ISO 13485:2016 vs ISO/IEC 23894:2023

What is the difference between ISO 13485:2016 and ISO/IEC 23894:2023?

ISO 13485:2016 is a other framework applying in International, with 83 controls across 6 domains. ISO/IEC 23894:2023 is a risk management framework applying in International, with 85 controls across 11 domains. They govern different subjects, so the overlap is limited to the governance requirements they share. The mapping below shows where that is.

ISO 13485:201683 controls

ISO/IEC 23894:202385 controls

Questions people ask about ISO 13485:2016 and ISO/IEC 23894:2023

What is the difference between ISO 13485:2016 and ISO/IEC 23894:2023?

ISO 13485:2016 has 83 controls while ISO/IEC 23894:2023 has 85 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.

Do I need both ISO 13485:2016 and ISO/IEC 23894:2023?

Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between ISO 13485:2016 and ISO/IEC 23894:2023 so you can identify shared requirements and avoid duplicate effort.

How do ISO 13485:2016 and ISO/IEC 23894:2023 controls map to each other?

Our platform maps controls between ISO 13485:2016 and ISO/IEC 23894:2023 at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.

Which framework should I implement first, ISO 13485:2016 or ISO/IEC 23894:2023?

The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.