Applicability
Cross-sector AI risk management; use within the organization’s applicable regulatory and quality-system context.
What Changed
NIST states that AI RMF 1.0 is being revised. The Generative AI Profile remains a published companion resource.
What Did Not Change
The framework is voluntary and does not replace GxP regulations, predicate rules, product requirements, or accountable Quality decisions.
Practical Impact
Use the framework to structure ownership, risk identification, measurement, management, and monitoring for AI-enabled uses.
Actions to Consider
Record which NIST concepts are applied and connect them to the system-specific intended use, risk controls, validation evidence, and monitoring.
Primary Source
Revision history
Version 1.2 · 12 September 2026: Terminology and source fields standardized for Version 32.