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ISO 42001Frequently asked questions

Frequently asked questions about ISO 42001

Answers to the most frequently asked questions about ISO 42001  certification. The standard is available in the Netherlands through NEN  and is closely linked to the EU AI Act .

General questions about ISO 42001

What exactly is ISO 42001?

ISO/IEC 42001 is the first international standard for AI management systems. The standard describes how organisations can develop, implement and use AI responsibly. It provides a framework for governance, risk management and continual improvement around AI.

The standard was published in December 2023 and was developed by ISO and IEC.

Is ISO 42001 mandatory?

No, certification is not legally required. However, the EU AI Act does set requirements for AI systems. ISO 42001 helps you meet many of those requirements.

In practice, customers, partners and regulators are asking for ISO 42001 more and more often. Especially in sectors where AI is critical (finance, healthcare, HR technology), the pressure to hold certification is growing.

Which organisations is ISO 42001 relevant for?

The standard is relevant for any organisation that develops, implements or uses AI. Specifically:

  • AI developers and tech companies
  • Organisations that use AI solutions for decision-making
  • IT service providers that supply AI
  • Government organisations that deploy AI
  • Companies in regulated sectors (finance, healthcare, HR)

The size of the organisation does not matter. A start-up with one AI product can certify just as well as a multinational.

What is the difference from ISO 27001?

ISO 27001 is about information security: protecting information against unauthorised access, loss or alteration.

ISO 42001 is about AI governance: responsible development and use of AI, impact on people, fairness and transparency.

There is overlap. AI systems process information. But the focus is different. Many organisations need both standards.

Read more in ISO 42001 vs ISO 27001.

Which AI falls under the standard?

ISO 42001 uses a broad definition of AI. This includes:

  • Machine learning models
  • Deep learning / neural networks
  • Natural language processing (chatbots, translators)
  • Computer vision (image recognition)
  • Recommendation systems
  • Predictive analytics
  • Automated decision systems
  • Generative AI

If a system learns autonomously, recognises patterns or makes decisions based on data, it probably falls under the definition.

Questions about ISO 42001 certification

How long does it take to get certified?

This depends on your starting position:

  • Small and experienced: 4-6 months
  • Medium-sized: 6-9 months
  • Large or complex: 9-15 months

If you already have ISO 27001, it can be quicker because you already have the governance structure in place.

Read more in costs and timeline.

What does ISO 42001 certification cost?

Indicative costs:

Cost itemSmallMediumLarge
Implementation€10,000-30,000€25,000-75,000€75,000-200,000
Certification audit€6,000-12,000€10,000-20,000€15,000-40,000
Annual surveillance€4,000-8,000€6,000-12,000€10,000-25,000

These are indications. The exact costs depend on your organisation, the number of AI systems and the approach you choose.

How long is the certificate valid?

The certificate is valid for 3 years. Each year there is a surveillance audit to check that you still comply. After 3 years a recertification audit follows.

Which certification bodies are there in the Netherlands?

The main certification bodies (CBs) in the Netherlands are:

  • DNV: issued the first Dutch certificate
  • BSI: accredited by the RvA (Dutch Accreditation Council)
  • TÜV: internationally known
  • Kiwa: Dutch certification body
  • LRQA: operates internationally

Choose a certification body that is accredited for ISO 42001.

Can I combine ISO 42001 with ISO 27001?

Yes, this is even recommended. The standards have the same structure (High Level Structure). You can:

  • Build one integrated management system
  • Carry out combined audits
  • Share many processes (governance, audit, review)

This saves time and money.

Questions about the ISO 42001 standard

How many controls does ISO 42001 have?

Annex A contains 38 controls divided over 9 domains:

  1. Policies for AI
  2. Internal organisation
  3. Resources for AI systems
  4. AI system lifecycle
  5. Data for AI systems
  6. Information for interested parties
  7. Use of AI systems
  8. Third-party relationships
  9. Assessment of AI systems

You do not have to implement all the controls. You select them based on your risks.

Read more in Annex A controls.

What is an AI impact assessment?

The AI System Impact Assessment (AISIA) is a unique element of ISO 42001. You assess the impact of your AI on individuals, groups and society.

Questions you answer:

  • Who is affected by this AI system?
  • What are the consequences if the AI makes mistakes?
  • Are certain groups disadvantaged?
  • Can people understand the decisions?

Read more in AI impact assessment.

What is the Statement of Applicability?

The Statement of Applicability (SoA) documents which controls you have selected and why. For each control you record:

  • Is the control applicable? Yes or no
  • Why or why not?
  • How has the control been implemented?

The auditor uses the SoA to assess whether your choices are logical.

Questions about ISO 42001 and the EU AI Act

Does ISO 42001 help with compliance with the EU AI Act?

Yes, significantly. ISO 42001 covers many of the requirements of the AI Act:

  • Risk management
  • Governance
  • Documentation
  • Impact assessment
  • Monitoring and logging
  • Training and awareness

However, ISO 42001 is not the same as AI Act compliance. The law also has requirements that the standard does not cover, such as the conformity assessment, CE marking and registration in the database.

Read more in EU AI Act and ISO 42001 and in the comparison ISO 42001 vs EU AI Act.

When do I have to comply with the AI Act?

The timeline (the high-risk dates are expected to be postponed through the Digital Omnibus package):

  • February 2025: Prohibited AI, AI literacy (in force)
  • August 2025: General purpose AI (in force)
  • December 2027: High-risk AI from Annex III (planned postponement from August 2026)
  • August 2028: High-risk AI in regulated products

Check the current dates in EU AI Act and ISO 42001.

Is my AI high-risk under the AI Act?

High-risk AI includes, among other things:

  • AI in medical devices
  • AI for access to education
  • AI for recruitment and selection
  • AI for credit assessment
  • AI in critical infrastructure
  • AI for law enforcement

Check the annexes of the AI Act for the full list.

Practical questions about ISO 42001

Do I need to hire a consultant?

Not mandatory, but often sensible. A consultant can:

  • Speed up the process
  • Bring in expertise
  • Help you avoid pitfalls
  • Guide the implementation

Especially if you have no experience with management systems.

Can I implement ISO 42001 myself?

Yes, if you:

  • Have enough time
  • Have experience with ISO standards
  • Have access to the standard
  • Have internal capacity

The standard can be bought from NEN or ISO.

What if I only have one AI system?

You can limit the scope to that one system. The management system is then smaller and simpler. The costs and lead time are proportionally lower.

Later you can extend the scope if you start using more AI.

Do I have to certify all my AI systems?

No, you decide the scope yourself. You can start with the most important or highest-risk systems. The scope does need to be logical and defensible.

How do I prepare for the audit?

Tips:

  1. Make sure the documentation is up to date
  2. Carry out an internal audit or pre-audit
  3. Prepare employees for interviews
  4. Gather evidence (risk analyses, training records, logs)
  5. Know your own system

Read more in the audit process.

Do you have a question that is not covered here? Get in touch. We expand this page regularly.

Further reading