Artificial intelligence has revolutionized many industries, but its rapid growth has also brought ethical, privacy, and security concerns. To address these challenges, the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) devised a new standard, ISO/IEC 42001. This standard provides guidance to organizations that design, develop, and deploy AI systems on factors such as transparency, accountability, bias identification and mitigation, safety, and privacy. This article will explore:

• Key elements of ISO 42001 
• The benefits of implementing this standard 
• Stories from organizations successfully instituting ISO 42001 
• Next steps for businesses 

Structure of ISO 42001 

Like several other ISO/IEC standards, ISO 42001 has several annexes that provide much of the detailed guidance organizations need. Here’s a quick breakdown of these annexes: 

• Annex A: Management guide for AI system development, including a list of controls 
• Annex B: Implementation guidance for the AI controls listed in Annex A, including data management processes 
• Annex C: AI-related organizational objectives and risk sources 
• Annex D: Domain- and sector-specific standards 

Key themes of ISO 42001 

ISO 42001 covers issues throughout the AI system lifecycle, from the initial concept phase to the final deployment and operation of the system. It is designed to help organizations manage the risks associated with AI and ensure that their AI systems are developed and used responsibly. 

Some of the key requirements covered in the published standard include: 

• Leadership: Top management should demonstrate leadership and commitment to the AI management system (AIMS) and establish policies and objectives that are consistent with the organization’s strategic direction. 
• Planning: Identify and assess risks and opportunities associated with AI and develop a plan to address them. 
• Support: Provide resources and support for the AIMS, including training, awareness, and communication. 
• Operation: Establish processes and procedures for the development, deployment, and maintenance of AI systems. 
• Performance evaluation: Monitor, measure, analyze, and evaluate the performance of AI systems and take corrective actions when necessary. 
• Continual improvement: Continually improve the AIMS, and ensure that it remains relevant and effective. 

Related resources 

ISO 42001 Buyer’s Guide 
The Ultimate Guide to ISO 42001 [WEBINAR] 
Synthesia Earns ISO 42001 Certification with A-LIGN 
Why Early Adoption of ISO 42001 Matters 
ISO 42001 Checklist 

Key themes of ISO 42001  

ISO 42001 covers issues throughout the AI system lifecycle, from the initial concept phase to the final deployment and operation of the system. It is designed to help organizations manage the risks associated with AI and ensure that their AI systems are developed and used responsibly. These key themes may look familiar as you identify the intersection between ISO 27001 and ISO 42001. 

Some of the key requirements covered in the published standard include:  

Leadership: Top management should demonstrate leadership and commitment to the AI management system (AIMS) and establish policies and objectives that are consistent with the organization’s strategic direction.  

Planning: Identify and assess risks and opportunities associated with AI and develop a plan to address them.  

Support: Provide resources and support for the AIMS, including training, awareness, and communication.  

Operation: Establish processes and procedures for the development, deployment, and maintenance of AI systems.  

Performance evaluation: Monitor, measure, analyze, and evaluate the performance of AI systems and take corrective actions when necessary.  

Continual improvement: Continually improve the AIMS, and ensure that it remains relevant and effective.  

Learn more about these requirements and how to start your organization’s compliance journey in our ISO 42001 buyer’s guide. 

Is ISO 42001 mandatory? 

If your organization produces, develops, or uses AI, you may be wondering to what extent you should be scrambling to become certified in ISO 42001. In short, this framework is a voluntary standard and is not legally binding. However, given its significance and emerging recognition, it is highly likely to become the benchmark for AI management systems in the future. Organizations should anticipate possible regulatory developments and consider proactively adopting this framework.

Get the ultimate guide to ISO 42001 in our two-part webinar series. 

Organizational roles and responsibilities 

Effectively implementing ISO 42001 starts with identifying your organization’s role in your current AI ecosystem:

• AI provider: An organization or entity that provides products or services that uses one or more AI systems. AI providers encompass AI platform providers and AI product or service providers. 
• AI producer: An organization or entity that designs, develops, tests and deploys products or services that use one or more AI system. This includes AI developers that are concerned with the development of AI services and products. Examples of AI developers include model designers, implementers, computation verifiers, and model verifiers. 
• AI user: An organization or entity that uses an AI product or service either directly or by its provision to AI users. 

Benefits of implementing ISO 42001 

Though few organizations relish the idea of more audits, there are good reasons to move forward with certification sooner rather than later. (Plus, if you practice strategic compliance and consolidate your audits, adding this standard to your compliance program may be easier than you think.) 

Learn more about the benefits of early adoption of ISO 42001 in our guide. 

