What is ISO 42001?

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ISO/IEC 42001 is the first international standard that defines how organizations should manage AI responsibly. Released in December 2023, it introduces the concept of an Artificial Intelligence Management System (AIMS)—a framework that ensures AI systems are developed, used, and governed with accountability and transparency.

Why it matters: As AI becomes more integrated into critical business decisions, regulators and customers alike are demanding visibility into how these systems work. ISO 42001 gives organizations a structured path to demonstrate ethical AI practices, mitigate risks, and build trust.

How ISO 42001 has been approached historically

Before ISO 42001, AI governance lacked a global benchmark. Most organizations relied on internal principles or sector-specific guidelines. Frameworks like NIST’s AI Risk Management Framework or the OECD AI Principles helped guide ethical use, but they didn’t offer a certifiable system.

Fragmented oversight left gaps. Without a standardized management system, companies often struggled to align internal controls with external expectations. Risk assessments were inconsistent, AI life cycle stages weren’t clearly defined, and transparency mechanisms varied widely—even within the same industry.

ISO/IEC 27001 was often the fallback. For organizations already certified in information security, ISO 27001 served as a partial anchor. But it wasn’t designed to address AI-specific risks, such as algorithmic bias, data drift, or autonomous decision-making.

AI governance was reactive, not proactive. Without a structured framework, organizations tended to manage AI concerns only when issues arose—such as a misclassification event or bias allegations. That approach left them vulnerable to reputational damage and regulatory scrutiny.

Understanding ISO 42001's approach

ISO 42001 introduces a proactive governance framework using a familiar Plan-Do-Check-Act (PDCA) structure, common across other ISO management systems.

Plan: Establish AI policies, conduct a risk assessment, define roles, and set objectives for responsible AI use.

Do: Implement controls, assign resources, and ensure operational procedures align with the AIMS.

Check: Monitor AI systems, evaluate controls, conduct internal audits, and analyze incidents.

Act: Adapt based on findings, continuously improve the system, and respond to evolving AI risks.

This PDCA model enables repeatable, auditable oversight of AI systems, helping organizations implement and adjust their governance as technologies and regulations change.

Certification process and audit readiness

Achieving ISO 42001 certification involves working with an accredited certification body (CB) that meets specific AI-related auditor qualifications under ISO/IEC 42006.

Stage 1 assesses readiness—reviewing AIMS documentation, including risk assessments, policies, and scope.

Stage 2 validates implementation—typically on-site or remote—by reviewing evidence, conducting interviews, and evaluating system effectiveness.

If both stages meet ISO 42001 requirements, certification is issued for three years, with annual surveillance audits and a required recertification cycle.

Key for organizations: Maintain documentation, streamline evidence collection, and clearly define which AI systems and lifecycle phases are in scope. Misalignment here commonly leads to delays.

Common challenges organizations face

As with any new framework, adoption of ISO 42001 comes with unique hurdles. Here are the most common ones we’ve seen:

Selecting the wrong certification body. Some organizations unknowingly partner with non-accredited CBs or those not recognized by national bodies like UKAS or ANAB. Since ISO 42001 is new, not all providers are approved yet, and using the wrong one can lead to rejected certifications.

Insufficient auditor expertise in AI. Auditors must not only know ISO management systems, but also understand AI development, lifecycle risks, and domain-specific impacts. Without that knowledge, audits can misrepresent scope or overlook critical controls.

Unclear scope and boundaries. ISO 42001 certifications require a defined scope—what AI systems are covered, under what conditions, and across which lifecycle stages. Vague definitions contribute to audit rework and inconsistent implementations.

Manual evidence gathering. Organizations often underestimate the volume and variability of documentation needed to satisfy ISO 42001. Without automation, preparing for audit cycles adds unnecessary time and stress.

Framework fragmentation. Companies already managing ISO 27001, SOC 2, or GDPR must juggle overlapping controls. Without centralized control and policy mapping, maintaining multiple frameworks becomes burdensome.

Looking ahead: ISO 42001 in 2026

By 2026, ISO 42001 adoption is expected to move from early adopters to mainstream use across industries that heavily rely on AI—finance, healthcare, SaaS, and manufacturing.

Global regulation will drive uptake. As national and regional regulators formalize AI laws—like the EU AI Act or U.S. algorithmic accountability rules—organizations will turn to ISO 42001 as a recognized path to demonstrate responsible AI governance.

Certification bodies will mature. More CBs will be accredited to deliver ISO 42001 audits, improving access across regions and sectors. Auditor competence standards under ISO 42006 will become clearer and more enforceable.

Convergence with existing frameworks. ISO 42001 is likely to be integrated alongside ISO 27001 and ISO 9001, enabling unified governance. Multi-framework mapping will streamline controls and reduce the need for duplicated processes.

Continuous monitoring will become standard. Surveillance audits, incident response, and control reviews will be increasingly automated, turning AIMS into a living system rather than a point-in-time checkbox.

Buyer and partner pressure will rise. By 2026, large enterprises and governments are expected to mandate ISO 42001 (or equivalent) certification from vendors, especially those delivering high-risk AI products or services.

In short, ISO 42001 will shift from a differentiator to a baseline expectation.

How Thoropass simplifies ISO 42001 compliance

Compliance shouldn’t slow you down. Thoropass delivers a unified platform designed to accelerate your ISO 42001 program from policy creation to certification and beyond.

Streamline your certification prep. With pre-built ISO 42001 policy templates, AI System Impact Assessments, and readiness checklists, you can get started faster—no blank-page problem.

Automate evidence collection. Integrate directly with your AI pipelines, access control systems, and documentation repositories to collect and organize evidence needed for audit, automatically.

Unify your controls. Map and reuse policies and procedures across ISO 42001, 27001, SOC 2, and more. That means no extra effort to maintain overlapping frameworks.

Maintain compliance with continuous monitoring. Real-time dashboards, alerts, and task tracking help you avoid surprises during annual surveillance or recertification.

Work with an expert-backed platform. Thoropass is ISO 42001 certified for its own AI use cases. That means we understand how to implement the framework in real-world settings—because we've done it ourselves.

Make audit day just another day. Our platform supports audits with clear, organized documentation and built-in auditor access. No last-minute stress, no hunting for lost files.

Final word

ISO 42001 offers a much-needed blueprint for responsible AI governance. But as with any emerging standard, getting it right takes preparation, strong frameworks, and the right tools.

Thoropass reduces uncertainty, simplifies certification, and ensures your AIMS is always audit-ready. Schedule a discovery session today and take control of your AI compliance journey.