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Equipment qualification

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Guest user Created:   Nov 17, 2020 Last commented:   Nov 19, 2020

Equipment qualification

I come from a cGMP background so DQ/IQ/OQ/PQ is standard for all equipment, but now I'm trying to set up an ISO 17025 compliant lab and am not sure if I need to do the same qualification. Would calibration and verification to make sure the equipment is functioning (using a lab developed reference standard, if CRM is not available) suffice?

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Tracey Evans Nov 19, 2020

Yes, it is a different approach for the same purpose. Typically the Design and Installation Qualification (DO and IQ) activities are performed by the supplier on commissioning, with some input by the laboratory to run certain samples and develop a method. In a 17025 those first steps need to cover clause 6.4 for equipment, as well as 6.5, Metrological traceability of results. That means making sure the equipment is selected and can perform as expected and there is a way through calibrations, to provide an unbroken link for measurements, to SI units (international references).

You are correct,

Yes, it is a different approach for the same purpose. Typically the Design and Installation Qualification (DO and IQ) activities are performed by the supplier on commissioning, with some input by the laboratory to run certain samples and develop a method. In a 17025 those first steps need to cover clause 6.4 for equipment, as well as 6.5, Metrological traceability of results. That means making sure the equipment is selected and can perform as expected and there is a way through calibrations, to provide an unbroken link for measurements, to SI units (international reference).

You are correct, in an average 17025 laboratory, the Operational Qualification and Performance Qualification is the same as method validation and measurement uncertainty evaluation (clause 7.2 and 7.6) and ongoing assurance, i.e. ensuring the validity of results through the use of controls and reference standards (clause 7.7).

Certain equipment must be calibrated, and the measurement uncertainty calculated, i.e. when it is used to establish the metrological traceability and if the validity of the reported results would be affected by the measurement accuracy and uncertainty of the equipment. Remember this does not only apply to apparatus, but also to standard reference materials or objects. This is where a laboratory will use an accredited calibration laboratory or a reputable supplier of certified reference materials. Once you have such material and a certificate of analysis, and you have evaluated the performance of your method, you can perform intermediate checks using your inhouse reference material, as long as it is well characterised (have lots of data) against the certified material (CRM) traceable to an International standards. For certain sectors, e.g pharmaceutical, a CRM has to be analysed for each analysis batch to verify, for example the performance of an HPLC or GC. The risk must be managed by the laboratory, based on the type of test and the regulatory nature of the sector.

For more information, have a look at

Also refer to  ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement Results and ILAC G24:2007 Guidelines for the determination of calibration intervals of measuring instruments, available from https://ilac.org/publications-and-resources/

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