AI and ISO 42001


A responsible and sustainable approach to Artificial Intelligence

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AI Act and ISO 42001: Transparency, Safety, and Protection of Fundamental Rights

The AI Act (EU Regulation 2024/1689) is the new European regulatory framework governing the development, commercialization, and use of artificial intelligence systems. Organizations looking to adopt AI must ensure compliance with strict requirements regarding transparency, safety, risk management, and the protection of fundamental rights.

To support compliance, the ISO/IEC 42001:2023 standard defines an AI Management System (AIMS) based on the PDCA (Plan-Do-Check-Act) continuous improvement cycle. This standard enables the integration of AI into business processes while ensuring governance, traceability, and human oversight.

Complying with the AI Act and ISO 42001 is not just a regulatory obligation, but also an opportunity to adopt AI in a reliable, responsible, and competitive manner.

AI Act, ISO/IEC 42001, and GDPR: An Integrated System for Ethics and Safety

Implementing an AI Management System in line with ISO 42001 facilitates alignment with both the AI Act and GDPR requirements, particularly regarding DPIAs (Data Protection Impact Assessments), system transparency, and bias minimization.

This integrated approach allows organizations to:

  • assess risks and classify AI systems according to the AI Act categories (unacceptable, high, limited, or minimal risk)
  • ensure data quality and traceability of automated decisions
  • promote social acceptability and public trust in AI, in line with the principles of the EU Charter of Fundamental Rights.

Our Services for Compliance with the AI Act and ISO 42001

Our multidisciplinary team provides operational and strategic support to organizations that plan to develop or adopt AI systems in compliance with the new European regulation.

Areas of Expertise

Assessment and Gap Analysis
Analysis of the level of compliance with the AI Act and ISO 42001, including identification of risks and corrective measures.

Definition of the AIMS
Design and implementation of an AI Management System in accordance with ISO/IEC 42001.

Support with Classification and DPIA
Framing the AI system in relation to the AI Act risk categories and providing support for the fundamental rights impact assessment.

Governance and Ethical Code
Drafting of an AI ethical code and definition of roles (provider, deployer) and responsibilities.

AI Training and Culture
Training programs to promote the conscious and reliable use of AI systems within the organization.

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