November 12, 2025

The History and Purpose of ISO 42001

Developed by the International Organisation for Standardisation (ISO), ISO 42001 emerged in response to the rapid growth of artificial intelligence and the need for clear governance frameworks. This landmark standard defines how organisations can design, deploy, and manage AI systems ethically — fostering accountability, safety, and trust in every stage of AI development.

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The AI Revolution Meets Regulation

Artificial intelligence is transforming industries at every level — from data analytics and automation to healthcare, finance, and education.

As these AI systems become more complex and integrated into critical business functions, the need for clear, consistent governance has become essential.

The growing influence of AI has introduced new challenges in risk management, ethics, and regulatory compliance. Organisations now face questions around accountability, transparency, and the safe, responsible use of AI technologies.

To address these challenges, the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC) developed ISO/IEC 42001:2023 — the world’s first international management system standard dedicated to artificial intelligence management systems.

This standard provides a structured framework for managing AI effectively throughout its lifecycle, from development to deployment and ongoing monitoring.

Its goal is to ensure that organisations develop, operate, and improve AI systems responsibly, maintaining trust, fairness, and compliance across all stages of AI management.

In short, the purpose of ISO 42001 is to help organisations align innovation with governance — enabling them to adopt AI responsibly while meeting ethical, legal, and business objectives.

What Is ISO 42001?

ISO 42001—officially ISO/IEC 42001:2023—is an AI management system standard designed to help organisations manage AI risks effectively and align with global AI regulations.

Developed jointly by the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC), it provides a structured management system for how organisations create, use, and maintain AI technologies responsibly.

It follows the same principles as familiar standards like ISO 9001 (quality management) and ISO 27001 (information security)—but applies them to the unique context of artificial intelligence management systems (AIMS).

ISO 42001 covers:

  • The AI system lifecycle – from concept to decommissioning
  • AI risk management frameworks – to identify and mitigate AI-specific risks
  • Ethical principles such as fairness, non-discrimination, and respect for privacy
  • Continuous monitoring and continual improvement of AI management processes
  • Stakeholder engagement and transparency in AI decision-making

In essence, ISO 42001 turns responsible AI governance from a concept into a repeatable, auditable process.

The Purpose of ISO 42001

The purpose of ISO 42001 is to provide an international standard for managing AI risks, ensuring that AI systems are trustworthy, accountable, and aligned with legal and ethical expectations.

Where previous frameworks like ISO 27001 focused on data protection, ISO 42001 extends governance into how AI uses that data.

It helps organisations:

  • Establish a formal AI management system
  • Embed ethical AI practices across teams
  • Proactively manage AI risks such as bias, misuse, and lack of explainability
  • Maintain compliance with legal and regulatory requirements like the EU AI Act
  • Build public and customer trust in AI technologies

The standard also promotes the involvement of AI developers, compliance teams, and risk management professionals in key decisions—ensuring that governance isn’t just a policy, but a practice.

In short: ISO 42001 makes responsible AI measurable.

The Background of ISO 42001

The background of ISO 42001 begins with an uncomfortable truth: while the world was quick to write AI ethics principles, few knew how to implement them in practice.

By the late 2010s, AI had moved far beyond research labs. AI technologies were making critical decisions—in healthcare, banking, recruitment, and national security—yet few organisations had the tools or frameworks to ensure those systems were being used responsibly.

Governments, researchers, and business leaders all recognised the same issue: AI adoption was accelerating faster than governance could keep up.

Initiatives such as the OECD AI Principles, the EU AI Act, and UNESCO’s Recommendation on the Ethics of Artificial Intelligence all provided guiding values like fairness, accountability, and transparency.
But they lacked something crucial: a certifiable management system that could prove those values were actually being applied.

That gap between ethical intention and operational implementation became the driving force behind ISO 42001’s development.

The Creation of ISO/IEC JTC 1/SC 42

To close that gap, the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC) created a joint committee to tackle the challenge.

In 2017, they formed ISO/IEC JTC 1/SC 42, a dedicated subcommittee responsible for developing international standards around artificial intelligence technologies, AI governance frameworks, and AI management systems.

SC 42 brought together global experts—from academia, government, and industry—to define what responsible AI governance should look like in practice.
Their goal was to create a structured framework that would:

  • Support the responsible development and deployment of AI systems
  • Define methods to identify and mitigate AI risks
  • Enable continuous monitoring and risk assessment
  • Align AI innovation with legal and regulatory requirements
  • Offer implementation guidance for organisations of all sizes

Over several years, the committee conducted global consultations, analysed emerging AI governance frameworks, and ran pilot studies across multiple industries.

This work identified a consistent set of challenges: a lack of traceability, weak AI lifecycle management, and limited collaboration between AI developers, risk managers, and compliance teams.

