Who needs ISO 42001 certification?

According to McKinsey’s 2025 State of AI report, 88% of organizations now use AI in at least one aspect of their business. The widespread adoption of AI also introduces new risks, such as bias, privacy concerns, lack of transparency, and potential misuse, which must be mitigated by a proper governance and risk management framework.

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ISO/IEC 42001:2023 is the world’s first standard for artificial intelligence management systems (AIMS), developed to help organizations address risks within AI systems with a transparent, end-to-end governance program.

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Despite its relevance, ISO 42001 certification requires major organizational commitment. Before you decide to pursue, you should evaluate whether your risk profile, AI use cases, and stakeholder expectations place you in scope.

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In this article, we’ll discuss:

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• If ISO 42001 certification is mandatory
• Who should get certified
• When to pursue certification

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ISO 42001: An overview

ISO 42001 is an internationally-recognized AI management system framework designed to guide organizations on how to develop, manage, deploy, and use AI systems. The standard provides a risk-based structure for embedding AI governance into existing organizational processes, rather than treating it as an isolated management function.

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ISO 42001 focuses on five AI governance areas:

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1. Accountability
2. Transparency
3. Ethical use
4. Safety
5. Privacy-by-design

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ISO 42001 typically integrates well with other ISO management standards, most notably ISO 27001, ISO 9001, and ISO 27701. Organizations that already meet some of these standards can reuse foundational artifacts and systems, including overlapping policies, controls, and management processes.

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{{cta_withimage7="/cta-modules"}} | ISO 42001 checklist

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Is ISO 42001 certification mandatory? 

ISO 42001 is a voluntary standard. While regulators and buyers can choose to reference it in laws, guidance, or procurement criteria, there's currently no legal requirement for organizations to pursue certification unless required by an SLA or business contract.

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In recent months, ISO 42001 certification has mostly become a market-driven consideration for organizations that develop or deploy AI systems with direct customer impact. Compliance has become a recognized baseline for AI governance worldwide and is frequently mentioned in different assurance and audit contexts.

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Particularly, buyers in high-risk industries such as healthcare or the public sector often make certification a contractual requirement. In these cases, the absence of ISO 42001 certification can jeopardize contracts or tenders.

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Many organizations delay ISO 42001 because it feels premature, resource-intensive, or even unnecessary before AI risks become more visible. What often changes their mind is increased customer scrutiny, regulatory pressure like the EU AI Act, or incidents that expose gaps in AI risk management. Companies also realize that ISO 42001 can act as a market differentiator, signaling mature and trustworthy AI practices before competitors are forced to catch up.”

Ethan Heller

GRC Subject Matter Expert, Vanta

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LinkedIn

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How to know if I need ISO 42001 certification

Many organizations aren’t sure if ISO 42001 applies to them when they use AI in limited or indirect ways, or if their organization is large or mature enough to pursue it. 

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ISO 42001 is relevant to any organization, regardless of industry, size, or maturity. The deciding factor is whether its AI systems influence outcomes, decisions, or trust. In practice, ISO 42001 certification is commonly pursued among: 

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• SaaS and tech vendors
• Enterprises that build or heavily integrate AI into workflows (including using third-party AI models)
• Service providers using AI for decision-making, automation, analytics, or customer-facing tools

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If you’re still not sure whether ISO 42001 makes sense for your organization, consider these questions:

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• Does AI significantly impact product functionality or customer outcomes?
• Do customers ask for AI governance documentation or assurances?
• Could your AI introduce regulatory, ethical, safety, or security risks?

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If the answer to one or more questions is yes, your organization would benefit from obtaining ISO 42001 certification.

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Do organizations need ISO 42001 if they comply with the EU AI Act?

The EU AI Act doesn’t require ISO 42001 compliance, but both emphasize documenting processes, governance, and accountability for AI systems. With the EU AI Act going into effect in 2026, many organizations want to prioritize it, but they often still use ISO 42001 to support alignment with the regulation’s governance expectations.

