Medical Device Repairs and ISO 13485 Scope

KatieQA

Starting to get Involved
#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

Trusted Information Resource
#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??
 

KatieQA

Starting to get Involved
#3
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??
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

Trusted Information Resource
#4
....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?
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);
'Repair' vs. 'Rework' - see 9000:2015 as these are both defined there, and have specific meanings.
 

James

Involved In Discussions
#5
9000:2015, under the definition of 'service' includes:

'Repair' vs. 'Rework' - see 9000:2015 as these are both defined there, and have specific meanings.
I'm struggling to see the difference in Katie's context:

rework: action on a nonconforming product or service to make it conform to the requirements
repair: action on a nonconforming product or service to make it acceptable for the intended use

1. A successful repair of a nonconforming product or service does not necessarily make the product or service conform to the requirements. It can be that in conjunction with a repair a concession is required.
2. Repair includes remedial action taken on a previously conforming product or service to restore it for use, for example as part of maintenance.
3. Repair can affect or change parts of the nonconforming product or service.

If a procedure is defined for both rework and repair (detailing concessions) that covers all bases; I'm guessing the difference is fundamentally that rework relates to pre-issue remedial work, and repair is post issue?
 

somashekar

Staff member
Admin
#6
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!
7.5.3 Servicing activities can be non-applicable to you from what you say.
Do you have servicing medical devices mentioned in your certificate scope ?
 

Tagin

Trusted Information Resource
#7
I'm struggling to see the difference in Katie's context:

rework: action on a nonconforming product or service to make it conform to the requirements
repair: action on a nonconforming product or service to make it acceptable for the intended use

1. A successful repair of a nonconforming product or service does not necessarily make the product or service conform to the requirements. It can be that in conjunction with a repair a concession is required.
2. Repair includes remedial action taken on a previously conforming product or service to restore it for use, for example as part of maintenance.
3. Repair can affect or change parts of the nonconforming product or service.

If a procedure is defined for both rework and repair (detailing concessions) that covers all bases; I'm guessing the difference is fundamentally that rework relates to pre-issue remedial work, and repair is post issue?
As an example, imagine a car with a leaky radiator.

- Rework would involve replacing the radiator with the same factory radiator part number that the car was manufactured with, using the same assembly process, and performed by factory certified technicians.
-- The car now continues to meet the original specification.

- Repair would be doing something else, like welding the hole in the radiator, or replacing the radiator with a third-party aftermarket radiator.
-- The car now differs from the original specification, but the repair makes it acceptable for the intended use.
 

James

Involved In Discussions
#8
As an example, imagine a car with a leaky radiator.

- Rework would involve replacing the radiator with the same factory radiator part number that the car was manufactured with, using the same assembly process, and performed by factory certified technicians.
-- The car now continues to meet the original specification.

- Repair would be doing something else, like welding the hole in the radiator, or replacing the radiator with a third-party aftermarket radiator.
-- The car now differs from the original specification, but the repair makes it acceptable for the intended use.
Thanks very much - Very clear explanation making the difference stark and obvious, appreciated!
 
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