What is ISO 42001?

ISO/IEC 42001:2023 is the first international standard for managing AI (artificial intelligence).

• ISO 42001 was developed to help organisations develop, implement and maintain AI systems responsibly and securely by aligning their operations with best practice.
• The Standard is applicable to any organisation developing, deploying or managing AI systems, from startups to multinationals.
• It helps businesses standardise AI management processes, manage risks, comply with legal and regulatory frameworks, and improve the transparency of AI decision-making.
• Because it follows the same high-level structure used by many other ISO management system standards, ISO 42001 is compatible with – and can be implemented alongside – standards such as ISO 27001 (information security) and ISO 9001 (quality management).

ISO 42001 is also the only AI standard against which organisations can achieve independently audited certification, demonstrating that their use of AI aligns with internationally recognised best practice.

ISO 42001 is an AIMS (AI management system) standard that provides a structured framework to help organisations manage AI risks effectively, ensure AI processes are deployed ethically and comply with evolving legal and regulatory requirements.

The Standard follows a risk-based approach to AI management and promotes:

• Ethical and responsible AI deployment: Ensuring AI systems align with human rights and fairness principles.
• Regulatory alignment: Supporting compliance with global AI laws and frameworks, including the EU AI Act and the NIST AI RMF (Risk Management Framework).
• Accountability and transparency: Defining clear roles and responsibilities for AI oversight.

ISO 42001 is the only certifiable AI management system standard. Other frameworks provide guidance only. These include:

• NIST AI RMF: A US-based voluntary framework that helps organisations manage AI risks.
• OECD AI Principles: Global principles focused on AI ethics, human rights and transparency.

Unlike these frameworks, ISO 42001 sets auditable requirements that organisations must meet to achieve certification, ensuring consistent AI management across industries.

By implementing an AIMS and achieving certification to ISO 42001, organisations can establish structured AI management processes, ensuring AI systems are trustworthy, compliant and aligned with business objectives.

AI adoption is accelerating, and AI risks and challenges are growing as quickly. Organisations face increasing regulatory scrutiny, and failing to manage AI risks effectively can result in legal penalties, reputational damage and financial losses.

Key AI challenges

• Bias and fairness: AI systems can reinforce discrimination if not properly managed.
• Security risks: AI models can be manipulated or exploited.
• Data privacy: AI systems process large volumes of personal data and are therefore governed by strict compliance requirements.
• Lack of accountability: Many AI models operate as ‘black boxes’, making it difficult to understand their decision-making process.

How ISO 42001 helps

• Standardising AI management: Provides a structured framework to manage AI operations.
• Reducing compliance risks: Helps businesses meet AI regulations, including the EU AI Act.
• Improving AI trustworthiness: Ensures AI is transparent, ethical and explainable.
• Aligning AI with ethical principles: Supports responsible AI development and human oversight.
• Supporting good governance: Having clear roles, responsibilities, policies and processes builds consistency and helps the organisation ensure it has clear oversight and accountability.

By implementing ISO 42001, organisations can proactively manage AI risks, build trust in AI-driven products and comply with evolving global regulations.

ISO 42001 specifies requirements for implementing, monitoring and managing AI systems to ensure AI is used safely and ethically. These include:

AI management and risk management

• Establishing an AI management framework with clear policies, roles and responsibilities.
• Identifying and mitigating AI-specific risks, including bias, security threats and ethical concerns.
• Implementing a risk assessment process and evaluating AI system impacts.
• Developing an AI policy to ensure compliance with the organisation’s needs and obligations.

AI system life cycle management

• Managing AI system development, deployment and decommissioning.
• Applying controls to ensure explainability and transparency in AI models to build trust.
• Establishing quality controls for AI datasets and model performance.
• Implementing continuous monitoring and validation of AI systems.

Compliance and regulatory alignment

• Establishing processes to identify and comply with applicable AI regulations and standards.
• Implementing data protection, security and fairness controls.
• Maintaining documentation to demonstrate regulatory compliance.
• Conducting regular audits of AI systems and processes.

Performance monitoring and continual improvement

• Defining AI objectives against which KPIs (key performance indicators) can be defined to track AI effectiveness.
• Conducting ongoing risk assessments and model retraining.
• Establishing human oversight mechanisms for high-risk AI applications.
• Using feedback loops to improve AI system reliability and accuracy.

By meeting these requirements, organisations can reduce AI risks, improve compliance and build trust in AI systems.

Despite its benefits, organisations may face challenges when implementing ISO 42001.

Key challenges

• Lack of AI risk management expertise: Many organisations lack experience in AI-specific risk management.
• High costs and resource requirements: Implementing an AI management system requires investment.
• Evolving AI regulations: AI laws are still developing, requiring ongoing updates.

How to overcome these challenges

• Training and awareness: Build AI management expertise through ISO 42001 training.
• Incremental implementation: Start with priority areas before scaling compliance efforts.
• Regulatory monitoring: Stay updated on global AI regulatory developments.

By addressing these challenges, organisations can successfully integrate ISO 42001 into their AI strategy.

Steps to certification

1. Gap analysis: Assess your current AI governance practices against ISO 42001 requirements.
2. Implementation: Develop policies and processes to comply with the Standard.
3. Internal audit: Review AI risk management effectiveness before the external audit.
4. Certification audit: Conducted by an accredited certification body.

ISO 42001 helps organisations manage AI systems and align with global best practices.

• Regulatory compliance: Helps comply with laws like the EU AI Act.
• Improved AI governance: Establishes structured AI policies and risk management.
• Competitive advantage: Builds trust with customers, regulators and investors.
• Better risk management: Reduces legal, financial and reputational risks.

Certification to ISO 42001 signals responsible AI adoption, ensuring AI technologies are secure, transparent and compliant with evolving regulations.

ISO 42001 applies to any organisation that develops, deploys or manages AI systems, including:

• AI technology providers: Companies building AI models or platforms.
• Businesses using AI: Enterprises integrating AI into their operations.
• Public-sector organisations: Governments and regulatory bodies using AI for public services and decision-making.

Regulatory impact

Many AI regulations, such as the EU AI Act, require AI governance frameworks. ISO 42001 certification helps businesses demonstrate compliance and proactively manage AI risks.

By adopting ISO 42001, organisations can enhance AI governance, improve regulatory alignment and gain a competitive advantage.

Overlap and integration

ISO 42001 can be integrated with existing standards, allowing organisations to build on current compliance efforts.

ISO 27001 + ISO 42001: Ensures both information security and AI management.

ISO 9001 + ISO 42001: Aligns AI management with quality control processes.

By adopting ISO 42001, organisations can enhance AI risk management while leveraging their existing ISO certifications.

We offer ISO 42001 consultancy services to help organisations achieve certification and build a robust AI management framework.

Our services include:

• Gap analysis: Identify compliance gaps and create an ISO 42001 roadmap.
• Implementation support: Develop AI risk management policies and processes.
• Certification readiness: Prepare for external certification audits.