ISO/IEC 42005 · AI system impact assessment
ISO 42005 AI system impact assessment, done properly and ready to show.
Know what each AI system could do to the people it touches, and have the record to prove you looked. ISO/IEC 42005 is guidance, so nobody issues a certificate against it; what counts is an assessment process your teams run and a file your customers, regulators and auditors can read. Sterling's expert and experienced consultants build that process with you, in 60+ countries. We help our clients put it into practice and prove it.
- Fixed scope, one proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced AI governance consultants, advising on management systems across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. ISO/IEC 42005 carries no certificate, and Sterling does not certify
8,100+ client engagements in 60+ countries.
Client experience across our standardsWhat it is
What is ISO 42005 and what is it used for?
ISO/IEC 42005 is the international guidance on AI system impact assessment, prepared by the joint ISO and IEC subcommittee for artificial intelligence, JTC 1/SC 42. It helps an organisation identify, evaluate and document the potential effects of an AI system, and of the uses it can reasonably be put to, on individuals, groups of people and society, across the whole life cycle from design to monitoring in service.
The point is accountability you can show. A hiring tool that screens out a group, a chatbot that gives unsafe advice or a scoring model that nobody can explain are impacts, not only technical faults. ISO/IEC 42005 gives the questions, the roles and the record that make such effects visible before launch and keep them visible afterwards. It sits beside ISO/IEC 42001 for AI management systems, ISO/IEC 23894 for AI risk management and ISO/IEC 38507 for governance, and focuses on the human and societal side those standards reference.
Current edition. ISO/IEC 42005:2025, the first edition, published by ISO in May 2025. ISO shows no amendment or revision in progress, so there is nothing to transition. It is guidance: organisations align with it, and no certification body certifies against it. Organisations using ISO/IEC 42001 can use it to design the impact assessment their management system requires. AI system impact assessment, with ISO/IEC 42005
Who it is for
Who needs ISO 42005?
Any organisation that builds, sells or relies on AI, from a software firm shipping a model to a bank, hospital or BPO using a vendor's system in decisions about people. Four situations usually bring it onto the agenda:
- A customer asks how you assess your AI. Enterprise buyers now send AI questionnaires alongside security ones. A documented ISO/IEC 42005 assessment per system answers them with evidence rather than assurances.
- A tender asks for responsible AI evidence. Public and regulated buyers want to see impacts considered, owners named and harms addressed. An assessment file built to international guidance travels well between bids.
- A regulator expects an assessment. Rules such as the EU AI Act place assessment duties on some providers and deployers. ISO/IEC 42005 gives a structured method; your legal advisers confirm what the law itself demands.
- Group policy calls for one method. Subsidiaries assessing AI in different ways leave the board without a comparable picture. One process, thresholds and template across the group fixes that, and feeds an ISO/IEC 42001 system if you pursue certification.
Requirements
What are the ISO 42005 requirements?
Strictly, ISO/IEC 42005 sets recommendations, not auditable requirements, because it is guidance. Its guidance sits in two main clauses, one on building the assessment process and one on what each assessment should document, followed by five informative annexes. Titles are summarised here; your process is checked against the standard itself during the programme.
- Clauses 1 to 4 Scope, references, terms and abbreviations: what the document covers and the vocabulary it uses.
- Clause 5 The assessment process, set-up: document the process, integrate it with your other management processes, decide when assessments happen and what each one covers.
- Clause 5 The assessment process, roles and thresholds: allocate responsibilities and set thresholds for sensitive uses, restricted uses and impact scales.
- Clause 5 The assessment process, carrying it out: perform the assessment, analyse the results, record and report them, approve them and monitor and review over time.
- Clause 6 Documenting the assessment, the system: scope, a description of the AI system, its functions, purpose, intended uses and unintended uses.
- Clause 6 Documenting the assessment, data, models and setting: data information and quality, algorithm and model information, and the deployment environment, including geography and languages.
- Clause 6 Documenting the assessment, people and impacts: directly affected and other relevant interested parties, benefits and harms, failures and reasonably foreseeable misuse, and the measures to address harms and benefits.
- Annexes A to E: guidance for use with ISO/IEC 42001 and with ISO/IEC 23894, a harms and benefits taxonomy, aligning with other assessments, and an example assessment template.
What does useful ISO/IEC 42005 evidence look like?
A written process with owners and triggers; agreed thresholds for sensitive and restricted uses; one completed assessment per AI system covering data, model, setting, affected people and impacts; the measures chosen and who approved them; review dates and the reassessment after each significant change. Records live in Effivity from the first workshop, so reviewers see assessments that are current rather than a file written once.
Putting it into practice
How do you implement ISO 42005?
There is no audit to pass, so the test is whether assessments happen, on time, for every system that matters. Five steps take you there:
- 01List the AI systems and decide what is in scope.Every system you develop, provide or use, your role for each, the people it reaches and the decisions it touches.
