Accredited Calibration Certificate Content - ISO 17025 Section 5.10.4.2 Question

C

CodyK

#1
I just wanted some clarification regarding this section of the standard. It appears that on Accredited Calibration Certificates you have a couple options:

1) State a compliance to a specification and call it: In or Out of Tolerance.

2) Don't state a compliance and just provide the data and have your incoming and out going conditions: As Found and As Left.

Of course uncertainties and all that entails would be considered on both.

If you go with (2) do you still mark or hi lite the points that are OOT and quote the accuracy of the unit or just provide the data only and not mention anything about OOT's or accuracy.

Thanks in advance!
 
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BradM

Staff member
Admin
#2
Re: 17025 Section 5.10.4.2 Question

I just wanted some clarification regarding this section of the standard. It appears that on Accredited Calibration Certificates you have a couple options:

1) State a compliance to a specification and call it: In or Out of Tolerance.

2) Don't state a compliance and just provide the data and have your incoming and out going conditions: As Found and As Left.

Of course uncertainties and all that entails would be considered on both.

If you go with (2) do you still mark or hi lite the points that are OOT and quote the accuracy of the unit or just provide the data only and not mention anything about OOT's or accuracy.

Thanks in advance!
If I understand your question, how would you be able to highlight the OOT points, if there is no specification to assess it against?

If you are just truly reporting the results and what you found, then that is all you can really do. There is nothing really to assess as pass/fail.

To assess a pass/fail, there needs to be a clear, objective point at which the observed values are within (or exceeds).

Not sure if that helps.
 
C

CodyK

#3
Re: 17025 Section 5.10.4.2 Question

I see what your saying Brad, but let me put it this way.

I notify a customer there unit is OOT. There response is, they don't want it adjusted for what ever reason. And they don't want there cert to say OOT. They just want the data with no compliance to specification made.

From a 17025 stand point, do I have any obligation to document the OOT condtition onto the certificate and/or data report?

Thanks!
 

BradM

Staff member
Admin
#4
Re: 17025 Section 5.10.4.2 Question

I see what your saying Brad, but let me put it this way.

I notify a customer there unit is OOT. There response is, they don't want it adjusted for what ever reason. And they don't want there cert to say OOT. They just want the data with no compliance to specification made.

From a 17025 stand point, do I have any obligation to document the OOT condtition onto the certificate and/or data report?

Thanks!
But that is the thing.... you won't be reporting an OOT.

Say I'm calibrating a thermometer. My standard read 50.0C; the unit under test read 51.2C. Is that out of tolerance?

Who knows;:D because there is no basis for comparison. I simply report to you what I observed and such.

I might try to determine some level of tolerance with the customer (mfg. specs; industry specs/guidelines; competitors specs; customer use tolerance; something). That way, as a calibration source you have some basis for adjustment while the device is in your shop.
 
M

machrk

#5
Re: 17025 Section 5.10.4.2 Question

:)
But that is the thing.... you won't be reporting an OOT.

Say I'm calibrating a thermometer. My standard read 50.0C; the unit under test read 51.2C. Is that out of tolerance?

Who knows;:D because there is no basis for comparison. I simply report to you what I observed and such.

I might try to determine some level of tolerance with the customer (mfg. specs; industry specs/guidelines; competitors specs; customer use tolerance; something). That way, as a calibration source you have some basis for adjustment while the device is in your shop.
we had a problem like that with our paint coating thickness shims - the original paperwork detailing the tolerance of each on thickness had been lost - came to light during our 3rd party ISO 9001 recertification audit - although we had been checking their thickness each year in our ISO 17025 lab - but without the original tolerances it was to no avail

so we decided to get a new set of shims & protect the details of their tolerances
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#6
This likely should include Clause 4.4 as the customer's requests can be documented and delivered.

I have been there myself, specifying that I wanted readings and not a pass/fail or OOT notation.

Document it under Clause 4.4 and you should be OK.
 
#7
Just for the sake of discussion, doesn't this circumvent part of ISO 9001:2008? The part of element 7.6 that addresses whet to do when measuring equipment is found to be out of spec: " . . . the organization shall assess and record the validity fo the previous measuring results when the equipment is found not to conform to requirements . . .
 

BradM

Staff member
Admin
#8
Just for the sake of discussion, doesn't this circumvent part of ISO 9001:2008? The part of element 7.6 that addresses whet to do when measuring equipment is found to be out of spec: " . . . the organization shall assess and record the validity fo the previous measuring results when the equipment is found not to conform to requirements . . .
Good question.

Say I am calibrating equipment for you. You may not want me reporting against tolerances. You want me to verify a pressure gauge, for example. You may want me to just report the values that I observe. I will not report any pass/fail, as there is nothing to report against.

As I return those results to you, it is then your responsibility to assess the results, and determine if there are any pass/fail results. As the customer, you would need to make the assessment.

So yes, you're correct. The results should be assessed by the end user for impact and fitness for use.
 
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