Who is Eligible to Grant ISO 13485 Certification?

Understanding who is eligible to grant ISO 13485 Certification is important to ensure your registrar (otherwise known as a Certification Body or “CB”) has the right credentials. Many people assume that ISO grants certification, but in fact that is not. A registrar will be the one to grant certification. You should ensure that your registrar is a member of the International Accreditation Forum (IAF) and additionally need to be ISO/IEC 17021:2015 certified.

One of these standards is ISO/IEC 17021:2015 Conformity assessment (buy a copy here), “Requirements for bodies providing audit and certification of management systems,“ which in effect stipulates the requirements for Registrars who certify organizations to ISO management standards like ISO 9001, ISO 14001, ISO 13485, etc.

People often say “ISO Certified” but ISO does not issue certificates or certify individual companies to any standard. They are issued by certification/registration bodies (also called Registrars or CB’s), which are independent of ISO. CB’s need to be accredited by an IAF member to be internationally recognized. This is especially important if you are doing international business.

ISO/IEC 17021 ensures international acceptance of the CB’s certifications by requiring that all Accreditation bodies (ANAB, etc.) belong to an internationally accredited organization, like the IAF. Likewise, the IAF ensures that CB’s comply with ISO/IEC 17021.

Some Quality System Registrars are not accredited by IAF, and thus are not meeting ISO 17021 — and will not be internationally recognized. Make sure that you choose a Registrar who is accredited by an IAF member (ANAB or the equivalent of ANAB in your country or region).

When you receive your registration certificate, it should display the ANAB and the IAF logos and unfortunately, without them, you are not officially ISO 13485 certified.


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