ISO 13485 vs NIST SP 800-66

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

ISO 13485 is a other framework applying in International, with 29 controls across 11 domains. NIST SP 800-66 is a information security framework applying in the United States, with 8 controls across 8 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

NIST SP 800-668 controls

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

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

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

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

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

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

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.