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ISO 13485 scope of certification - We are a virtual manufacturer

Shonver

Starting to get Involved
#1
Our brand new ISO 13485 certificate indicates that we are certified for

"THE SUPPLY OF MEDICAL DEVICES & LIFESTYLE PRODUCTS"
.

We are a virtual manufacturer. On seeing the certificate, I enquired from the outgoing quality manager why the scope did not say that we are a manufacturer and distributor of medical devices. He replied that "Supply" covers both activities according to ISO 9000:2015.

To quote:

"Supplier" by definition under ISO is "an organisation that provides a product or a service" (Refer you to ISO9000:2015). ISO13485:2016 specifies that a product is the "result of a process" and that it includes "services, software, hardware and processed material".

In other words, ISO13485 speaks of "Manufacturers" as "Suppliers".
Translated to the MD Regs, Suppliers include for example:

Raw Material suppliers, sub-assembly suppliers, design/manufacturing subcontractors and any other service providers. Its under the MD Regs that we are legally a manufacturer, so if it were a CE certificate, [we] would be referred to as the "Manufacturer of Class 1...."
He said that we define our activities in the QMS Scope document and that managing it this way would allow flexibility should it change.

Now we have a customer asking why our ISO 13485 certificate does not specify categories of medical devices that we offer (essentially also querying scope, but from a different aspect).

My question: what is best practice?
 
Elsmar Forum Sponsor

DannyK

Trusted Information Resource
#2
Best practice is to specify the products that are applicable to the scope. The scope would never be accepted by an MDSAP auditing organization or for a notified body for CE Mark.
 
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