ISO指南80概述了用于质量控制（QC）目的的标准物质的基本特征，并描述了由合格人员在其使用设施内制备标准物质的过程（即避免因运输条件而产生的不稳定性）。本指南的内容也适用于内在稳定的材料，这些材料可以运输到其他地点，而不会导致相关财产价值发生任何重大变化。 本指南的主要受众是实验室工作人员，他们需要准备和使用特定内部质量控制应用的材料。 如果运输是供应链的一个必要组成部分，如不同地点的实验室或能力验证方案，QCM的准备应符合ISO指南34和35的相关要求。 ISO指南34和ISO指南35中详述的标准物质（RMs）生产说明也适用于质量控制材料（QCM）的制备。然而，“内部”QCM的要求比认证标准物质（CRM）的要求要低。QCM的制备应包括均匀性和稳定性评估，以及材料的有限表征，以在使用前提供相关性能值及其变化的指示。 本文件提供了材料应满足的质量标准，以证明测量系统处于统计控制之下。本指南不包括此类材料的使用指南。 本指南的布局和结构在主要章节中提供了QCM准备的一般信息，具体案例研究涵盖了附件中的一系列部门。案例研究不是完整的“过程手册”，但其目的是强调编制QCM时的一些关键考虑因素。案例研究的复杂性和细节各不相同，包括特定行业的术语，但为实验室工作人员提供了一系列可供借鉴的信息。 预计参与QCM制备的人员将对拟制备的材料类型有所了解，并了解因基质效应、污染等而产生的任何潜在问题。

ISO Guide 80 outlines the essential characteristics of reference materials for quality control (QC) purposes, and describes the processes by which they can be prepared by competent staff within the facility in which they will be used (i.e. where instability due to transportation conditions is avoided). The content of this Guide also applies to inherently stable materials, which can be transported to other locations without risk of any significant change in the property values of interest. The primary audience for this Guide is laboratory staff who are required to prepare and use materials for specific in-house quality control applications. Preparation of QCMs, where transportation is a necessary component of the supply chain, such as laboratory sites at different locations or for proficiency testing schemes, should conform to the relevant requirements of ISO Guides 34 and 35. The description of the production of reference materials (RMs), as detailed in ISO Guide 34 and ISO Guide 35 is also applicable to the preparation of quality control materials (QCMs). However, the requirements for "in-house" QCMs are less demanding than those for a certified reference material (CRM). The preparation 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. This document provides the quality criteria that a material should fulfil to be considered fit-for-purpose for demonstrating a measurement system is under statistical control. Guidance on uses of such materials is not included in this Guide. The layout and structure of this Guide provides general information on the preparation of QCMs in the main chapters, with specific case studies covering a range of sectors in the annexes. The case studies are not complete "process manuals" but are included to highlight some of the key considerations when preparing QCMs. The case studies vary in complexity and detail, including sector specific terminology, but provide a range of information for laboratory staff to draw from. It is expected that those involved in QCM preparation will have some knowledge of the type of material to be prepared and be aware of any potential problems due to matrix effects, contamination, etc.