, with a named owner and a due date for the reassessment it triggers. Dashboards show which systems have assessments overdue and which treatments are still open, and reminders escalate what nobody picked up. Incidents, including a complaint about an AI output, are recorded with their response and communication, and a recurring cause becomes a nonconformity with a corrective action and an effectiveness check.
Organisations already running ISO/IEC 27001 in Effivity usually extend the same system: document control, supplier records, audits and corrective actions are shared, and the AI registers are added. ISO/IEC 27001 to ISO/IEC 42001: extending an ISMS into an AIMS explains that route.
Internal audit, surveillance and Sustain™
Before the certification body's Stage 1 readiness review, the internal audit covering clauses and controls is planned and reported in the Internal Audit module, and the management review is minuted in Management Review. Findings become nonconformity records and are closed with evidence before Stage 2. The audit method is set out in ISO/IEC 42001 internal audit: auditing an AI management system, and the review itself in ISO/IEC 42001 management review: inputs, outputs and the record.
After certification, the body returns for surveillance audits every year and for recertification in the third year. Surveillance looks for continuity: reassessments done when systems changed, audits held, reviews completed, actions verified. Under Sustain™, Sterling continues internal audits and system upkeep in the same Effivity system as new AI systems enter scope.
How Sterling uses Effivity
Your AIMS in one system, from inventory to surveillance.
Effivity is included with the engagement, at no additional cost, with users and access period confirmed in the proposal. Our expert and experienced consultants configure it with your system owners, run the assessments with them and complete the internal audit and management review before the certification body arrives. We ensure successful certification for our clients. Sterling does not certify: the certificate comes from the independent, accredited certification body you appoint.
Book a free discovery callWhat Effivity does not do
Effivity holds the AIMS; it does not make its judgements. Whether a risk is acceptable, whether an impact on a group of people is significant or whether a control can be excluded remains a decision for your designated management, who must explain it to the auditor. Nor does it test models or monitor outputs; it records that those checks happened and what they found.
- An inventory nobody updates. A system missing from the register is outside every other record, and auditors often find one in an interview.
- Impact assessments filled once. A form completed at set-up and never revisited contradicts the change log.
- A Statement of Applicability detached from the register. Controls marked as implemented with no risk or treatment behind them are hard to defend.
Effivity for ISO/IEC 42001: questions buyers ask
Is there ISO 42001 software that makes certification automatic?
No. Software can hold the AIMS and keep it current, but certification depends on an independent, accredited body finding that your risk and impact assessments and controls operate in practice. Effivity makes that evidence easy to produce; your people still do the work and answer the auditor.
Does Effivity have a dedicated ISO/IEC 42001 module?
The AIMS runs on Effivity's management-system modules, such as Risk Management, Documented Information, Internal Audit and Management Review, with the AI system inventory and impact assessment configured as registers for your organisation. The exact set is confirmed in your proposal.
Can we record AI systems we use but did not build?
Yes, and you should. Bought-in tools and third-party models go into the inventory with your role as user or provider, and the supplier record in Purchase holds the responsibilities agreed with the vendor.
Will the certification auditor look at our records in Effivity?
Usually. Your system owners open the records the auditor selects and explain them. For remote parts of an audit, how records are shared is agreed with the certification body in advance.
Does Effivity replace our model monitoring or MLOps tools?
No. Technical monitoring stays in your engineering tools. Effivity records the governance around it: who reviewed the results, what was decided and which actions followed.
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
- Do I need ISO 42001? A decision guide to ISO/IEC 42001 for AI providers and users
- ISO 42001 documentation
- Effivity for ISO/IEC 42001: the guide
- ISO/IEC 27001 to ISO/IEC 42001: extending an ISMS into an AIMS
- ISO 42001 gap analysis
- ISO 42001 for healthcare
- ISO/IEC 42001 requirements explained, clause by clause
- ISO/IEC 42001 training: who needs what, and the competence evidence
- ISO/IEC 42001 and the EU AI Act: what the certificate does not give
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
Services for ISO/IEC 42001
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