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

GB/T 15000.5-2023 is the English-translated version of 标准样品工作导则 第5部分：质量控制样品的内部研制.

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

Its scope clause reads: This document provides the basic characteristics of standards for use in quality control (QC), suitable for use in laboratories developed by competent personnel.

Process for standard samples (to avoid instabilities due to shipping conditions). This document also applies to very stable samples (during transport There is no risk of significant changes in the value of the characteristic of interest).

The primary users of this document are laboratory personnel who need to develop specific quality control samples (QCM). If there are transport requirements, e.g. Laboratories have different application locations or proficiency testing plans.

The development of QCM should refer to the relevant ISO Guide34 and ISO Guide35. Require. The detailed description of the development of reference samples (RM) in ISO Guide34 and ISO Guide35 also applies to the development of QCM, but for "internal The requirements for "Part 1" QCM are lower than those for certified reference samples (CRM).

The development of QCM includes uniformity and stability assessment, providing tables Indicative values of 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 performs under statistical control. Guidance on the application of QCM, such as drawing quality control charts, has been included in references [3], [4], [5], [6]. cover, so it is not included in this document.

The framework and structure of this document provide general information on developing QCM in the main chapters and include some industry-specific information in the appendices. case study.

The case studies are not intended to be complete "how-to manuals" but highlight key considerations when developing a QCM. case study Studies vary in complexity and detail and contain industry-specific terminology, but provide a range of Information.

All parties involved in the development of QCM need to have a certain understanding of the type of sample being developed, and must pay attention to aspects such as matrix effects and contamination. potential problems. Its clauses include normative reference documents; terms and definitions.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 46 pages — is available in the English PDF.

GB 38031-2025|GB/T 15000.5|GB/T 15000.5-1994|GB/T15000.5-2023|GB/T 1.1-2020|GB/T 15000|GB/T 15000.7-2021|GB/T 3358.1-2009

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