IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) vs ISO 9001:2015

What is the difference between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and ISO 9001:2015?

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) is a healthcare framework applying in International, with 21 controls across 6 domains. ISO 9001:2015 is a quality management framework applying in International, with 56 controls across 7 domains. They govern different subjects, so the overlap is limited to the governance requirements they share. The mapping below shows where that is.

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)21 controls

ISO 9001:201556 controls

Questions people ask about IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and ISO 9001:2015

What is the difference between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and ISO 9001:2015?

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) has 21 controls while ISO 9001:2015 has 56 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 IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and ISO 9001:2015?

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 IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and ISO 9001:2015 so you can identify shared requirements and avoid duplicate effort.

How do IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and ISO 9001:2015 controls map to each other?

Our platform maps controls between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and ISO 9001:2015 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, IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) or ISO 9001:2015?

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.

Each framework on its own

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)

21 controls · Healthcare

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ISO 9001:2015

56 controls · Quality Management

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Comparisons people read next

Each of these compares one of the two standards above against another it shares controls with.

ISO 9001:2015 vs ISO 13485:201614 shared controls ISO 9001:2015 vs ISO 19011:201813 shared controls ISO 9001:2015 vs AS9100D - Aerospace Quality Management System12 shared controls

See all control mappings with interactive gap analysis

Explore the complete mapping between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and ISO 9001:2015 on our compliance platform.

Written and maintained by Gerard Blokdyk, The Art of Service.