As artificial intelligence becomes embedded in products, decisions and everyday processes, the pressure to establish clear governance is increasing. Regulators, businesses and users are demanding more transparency, control and accountability.
This is where ISO/IEC 42001 comes in, the first international standard for managing AI systems.
If your company develops, deploys or relies on AI models, this standard gives you a practical framework to manage risks, apply ethical principles and demonstrate responsible use.
What is ISO 42001?
ISO 42001 is a new international standard that defines the requirements for implementing an Artificial Intelligence Management System (AIMS). Just as ISO 27001 does for information security, this standard allows organisations to structure policies, processes and controls to govern their use of AI.
It is designed to be scalable and flexible, suitable both for startups developing models and for large organisations integrating AI into their operations.
Its scope covers areas such as:
- Responsible design and deployment of AI systems
- Risk management across the entire lifecycle
- Transparency and traceability
- Human oversight and ethical alignment
- Incident response for AI-specific failures
“ISO 42001 is to AI governance what ISO 27001 is to cybersecurity.”
Why is it relevant now?
Until now, AI governance relied on broad principles, fairness, transparency, non-discrimination, but lacked a clear operational guide.
ISO 42001 changes that. It provides structured, auditable processes for managing AI risks, making it easier to demonstrate compliance to regulators, partners and customers.
With the EU AI Act moving quickly (expected to apply between 2025 and 2026), ISO 42001 becomes a key tool to anticipate and prepare, especially if your company works with high-risk or general-purpose AI models.
What does the standard include?
ISO 42001 follows a structure similar to other ISO management standards like 27001 or 9001. It includes requirements relating to:
- Organisational context
- Leadership and responsibilities
- Planning (including risk and opportunity assessment)
- Support (resources, training, documentation)
- Operational control of AI systems
- Performance evaluation and continuous improvement
It also introduces specific requirements for AI risk management, explainability, data quality and human–machine interaction.
“ISO 42001 turns AI ethics principles into measurable operational processes.”
Who should care about it?
If your company uses or develops AI in any of the following contexts, ISO 42001 is highly recommended:
- Models that affect pricing, credit or user access
- Automated processes in recruitment, healthcare or legal decisions
- Generative or general-purpose models integrated into your own or third-party tools
- AI in regulated sectors such as banking, healthcare or critical infrastructure
Even if you don’t yet face legal obligations, aligning with this standard shows maturity, preparedness and can support B2B sales, audits and procurement processes.
Where to start?
You don’t need to implement everything at once. Start with a gap analysis to identify which areas of your AI lifecycle lack controls or policies. From there, define a plan: responsibilities, KPIs, risk reviews and continuous monitoring.
If you already work with standards like ISO 27001 or ISO 9001, you’ll find many structural similarities and synergies you can leverage.
Conclusion
AI is advancing rapidly, and so are legal and societal expectations. ISO 42001 gives companies a concrete way to demonstrate responsibility, reduce risks and prepare for what’s coming next.
At PrivaLex, we help organisations build AI governance with strategic vision, combining ISO 42001 with the requirements of the EU AI Act.