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Laboratory Verification after validation

T

Tallinec

Involved In Discussions
#1
#1
Hello.

Please give us your opinion about the question.

Our lab has validated the laboratory-developed method according to requirements of clause 7.2.2.1 of the standard. Shall this laboratory-developed method be verified or validation is enough?
 
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T

Tallinec

Involved In Discussions
#3
#3
John Broomfield said:
I’ve always verified a test for conformity to its method before validating it. Then I know what I’ve validated.

But for some reason this guidance suggests that validation comes before verification:

https://www.nata.com.au/phocadownlo...Quantitative-and-Qualitative-Test-Methods.pdf

Please study it for your situation and then let us know.
Click to expand...
Our laboratory-developed method covers calibration of measuring equipment but not test methods. Does the mentioned "NATA General Accreditation Guidance" suitable for laboratory-developed methods of calibration?
 
D

dwperron

Trusted Information Resource
#4
#4
ISO 17025 calls for you to "verify" the method first. The verification for a laboratory developed procedure includes specifying it to the customer and getting their approval (7.2.1.4), verifying that you can perform the procedure (7.1.2.5), and that the development of the method follows the requirements in 7.2.1.6.
The validation process is where you prove that your method produces acceptable results (7.2.2.1)
 
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