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Because the expectations are complementary, many organizations have also chosen to pursue them simultaneously, using work done for one standard to support the other.

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If you want to pursue both, a key differentiator to be aware of is how both interpret AI roles. The EU AI Act assigns different obligations depending on an organization’s role in the AI supply chain, such as provider or deployer. In contrast, ISO 42001 guidance is role-agnostic and applies to any AIMS. Instead, the standard refers to AI roles to define stakeholder responsibilities within the organization and across functions.

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{{cta_withimage28="/cta-blocks"}} | Vanta’s AI Security Assessment

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Do organizations need ISO 42001 if they comply with ISO 27001?

While there’s overlap between ISO 27001 and ISO 42001, the former has AI governance gaps that only the latter can address. 

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ISO 27001 controls focus on information security, ensuring organizations can safeguard the confidentiality, integrity, and availability of sensitive data. Conversely, ISO 42001 controls focus on addressing the unique privacy, security, and management risks associated with AI use.

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Both standards have shared management system structures, such as audits, a risk-based approach, and control mapping. If you’re already ISO 27001-certified, you’ll likely just need to implement additional domain-specific controls for the AI lifecycle, resulting in faster certification timelines. In fact, many top compliance audit software today can help you pursue both in an integrated manner.

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Here are some examples comparing each standard’s relevance based on an organization’s AI use and regulatory and risk profile:

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When to pursue ISO 42001 certification

You may want to start looking into ISO 42001 certification when attention to AI risk, governance, or accountability increases. Common triggers include:

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• Prospects or customers frequently referencing AI risk or governance
• Deals blocked due to AI systems or governance practices with poor transparency
• Security incidents or misuse related to AI systems
• Leadership concerns about liability, compliance, or reputational risks

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{{cta_withimage7="/cta-modules"}} | ISO 42001 checklist

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Common challenges when pursuing ISO 42001 certification

You can anticipate some common challenges when pursuing ISO 42001 certification:

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• Operationalizing AI governance: Creating policies, defining roles, and implementing oversight mechanisms from scratch can be challenging and often requires iteration as use cases evolve.
• Defining AI system scope: Identifying in-scope workflows, datasets, models, and tools isn’t always straightforward, particularly in environments that rely on third-party AI models or evolving tooling.
• Aligning cross-functional teams: ISO 42001 requires coordination between engineering, security, legal, and product teams for maintaining accountability and effective human oversight. In practice, the alignment can be hard to achieve as these teams have different priorities.
• Manually process and oversight tasks: Pursuing ISO 42001 certification comes with scattered tasks, such as managing AI policy documentation, model inventories, and continuous monitoring, which block time and resources when done manually. Such frameworks are often difficult to scale and maintain over time.

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You can explore compliance solutions such as Vanta to build efficient and scalable ISO 42001 readiness processes. Vanta helps you automate tasks like managing AIMS and documentation templates, AI risk training, and continuous monitoring across key aspects that save your team hours in routine work.

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Streamline the ISO 42001 certification process with Vanta

Vanta is a leading agentic trust platform that helps organizations achieve compliance with 35+ standards and regulatory frameworks within a unified dashboard. Vanta helps you build your ISO 42001 compliance program confidently with operationalized guidance, built-in agentic workflows, trackable tasks, and ready-to-use templates.

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Watch this free webinar to see how you can adopt and demonstrate some of the best practices for AI security using automation and other tooling in Vanta. The platform also enables you to publish your compliance posture in a public trust center for faster security reviews.

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Vanta’s dedicated ISO 42001 compliance solution can support you with:

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• Real-time monitoring and evidence collection through 400+ integrations
• Pre-built risk scenarios
• Issue management for continuous improvement
• Document management with version control
• 1,200+ automated, hourly control tests
• Control cross-mapping for overlapping evidence
• Partner network to find ISO 42001 experts

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Schedule an on-demand demo to explore Vanta’s ISO 42001 features firsthand.

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{{cta_simple21="/cta-modules"}} | ISO 42001 product page

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