How we govern the AI behind regulated decisions

When AI contributes to a regulatory or product-compliance decision, teams need more than a useful answer. They also need to trace the information behind it, explain how the technology was governed, and show where human judgment and accountability remained. This article explains what our ISO 42001 certification covers, what it doesn't, and how you can use it in a vendor review.

For organizations evaluating AI regulatory compliance software, governance therefore becomes part of the vendor review alongside performance. We pursued ISO/IEC 42001:2023 certification for 3E's artificial intelligence management system (AIMS) to give customers independent evidence of that governance. This article explains what the certification covers, what it does not, and how customers can use it during vendor review.

Key takeaways

• 3E pursued ISO/IEC 42001:2023 certification voluntarily to give customers independent evidence of how 3E's artificial intelligence management system is governed.
• 3E's certified scope supports software and data services for regulatory compliance, safety data sheet management, and product stewardship. The certified scope also covers 3E as both an AI provider and an AI customer or consumer.
• ISO/IEC 42001 certification gives customers a governance baseline for vendor review. Customers still need to evaluate the specific use case, including provenance, traceability, security, human oversight, and how AI-supported outputs will be reviewed.

Why we pursued ISO 42001 certification when nothing required it

Customers are increasingly being asked to account for how AI factors into regulated decisions. We pursued ISO/IEC 42001 certification so customers have an independently assessed answer about how 3E governs AI, rather than relying only on 3E's description of its own practices.

The certified scope also covers 3E as an AI Customer/Consumer. That means 3E's AIMS addresses AI services 3E uses within the certified scope as well as AI-enabled services 3E provides.

ISO/IEC 42001 provides a structured management-system framework for organizations that develop, provide, or use AI. The standard addresses how an organization establishes, maintains, and continually improves the policies and processes used to manage AI-related risks and responsibilities.

Our original certification announcement covered the milestone itself. Here, the focus is the governance behind it.

What 3E's ISO 42001 certification covers

3E's artificial intelligence management system is certified to ISO/IEC 42001:2023 by Prescient Security within the scope stated on the certificate.

The certificate defines that scope across four areas:

• Services: software and data services supporting regulatory compliance, safety data sheet management, and product stewardship
• AI roles: 3E as both an AI Service/Product Provider and AI Customer/Consumer
• Infrastructure: Amazon Web Services and Microsoft Azure
• Departments: Information Technology, Software Development, Human Resources, Information Security, and Legal

That scope sets the boundary of what was independently assessed against ISO/IEC 42001:2023. The certificate also remains valid subject to satisfactory surveillance audits, consistent with ISO/IEC 42001's focus on maintaining and continually improving the management system.

Does ISO 42001 certify an AI product or model?

3E's ISO/IEC 42001:2023 certification applies to its artificial intelligence management system within the certified scope. It does not certify any individual product, model, service, or AI-generated answer.

Prescient Security assessed that management system against the standard. The certification should not be interpreted as certification or endorsement of a specific AI application or output.

Governing the AI we build and the AI we use

3E's certified scope covers 3E as both a provider of AI-enabled services and a customer or consumer of AI.

The 3E Trust Center documents controls that support governance. System changes require approval from at least one independent person before deployment into production, and 3E reviews vendor SOC 2 reports, or equivalent, at least annually. 

3E also applies a human-over-the-loop approach across AI systems, keeping human accountability in place from design through operation.

What this changes when you evaluate an AI provider

3E's certification gives customers concrete evidence to use during an AI vendor review. Buyers can examine the certified organization and management system, its stated scope, and the roles and functions included. They can then assess what that evidence means for the specific workflow they are considering.

If an AI system identifies that a regulatory change may affect a product portfolio, the evaluation should go beyond whether the answer appears correct. A compliance team also needs to know the underlying source, how the result can be checked, where human review occurs, and who owns the final action.

Security and procurement teams will have their own questions about architecture, access, data handling, and third-party dependencies. The certification gives those teams common governance evidence to work from, while the specific use case determines what else they need to verify.

Across our AI solutions for regulatory compliance, outputs trace back to source regulations, SDS data, or supplier submissions. 3E regulatory and chemical experts review and validate key outputs where required, so AI can accelerate the work without removing human accountability.

What ISO 42001 certification does not tell you

3E's ISO/IEC 42001:2023 certification does not answer every question a customer still needs to ask.

It does not guarantee that a specific AI-generated answer is correct or establish that a particular use case is appropriate. It also does not make 3E or a customer compliant with the EU AI Act or another regulation.

Customers still need to evaluate the technology against their own requirements. That includes understanding where the data comes from, how outputs can be traced and reviewed, what security controls apply, and where human oversight remains.

ISO/IEC 42001 gives customers an independently assessed governance baseline to weigh alongside those requirements. If your team is evaluating AI for regulatory compliance, download our 2026 Buyer's Guide to AI Regulatory Compliance Solutions for a practical framework to use in your vendor review.