By Grant Ramaley
The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, recently 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.
Because the proper design and manufacture of these specialized masks are critical to healthcare worker safety, governments check that manufacturers are applying proper design and manufacturing criteria to these products. As such, these masks are ideally manufactured according to the requirements laid out in the quality management system for medical devices, ISO 13485.
During the discussions with the IAF committee responsible for the new IAF certification database CertSearch, a proposal was drafted that recommends all of the accredited certification bodies worldwide should be required to upload all their clients’ medical device ISO 13485 certificates into the CertSearch database.
According to the manager of the database, the proposal would affect 156 certification bodies that have issued 20,000 ISO 13485 certificates worldwide to manufacturers that have successfully completed third-party audits to this critical standard. The proposal would allow the database to be used to its full potential and remedy this new crisis that has stemmed from the COVID-19 pandemic.
This proposal mirrors other urgent warnings regarding many other fake certificates. This posting from Europe indicates just how widespread the use of fake certificates has become. There is, however, no other database available to validate certificates worldwide. Currently, for those certificates not in CertSearch, a company must check its validity against a certification body’s database, if one exists (not all certification bodies have publicly available certification databases), or they must contact the certification body directly.
Because it is impossible to upload fake certificates to the CertSearch database, and because these certificates are so widely used for regulating medical devices, this new proposal from the Database Management Committee was deemed to be an important response to the current public health crisis.
It isn’t just the IAF that desires that CertSearch be 100-percent complete. In a letter to the IAF, Fred Freedman, vice president of member services for the Dental Trade Alliance (DTA), urged the IAF to “quickly respond to the crisis by requiring all valid… certificates be immediately uploaded to IAF CertSearch, especially those certificates issued to the ISO 13485 standard…. This is not only for commercial equality, but to help regulators protect our healthcare system at this most perilous hour.”
Disclosure statement: I represent the Dental Trade Alliance (DTA) as chairman of the Regulatory Affairs and Standards Committee to act as its liaison to the IAF. The IAF has appointed me to act as a convener of the ISO 13485 Medical Device Working Group and as vice-chairman of the user advisory committee. I do not represent the DTA directly but have been given permission by the IAF to represent it in working with the press under these circumstances.
About the author
Grant Ramaley is the director of regulatory affairs for Aseptico Inc., a manufacturer and marketer of dental support equipment in the United States and Canada since 1975. Ramaley also is co-chairman of the Regulatory Affairs and Standards Committee for the Dental Trade Alliance, Convener for the ISO 13485 Working Group at the International Accreditation Forum, and Technical Committee advisor to the Asian Harmonization Working Party.
This article first appeared on the Quality Digest website and is published here with permission.