At what point is it considered just a repair not a complaint. If the unit goes out of specification after the warrenty period would'nt that be considered a repair. Or would this still be a complaint since the product is not in specification any more do to some failure. ex: When my car breaks after the warrenty period I would not consider it a complaint to have it fixed just normal maintenance or wear and tear.

Thanks
Mark

we don't differentiate.
There are just different paths that are taken in the same process.
In fact - we don't even measure complaints, per se. We measure returns and the break them down into categories like "stock returns", "warranty returns", "non-warranty returns", etc.
We group them all into returns even if the customer is scrapping on site, but usually we do get parts back for analysis.
Non-warranty returns would include a repair or replacement that the customer is paying for.

We were handling all returns as complaints. Our ISO 13485 auditor was telling us this was wrong and that the normal repairs of out of warrenty parts were not actual complaints. But I have also been told by FDA that all returns were complaints regardless confused on how to handle this.

Thanks
Mark

At what point is it considered just a repair not a complaint.It depends. An appropriate answer for a TV set could be inappropriate for a medical device.

If you really need meaningful feedback, please be forthcoming with details of the scenario. Otherwise, speculation could lead nowhere.

At what point is it considered just a repair not a complaint. If the unit goes out of specification after the warrenty period would'nt that be considered a repair. Or would this still be a complaint since the product is not in specification any more do to some failure. ex: When my car breaks after the warrenty period I would not consider it a complaint to have it fixed just normal maintenance or wear and tear.

Thanks
Mark

Since your profile says your products are "medical" then I'll give you a couple of medical device quotes:
3.4
customer complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market
Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
It seems that in this context, if the customer "alleges deficiencies" in the product, it's a customer complaint regardless of the warranty period.

Several examples:

Ex: A electronic stethoscope that has been in used past the warrenty period has a component failure over time and is returned for repair. Would this be a complaint or handled just as a repair.

Ex: Product is retruned with dead battery. No problem with unit customer just did not check battery.

Ex: Tubing cut on unit through normal wear and tear.

Since your profile says your products are "medical" then I'll give you a couple of medical device quotes:Holy Sherlock investigative powers, Howste. http://www.greensmilies.com/smile/smiley_emoticons_batman_rolleyes.gif
You hit the medical nail in the proverbial head. :agree1:

Holy Sherlock investigative powers, Howste. http://www.greensmilies.com/smile/smiley_emoticons_batman_rolleyes.gif
You've just been dying to use that smiley, haven't you Sidney? :cool:

Several examples:

Ex: A electronic stethoscope that has been in used past the warrenty period has a component failure over time and is returned for repair. Would this be a complaint or handled just as a repair.

Ex: Product is retruned with dead battery. No problem with unit customer just did not check battery.

Ex: Tubing cut on unit through normal wear and tear.
To be on the safe side, I would treat them all as complaints. If you choose not to take corrective action, you would just document why not per ISO 13485 clause 8.5.1.