Re: ISO13485:2016 Cl. 7.5.1 - Production and Service Provision - Medical Device Repai
Hi all
We import medical devices , monitor, defibs recorders etc and do service and repairs on these units. With reference to 7.5.1 Control of production and service provision- do we need to complete this section as we import the units ( complete ) but do repairs on them - after sales service? We do no assembly of products but we do disassemble ,repair and assemble when returned as faulty. My understanding of 7.5.4 Servicing activities - this only covers preventive servicing and not repairs. Am I correct to say that we also need to do some of the steps listed under 7.5.1 ? Your help will be highly appreciated.
Hello go4it and welcome to the Cove
You wrote that you import devices but you doidn't mention the country. Generally speaking ISO 13485 is not mandatory in most significant regulatory domains. Either way, I will address your questions based on an assumption that - for one reason or another - you need/want to comply with ISO 13485:2016, ie address what I think is required in order to be
in compliance with the standard (and nothing else).
Apparently your org has two separate roles: and importer and a repairer (I'm assuming that you do no planned/routine service; otherwise that's a third role that requires addressing). Your ISO 13485 certification (and certificate) must be for a specific, stated scope. In my opinion your role as a distributor is irrelevant for that certification's scope because it's essentially a distributor's role (this is from a strict ISO 13485 compliance perspective, not a regulatory one). You probably
can get certified with distribution as your scope, but that's not normally necessary. The other role - repairer - is more relevant to such a certification, and apparently that's the perspective you're most interested in, so that's the perspective I'm going to address.
As a repairer your "product" (service actually) is the repair you provide, including all associated activities (packaging, shipping etc.). It is not the device itself. This is important to remember. So when s. 7.5.1 says, for instance "product conforms to specification" it should be read as "service conforms to specification" and understood as meaning that the repair service you provide conforms with the way you have specified
the repair service (not the device and not the technical details of the repair, although the latter may eventuate as a result of compliance with this or other applicable requirements in 13485). Similarly, "production" should be read as "creation of the service". Labelling and packaging are relevant because you most likely issue some labelling and package when you ship the repaired devices back. Release is the final check that the service has been delivered as specified and that all deviations have been properly settled, including the sign-off that designates the specific service provision (repair) instance as acceptable and finished.
I agree with you that s. 7.5.4 is not applicable to your org unless your ISO 13485 certification scope includes the provision of planned service on behalf of / in coordination with / as prescribed by the original (label) manufacturer; or where your repair creates a situation where planned service is required where it wasn't part of the original manufacturer's intended use - in which it will be your responsibility to specify such servicing and follow through s. 7.5.4.
Cheers,
Ronen.