To address these, SC 42 drafted a comprehensive management system model—mirroring successful ISO frameworks like ISO 9001 and ISO 27001—but tailored to AI-specific risks.

After years of research, consultation, and gap analysis, the result was published as ISO/IEC 42001:2023.

This became the first international standard dedicated to artificial intelligence management systems (AIMS)—offering a universal blueprint for responsible AI governance and AI risk management.

Where previous initiatives outlined “what” responsible AI should look like, ISO 42001 defined how to make it real.

The Origins of AI Governance

The origins of AI governance stretch back decades.

Long before ISO 42001, the idea of ethical AI was taking shape in academic and policy circles.

Early Ethical and Policy Foundations

  • 2016: The Asilomar AI Principles introduced foundational concepts like safety, transparency, and human oversight.
  • 2017: The OECD Principles on AI were published and later adopted by more than 40 countries, promoting fairness, accountability, and reliability.
  • 2019: The IEEE’s Ethically Aligned Design initiative called for explicit consideration of human rights and social impact in AI development.
  • 2021: The UNESCO Recommendation on the Ethics of AI became the first global normative framework for AI ethics.
  • 2018–2023: The EU AI Act evolved into the world’s most comprehensive regulatory framework, introducing a risk-based classification system for AI use cases.

These milestones marked a global shift—from high-level ethics to structured governance.

However, while these initiatives defined ethical principles and policy goals, they didn’t explain how to build and audit systems that met those standards.

That’s the gap ISO 42001 fills.

By combining ethical, legal, and operational perspectives into a management system, ISO 42001 turned responsible AI into a certifiable discipline.

The Evolution of AI Standards

The evolution of AI standards mirrors how industries learned to manage complexity.
Before AI, we created frameworks to ensure quality (ISO 9001), security (ISO 27001), and privacy (ISO 27701).

Each one addressed a growing need for accountability. ISO 42001 is the next logical step—applying that same discipline to artificial intelligence systems.

Era Focus Key Standards
1980-1990s Quality Management ISO 9001
2000s Information Security ISO 27001
2010s Privacy and Data Protection ISO 27701, GDPR
2020s AI Governance and Risk Management ISO/IEC 42001:2023

Each generation of standards expanded the definition of responsible management.

Where ISO 9001 ensured product quality and ISO 27001 safeguarded data, ISO 42001 ensures that AI systems are designed, deployed, and monitored responsibly throughout the AI lifecycle.

New Layers of Accountability

Unlike earlier standards, ISO 42001 addresses the dynamic and adaptive nature of AI.
It incorporates AI-specific risk management frameworks covering issues like:

  • Algorithmic bias and fairness
  • Explainability and transparency
  • Model drift and data quality
  • Human oversight and accountability
  • Ethical considerations and stakeholder engagement

It also introduces tools such as AI system impact assessments and continuous improvement cycles to help organisations proactively manage AI risks.

These elements make ISO 42001 a direct response to the increasing regulatory scrutiny surrounding AI — from the EU AI Act to national laws emerging across North America and Asia.

Together, these standards now form the backbone of modern responsible development — ensuring organisations can build trustworthy AI systems that are auditable, transparent, and aligned with both business objectives and ethical principles.

Key Objectives of ISO 42001

The objectives of ISO 42001 are to strengthen AI governance frameworks, enable trustworthy AI, and help organisations manage AI risks effectively through structure and documentation.

1. Ethical and Responsible AI Governance

The standard emphasises ethical principles such as fairness, non-discrimination, and respect for privacy in AI systems.

It promotes responsible AI governance, ensuring all AI initiatives are aligned with corporate ethics and legal and regulatory requirements.

2. AI Risk Management

ISO 42001 introduces risk and impact assessment tools tailored for high-risk AI use cases.

This allows organisations to identify AI-specific risks, assess potential harm, and take corrective action—before systems reach production.

3. Lifecycle Accountability

From AI system development and testing to deployment and retirement, ISO 42001 requires documentation at every step of the AI lifecycle.

This ensures ongoing traceability and continuous improvement.

4. Transparency and Stakeholder Engagement

The standard encourages stakeholder involvement—from developers to compliance teams—to ensure AI systems reflect diverse perspectives and remain accountable.

5. Continuous Monitoring and Improvement

An effective AI management system doesn’t stop at certification.

It includes continuous monitoring, internal audits, and continual improvement processes to adapt to evolving technologies and global regulations.

How ISO 42001 Supports Responsible AI Development

Building trustworthy AI requires structure.

ISO 42001 provides that by setting out practical methods for risk assessment, AI system impact assessments, and implementation guidance.

It helps organisations:

  • Define AI objectives aligned with business objectives and ethical standards
  • Integrate risk management frameworks into AI processes
  • Document and audit AI practices for accountability
  • Balance innovation with responsible AI governance

Importantly, ISO 42001 promotes collaboration between AI developers, risk managers, and compliance leaders—a key factor in ensuring AI systems responsibly serve their intended purpose.

