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  17025, Guide 25, A2LA (Cal., Meas., and Test)
  In-house Calibration Update

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Author Topic:   In-house Calibration Update
Valente Moreno
Lurker (<10 Posts)

Posts: 1
From:Hermosillo, Sonora, México
Registered: Mar 2001

posted 07 July 2001 03:55 AM     Click Here to See the Profile for Valente Moreno   Click Here to Email Valente Moreno     Edit/Delete Message   Reply w/Quote
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

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Al Dyer
Forum Wizard

Posts: 814
From:Lapeer, MI USA
Registered: Oct 2000

posted 10 July 2001 07:04 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
... 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...

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Graeme
Forum Contributor

Posts: 58
From:Lilburn, GA, USA
Registered: Sep 2000

posted 10 July 2001 11:35 PM     Click Here to See the Profile for Graeme   Click Here to Email Graeme     Edit/Delete Message   Reply w/Quote
quote:
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.

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Ryan Wilde
Forum Contributor

Posts: 34
From:Mineola, NY, USA
Registered: Feb 2001

posted 11 July 2001 08:24 AM     Click Here to See the Profile for Ryan Wilde   Click Here to Email Ryan Wilde     Edit/Delete Message   Reply w/Quote
quote:
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

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