Interpretation of the new ISO Guide 80—Guidance for the in-house preparation of quality control materials in the laboratory

Abstract

Reference materials (RMs) have been widely used in measurement laboratories, and it is critical to recognise that the material most appropriate for a particular application should be used. Certified reference materials (CRMs) are used for method validation, the calibration of a measurement system and all other aspects of the evaluation of the measurement system where the trueness of the measurement result is required. For other aspects, such as quality control, precision studies, the checking of the variability between operators, where the results are compared relatively, any suitable reference material can be used. ISO/REMCO, the ISO Committee on Reference Materials, has prepared ISO Guide 80, a guidance document for the preparation of quality control materials (QCMs). QCMs are mostly used to monitor the performance of laboratory methods that have already been validated over time to be able to detect change or when a method goes out of statistical control. QCMs are RMs and have to be sufficiently homogeneous and stable for the intended use. QCMs are usually prepared by laboratory staff for use only, and therefore, the requirements for in-house QCMs are less demanding than those for a CRM.The quality assessment of QCMs should involve homogeneity and stability assessments, and a limited characterization of the material to provide an indication of its relevant property values and their variation, prior to use.(Chin J Lab Med, 2016, 39: 988-990) Key words: Reference standard; Quality control