Managing AI risks and opportunities  

ISO 42001 provides organizations with a systematic approach to identify, evaluate, and address the risks associated with AI. This can help organizations mitigate the risks of AI and protect themselves from potential harm. 

Competitive advantage 

Implementing this standard enables organizations to showcase their early adopter status, demonstrating their commitment to responsible AI use. This can enhance stakeholders’ trust and distinguish the organization from competitors. 

Streamlined process

By incorporating ISO 42001’s best practices, organizations can streamline their AI processes, identify and rectify vulnerabilities earlier, and reduce the potential financial and reputational costs associated with AI failures. 

Preparing for EU AI Act Compliance with ISO 42001 

The EU AI Act mandates an ongoing governance framework for AI risk management, transparency, and compliance. Unlike one-time risk assessments or ad hoc governance policies, ISO 42001 establishes a systematic, repeatable process for AI compliance, ensuring organizations:  

• Proactively manage AI risks rather than responding to enforcement actions.  
• Align AI governance with business operations using structured risk-management frameworks.  
• Demonstrate compliance through audit-ready documentation and performance evaluation.  

This standard provides an adaptable compliance framework that evolves alongside regulatory requirements, making it an ideal foundation for AI governance.  Though it is not an approved harmonized standard for AI Act conformity, it does provide the foundation you’ll need to be successful when the final QMS conformity standard is released. 

Learn more: How to prepare for the EU AI Act with ISO 42001 

Case study: Synthesia  

London-based Synthesia is the leading AI video platform to enable the creation of studio-quality videos with AI avatars and voiceovers in over 140 languages. 

With an innovative product used by 65,000 clients worldwide, including 70% of Fortune 100 companies, Synthesia aimed to showcase their dedication to responsible AI use and high-quality security practices. To do this, Synthesia partnered with A-LIGN to achieve ISO/IEC 42001 certification and become trailblazers in AI compliance. 

The challenge 

As AI technology progresses, global regulations evolve to address emerging challenges. The EU AI Act set transparency, fairness, and accountability standards for AI systems, prompting Synthesia to proactively adapt and lead in compliance, standing apart from companies slower to react. 

“It was challenging to find the right audit partner, as no firms were yet accredited. We saw A-LIGN as a market leader ready to take on the challenge with us.” 
-Nicolás Barberis, Security Manager 

With robust governance and a strong ethical foundation, Synthesia prioritized data protection, responsible use, and abuse prevention to build customer trust. The EU AI Act became a catalyst for strengthening security measures and meeting the rising expectations for compliance. 

Why A-LIGN 

Synthesia identified A-LIGN as a market leader and trusted collaborator, partnering with them to overcome challenges and achieve certification as a team. 

Moreover, Synthesia recognized that certifications from established organizations like A-LIGN fostered greater trust in the accreditation process. This credibility influenced how Synthesia’s customers perceived certifications, emphasizing the clear advantage of working with reputable and experienced firm. 

Results 

After a successful assessment, Synthesia became the first AI video generation company to become ISO 42001 certified. 

Earning ISO 42001 certification validated Synthesia’s already stringent security practices, which included robust AI governance, supply chain accountability, and adherence to strict obligations. This milestone showcased to the world that Synthesia meets the highest standards for security and compliance. 

The achievement had a positive reputational impact, drawing media coverage and significant interest from customers, vendors, and other stakeholders who were eager to learn about their journey, motivations, and approach. Learn more about Synthesia’s work with A-LIGN. 

ISO 42001: Next steps for businesses 

To navigate the complex landscape of AI governance and compliance, compliance managers should consider the following steps: 

• Purchase and understand the standard: Obtain a copy of ISO/IEC 42001 and familiarize yourself with its provisions. It is crucial to understand the requirements,  recommendations, and other applicable requirements (i.e. ISO/IEC 22989, ISO/IEC 23894) to effectively implement the standard. 
• Start internal talks about certification: Initiating conversations about the certification audit process within your organization is essential. Understanding the steps involved and allocating necessary resources will ensure a smooth transition toward ISO 42001 compliance. 
• Get a readiness assessment: Consider engaging a trusted compliance partner like A-LIGN to conduct a readiness assessment tailored to your organization’s specific needs. This assessment will help identify any potential findings when pursuing this certification. Download our ISO 42001 checklist to ensure your organization is ready to take the next step.

As the AI landscape continues to evolve, embracing ISO 42001 will position businesses as leaders in the field, fostering trust and ensuring the long-term success of AI initiatives. Stay ahead in the AI era by leveraging ISO 42001 and building a solid foundation for your AI management system. Contact us today to get started.