本标准是为放射性分析界的专业部门（即生物测定、常规环境监测、环境恢复和废物管理、放射性药物和核能化学）开发的MQA项目的指南。该标准还提供了建立更有限目标的方法，这些目标管理单个实验室的日常运营，包括强制执行的协议、建议和信息，以实施和维护放射分析QA计划。放射分析数据的整体效用来自于可防御和可追踪测量的结合，然后经过仔细规划以确定数据质量目标（DQO）。 本标准仅涉及用户程序中处理测量相关问题的方面。关于DQOs的使用指南见附录。本标准涉及a）国家计量保证计划的运行框架b）认证机构的作用；美国国家标准与技术研究所（NIST）；以及参考，监控，和服务实验室c）监控或参考实验室制备和分配测试介质的协议d）计算放射性分析测量所需精度和精密度参数的基础e）测试结果评估和报告的协议f）测试结果评估和评估以及报告评估的协议认证机构的调查结果g）确定每种放射性核素的决定极限浓度和先验最低可检测浓度的指南（见附件）h）服务实验室向客户报告放射性分析结果的要求i）适用于服务、监测和试验的可行QA计划的十一个关键要素，和参考实验室j）服务、监测和参考实验室的QA和QC计划由于这是一项总括性MQA标准，因此没有针对适用于放射分析实验室常规操作的精度、准确度或检测限的最低性能标准制定指导或要求。 然而，本标准要求服务实验室及其客户（来自同一公司或政府组织内部，或外部）在预处理协议或合同中为每种放射性核素制定精度、偏差、检测限和其他质量性能规范。这些质量性能规范应与要求放射性分析的数据质量目标相关。对于需要质量测量保证计划的放射分析，本标准要求使用第三方监测实验室来评估服务实验室的持续能力，以满足预测试要求- 已制定的合同绩效规范。如果客户和服务实验室同意，只要满足本标准中规定的监控实验室要求，服务实验室的内部质量保证计划可作为监控实验室使用。本标准概述了维持放射分析实验室可行的测量保证计划所需的最低要求。如本标准所述，对参考实验室、监测实验室和服务实验室进行测试，以正确测定各种测试类别中规定的放射性核素，仅用于认证目的。 制定本测试计划是为了确保所有放射性分析实验室至少拥有代表每种放射性排放类型的辐射测量仪器，该仪器已使用可追溯至NIST的放射性材料进行校准。该测试被认为是认证过程中的最低努力。如前所述，要求放射性分析的个人或组织有责任在服务实验室合同中纳入每种放射性核素和基质的详细性能规范。应使用监测实验室评估服务实验室是否符合性能规范。 已经制定了几个附件，以提供额外的背景信息、澄清，以及在某些情况下，标准的要求。附件被视为本标准的一部分，因此，应遵循规定的要求。并提供信息和指导，以支持本标准中概述的一般概念和建议。

This standard serves as a guide for MQA programs developed for specialized sectors of the radioassay community, that is bioassay, routine environmental monitoring, environmental restoration and waste management, radiopharmaceuticals, and nuclear power chemistry. The standard also provides the means for establishing the more limited objectives that govern day-to-day operations of an individual laboratory, including mandated protocols, recommendations, and information to implement and maintain a radioassay QA program. The overall utility of radioassay data results from the combination of defensible and traceable measurements, preceded by careful planning to determine data quality objectives (DQO). This standard addresses only those aspects of the user's program that deal with measurement-related issues. Guidance on the use of DQOs is provided in annex. This standard addresses a)The operational framework of a national measurement assurance program b)The roles of the accrediting organization; the National Institute of Standards and Technology (NIST); and the reference, monitoring, and service laboratories c)The protocol for the preparation and distribution of test media by the monitoring or reference laboratories d)The bases for calculating the required accuracy and precision parameters of radioassay measurements e)The protocol for the evaluation and reporting of test results f)The protocol for the assessment and evaluation of test results and reporting assessment findings by the accrediting organization g)Guidance for determining the decision limit concentration and the a priori minimum detectable concentration for each radionuclide (see annex ) h)The requirements for reporting radioassay results by service laboratories to the customer i)Eleven key elements of a viable QA program applicable to the service, monitoring, and reference laboratories j)The QA and QC programs for the service, monitoring, and reference laboratories Since this is an umbrella MQA standard, no guidance or requirements have been established for the minimum performance criteria of precision, accuracy, or detection limits applicable to the routine operation of a radioassay laboratory. However, this standard requires that the service laboratory and its client (either from within the same company or governmental organization, or external) establish precision, bias, detection limit, and other quality performance specifications for each radionuclide within a preprocessing agreement or contract. These quality performance specifications shall be related to the data quality objectives requiring the radioassays. For radioassays requiring a quality measurement assurance program, this standard requires the use of a third-party monitoring laboratory to evaluate the ongoing capability of the service laboratory to meet pre-established, contractual performance specifications. If agreed by the client and service laboratory, the internal QA program of the service laboratory may function as a monitoring laboratory as long as the requirements for the monitoring laboratory as established in this standard are met. This standard has outlined the minimum requirements necessary to maintain a viable measurement assurance program by a radioassay laboratory. As outlined in this standard, the testing of the reference, monitoring, and service laboratories to assay radionuclides specified in the various testing categories properly is for accreditation purposes only. This testing program has been developed to ensure that all radioassay laboratories have, at a minimum, radiation measurement instrumentation, representing each radioactive emission type, that has been calibrated with radioactive materials traceable to NIST. This testing is considered a minimum effort in the accreditation process. As stated previously, it is the responsibility of a person or organization requiring radioassays to incorporate detailed performance specifications for each radionuclide and matrix within a contract for the service laboratory. A monitoring laboratory shall be utilized to evaluate the compliance by the service laboratory with the performance specifications. Several annexes have been developed to provide additional background information, clarifications, and, in some cases, requirements of the standard. Annex is considered part of this standard and, as such, the requirements specified shall be followed. Annexes, and provide information and guidance to support the general concepts and recommendations outlined in this standard.