Repairs vs. ISO 13485:2003 Section 7.5.1.2.3 Servicing

[LHAMROWCT]

Do repairs have to fall under servicing? We define servicing as a specified requirement for our products to perform properly. Examples would be specified intervals for calibration, cleaning, etc. If for some reason the product ceases to work, we handle a repair under our customer complaint system.
For years we have taken an exclusion to 7.5.1.2.3 and have had no problems with it during our audits. During a recent audit, this was challenged, with the reason being that we have a warranty on our units and therefore warranty repairs fall under servicing.
Anyone have experience with handling this?

 

[Sidney Vianna]

Re: ISO 13485:2003 Section 7.5.1.2.3 Servicing

Do repairs have to fall under servicing? We define servicing as a specified requirement for our products to perform properly. Examples would be specified intervals for calibration, cleaning, etc. If for some reason the product ceases to work, we handle a repair under our customer complaint system.
For years we have taken an exclusion to 7.5.1.2.3 and have had no problems with it during our audits. During a recent audit, this was challenged, with the reason being that we have a warranty on our units and therefore warranty repairs fall under servicing.
Anyone have experience with handling this?

The note in 7.5.1.2.3 explains that servicing includes repair. Done in or out of warranty is irrelevant, imo.

 

[AndyN]

Re: ISO 13485:2003 Section 7.5.1.2.3 Servicing

In my experience, 'servicing' - as far as the standards are concerned - applied when a company offered the customer a service of maintenance and repair, after sales. Just like a copier company (I worked for Xerox for a while) Their scope is 'Copy machine design, manufacture and service'. Service can be what is agreed, from repair "Help, my copier broke' to preventive maintenance - changing the document lamps at 1,000 hours.

There is usually a contractual arrangement involved. Is that the case for you? Why has the scope suddenly been challenged? Did the other auditors fail to understand, or has the most recent one thrown a wrench? (I wish they wouldn't do that...)

 

[LHAMROWCT]

Re: ISO 13485:2003 Section 7.5.1.2.3 Servicing

I agree...."Cause you know sometimes words have two meanings....." especially in regulations and standards. We also define "service" like a copier company. There is no contract for service of our products, as they don't need service. Previous auditors agreed with our interpretation, the most recent auditor disagreed. Thanks for your feedback!

 

[Doug Tropf]

Re: ISO 13485:2003 Section 7.5.1.2.3 Servicing

Do repairs have to fall under servicing? We define servicing as a specified requirement for our products to perform properly. Examples would be specified intervals for calibration, cleaning, etc. If for some reason the product ceases to work, we handle a repair under our customer complaint system.
For years we have taken an exclusion to 7.5.1.2.3 and have had no problems with it during our audits. During a recent audit, this was challenged, with the reason being that we have a warranty on our units and therefore warranty repairs fall under servicing.
Anyone have experience with handling this?

Per ISO 14969, "if the organization provides for some or all of the product servicing by either warranty or contract, then the organization's quality management system should include provisions for the type and extent of servicing provided."

 

[somashekar]

Re: ISO 13485:2003 Section 7.5.1.2.3 Servicing

Do repairs have to fall under servicing? We define servicing as a specified requirement for our products to perform properly. Examples would be specified intervals for calibration, cleaning, etc. If for some reason the product ceases to work, we handle a repair under our customer complaint system.
For years we have taken an exclusion to 7.5.1.2.3 and have had no problems with it during our audits. During a recent audit, this was challenged, with the reason being that we have a warranty on our units and therefore warranty repairs fall under servicing.
Anyone have experience with handling this?

Many a times what gets away is taken as correct. In your case if you are defining servicing as a specified requirement, and the same is mapped in the quality management system, then I seek to know how you have justified the exclusion of 7.5.1.2.3.
I feel it is an error of judgement in maping as exclusion. If you have defined and documented servicing (repairs included) of your product, it is perhaps a simple correction of your exclusion. Another example for how good audit corrects a good system making it even better .....

 

[AndyN]

Re: ISO 13485:2003 Section 7.5.1.2.3 Servicing

I agree...."Cause you know sometimes words have two meanings....." especially in regulations and standards. We also define "service" like a copier company. There is no contract for service of our products, as they don't need service. Previous auditors agreed with our interpretation, the most recent auditor disagreed. Thanks for your feedback!

You clearly have 'provisions' for repairs to be carried out - as you say - under 'customer complaints'. I don't see why you'd have to do anything different. All previous auditors have been comfortable with that, except one. I'd question the (one) before I made any changes. Is there any evidence that the process you follow isn't working?