ASTM D8428-21 建立分析员执行试验方法能力的标准指南
基本信息
标准号：ASTM D8428-21
发布单位或类别：美国-美国材料与试验协会（US-ASTM）
发布日期：2021-12-01
实施日期：
废止日期：
CCS分类：
ICS分类：
03.100.30 公司(企业)的组织和管理 – 劳动资源管理
适用范围/摘要
1.1 本指南涵盖了评估分析员对特定产品或一组产品（例如轻馏分）执行特定测试方法的能力的一般指南。它还为执行评估可能采取的一些方法提供了指导。 1.2 本指南旨在建立测试方法整个性能的能力（即样品制备、仪器设置、标准和试剂的制备、测试方法的性能、计算等），或者能力的建立可能仅限于测试方法性能的特定方面（例如，样品制备）。 1.3 只有当实验室本身能够严格按照测试方法进行测试（即，具有满足测试方法要求的设备、标准和试剂、材料等）时，才能建立分析能力。 1.4 本指南不包括分析员的培训，但审查培训记录以表明分析员已接受培训。 1.5 本指南不包括建立分析师的一般技术能力。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。 本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 分析员的能力是影响在实验室中执行的测试方法是否产生准确和精确的测试结果的最大因素之一，因此是管理实验室的一个重要方面。 4.2 一些法规、国际管理体系标准（如ISO 9001、ISO 17025、AASHTO R-18等）和质量管理体系可能需要建立分析员能力。本指南旨在为满足此类要求可能采取的一些方法提供一般指导。
1.1 This guide covers general guidance on assessing the competence of an analyst to perform a specific test method for a specific product or set of products (for example, light distillates). It also provides guidance on some of the possible approaches that may be taken to perform the assessment. 1.2 This guide is intended for the establishment of competence for the entire performance of a test method (that is, sample preparation, instrument set up, preparation of standards and reagents, performance of the test method, calculations, etc.) or the establishment of competence may be limited to a specific aspect in the performance of a test method (for example, sample preparation). 1.3 The establishment of analyst competence should only be performed if the laboratory itself is capable of performing the test in strict conformance with the test method (that is, has the equipment, standards and reagents, materials, etc. which meet test method requirements). 1.4 This guide does not cover training of an analyst, other than a review of training records to indicate the analyst has been trained. 1.5 This guide does not cover the establishment of general technical competence of an analyst. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 Analyst Competence is one of the largest influencing factors in whether a test method performed in a laboratory yields accurate and precise test results and thus is an important aspect in managing a laboratory. 4.2 Some Regulations, International Management System Standards, such as ISO 9001, ISO 17025, AASHTO R-18, etc., and Quality Management Systems may require the establishment of analyst competence. This guide aims to provide general guidance in some of the possible approaches that may be taken to fulfill such requirements.
研制信息
起草单位：
起 草 人：
归口单位：
D02.94