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ISO 17025 Clause 5.4.2 - Calibration and Test Method Requirements

tacom

Involved In Discussions
#1
ISO 17025 Clause 5.4.2 says

“The laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations. If the standard method changes, the confirmation shall be repeated.”

According to this statament The Standard test method must be confirmed before use in the first time by laboratory.

My question:

İf the Standard test method does not changes at all
a) we do not have to confirm method any more
or
b) we have to confirm that we properly operate Standard methods for predetermined period (for instance once a year)

which one is correct.

Thanks in advance

TACO
 
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Marcelo

Inactive Registered Visitor
#2
If it dos not change, there's no need to reconfirm it. Think of the confirmation as a qualification, meaning, you confirm that you can operate the method and the only need to reconfirm it if there's any change in the process.
 

tacom

Involved In Discussions
#3
Thanks Marcelo

What do you mean saying “…the only need to reconfirm it if there's any change in the process”

I think if any of the paremeters (new equipment, new laboratory staff, noticeable change in equipment suh as usage of new column in chromotography etc. .) contributed to test result changed significantly after the inital confirmation , reconfirmationstudies should be done.

As it can be easily known that many testing equipment especially used instrumental analysis will began to lost their performance with time .
For instance , Dedection limit (LOD) may get worse in the course of time
What is your opinion?

TACO
 

Marcelo

Inactive Registered Visitor
#4
“…the only need to reconfirm it if there's any change in the process”

I think if any of the paremeters (new equipment, new laboratory staff, noticeable change in equipment suh as usage of new column in chromotography etc. .) contributed to test result changed significantly after the inital confirmation , reconfirmation studies should be done.
We meant almost the same thing. However, I do not think you need to reconfirm the process if new staff id added - this is handled by the training process. As you mentioned, the standard only require reconfirmattion (requalification) "If the standard method changes".

As it can be easily known that many testing equipment especially used instrumental analysis will began to lost their performance with time .
For instance , Dedection limit (LOD) may get worse in the course of time
What is your opinion?
This is generally related to process limits, not to changes in standard method. If your equipment cannot fulfill it's objective inside your test method (process) you need to replace the equipment. There's no change to the test method here.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#5
Generally, if the method is a validated published method/procedure, the lab does not need to verify the method/procedure, but will have to prove to the assessor that they can conduct the test or calibration in accordance with the method/procedure. The verification then basically means that the method/procedure is up to date and that the lab can complete it with any changes it may have.
 

tacom

Involved In Discussions
#6
Dear Marcelo and Hershal

AOAC INTERNATIONAL describe confirmation (verification) as given below in its guide called “ H o w t o M e e t I S O 1 7 0 2 5 R e q u i r e m e n t s f o r M e t h o d V e r i f i c a t i on)”

In this guide, to confirm is the same as to verify.
Verification that a laboratory can adequately operate a standard method requires that the laboratory provideobjective evidence the performance parameters specified in the test method have been met with the matrices to which the method is being applied. Most often, the critical requirements are the accuracy and the precision(generally accepted as repeatability and reproducibility) which are reflected in the measurement uncertainty. The objective evidence is the accuracy and precision obtained from actual lab data.

Therefore confirmation studies generally include precision (repetability, intermediate precision) , trueness (bias,/recovery) and LOD&LOQ studies. Some publication I have read (published by European Communities) claim “verification should be performed every year if the method is used regularly”.

Normally accreditation process renews once evey four year according to accreditation body’s request. I believe, under normal condition this studies must be performed again once evey four year.
What I need to know is whether it is really necessary to perform these studies every year like the way some publications says or not.

Thanks your interest

TACO
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#7
I note the quote includes the statement that verification is the same as confirmation. Confirm annually.

If your national AB has their own rules then of course you need to abide by them.
 
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