The new ISO Guide 80: Guidance for the in-house preparation of quality control materials (QCMs)

Abstract

Reference materials (RMs) are widely used in measurement laboratories for a variety of purposes, and it is important 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 in-house 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 as such have to be sufficiently homogeneous and stable for the intended use. QCMs are usually prepared in-house by laboratory staff for in-house use only, and therefore, the requirements for “in-house” QCMs are less demanding than those for a CRM. For example, transport issues are not of concern. The quality assessment of QCMs should involve homogeneity and stability assessments, and a limited characterisation of the material to provide an indication of its relevant property values and their variation, prior to use.