- 02Gap analysis: compare current practice with the guidance.Existing privacy, risk and ethics reviews are measured against ISO/IEC 42005, keeping what works and agreeing actions and owners.
- 03Design the process.Timing, responsibilities, thresholds for sensitive and restricted uses, impact scales, approval routes and a template adapted to your systems.
- 04Assess the priority systems.Workshops with product, data, legal and business owners produce the first completed assessments, with measures and approvals recorded.
- 05Monitor, review and connect.Reassessment on change and on schedule, reporting to management, and links into ISO/IEC 42001, risk registers or other assessments.
Check the route before you sign. No body can certify you to ISO/IEC 42005, so treat any "ISO 42005 certificate" offer as a warning sign. If a customer needs a certificate, the route is ISO/IEC 42001 through an accredited certification body; confirm its accreditation for that standard, recognised through the Global ACI arrangement, on the accreditation body's public register. The certification buyer's checklist
Cost
How much does ISO 42005 implementation cost?
The price follows the number of AI systems and how much each one can affect people, not headcount alone. One internal assistant is a different task from a portfolio of customer-facing models in lending or health. Every component is visible in a Sterling proposal, and nothing is added later.
| Cost component | What affects it |
|---|---|
| Consulting and implementation | The systems in scope, their sensitivity, existing privacy or risk processes and how much of the work your team carries (Design™ or Drive™) |
| Independent certification | None for ISO/IEC 42005; certification-body fees arise only if ISO/IEC 42001 certification is added |
| Internal resources | Time from product, data science, legal and business owners for workshops, approvals and reassessment |
| Software and learning | Included in a Sterling engagement: Effivity for the records and Sterling Academy access for your people, confirmed in the proposal |
| Continued support | Reassessments as systems change, periodic reviews and extension to new systems under Sustain™ |
What moves the price
- How many AI systems, and whether they are built in-house or bought
- Uses that fall into sensitive or restricted categories
- Countries, languages and affected groups involved
- Whether a risk or privacy assessment process already exists
- The deadline set by a customer, tender or regulator
What a Sterling proposal always shows
- Systems in scope, deliverables and responsibilities, in writing
- Assumptions and exclusions stated plainly
- Effivity and Academy access itemised at no additional cost
- Payments tied to deliverables
- One all-inclusive proposal, with nothing added later
Timeline
How long does ISO 42005 implementation take?
Pace depends on how quickly system owners and data teams are available, how much is known about third-party models and how many systems need a full assessment. As an estimate, a first process with the priority systems assessed takes two to four months; the remaining systems follow on a schedule set by their risk.
| Phase | What determines the pace |
|---|---|
| Inventory and gap analysis | Whether a list of AI systems exists, and access to their owners and documentation |
| Process design | Agreement on thresholds, impact scales and approval routes |
| First assessments | Workshop availability and information from model or data suppliers |
| Review and hand-over | Management approval and the first scheduled reassessments |
Your engagement
What your ISO 42005 engagement includes
One team takes you from the first inventory to assessments your people run on their own. Sterling does not certify, and no certificate exists for ISO/IEC 42005; our work is the process, the first assessments and the capability to keep them current.
Inventory, gap analysis and plan
Systems, owners, priorities and dates agreed before work starts.
Process and template
Built on the ISO/IEC 42005 structure and adapted to how your teams build and procure AI.
Effivity ISO & GRC software
Assessments, approvals and review dates in one place, included with the engagement at no additional cost.
Training
Internal auditor training, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.
First assessments
Facilitated with your owners for the priority systems, with measures and approvals recorded.
Review and connection
Reporting to management and links into ISO/IEC 42001 or other assessments where you run them.
You choose the level of support under Sterling OS™. With Design™ we guide and your team does the work; with Drive™ we manage delivery and your people approve and own it. Either is a complete route on its own. Sustain™ follows once the process is running, keeping reassessments on schedule, and Automate™ is Effivity.
Where ISO/IEC 42001 certification is added, certification decisions remain with the independent certification body.
Often combined with
Standards organisations pair with ISO/IEC 42005
- EU AI ActEU AI Act compliance consulting: classify each AI system, document high-risk requirements and transparency duties, and prepare conformity assessment evidence.
- ISO/IEC 23894ISO 23894 AI risk management made practical: the ISO 31000-based guidance, its structure, no certificate, and how Sterling builds it, with a route to ISO 42001.
- ISO/IEC 38507ISO 38507 AI governance and requirements explained: the 2022 guidance for boards on AI use, why no certificate exists and how Sterling puts it into practice.
- ISO/IEC 42001ISO/IEC 42001 certification consulting for AI governance: risks and impacts assessed, treated and evidenced, then supported through the certification audit.
- ISO/IEC 42006ISO 42006 explained: the requirements for bodies that audit and certify ISO/IEC 42001 AI management systems, how accreditation works and what to check.
- ISO/IEC 5338ISO/IEC 5338 AI life cycle processes explained: the 2023 process groups, what they ask of AI teams, why there is no certificate and how Sterling helps.
