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Interesting Topic Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate?

Sidney Vianna

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The whole article is available @ MDSAP: When Is a Certificate Not a Certificate? | Quality Digest


The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards Institution (BSI). Health Canada had ordered these certification bodies to stop issuing ISO 13485 certificates, which had been granted under the purview of the Canadian Medical Devices Conformity Assessment System (CMDCAS), with any expiration dates beyond Dec. 31, 2018.

Health Canada told them that only ISO 13485 certificates issued by the Medical Device Single Audit Program (MDSAP) would be accepted by Health Canada after that date. As many medical device manufacturers were just getting brand new ISO 13485:2016 certificates, they were stunned when they saw their new certificates had been cut off at the knees. Instead of getting a certificate with a three-year expiration date as usual, the new certificates were set to expire in less than one year.

Considering that thousands of companies pay between $10,000 and $20,000 or more for their certificates, this behind-the-scenes demand by Health Canada could have amounted to tens of millions of dollars in lost value.

After a meeting with the U.S. Department of Commerce (DOC) in early June 2018 to discuss the matter, the DOC decided to discuss the matter with Canadian trade representatives at a forthcoming World Trade Organization meeting that month. The DOC insisted it would demand the return of lost years on the ISO 13485 certificates. Was it successful?

Perhaps. It seems a little too coincidental that shortly after the DOC made its promise, BSI sent the following notice to its customers:
“The MDSAP certificates are NOT accredited and BSI recommends all clients to maintain an accredited ISO 13485 certificate to support your market needs.”... “BSI will now be issuing all CMDCAS clients a duplicate new SCC-accredited certificate without the CMDCAS logo. The new certificate will have the same scope, standard and the appropriate expiration. These will be issued as part of a project, taking into consideration the natural expiration of existing certificates.” (That would be three years, as indicated by ISO standard ISO 17021-1. Emphasis added.)

The SCC is also a full member of the International Accreditation Forum (IAF). It, like many other IAF member accreditation bodies, will provide industry with an ISO 13485 certificate that is recognized internationally. Moreover, bearing a proper internationally recognized accreditation mark will support their access to the new worldwide certification database that is being developed by the IAF.
Note: Because ISO 13485 certificates issued by the MDSAP are not accredited, they do not qualify as acceptable in the new IAF worldwide certification database
 
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