ISO 42001

History and overview

ISO/IEC 42001, published in 2023, is the first international standard dedicated to AI Management Systems. It provides a governance framework for AI systems across sectors.

Why is it relevant?

– Establishes organizational accountability

– Aligns AI risk management with healthcare safety

– Helps meet regulatory expectations across jurisdictions

Scope of Application

Applicable to organizations that:

– Design, develop, or deploy AI systems

– Operate AI systems in regulated sectors like healthcare

Key Obligations and Requirements

– Define AI-specific policies and objectives

– Risk-based approach to AI lifecycle management

– Monitoring and continual improvement

Documentation and Governance Requirements:

– AI project inventory

– Impact assessments

– Audit logs and version control

Best Practices

– Integrating with ISO 27001 and HIPAA

– Using for cross-border compliance readiness