ISO 13485 vs ISO 27799

What is the difference between ISO 13485 and ISO 27799?

ISO 13485 is a other framework applying in International, with 29 controls across 11 domains. ISO 27799 is a information security framework applying in International, with 46 controls across 18 domains. They govern different subjects, so the overlap is limited to the governance requirements they share. The mapping below shows where that is.

ISO 1348529 controls

ISO 2779946 controls

Questions people ask about ISO 13485 and ISO 27799

What is the difference between ISO 13485 and ISO 27799?

ISO 13485 has 29 controls while ISO 27799 has 46 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 and ISO 27799?

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 and ISO 27799 so you can identify shared requirements and avoid duplicate effort.

How do ISO 13485 and ISO 27799 controls map to each other?

Our platform maps controls between ISO 13485 and ISO 27799 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 or ISO 27799?

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.