Important parameters when analyzing samples in ISO accredited laboratory

The parameters all depend on the purpose of the test. You must meet the requirements of ISO 17025:2017 Clause 7.2.  A laboratory needs to understand the client’s requirement, i.e. the purpose of the test and if there are any self-imposed or regulatory specifications for a pass or fail. For example, a specific measurement should be below a particular threshold. When these conformity statements are made, the laboratory must specify the decision rule and get agreement from the client. This addresses whether measurement uncertainty is considered in the decision of a pass or failed result. When deeming the actual test method as suitable (fit for purpose) the laboratory needs to follow regulatory or sector guidelines and any mandatory requirements from the accreditation body. For example which method performance parameters such as limit of detection are evaluated. It usually starts by proving the method is specific, sensitive enough, and accurate (from assessing trueness and precision).

If you are interested, view the ISO 17025 toolkit procedure for validation and verification of methods, named Test and Calibration Method Procedure, along with two supporting documents Test Method Development, Verification and Validation Register and Test Method Development, Verification, and Validation Record. The procedure is also available separately at https://advisera.com/17025academy/documentation/test-and-calibration-method-procedure/