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Method validation and method verification... Help

Discussion in 'ISO 17025 - Calibration and Test Laboratories' started by Test_Engineer, Nov 10, 2019.

  1. Test_Engineer

    Test_Engineer New Member

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    Hi all,

    I am struggling in building the system for ISO 17025:2017. specially in method validation and method verification.

    As I understand that, the Verification means I must ensure the parameters required by the test method can be done by my equipment ( so I just need to show that the parameter can reach the limit and the equipment performance is acceptable). <<<< Correct me if I am wrong.

    And for method validation ( this is the tough one) I need to do it if I used non standard method

    ISO 17025 says.
    "The laboratory shall validate non-standard methods, laboratory-developed methods and
    standard methods used outside their intended scope or otherwise modified " so the standard method ( such as ISO IEC etc..) need only verification (as I explained above) and I don't need any validation!.

    But I meet some experts talking about the repeatability and reproducibility in the test method and I must do validation to endure I can get these result.o_O

    Actually I don't mind doing it ( to stay in the safe side) but one major issue with me is that I perform qualitative tests (for example IEC 60068-2-1 2007 Test A - Cold) which is basically placing the test item inside the chamber for a period of time then identify any visual changes on the test item!
    so the only output I can get is the chart from the chamber Temperature versus time graph!
    beside the IEC 60068 standard don't mention anything about repeatability or reproducibility !!!



    Please if any one know what should I do ! :confused:
     
  2. Test_Engineer

    Test_Engineer New Member

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    .... any Ideas guys?
     

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