Issued2023-12-01

ISO/IEC 42001:2023 – Artificial Intelligence Management System

StandardVoluntary

Summary

International management‑system standard specifying requirements to establish, implement, maintain, and continually improve an AI Management System. Covers governance, risk controls, competence, documentation, and continual improvement across the AI lifecycle.

Healthcare Implications

Health providers and vendors can align governance and controls for AI systems with an auditable standard. Adoption supports safer deployment, evidence traceability, and integration with existing quality systems (e.g., ISO 9001/13485) and complements NIST AI RMF practices.

Impact Level

Medium

Keywords

Transparency & Governance; Safety & Risk; Privacy & Data

Stakeholders

Providers & Health Systems; Developers & Vendors; Regulators & Government