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Reference materials (RMs) are widely used in measurement laboratories for a variety of purposes and it is important to recognize that the material most appropriate for a particular application should be used. Certified reference materials (CRMs), i.e. those which have property values and associated uncertainties assigned by metrologically valid procedures are primarily used for method validation and calibrations providing metrological traceability.
The preparation of reference materials for metrological quality control (i.e. control of the quality of measurements not products) is an important activity which provides materials suitable for the day-today demonstration that a particular (part of a) measurement system is under statistical control. Such materials do not require characterization by metrologically valid procedures, and can be prepared “inhouse”,i.e. by laboratory staff familiar with their behaviour, to fulfil specific quality control requirements.
Reference materials which are sufficiently homogeneous and stable are necessary for metrological quality control purposes, such as demonstrating a measurement system is under statistical control, performs as expected and provides reliable results; where the trueness of the measurement result is not critical. Different industries use various terminologies to describe such materials (e.g. in-house reference materials, quality control materials, check samples, etc.). For the purposes of this Guide, the term “Quality Control Materials” (QCMs) will be used to simplify repeated citation. While CRMs are produced by established reference material producers and are commercially available,
QCMs are often prepared by a laboratory for its own internal use. Frequently, QCMs are characterized only for a limited scope (a limited number of property values) and for specific laboratory applications.
The rationale for preparing quality control materials can be one or a combination of the following factors:
— to have an RM representing as closely as possible routine samples, suitable for quality control;
— to have a suitable day-to-day RM to complement a commercially available CRM;
— no suitable CRM exists;
— the application does not require a material having the full characteristics of a CRM (e.g. traceability and uncertainty for specified property values).
QCMs are RMs and as such the requirements of ISO Guide 34[1] for the production of RMs apply. However, if the material is only used in-house by the preparing laboratory, some requirements (e.g. for transport stability) can be relaxed. The preparation of a QCM is related to that of a CRM and those preparing QCMs may wish to consult ISO Guides 34[1] and 35[2] for further guidance. Where appropriate, this Guide will refer to relevant parts of these Guides.
It is recognized that the aim of many laboratories requiring QCMs is to minimize the time and effort needed to prepare the materials. To this end, many laboratories use samples of real products for which there is a body of analytical data available. A number of case studies are included as annexes of this guidance document to provide examples of how such data may be processed to confirm fitness for purpose of the materials.
翻译：只作为参考
参考材料（RMS）被广泛用于测量实验室用于各种目的，并认识到，最适合于特定应用的材料，应使用是很重要的。认证标准物质（CRM），即那些具有财产价值和计量学的有效方法主要用于方法验证和校准提供计量溯源性分配相关的不确定性。
用于计量的质量控制参考材料的制备（即控制测量的质量而不是产品的）是重要的活动，它提供适合于日常的示范该测量系统中的特定（部分）是根据统计控制材料。这样的材料不要求表征计量学有效的程序，并且可以制备“点播”，即通过实验室工作人员熟悉自己的行为，以满足特定的质量控制要求。
参考材料具有充分均匀和稳定是必要的计量质量控制的目的，如展示的测量系统处于统计控制，按预期执行，并提供了可靠的结果;哪里的测定结果的正确度不是关键的。不同行业使用各种术语来描述这些材料（例如，在内部参考材料，质量控制材料，检查样品等）。对于本指南的目的，术语“质控品”（QCMS）将被用于简化反复引用。而标准物质是通过建立的参考材料生产商生产的并且是可商购的，
QCMS往往是由一个实验室供自己内部使用准备。频繁，QCMS的特征在于只在有限的范围内（属性值的有限数目），并为特定的实验室应用。
制备质控品的理由可以是一种或下列因素的组合：
- 有代表尽可能接近常规样品，适用于质量控制的RM;
- 有一个合适的一天到一天的RM来补充市售的CRM;
- 没有合适的CRM存在;
- 应用程序不需要有（对指定的属性值如可追踪性和不确定性），客户关系管理的颇具特色的材料。
QCMS是客户经理，并作为ISO指南34这样的要求[1]生产RM的应用。但是，如果该材料是由制备实验室仅用于在内部，一些要求（例如运输稳定性）可以放宽。一个QCM的制备与一个CRM和那些准备QCMS不妨咨询ISO指南34 [1] 35 [2]为进一步的指导。在适当情况下，本指南将参考这些指南的有关部分。
人们认识到，许多实验室需要QCMS的目的是最大限度地减少需要准备的材料的时间和精力。为此，许多实验室使用对此有分析数据的身体提供实实在在的产品样品。许多案例都包括在本指导文件附件提供如何将这些数据进行处理，以确认适用性材料的目的例子。
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