Interpretation of the new ISO Guide 80-Guidance for the in-house preparation of quality control materials in the laboratory / 中华检验医学杂志

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 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 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 .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.