标准编号：ISO Guide 80:2014
中文名称：质量控制材料（QCMs）的内部准备指南
英文名称：Guidance for the in-house preparation of quality control materials (QCMs)
发布日期：2014-08
标准范围
This Guide 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 inwhich they will be used (i.e. where instability due to transportation conditions is avoided). The contentof this Guide also applies to inherently stable materials, which can be transported to other locationswithout 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 forspecific in-house quality control applications. Preparation of QCMs, where transportation is a necessarycomponent of the supply chain, such as laboratory sites at different locations or for proficiency testingschemes, should conform to the relevant requirements of ISO Guides 34[1] and 35.[2]The description of the production of reference materials (RMs), as detailed in ISO Guide 34[1] andISO Guide 35[2] is also applicable to the preparation of quality control materials (QCMs). However, therequirements 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 limitedcharacterization of the material to provide an indication of its relevant property values and theirvariation, prior to use. This document provides the quality criteria that a material should fulfil tobe considered fit-for-purpose for demonstrating a measurement system is under statistical control.Guidance on uses of such materials, for example setting up a QC chart, is adequately covered elsewhere[3],[4],[5],[6] and is not included in this Guide.The layout and structure of this Guide provides general information on the preparation of QCMs in themain chapters, with specific case studies covering a range of sectors in the annexes. The case studiesare not complete “process manuals” but are included to highlight some of the key considerations whenpreparing 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 materialto be prepared and be aware of any potential problems due to matrix effects, contamination, etc.
立即下载标准文件