NIST SP 800-66 vs ISO 13485

What is the difference between NIST SP 800-66 and ISO 13485?

NIST SP 800-66 is a information security framework applying in the United States, with 8 controls across 8 domains. ISO 13485 is a other framework applying in International, with 29 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.

NIST SP 800-668 controls

ISO 1348529 controls

Questions people ask about NIST SP 800-66 and ISO 13485

What is the difference between NIST SP 800-66 and ISO 13485?

NIST SP 800-66 has 8 controls while ISO 13485 has 29 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 NIST SP 800-66 and ISO 13485?

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 NIST SP 800-66 and ISO 13485 so you can identify shared requirements and avoid duplicate effort.

How do NIST SP 800-66 and ISO 13485 controls map to each other?

Our platform maps controls between NIST SP 800-66 and ISO 13485 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, NIST SP 800-66 or ISO 13485?

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.