
The development of artificial intelligence in Europe is increasingly based on two pillars: legal regulations and management standards. In practice, this means that organisations implementing AI are increasingly faced with the requirements of both the EU’s AI Act and the ISO/IEC 42001 standard. Although both documents relate to artificial intelligence, their roles are entirely different.
The AI Act is an EU legal regulation that sets out obligations relating to the design, deployment and use of AI systems. The provisions focus primarily on safety, the protection of users’ rights and the mitigation of risks arising from the use of artificial intelligence.
ISO 42001, on the other hand, is not a piece of legislation. It is a management standard that helps organisations streamline their AI-related processes and establish a system for overseeing the technology. Its aim is to ensure the responsible management of artificial intelligence throughout the system’s entire life cycle. In practice, the AI Act tells companies ‘what they must comply with’, whilst ISO 42001 helps answer the question ‘how to organise processes to achieve this’.

| Area | ISO/IEC 42001 | AI Act |
| Nature of the document | International ISO standard | EU Regulation |
| Legal status | Voluntary | Mandatory within the EU |
| Main objective | AI management system | Regulation of AI use |
| Scope | Management of the organisation and AI processes | Requirements for specific AI systems |
| Certification | Certification possible | No traditional ISO certification |
| Approach to risk | Continuous risk management | Classification of systems by risk level |
| Application | All organisations using AI | Entities falling within the scope of the AI Act |
Companies implementing AI are increasingly realising that simply meeting legal requirements may not be enough. The AI Act imposes obligations regarding documentation, oversight, data quality and the monitoring of high-risk systems, but does not describe in detail how to organise the entire AI management framework within a company.
This is precisely where ISO 42001 plays a major role. The standard helps to establish structured processes relating to risk assessment, accountability, audits, supplier oversight and incident management. This makes it easier for an organisation to demonstrate compliance with regulatory requirements. For many companies, ISO 42001 is therefore becoming a practical foundation for preparing for the AI Act – particularly where AI influences business decisions, customers or data security.
More and more organisations are using artificial intelligence in their day-to-day business processes. If you want to streamline the way you manage AI and prepare your organisation to meet the requirements of the standard, find out what implementing ISO 42001 involves.