Introducing ISO 42001 – the world’s first international management system standard focused specifically on AI. Designed to support organisations in establishing, implementing, maintaining and continually improving an AI Management System (AIMS). It offers a clear and structured approach to the responsible governance, development, deployment and oversight of AI technologies.
Developed with active input from the EU Commission, the ISO 42001 Standard bridges legal requirements with practical implementation – embedding principles like risk management, transparency and accountability into everyday operations. Aligning global best practices with EU AI Act compliance enables organisations to stay ahead of regulation while prioritising secure and ethically grounded AI systems.
In this blog, you will learn how the Standard aligns with existing compliance frameworks, why it’s essential for organisations deploying AI technologies and understand precisely what would be involved in the journey to compliance. More importantly, you will find out why this journey might be one worth taking.
The AI Management System (AIMS) is the foundation for managing AI technologies in a way that aligns with organisational values, regulatory requirements and societal expectations. ISO 42001 provides a structured framework for embedding trust, accountability and resilience into every stage of your AI lifecycle.
Trustworthy AI is guided by the following key principles:
By implementing ISO 42001, your organisation will build trust, enhance compliance and future-proof your AI systems against emerging risks.
If you’re already familiar with ISO 27001, you’ll know it provides the framework for establishing, implementing, maintaining and continually improving an information security management system to safeguard valuable information assets.
AI technology doesn’t have the same risk profile as information assets.
AI simply behaves differently, sometimes unpredictably, and as a result, ISO 42001 is primarily focused on the human impact AI systems could have.
The AI Impact Assessment, the centrepiece of an AI management system according to the standard, is designed to evaluate all human impacts, both positive and negative – that this technology could have on our minds, our society and even our human rights.
ISO 27001 aims at securing our information, whilst 42001 focuses on using AI responsibly. It emphasises enhancing the trustworthiness, security and ethical behaviour of AI technologies.
The following objectives represent the core focus areas of ISO 42001, offering organisations a roadmap to responsible AI governance.
Objective |
Description |
1. Secure and Resilient AI Systems | Safeguard AI from cyber threats, data breaches and system failures through robust security controls. |
2. Fairness, Accountability and Ethics | Mitigate bias, promote human oversight and embed ethical principles into AI design and use. |
3. Transparency and Explainability | Make AI decision-making clear and traceable for stakeholders to build trust and accountability. |
4. Proactive Risk Management | Identify, assess, and treat technical, legal and social risks throughout the AI lifecycle. |
5. Regulatory and Legal Compliance | Align AI systems with laws like the EU AI Act and data protection regulations. |
6. Continuous Improvement | Monitor AI performance and update controls to adapt to emerging risks and evolving tech. |
7. Organisational Awareness & Competence | Enhance AI literacy and ensure roles and responsibilities for AI risk management are understood. |
For an in-depth dive into responsible AI practices, read the blog post: AI Governance – Secure the Future by Embracing Responsible AI Practices.
Within an organisation adopting ISO 42001, AI Impact Assessment and AI Risk Management should be a shared responsibility, and leadership must be clearly defined to avoid any gaps. The ideal lead depends on the company’s size, industry and regulatory exposure, but the Standard recommends a dedicated AI Security Officer (AISO), who will head up the AI Management Team.
Ideally, the AI Management team should include the roles of a Chief Information Security Officer, Compliance and Risk Managers and possibly AI developers and scientists. Let’s look at how each role sees it.
From a CISO’s perspective, getting compliant means:
Whether it’s your Information Security Manager (ISM), a humble ’risk manager’ or even a dedicated AI Security Officer, the middle managers of the GRC world will benefit from compliance enormously by:
The worker bees of the AI world (AKA the developers and data scientists) will be guided by the dev-ops side of ISO 42001 so that responsible AI use is ‘baked into the development process, from inception to retirement. Expect to:
You may be used to the structure of other ISO management systems, or this might all be new to you. Either way, ISO 42001, whilst it shares some qualities with other management systems, has some key differences you should be aware of.
Clauses 4-10. The management clauses of ISO remain fairly similar to other ISO standards and are designed to get the leaders of your organisation fully bought into the high-level running of the AIMS.
Working through these clauses, you will also address AI governance, risk assessment and monitoring (via a Statement of Applicability (SoA), as well as how to audit and manage review best practices.
AI Impact Assessment – Here’s where it gets tricky. You might be used to quantifying all sorts of risks, but ISO 42001 expects you to quantify the potential impact of AI on human beings. You’ll need to consider and evaluate how AI technology being deployed might affect the rights, well-being and life choices of both individuals and groups.
