The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, held an emergency meeting after confirming what appears to be an outbreak in the use of fake ISO 13485 certificates. ISO 13485 is a quality management system standard particular to medical devices and specifies requirements for “a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”

The fake certificates are being used to solicit sales of medical equipment and highly specialized personal protective equipment (PPE) to supply the high demand needed by governments to cope with the Covid-19 pandemic.

The use of fake certificates is most commonly found among certain companies trying to sell specialized N95 filtering masks that are now widely used to protect healthcare workers from inhaling the deadly Covid-19 virus. These masks are not simple barrier masks to contain a cough. They are meant to be certified to very specific safety standards (see article, “The Problem With Fake N95 masks”). If they are manufactured improperly, they could allow the virus to be inhaled.

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