GB/T 15000.5-2023 Directives for the work of reference materials—Part 5:The in-house preparation of quality control materials(QCMs)

Scope

This document provides the basic characteristics of standard samples used for quality control (QC), which are suitable for the process of developing standard samples in laboratories by competent personnel (to avoid instability caused by transportation conditions). This document is also applicable to very stable samples (with no significant risk of changes in the characteristic values during transportation). The main users of this document are laboratory personnel who need to develop specific quality control samples (QCMs). If there are transportation requirements, such as when laboratories have different application sites or participate in proficiency testing programs, the development of QCMs should refer to the relevant requirements of ISO Guide 34 and ISO Guide 35. The detailed description of the development of reference materials (RMs) in ISO Guide 34 and ISO Guide 35 is also applicable to the development of QCMs. However, the requirements for "internal" QCMs are lower than those for certified reference materials (CRMs). The development of QCMs includes evaluations of uniformity and stability, providing indicative values to characterize relevant characteristics and their changes for ease of use. This document provides the quality standards that samples should meet to demonstrate that the measurement system is under statistical control. Guidelines for the application of QCMs, such as plotting quality control charts, are covered in references [3], [4], [5], and [6], so this document does not include them. The framework and structure of this document provide general information on the development of QCMs in the main chapters, and some industry-specific case studies are included in the appendix. The case studies are not complete "operating manuals", but highlight the key considerations when developing QCMs. The complexity and detail of the case studies vary, and they contain industry-specific professional terminology, but can provide a range of information for labora

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