Outsourced Calibrator (Calibration Laboratory) Qualification

LUV-d-4UM

Quite Involved in Discussions
#1
he following finding was picked up by the Third party auditor during an
> ISO9001:2000 recertification and TS16949 surveillance audit:
>
> The calibration of Karl Fischer water titrator is outsourced to Allometrics
> Inc. which is ISO9001 and ISO 17025 certified but is not certified to
> calibrate titrators- as defined by the scope of the certificate. The Karl
> Fischer apparatus is not used for OEM testing neither is it defined in the
> Control Plan. This is being used to verify a crackle test.
>
> Would this be a finding against ISO9001:2000 or TS16949? From my standpoint,
> this finding is not valid because by ISO standard the requirement is for
> outsourced service organization to be ISO9001 only, not ISO17025 as required
> by TS. Appreciate your feedback
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Re: Outsourced Calibrator Qualification

Thanks Andy and Jan.

<snip> The Karl Fischer apparatus is not used for OEM testing neither is it defined in the Control Plan. This is being used to verify a crackle test. <snip>
As I understand it, typically if it's not an 'inspection' or 'test' in the control plan or in the quality plan, whether you have an instrument calibrated or not is up to your judgment. But this is outside my field so let's see what others have to say.

Here is a recent thread that might interest you: Where do you draw the line on what fixtures/testing equipment requires calibration.
 

BradM

Staff member
Admin
#5
he following finding was picked up by the Third party auditor during an
> ISO9001:2000 recertification and TS16949 surveillance audit:
>
> The calibration of Karl Fischer water titrator is outsourced to Allometrics
> Inc. which is ISO9001 and ISO 17025 certified but is not certified to
> calibrate titrators- as defined by the scope of the certificate. The Karl
> Fischer apparatus is not used for OEM testing neither is it defined in the
> Control Plan. This is being used to verify a crackle test.
>
> Would this be a finding against ISO9001:2000 or TS16949? From my standpoint,
> this finding is not valid because by ISO standard the requirement is for
> outsourced service organization to be ISO9001 only, not ISO17025 as required
> by TS. Appreciate your feedback
Good question. This thread could also be located in the TS16949 forum.

Now... I can't speak to the TS16949 perspective. However, I do think that spec requires 17025 accreditation of calibration suppliers.

I cannot see where it would fit under ISO9001:2000 as a finding of not being 17025 accredited. As long as there is traceability and the documentation satisfies your internal requirements, I would think that would be sufficient.

I am intrigued, though, why you don't send it to an accredited lab.:D Maybe if you send enough business to this one source, you might ask them to include it in their scope.
 
#6
Brad - it look like they are accredited, but the titrator isn't in their accredited scope, which being a 17025 lab, they should've indicated that to the client. It's an 'insider' kind of auditor knowledge that most ISO 9001 auditors might not pick up on, but a TS auditor might!
 

LUV-d-4UM

Quite Involved in Discussions
#7
The equipment is not in the Control Plan. Should it be a finding against 7.6.3 of the TS standard? The auditor said that this is a gray area and will be registered against that clause. Anyway now that it is discovered that Allometrics is not certified to calibrated the titrators, we will not use them anymore. Instead we will follow ASTM method.Thank you.
 
#8
The equipment is not in the Control Plan. Should it be a finding against 7.6.3 of the TS standard? The auditor said that this is a gray area and will be registered against that clause. Anyway now that it is discovered that Allometrics is not certified to calibrated the titrators, we will not use them anymore. Instead we will follow ASTM method.Thank you.
The auditor doesn't know? OMG! If it's not referenced in the control plan, is it indeed used for process control? If so, it's an easy fix, take the NC and look grateful.

If it's not in the CP and not used for process control, added to which the auditor isn't clear - doesn't matter which requirement of what standard - it's not a finding - yet! If they can conclude what it's used for and if it needs calibrating, they shouldn't be bringing it up with you. I would be very wary of accepting any NC based on being told that.
 

BradM

Staff member
Admin
#9
Brad - it look like they are accredited, but the titrator isn't in their accredited scope, which being a 17025 lab, they should've indicated that to the client. It's an 'insider' kind of auditor knowledge that most ISO 9001 auditors might not pick up on, but a TS auditor might!
Agreed, Andy.:agree1: I figured as much. Maria asked which one it would go against, and thus I suggested the TS angle.

So I would still either ask them to get their accreditation, or get another vendor.:agree1:
 
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