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ISO 42001: AI Quality Management

The Management System for Machine Learning and Artificial Intelligence Systems

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Unlocking the potential of AI

ISO 42001 is the first international standard specifically designed for Artificial Intelligence Management Systems (AIMS). Published in December 2023, it provides a framework for organisations to develop, implement, maintain, and continually improve AI systems responsibly, controls which are especially important for the healthcare environment

Collaborate with 8fold to develop an ISO 42001 compliant Management System and integrate controls with existing management systems for ISO 13845, ISO 27001 and ISO 9001.

ISO 42001 ensures ethical, transparent and trustworthy AI practices – collaborate with 8fold to develop your AI Quality Management System.
For Patients. For Healthcare. For Good.

Get in Touch

Why ISO 42001 for Healthcare?

The excitement surrounding the potential of AI solutions in healthcare is significant, but it’s balanced by uncertainty regarding the safety and risks these systems present. 

Adopting ISO 42001 demonstrates a commitment to developing, deploying, and managing AI technologies responsibly and ethically, and can:

  • Easily be integrated with the familiar requirements of ISO 9001 and ISO 13485.
  • Enhance assurances of safety with Healthcare Professionals
  • Illustrate a risk-based approach to quality management with clear strategies for risk mitigation.

Developing an AI Medical Device?

Thinking about adding ISO 42001  to your compliance roadmap? 

Why not deliver them together?

Book a Call
iso 42001 ISO 42001 Certification iso 42001,iso 42001 certification,iso 42001 ai certification

Our Approach.

Working with our team of International Standards experts, we’ll work with you to:

Engage Key Team Members

Ensuring organisational alignment to the project's success is critical, and defining from the outset a clear RACI matrix will enable senior stakeholders to understand their role in the project.

Develop Bespoke Policies and Procedures

We don’t believe in a ‘tick-box’ approach. Using our experience in developing certified management systems, we’ll help you develop policies and procedures that work for your business. 

Integrate Existing Quality Management Practices into a Complete Management System

We believe compliance should not live in silos. We can review and harmonise your documentation, ensuring market compliance is maintained for ISO 13485, ISO 9001 and ISO 27001, streamlining the process of policy and procedural management.

Engage Key Team Members

Ensuring organisational alignment to the project's success is critical, and defining from the outset a clear RACI matrix will enable senior stakeholders to understand their role in the project.

Develop Bespoke Policies and Procedures

We don’t believe in a ‘tick-box’ approach. Using our experience in developing certified management systems, we’ll help you develop policies and procedures that work for your business. 

Integrate Existing Quality Management Practices into a Complete Management System

We believe compliance should not live in silos. We can review and harmonise your documentation, ensuring market compliance is maintained for ISO 13485, ISO 9001 and ISO 27001, streamlining the process of policy and procedural management.

Book a Call

Still Learning?

Committing to compliance with ISO 42001 is not a small decision, so we’ve collated several resources to help you. Access our free Blogs to learn more about ISO 42001 alongside our expert insights on effectively implementing and adopting this global standard.

DCB0129 Compliance for Fall Detection Software

Clinical Safety Compliance for Fall Detection Software

Read More →

June 1, 2026
iso 42001 ISO 42001 Certification iso 42001,iso 42001 certification,iso 42001 ai certification

Case Study: Registering Perci Health with the CQC

Read More →

February 16, 2026
iso 42001 ISO 42001 Certification iso 42001,iso 42001 certification,iso 42001 ai certification

Bringing NICE-recommended treatments to UK Dementia patients through SaMD

Read More →

October 15, 2025
How ISO 42001 Compliments Other Regulatory Frameworks

How ISO 42001 Compliments Other Regulatory Frameworks

Read More →

November 26, 2025
iso 42001 ISO 42001 Certification iso 42001,iso 42001 certification,iso 42001 ai certification

How to integrate ISO 42001 with other Management Systems

Read More →

October 8, 2025
iso 42001 ISO 42001 Certification iso 42001,iso 42001 certification,iso 42001 ai certification

FAQ: What is ISO 42001?

Read More →

September 26, 2025
Read more

Get expert ISO compliance support today.

Speak to a Member of our Expert Team about how you can adopt ISO 42001 into your business

Book Your Call Now →
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