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© 2025 Leave a Mark Consulting Group ApS
CVR: 39411458
With the growing adoption and interest in artificial intelligence (AI), there has been a strong demand for a structured approach to managing its use. The ISO/IEC 42001 standard is the result of this demand. It is applicable to organizations of any size or type that intend to use AI to develop, support, or deliver their products or services.
ISO/IEC 42001 is the world’s first international AI management system standard. It can be used as a tool to build trust through certification or as a general framework for managing the use of artificial intelligence.
The standard marks a significant step forward in the governance and responsible use of AI, providing a detailed foundation for trustworthy and accountable AI practices. ISO/IEC 42001 is suitable for organizations of all sizes and across all sectors.
It is part of a broader family of standards designed to guide best practices for the development, deployment, and continual improvement of reliable AI systems.
The increasing use of AI has raised many concerns about its impact on fundamental rights and freedoms. In response, the European Union (EU) has taken a major step toward regulating AI.
The EU’s AI Act is the world’s first concrete initiative for regulating AI. Its goal is to make Europe a global hub for trustworthy AI by establishing rules for the development, marketing, and use of AI within the EU. The regulation aims to ensure that AI systems in the EU are safe and respect fundamental rights and values. Furthermore, its purpose is to promote investment and innovation in AI, improve governance and enforcement, and encourage a unified EU market for AI.
The regulation has introduced clear definitions for the various actors involved in AI: providers, deployers, importers, distributors, and manufacturers. This means that all parties involved in developing, using, importing, distributing, or producing AI models will be held accountable.
Although legislation specifically governing the use of AI has not yet been fully implemented, your company can demonstrate responsibility and accountability — both internally and to your customers — by proactively adopting ISO/IEC 42001.
ISO 42001 helps organizations comply with the EU AI Act by ensuring responsible use of AI, promoting innovation, and safeguarding fundamental rights and security.
The scope refers to the organization’s range of activities and elements that are included within the AI management system.
Normative references refer to documents that are officially cited and form an integral part of the standard.
Terms and definitions refer to the specific terminology and meanings that govern the interpretation and application of the standard.
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the AI management system
4.4 AI management system
5.1 Leadership and commitment
5.2 AI policy
5.3 Roles, responsibilities and authorities
6.1 Actions to address risks and opportunities
6.2 AI objectives and planning to achieve them
6.3 Planning of changes
7.1 Ressources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8.1 Operational planning and control
8.2 AI risk assessment
8.3 AI risk treatment
8.4 AI system impact assessment
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10.1 Continual improvement
10.2 Nonconformity and corrective action
ISO recommends ISO/IEC 42001 for organizations of all sizes.
As AI becomes increasingly integrated into business operations, companies across sectors — including software firms, consulting services, and support functions — are encouraged to adopt the standard to ensure the trustworthy and effective use of artificial intelligence.
© 2025 Leave a Mark Consulting Group ApS
CVR: 39411458
