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.
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:
Thinking about adding ISO 42001 to your compliance roadmap?
Why not deliver them together?
Working with our team of International Standards experts, we’ll work with you to:

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.

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.

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.

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.

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.

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