Effivity · ISO and GRC software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of ISO/IEC 42005:2025.
Every Sterling ISO/IEC 42005 engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures a workspace within the agreed scope, so the AI system list, assessments, thresholds, approvals, measures and review dates sit together and reassessment reminders arrive on time. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.

One written method
The procedure, template and version history held centrally, so every team assesses the same way.
Triggers and schedules
Assessments raised at design, before release and on change, with review dates tracked.
Owners for every system
Assessors, reviewers and approvers assigned per system, with tasks in their queue.
Sensitive and restricted uses
Agreed categories and impact scales applied consistently, flagging systems that need deeper review.
System, data and model records
Purpose, uses, data sources and model details captured once and reused across assessments.
Affected people and groups
Directly affected and other relevant parties listed per system, with their concerns noted.
Impacts, measures and approval
Benefits, harms and measures recorded, approved and reported to management from live data.
Reassessment that happens
Changes to a system reopen its assessment, and overdue reviews are visible before anyone asks.
What this means when someone asks
A customer, regulator or certification auditor asks which AI systems you use and how you assessed them. In Effivity that is one list, each system with its current assessment, approver and next review date, not a search through shared drives. Sustain™ runs in the same workspace.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Existing assessments and registers migrated, not retyped
- Admin and user training for your team
- Modules for EMS, OHSMS, ISMS, FSMS and more when you integrate other standards
Sterling Academy · e-learning for your people
Help everyone who touches AI understand why impacts matter.
Sterling Academy provides online learning with video lessons, practice checkpoints, a final exam and a numbered Certificate of Completion, verifiable online. Sterling consulting clients benefit from preferential Sterling Academy course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- Awareness for the wider workforce, as part of the engagement
- Learner progress by team, with records kept for reviewers
- New joiners trained as they arrive
- A Sterling consultant reachable when a learner needs one
Keep exploring
Explore more about ISO/IEC 42005
ISO/IEC 42005 resources
Services for ISO/IEC 42005
Why Sterling
Why choose Sterling for ISO 42005?
Impact assessment fails when it becomes a form nobody reads. We build it into how your teams design, procure and change AI, so it runs at the moment decisions are made, and so the same file serves customers, regulators and an ISO/IEC 42001 auditor.
60+ countries since 2003
Management system consulting across sectors and regions, with offices in 21 countries and one engagement team accountable for your programme.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with nothing added later.
Built into your AI governance
One method linked to your risk, privacy and management system processes, not a separate exercise.
Expert and experienced consultants
Expert and experienced consultants in AI governance and management systems, who leave your teams able to run assessments themselves.
The Sterling Promise
What the Sterling Promise means for ISO/IEC 42005
We stay with you until your agreed ISO/IEC 42005 outcome is achieved: the process in place, the priority systems assessed and your people able to continue. Clear explanations, practical delivery, included software and employee learning turn the investment into lasting capability.
The engagement identifies the guidance, scope, outcome and responsibilities. Your organisation supplies accurate information and puts the agreed measures into use. ISO/IEC 42005 has no certificate; where ISO/IEC 42001 certification is added, the independent certification body assesses conformity and retains its decision. Our commitment concerns the agreed support, not a promise of every future tender award or regulatory outcome.
FAQs
Frequently asked questions about ISO 42005
Can you get ISO 42005 certified?
No. ISO/IEC 42005 is guidance, so there is nothing for a certification body to certify against. Organisations align with it and keep the evidence. If a customer wants a certificate for AI governance, the certifiable standard is ISO/IEC 42001, and an ISO/IEC 42005-based process supports its impact assessment requirement.
What is the difference between ISO 42001 and ISO 42005?
ISO/IEC 42001 sets requirements for a whole AI management system and can be certified; ISO/IEC 42005 gives detailed guidance on one part of it, assessing an AI system's impact on people and society. ISO describes the two as designed to work together, and Annex A of ISO/IEC 42005 gives guidance for using it with ISO/IEC 42001.
Does ISO 42005 include an impact assessment template?
Yes, as an example. Annex E is an informative example of an AI system impact assessment template. Most organisations adapt it to their own systems, thresholds and approval routes rather than use it unchanged, and we build that version with you.
Does ISO 42005 satisfy the EU AI Act?
Not by itself. The EU AI Act sets its own duties, such as the fundamental rights impact assessment required of certain deployers of high-risk systems, and the legal text decides what counts. ISO/IEC 42005 offers a structured method, and Annex D covers aligning it with other assessments. We work alongside your legal advisers; we do not give legal advice.
How often should an AI system impact assessment be repeated?
Throughout the life cycle rather than once. ISO/IEC 42005 addresses timing and monitoring and review as part of the process, so each organisation sets its triggers, typically at design, before deployment, after significant change and on a fixed review schedule suited to the system's sensitivity.
Keep exploring
More on ISO/IEC 42005 and related standards
More in AI governance & digital trust
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