For Heads-of · Practitioner

ISO/IEC 42005

Also known as: ISO 42005

The international standard, published in May 2025, giving guidance on how to carry out an AI system impact assessment: identifying the people and groups a system affects and assessing its potential benefits and harms. It is the method ISO/IEC 42001 assumes.

  • ISO
  • impact assessment
  • AIMS
  • standards
  • FRIA

What it covers

Scoping the system and its context, identifying stakeholders and affected groups, assessing reasonably foreseeable benefits and harms (including from misuse), documenting the results, and feeding them into risk management and decisions about the system. It applies throughout the lifecycle, not only before deployment.

How it fits

ISO/IEC 42001 requires an AI system impact assessment (Clause 6.1.4) but does not say how to do it; 42005 does. It is guidance, so an organisation cannot be certified against it. It overlaps with the EU AI Act's fundamental rights impact assessment and with a DPIA, and one well-run process can serve all three; see impact assessment and ISO/IEC 42001.

Where it sits in the register

The gap it closes is missing AI impact assessment process; the control is the AI impact assessment process.

Sources

Related Terms

Compliance & Regulation

High-Risk AI System

An AI system that the EU AI Act subjects to its full set of requirements, either because it is a safety component of a product covered by EU product law (Annex I) or because it is used in one of eight listed areas (Annex III), which include credit scoring and life and health insurance pricing. Since the 2026 Digital Omnibus the obligations apply from 2 December 2027 for Annex III systems and 2 August 2028 for Annex I systems.

Compliance & Regulation

Impact Assessment

A systematic evaluation of the potential positive and negative effects of deploying an AI system on individuals, communities and society. Distinct from a data protection impact assessment, which examines the lawfulness of the data processing rather than the consequences of the decision.

Compliance & Regulation

ISO/IEC 23894

International guidance, published in 2023, on managing risk related to AI. It applies the general risk management principles of ISO 31000 to AI and adds what is specific to AI systems.

Compliance & Regulation

ISO/IEC 42001

The international standard for an AI management system (AIMS): the policies, roles, risk assessment, impact assessment, controls and evidence an organisation puts around its development and use of AI so that the whole can be audited and certified. Published December 2023, and since 2025 surrounded by companion standards for impact assessment (42005) and for the bodies that certify against it (42006), and from 2026 by EN 18286, the European quality management standard written for the EU AI Act.

Related risks and controls

← Back to Glossary