ISO 17025 accredited certificate requirements

[MERRICK65]

I have a question concerning what data can be listed on a calibration certificate. If a labs scope of accreditation for pipettes has a lower limit of 2µL and they calibrated a pipette at 1µL are they allowed to still have this as an accredited calibration cert. with the accrediting body’s logo displayed? I have reviewed section 7.8 and I’ve had no luck one way or another.

They tested the pipette at: low range 1µL (not on scope); mid range 5µL (on scope) and high range 10µL (on scope).

Thank you for the help

 

[AllTheThings]

If you have a calibration certificate with values outside the scope of accreditation, you shall indicate that those values are outside the scope on the certificate.

The appropriate clauses would be 7.8.2.1n and 7.8.4.1e

This is the interpretation I was given by a US accreditation body during 17025 audit training. There are probably other interpretations and opinions, some of which may be more valid...

 

[qualitymanagerTT]

No - my understanding is that the the accreditation logo can only be used for calibrations (or tests, or sampling) which are fully within the scope of accreditation.

Your accreditation body is the best source for an answer.

 

[MERRICK65]

I did find an answer from ANAB document PR 1018 paragraph 6.1:

"
6.1. When an ANAB-accredited CAB makes use of the symbol or a reference to accreditation, the CAB
shall ensure:
a. No use on reports, certificates, or any enclosures when none of the work included in a report or
certificate is within the scope of accreditation;1 and
b. Unaccredited work is clearly identified as such by a disclaimer."

 

[dwperron]

I did find an answer from ANAB document PR 1018 paragraph 6.1:

"
6.1. When an ANAB-accredited CAB makes use of the symbol or a reference to accreditation, the CAB
shall ensure:
a. No use on reports, certificates, or any enclosures when none of the work included in a report or
certificate is within the scope of accreditation;1 and
b. Unaccredited work is clearly identified as such by a disclaimer."

17025 does not specifically address a situation like this regarding a calibration certificate that includes results that are both within and outside of the lab's scope. The closest I can see is:
"7.8.1.2 The results shall be provided accurately, clearly, unambiguously and objectively, usually in a report (e.g. a test report or a calibration certificate or report of sampling), and shall include all the information agreed with the customer and necessary for the interpretation of the results and all information required by the method used"
If the lab notes on the certificate the the test result(s) was not within their scope then they are fulfilling the requirement of supplying all information required so the customer can correctly interpret the results.

The job of deciding how this information is passed on to the customer has fallen upon the individual Accreditation Bodies. As you have shown, ANAB allows this by the lab clearly identifying results that are outside the lab's scope. In your original post you did not mention if the out of scope result was clearly marked as such.

 

[MERRICK65]

17025 does not specifically address a situation like this regarding a calibration certificate that includes results that are both within and outside of the lab's scope. The closest I can see is:
"7.8.1.2 The results shall be provided accurately, clearly, unambiguously and objectively, usually in a report (e.g. a test report or a calibration certificate or report of sampling), and shall include all the information agreed with the customer and necessary for the interpretation of the results and all information required by the method used"
If the lab notes on the certificate the the test result(s) was not within their scope then they are fulfilling the requirement of supplying all information required so the customer can correctly interpret the results.

The job of deciding how this information is passed on to the customer has fallen upon the individual Accreditation Bodies. As you have shown, ANAB allows this by the lab clearly identifying results that are outside the lab's scope. In your original post you did not mention if the out of scope result was clearly marked as such.

It was in the comments section of the cert. I had just never seen it handled this way before. I could post a snip of the cert, if anyone wants to see what I was questioning.

 

[AllTheThings]

Well, the ANAB PR 1018 interpretation that out of scope points need to be clearly marked on an accredited cert aligns with the ANAB assessor who was giving the training I took. At least they are consistent