[ISO 13485] OQC Standard as Importer

[Danielkim]

Hello Guys,

I'm preparing ISO 13485 QMS as Importer in Europe. Our scope of work is "Sales, Logistics and Warranty Service".

To ensure safety and quality of our product, we should conduct outcome inspection (OQC) after we repair the defective devices or reworks.
However, we do not have any inspection standard or test report forms yet.

The question is, "Do we have to have identical inspection standard(criteria) and OQC test report as our Manufacturer?"


Any feedback would be very appreciated.

 

[Tidge]

It is highly unlikely that a service center will have identical inspection criteria. For example: the original manufacturer may not ship product with cosmetic defects that could be tolerated on a serviced medical device.

A service center is obligated to demonstrate (via objective evidence) that the serviced products meet the necessary requirements to be safe and effective; per the manufacturer. A typical example: if these are medical electrical devices it is improbable that either a manufacturer could build the devices or a service center could repair the devices and not perform basic electrical safety testing at either the manufacturer or service center prior to sending them to a customer.

 

[Danielkim]

It is highly unlikely that a service center will have identical inspection criteria. For example: the original manufacturer may not ship product with cosmetic defects that could be tolerated on a serviced medical device.

A service center is obligated to demonstrate (via objective evidence) that the serviced products meet the necessary requirements to be safe and effective; per the manufacturer. A typical example: if these are medical electrical devices it is improbable that either a manufacturer could build the devices or a service center could repair the devices and not perform basic electrical safety testing at either the manufacturer or service center prior to sending them to a customer.

Thank you for your reply.

I understand that we can loose the cosmetic quality standard as it's already used.
So I guess we don't have to have identical safety & function test standards as Manufacturer, but we need to prove that our refurbished devices meet basic requirements of safety and functions. Is it alright?

Best regards,

 

[Tidge]

You have to work it out with the owner of the Design History File. Which company wants their owner to be the one in handcuffs?

 

[Danielkim]

You have to work it out with the owner of the Design History File. Which company wants their owner to be the one in handcuffs?

I didn't get it. What do you mean by the owner of the design history file?

 

[Tidge]

Is this a Medical Device?

 

[Danielkim]

Is this a Medical Device?

Yes, it is electronic medical device (class I)

 

[Tidge]

I didn't get it. What do you mean by the owner of the design history file?

Is this a Medical Device?

Yes, it is electronic medical device (class I)

So who owns the DHF?

EDIT: My assumption is that because these products receive servicing, that there is a DHF. I write this based on the requirement to maintain a record for each of the manufactured devices. If there isn't a DHF, I wouldn't want to be in the business of servicing the devices... as a layman I would be concerned that the service activities aren't maintaining the device as approved for the market.

 

[Danielkim]

So who owns the DHF?

EDIT: My assumption is that because these products receive servicing, that there is a DHF. I write this based on the requirement to maintain a record for each of the manufactured devices. If there isn't a DHF, I wouldn't want to be in the business of servicing the devices... as a layman I would be concerned that the service activities aren't maintaining the device as approved for the market.

Our legal manufacturer owns the DHF.

 

[Tidge]

The DHF owner almost certainly has the requirements relating to servicing, so a service center should be in conversation with them about what is to be done during service and maintenance.