Medical Device Repairs and ISO Scope

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KatieQA

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#1
#1
During a recent audit, our auditor mentioned that repair of medical devices (returned by the customer and to be sent back to the customer after repair) required Service be within scope. Can anyone confirm or reject that statement?

Background: we have an active, audited rework program that to date has been used for failures identified prior to release. It is closely tied to our nonconforming material program. We also have an RMA program to handle returned materials from customers for complaint investigations. We have service as a scope exclusion and would not do the repairs on-site at the customer facility. Would those be sufficient to repair and return devices? Or do we need to expand our scope to do repairs?

Thanks!
 
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Tagin

Tagin

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#2
#2
To make sure I understand: are you saying that 1) you DO service (i.e., repair) returned product, and 2) you EXCLUDE service from your scope?

I would think you at least need to remove the exclusion. How do you justify that repairing a medical device should not fall under the same controls, constraints, monitoring, etc. as production of new medical devices??
 
K

KatieQA

Starting to get Involved
#3
#3
Tagin said:
To make sure I understand: are you saying that 1) you DO service (i.e., repair) returned product, and 2) you EXCLUDE service from your scope?

I would think you at least need to remove the exclusion. How do you justify that repairing a medical device should not fall under the same controls, constraints, monitoring, etc. as production of new medical devices??
Click to expand...
We currently do rework for nonconforming material under the same controls as production (approved rework instructions, same controls and inspections, same monitoring). We would like to expand that program to include rework / repair of returned devices. So the controls exist and are implemented, the question is are those controls now called "service" if the product was in the hands of the customer at some point in this process? Is repair different than rework?
 
Tagin

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#4
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KatieQA said:
....the question is are those controls now called "service" if the product was in the hands of the customer at some point in this process? Is repair different than rework?
Click to expand...
9000:2015, under the definition of 'service' includes:
Note 3 to entry: Provision of a service can involve, for example, the following:
— an activity performed on a customer-supplied tangible product (3.7.6) (e.g. a car to be repaired);
Click to expand...
'Repair' vs. 'Rework' - see 9000:2015 as these are both defined there, and have specific meanings.
 
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