ISO/IEC 42001 is the world’s first international management system standard focused on AI governance. For pharma, it can function as a structured way to demonstrate “responsible AI” controls to partners, auditors, and regulators, especially for supplier oversight and internal AI governance.
- Why it matters: Provides a management-system framework to govern AI risks (transparency, accountability, continual improvement) — useful when deploying GenAI/ML in regulated workflows.
- What to watch: Increasing use of ISO/IEC 42001 in vendor qualification, AI governance programs, and as a “compliance bridge” alongside EU AI Act / GxP expectations.
ISO explainer (overview of what it is): https://www.iso.org/ … ined-what-it-is.html