It seems that I've had this discussion with auditors many times over the years. In this clause it states, "If servicing is a specified requirement, ......" Some auditors tell me that our repair department qualifies under this clause. I disagree because a repair to a medical device is not a specified requirement in my opinion. Repair may happen if a device becomes faulty or it may not occur and it is not a requirement for a new device to function over time. Who distinguishes repair activity from servicing activity? I do not consider them synonymous, but I have others argue that they are. Need help. Thanks.
Servicing activities: 7.5.4
- Thread starter MJW66
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If a faulty device, new or old, under or out of warranty requires repair to regain or maintain it's functionality, either in-house or at the customer's site, you are servicing the product.
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Tagin
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Well, ISO 9000 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);"
So, it would seem that SERVICING in 13485 references the root word SERVICE that is in 9000, and so repairs would be included under 7.5.4.
So, it would seem that SERVICING in 13485 references the root word SERVICE that is in 9000, and so repairs would be included under 7.5.4.
Sidney Vianna: Thank you for your reply. That is interesting, but what about where a device is not faulty? In this case servicing is not a "specified requirement" and may NEVER be a specified requirement. If the intent is to include repair/refurbish activities as part of the servicing definition, then why not make it abundantly clear to state that servicing includes repair? To me and I may certainly be incorrect, but I find it problematic to state the clause in a way where I can make the interpretation that some amount of servicing MUST occur for the device to function as intended and is specified by the OEM. Again, the clause does not state that servicing MAY be a specified requirement, it states that where servicing IS a specified requirement. I use the analogy of changing the oil in a car as a servicing requirement. The car is not faulty or broken, but oil an change servicing is a specified requirement for the car to continue functioning as originally intended by the OEM.
Thank you for that reference. I will investigate.
Also, if the terms service and repair were meant to be used interchangeably, then why have two different definitions, 3.7.7 service and 3.12.9 repair?
I don't understand. In your original post you mentioned a REPAIR dept. Why would a device be sent for repair if it is not faulty?
Tagin
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REPAIR needs to be distinguished from REWORK, so there are definitions for those two words. Definition 3.7.7 for SERVICE shows that REPAIR is a type of SERVICE, but SERVICE encompasses many more activities as well. So, REPAIR and SERVICE are not interchangeable.
It would only be sent to the Repair department if it was faulty. I think I was trying to state that my impression of the statement "Where service is a specified requirement.." meant that servicing might be done both on faulty and non-faulty devices. Regardless, if Repair is a subset of Service as stated by Tagin, then that makes sense to me for the inclusion of repair within the larger service (or servicing) definition.
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