ISO 17025 Calibration Laboratory Assessor's Common Questions and Procedures

garyf2017

Involved In Discussions
#1
Hi, we're about to get assessed in our Calibration Lab and wanted to ask what are the common questions or procedures assessor's have when it comes to dimensional laboratory... (going for accreditation for caliper,micrometer and dti)

I would like to have an idea to better pace and prepare our lab.


TIA:bigwave:
 
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brucefon

Quality Coordinator - Hitachi High-Tech
#2
Is this the initial, a renewal or surveillance audit?
They normally, at least with A2LA, walk through checklists that refer to each line in ISO 17025. A good audit will cover every aspect of the Standard.
Make sure you have a Quality Manual that addresses everything and make sure you do what you say you will do and even more importantly, have records of everything.
 

garyf2017

Involved In Discussions
#3
Hi Brucefon,

Thanks for your reply.

It's the initial, would it be a problem if I'll mention that we are still purchasing the standard we're going to use.

But I will show them a manual procedure for a calibration of example a micrometer but we don't have the proper standard to be used yet?
 

brucefon

Quality Coordinator - Hitachi High-Tech
#4
It seems premature to be getting your initial audit if you're not prepared for them. They normally expect you to provide them some proof you're up and running with validated procedures, meaning tested and proven. That also means you need to have the MT&E and certified secondary standards in place so you can walk them through one or more of your procedures.
 

garyf2017

Involved In Discussions
#5
Oh, I see...We do have the secondary standards (not ISO certified) calibrated in-house.
So we need to validate the procedure ourselves?
 

itsbiodiversity

Involved In Discussions
#6
gary,

you do not sound near prepared to have an accreditation audit. have you read iso/iec 17025:2005? it will walk you through the steps and would answer both questions you have posed so far. you MUST validate your procedures. you MUST have ISO 17025 standards with uncertainties. you MUST be able to calculate MU for all calibrations you plan on performing. there are about 60 or so SHALLs in the document that will tell you exactly what to do.
 

garyf2017

Involved In Discussions
#7
Thanks Itsbiodiversity.

Yes, I understand...We are still preparing. and right now we're focusing on procedures and trying to get some training about uncertainties as well...I'm trying to learn where should we give more of our attention first to better prepare ourselves for the assessment alone.
 

brucefon

Quality Coordinator - Hitachi High-Tech
#9
Yes, I was going to ask who the organization you're going through. I'm surprised you have a date set. You may want to reschedule.
 

itsbiodiversity

Involved In Discussions
#10
Thanks Itsbiodiversity.

Yes, I understand...We are still preparing. and right now we're focusing on procedures and trying to get some training about uncertainties as well...I'm trying to learn where should we give more of our attention first to better prepare ourselves for the assessment alone.
I am not trying to be rude - just real. When it comes to ISO/IEC 17025 accreditation you MUST have all of your "ducks in a row". 17025 covers not only actual performance of calibrations, but the entire Quality Management System. It takes months to develop a QMS that is 17025 compliant in practice. It may take months to years to understand uncertainty and be able to apply it to the performance of a calibration.
 
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