I agree that if a piece of equipment is being sold to someone else, that "customer property" doesn't apply. I mentioned this only because some folks will casually treat a 'preventative maintenance' to include 'refurbishment', and I didn't want to elements of 13485 to be ignored without due consideration.
Does "Refurbishment" fall under "Service"?
- Thread starter Ajit Basrur
- Start date
FDA would consider remanufacturing and servicing to be completely different. There is recently issued guidance on remanufacturing (June 2021) that is likely to discuss whether refurbishing is remanufacturing or not, but regardless, it's not servicing, imo.
Also see Remanufacturing and Servicing Medical Devices.
Also see Remanufacturing and Servicing Medical Devices.
I was kind of on the fence when I first replied. My initial thought was no, not servicing. But after looking at the content and finding no other better clause, it seemed not inappropriate:
...document servicing procedures, reference materials, and reference measurements, as necessary, for performing servicing activities and verifying that product requirements are met.
(use the data) as appropriate, for input to the improvement process.
Records of servicing activities carried out by the organization or its supplier shall be maintained
I think the intent of refurbishment is to ensure it's meeting requirements. It may well NOT be nonconforming so I don't know why that would always be the case (if it is nonconforming then sure!). Regardless of the clause it falls under I think you would likely have procedures and that following refurbishment, you will verify that product requirements are met, and it's probably a good idea to use that data to see if there are any improvements that can be made. (And, of course, you'll need records of the activities.)
...document servicing procedures, reference materials, and reference measurements, as necessary, for performing servicing activities and verifying that product requirements are met.
(use the data) as appropriate, for input to the improvement process.
Records of servicing activities carried out by the organization or its supplier shall be maintained
I think the intent of refurbishment is to ensure it's meeting requirements. It may well NOT be nonconforming so I don't know why that would always be the case (if it is nonconforming then sure!). Regardless of the clause it falls under I think you would likely have procedures and that following refurbishment, you will verify that product requirements are met, and it's probably a good idea to use that data to see if there are any improvements that can be made. (And, of course, you'll need records of the activities.)
In the context of consumer products, many unsold products are returned to the OEM, still in the original package and are re-sold as refurbished.
In most cases, retrofitting/refurbishing a product would be deemed servicing, irrespective if the actual hardware returns to the original customer or not.
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