ISO 42001 and Global AI Regulations

AI regulation is no longer theoretical—it’s law in motion.

Frameworks like the EU AI Act, NIST AI Risk Management Framework, and OECD AI Principles have all helped shape how AI compliance is defined worldwide.

ISO/IEC 42001 acts as a bridge between these global regulations and real-world implementation. It offers a consistent, certifiable approach to meeting legal and regulatory requirements for AI.

Regulation/Framework Focus ISO 42001 Alignment
EU AI Act Risk-based regulation of AI systems ISO 42001 provides the governance model for compliance
NIST AI RMF AI risk management best practices ISO 42001 operationalises those practices in management systems
OECD AI Principles Ethical and human-centred AI ISO 42001 turns them into measurable controls
ISO 27001 Information security and data protection ISO 42001 ensures AI uses that data ethically and securely 

Together, they create a global AI governance ecosystem, and ISO 42001 serves as the practical backbone of compliance.

Implementing an AI Management System (AIMS)

Transitioning from theory to implementation requires planning, documentation, and cultural change.

Steps to Implement ISO 42001:

  1. Conduct a Gap Analysis: Evaluate how your existing AI management systems compare against the ISO 42001 standard.
  2. Define Scope and Objectives: Identify which AI systems and AI projects fall within the framework.
  3. Develop Governance Policies: Align policies with ethical AI and regulatory compliance requirements.
  4. Perform Risk and Impact Assessments: Identify, prioritise, and mitigate identified risks across the AI lifecycle.
  5. Document Processes and Controls: Maintain traceability and accountability for all AI models and data sets.
  6. Implement Continuous Monitoring: Regularly test, audit, and improve your AI management system.
  7. Undergo Internal and External Audits: Validate compliance through internal audits and independent certification.

When implemented correctly, an AI management system becomes a living process—constantly adapting to evolving global regulations and emerging technologies like generative AI systems.

How Hicomply Simplifies ISO 42001 Compliance

Managing AI governance manually? That’s a full-time job for a small army.

Hicomply makes it easier.

Our platform automates the heavy lifting of AI risk management, policy control, and continuous monitoring, helping organisations stay aligned with ISO/IEC 42001 and other international standards.

With Hicomply, you can:

  • Map and automate AI risk assessments and AI impact assessments
  • Create and maintain a complete AI management system without the spreadsheets
  • Track AI compliance across frameworks and regulations
  • Maintain an audit-ready record of policies, actions, and evidence
  • Build a culture of responsible AI use and continual improvement

Whether you’re building your first AI governance framework or scaling a global compliance program, Hicomply helps you manage AI responsibly and maintain compliance without slowing innovation.

The Future of AI Governance

As AI adoption accelerates, global regulations will continue to tighten.

Expect to see:

  • Greater regulatory scrutiny of high-risk AI systems
  • Expansion of ISO 42001 certification across industries
  • Integration of AI ethics metrics into business reporting
  • Stronger links between AI security, data protection, and governance
  • Broader emphasis on responsible development and responsible AI practices

The evolution of AI standards will continue, but ISO 42001 provides the stable foundation every organisation needs to ensure AI systems remain safe, transparent, and accountable.

FAQs

What is the main purpose of ISO 42001?

The purpose of ISO 42001 is to provide a structured framework for managing AI risks responsibly through a certified AI management system (AIMS).

Who developed ISO 42001?

It was developed by the ISO/IEC JTC 1/SC 42 committee, which focuses on standardising artificial intelligence management systems globally.

When was ISO 42001 published?

The ISO/IEC 42001:2023 standard was published in December 2023 by the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC).

How does ISO 42001 support AI governance?

ISO 42001 operationalises AI governance frameworks by turning ethical and regulatory guidance into practical, auditable processes.

What are the key benefits of ISO 42001 certification?

  • Strengthens responsible AI governance
  • Enables risk management and continuous improvement
  • Supports regulatory compliance with frameworks like the EU AI Act
  • Builds trust through transparent AI practices

Conclusion: Responsible AI Needs Structure

Artificial intelligence is reshaping industries and redefining how decisions are made. But progress without governance creates risk — and that’s where ISO/IEC 42001 matters.

The standard turns responsible AI governance into something measurable: a clear framework for managing AI risks, maintaining compliance, and ensuring trust in every system you deploy.

With Hicomply, that framework becomes simpler to manage. Our platform automates the controls, monitoring, and evidence needed to stay compliant — so you can focus on innovation, not administration.

Because in a world powered by intelligent systems, trust isn’t optional — it’s engineered.

And ISO 42001 is how you build it.

Risk Management
Compliance Reporting
Policy Management
Incident Management
Audits and Assessments

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