ISO 17025 Method Validation and Verification for Test Lab

#1
Hi everyone,

We are a testing lab looking to become ISO 17025 accredited, but I have some confusion surrounding the method validation and verification that needs to be completed for each analysis we offer.

For example, we purchased a Total Organic Carbon analyzer to measure TOC, and purchased an installation package which included IQOQ and operator training. We are using a standard method according to the US Pharmacopoeia (USP). My question is how do we validate and verify this method? Do we run TOC analysis on reference standard controls of known concentration multiple times? How many samples will we need to test in order for it to be a verified method in our lab?

Any advice on the best way to accomplish this would be greatly appreciated.

Thanks!
 
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Enghabashy

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#2
*Some of this issues could be stated in the regulatory procedures issued by the accreditation body " A2l /UKAS/Dkks ; most of them are referenced with ILAC as well ---"

** the accreditation period could be valid for 4 years ; therefore all tests scope should be covered through 4 years programs


** the validation & verification should cover accreditation procedures “ we can find them in accreditation published ‘ in web “ ; the own lab. procedures ; it’s covering also the internal verification of test by another independent competent personnel , the referenced material / masters from accredit sources ; intermediate checks programs /plans؛ statistical QC / Cont charts ; MSA, the Interlaboratory comparison programs ؛ the blind samples methods ; sharing with other Labs in proficiency testing programs ; measurement Audit by competent independent party
*there’s specific requirements for clinical /medical; foods --- including special requirements for forensic labs also ; --- all testing standards Specs should be considered when setting valid. & verification processes & to cover 7.2 , 7.6 , 7.7& 8.5 clauses
 

dwperron

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#3
First, as long as you do not deviate from the USP standard method you are in good shape. 17025 only requires that you validate "non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. "

17025 is vague regarding the level of rigor for verification that you are competent to perform the test: " 7.2.1.5 The laboratory shall verify that it can properly perform methods before introducing them by ensuring that it can achieve the required performance. Records of the verification shall be retained. If the method is revised by the issuing body, verification shall be repeated to the extent necessary". I would contact my accreditation body to see what guidance they might have for the acceptable level of verification of a method, otherwise that is left to the discretion of the auditor.
 
#4
First, as long as you do not deviate from the USP standard method you are in good shape. 17025 only requires that you validate "non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. "

17025 is vague regarding the level of rigor for verification that you are competent to perform the test: " 7.2.1.5 The laboratory shall verify that it can properly perform methods before introducing them by ensuring that it can achieve the required performance. Records of the verification shall be retained. If the method is revised by the issuing body, verification shall be repeated to the extent necessary". I would contact my accreditation body to see what guidance they might have for the acceptable level of verification of a method, otherwise that is left to the discretion of the auditor.
Thank you so much for your reply @dwperron. It is good to know that as long as we stick to the USP methods then we do not need to validate them. That makes things a small bit easier for us!! Regarding the verification, I did contact my accrediting body but they were not as helpful as I had hoped. They suggested simply doing research to see what was 'the norm' and couldn't give direction as they wanted to remain impartial and non-biased.

I think we will run test samples using different accredited control reagents and go from there. I can't see what other way we could go about verifying all methods.
 

Miner

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#5
I will preface this with acknowledging that I am not an expert in 17025, but the following MAY be options for validating "non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. " if this, in fact, applies to you.
  • Perform the standard and the non-standard tests side by side on the same specimens then evaluate the results using a Bland-Altman plot or a Youden plot
  • Perform the tests using known standards then evaluate the results using a 1-sample t-test.
 
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