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| 計量的質量控制參考材料示范測量系統中的特定 | |||
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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.
翻譯：只作為參考
參考材料（RMS）被廣泛用于測量實驗室用于各種目的，并認識到，最適合于特定應用的材料，應使用是很重要的。認證標準物質（CRM），即那些具有財產價值和計量學的有效方法主要用于方法驗證和校準提供計量溯源性分配相關的不確定性。
用于計量的質量控制參考材料的制備（即控制測量的質量而不是產品的）是重要的活動，它提供適合于日常的示范該測量系統中的特定（部分）是根據統計控制材料。這樣的材料不要求表征計量學有效的程序，并且可以制備“點播”，即通過實驗室工作人員熟悉自己的行為，以滿足特定的質量控制要求。
參考材料具有充分均勻和穩定是必要的計量質量控制的目的，如展示的測量系統處于統計控制，按預期執行，并提供了可靠的結果;哪里的測定結果的正確度不是關鍵的。不同行業使用各種術語來描述這些材料（例如，在內部參考材料，質量控制材料，檢查樣品等）。對于本指南的目的，術語“質控品”（QCMS）將被用于簡化反復引用。而標準物質是通過建立的參考材料生產商生產的并且是可商購的，
QCMS往往是由一個實驗室供自己內部使用準備。頻繁，QCMS的特征在于只在有限的范圍內（屬性值的有限數目），并為特定的實驗室應用。
制備質控品的理由可以是一種或下列因素的組合：
- 有代表盡可能接近常規樣品，適用于質量控制的RM;
- 有一個合適的一天到一天的RM來補充市售的CRM;
- 沒有合適的CRM存在;
- 應用程序不需要有（對指定的屬性值如可追蹤性和不確定性），客戶關系管理的頗具特色的材料。
QCMS是客戶經理，并作為ISO指南34這樣的要求[1]生產RM的應用。但是，如果該材料是由制備實驗室僅用于在內部，一些要求（例如運輸穩定性）可以放寬。一個QCM的制備與一個CRM和那些準備QCMS不妨咨詢ISO指南34 [1] 35 [2]為進一步的指導。在適當情況下，本指南將參考這些指南的有關部分。
人們認識到，許多實驗室需要QCMS的目的是最大限度地減少需要準備的材料的時間和精力。為此，許多實驗室使用對此有分析數據的身體提供實實在在的產品樣品。許多案例都包括在本指導文件附件提供如何將這些數據進行處理，以確認適用性材料的目的例子。
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