Artificial intelligence is no longer just a technological trend; it is now also regulated by law. With the approval of the European Artificial Intelligence Act (AI Act) and the publication of the international standard ISO/IEC 42001, all European companies—including SMEs—must begin to organise themselves to use AI responsibly and transparently. This means understanding how their AI systems behave, avoiding unnecessary risks, and demonstrating that they are managed with rigour and common sense. It is a new era in which it is not only what the technology does that matters, but also how you explain and control it as a company.

📜 What is the AI Act?

The AI Act is the European regulation that, among other things, classifies AI systems according to their level of risk — minimal (with few requirements, such as spam filters), limited (requiring transparency, such as chatbots that must identify themselves as AI), high (strict management and documentation obligations, such as AI used in human resources or education) and prohibited (AI that subliminally manipulates behaviour)—and establishes specific obligations based on that classification. If your company develops, uses or distributes AI systems in the European Union, this regulation affects you.

📘 What is ISO 42001?

ISO/IEC 42001 is the first international standard that establishes how the use of artificial intelligence should be organised and managed in a company, through what is known as an AI Management System (AIMS). Its objective is to help organisations use AI responsibly, safely and in line with current laws and ethical values. This includes aspects such as defining roles and responsibilities, assessing risks, documenting processes, etc.

For an SME or a growing company, applying this standard means bringing order and clarity to the use of intelligent tools, whether it be an assistant such as ChatGPT, a recommendation engine, or a predictive solution. In short, it is a roadmap for using AI with business acumen and a forward-looking vision.

🔗 How do they relate to and complement each other?

While the AI Act defines what is legally mandatory—for example, which practices are prohibited or what requirements a high-risk system must meet—ISO 42001 provides a structured framework for complying with those obligations. This standard facilitates the implementation of clear processes, defined roles, and continuous monitoring mechanisms, helping your company manage your AI systems and demonstrate this to customers, partners, or authorities.

Therefore, it can be concluded that the AI Act defines what is legally mandatory, and ISO 42001 offers a practical methodology for complying with those obligations and demonstrating compliance in a structured manner. Together, they form a solid and complementary basis for responsible AI management, particularly useful in business environments where trust, traceability, and reputation are key assets.

✅ Essential things to review in your company

• Have you identified your AI systems and their level of risk according to the AI Act?
• Have you assessed the ethical, social, and legal impacts of your AI systems?
• Are there internal policies and designated individuals responsible for the use of AI?
• Do you keep a record of training, tests, and automated decisions?
• Are you prepared to respond to customers, regulators, or audits?

The good news is that you are not alone: the AI Act and ISO 42001 not only set requirements, they also offer you a roadmap for innovating with confidence. Preparing today means avoiding problems tomorrow... and, above all, building and using reliable, ethical, and sustainable AI solutions.