Does an internal calibration laboratory need to be certified on ISO 17025?

[Valente Moreno]

Hi, I wrote element 4.11 policies, SOPs and trained calib. technicians on them in a manufacturing company in my last job, and I want to update myself on Calibration matters.

Does an internal calibration laboratory need to be certified on ISO 17025? or is this only for external laboratories?
Does the calibration management software have to be certified also?

I would appreciate any additional information you can tell me about it.
Thanks

 

[Al Dyer]

... Your questions


...Does an internal calibration laboratory need to be certified on ISO 17025? or is this only for external laboratories?

Depends, who are your major customers?

...Does the calibration management software have to be certified also?

I'm not sure abour certified, but it has to be verified to ensure that the outgoing data is correct.

MHO

ASD...

 

[Graeme]

Originally posted by Valente Moreno:

Does an internal calibration laboratory need to be certified on ISO 17025? or is this only for external laboratories?
Does the calibration management software have to be certified also?

In my opinion, an internal calibration lab (one that does not take work from customers outside the parent company) does not need to be accredited to ISO 17025. You may desire it, or an important customer may require it. But actually doing it or not is a business decision. However, that lab should consider having their transfer standards calibrated by an accredited laboratory wherever possible.

ISO 17025 is a lot of work beyond the requirements of ISO 9001. You have to weigh the cost and effort against the expected benefits.

"Calibration Management Software" ... exactly what do you mean by that? Is this a database program that keeps the inventory, history and recall schedule? Or are you talking about software that controls the measurement systems and/or makes calculations that contribute to the result of a calibration? The first type is a "gray area"; it may or may not need to be validated. The second type almost certainly does need to be validated in some way.

 

[Ryan Wilde]

Originally posted by Graeme:
"Calibration Management Software" ... exactly what do you mean by that? Is this a database program that keeps the inventory, history and recall schedule? Or are you talking about software that controls the measurement systems and/or makes calculations that contribute to the result of a calibration? The first type is a "gray area"; it may or may not need to be validated. The second type almost certainly does need to be validated in some way.

I agree with Graeme on this, it depends. If the calibration management software has anything to do with 'data integrity', it must be validated. 17025 is specific on this, if it affects the calibration data, then it MUST be validated.

As for the rest of it, more full agreement with Graeme. 'I concur'

Ryan