Annexes: Similar to other standards, AIMS offers up a varied tasting menu of controls across various sectors. For each control, you must justify the inclusion in your SoA. If any controls are not relevant (i.e. you don’t develop your own AI technology), then you simply justify their exclusion rather than inclusion.
In other words, you justify the exclusion or inclusion of every single control. The standard offers voluminous guidance on implementing each control in subsequent annexes, should you need more practical assistance. Or you could just call Risk Crew – we’re happy to help.
ISO designed this standard to align and slot in with its many other standards. How well it will slot in depends on how willing you are to homogenise your various other management systems. For instance, some organisations prefer to keep their reporting of information security incidents and AI incidents as separate procedures, whereas some choose to combine them. The point is this: it’s highly customisable.
In terms of the GDPR and the DPA 2018, ISO 42001 puts privacy upfront, as within the clauses of the standard, it’s made clear that to be compliant, adherents must abide by any relevant legislation. Any deployed AI technology, therefore, must not contravene these privacy laws and all they involve regarding data protection.
Certain sectors, like healthcare and finance, have their own AI regulations. But here is the difference: industry-specific frameworks are often too narrow to work beyond their intended domain. AI frameworks (like those in healthcare or finance) focus only on domain-specific risks.
An ISO 42001-compliant AIMS provides a holistic governance approach to responsible AI use and applies universal AI management strategies, applicable regardless of industry. In other words, it is a standard designed with global regulatory alignment in mind. Let’s review two of the big ones.
This legislation classifies AI systems based on risk. It imposes stringent requirements on high-risk applications, focusing on transparency, human oversight and risk management. ISO 42001 provides a structured approach to implementing these controls by:
The NIST AI RMF is already widely adopted across the USA. It focuses on trustworthy AI with an emphasis on fairness, transparency, security and reliability. ISO 42001 compliance complements this framework by:
The debate between ISO 42001 AIMS and NIST AI RMF boils down to compliance vs. flexibility.
AIMS is a more structured approach to compliance and results in certification. If you want a formalised approach to AI governance, this is it.
NIST AI RMF is more of a ‘best practices’ guide. It has no certification or strict requirements, and it’s more of a flexible, risk-based approach to AI governance.
If your organisation is ready for a deep dive into AI impacts, governance and responsible use – and you’d value a recognised certification to showcase it –ISO 42001 is likely the right fit.
If you’re looking for a lighter-touch, flexible, risk-based framework without formal certification, the NIST AI RMF might suit you better.
If you feel it’s time to get serious about AI governance, security and compliance, implementing this standard would be a solid investment. It bridges security, privacy, and AI risk classification, making it a comprehensive governance framework.
For those who have decided to embark on the ISO 42001 journey, congratulations! You’re going to be ahead of the curve.
Your early adoption will give your organisation a competitive edge while ensuring compliance with future laws, such as the UK AI Regulation, and you can boast about your responsible use of AI. But let’s get real: getting certified is no walk in the park. It’s a long and complicated journey, best undertaken with an experienced guide.
Before diving in, figure out where you stand. Conduct a gap analysis to:
Requirements include structured policies and processes covering AI risk management, accountability, transparency and ethical considerations. This means:
Once your policies and controls are in place, it’s time to test them. Conduct:
Now, for the formal undertaking…
Some of the common pitfalls we see when organisations try managing their responsible use of AI include:
On the other hand, organisations that successfully adopt ISO 42001:
Find further insights on best practices for effective AI governance in the blog post: Ideation to Execution: Building Your AI Governance Framework.
AI laws are appearing all over the place. And we expect them to keep evolving with the technology. You should expect to see the Standard develop continually, as -at its core- it aligns responsible use of AI with use that is also bound by relevant legislation.
Expect to see an increased emphasis on AI transparency, explainability and accountability. Along with stricter bias detection and both risk and impact mitigation requirements.
Given the increased ubiquity of AI technology across all sectors, it can be predicted that AI risk assessments will become mandatory for compliance.
Before long, automation will drive AI governance, reducing human error in compliance monitoring. Nevertheless, human oversight is essential to the responsible use of AI, and we believe that it always will be. Such oversight will have to be continuous in order to be successful.
ISO 42001 is the new standard in AI governance, and early adopters will set the benchmark for compliance. Leadership, CISOs, risk managers, compliance officers and AI developers should start preparing now, as AI regulations will only get stricter as the technology develops and becomes more complex.
Ready to get started? Get in touch with a Crew Member today.
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