1.1 本指南涵盖了核工业内分析实验室质量保证（QA）计划的建立和维护。参考ASME NQA-1和ISO/IEC 17025的关键要素，为分析实验室操作的功能方面提供指导。当按照建议实施时，本指南中的实践将为实验室提供全面的质量保证计划。实践按功能分组，构成实验室质量保证计划的基本要素。 1.2 实验室质量保证计划的基本要素按以下顺序出现: 部分 组织 5. 质量保证计划 6. 培训和资格 7. 程序 8. 实验室记录 9 记录的控制 10 管理客户请求和对客户的承诺 11 采购控制 12 测量设备和材料的控制 13 测量控制 14 不合格工作的控制 15 候选操作 16 预防措施 17 1.3 样本采集和相关采样程序不在本指南的范围内。 用户可参考小组委员会C26.02制定的采样规程。 1.4 核实验室需要处理各种危险材料，包括但不限于放射性样品和材料。中讨论了正确处理这些材料的必要性 13.2.4 . 虽然本指南侧重于核实验室质量保证计划，但核材料的正确处理对于质量保证计划的正常运行至关重要。 1.5 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 分析实验室的任务是提供核燃料循环材料的质量分析。分析实验室质量保证计划由计划和系统的行动组成，这些行动需要提供信心，以确保该任务以可接受和一致的方式进行。 4.2 参与核燃料循环材料分析的分析实验室需要执行记录在案的质量保证计划。监管机构可能会对实验室的全部或部分操作强制执行某种形式的控制要求。 对于需要遵守ASME NQA-1或ISO/IEC 17025或许多认证机构的要求的实验室操作，也需要有记录的QA程序。即使未经授权，实验室质量保证计划也应作为一种健全的科学技术实践而制定。本指南为建立和维护质量保证计划提供指导，以控制对确保化学分析质量至关重要的分析操作。 4.3 质量保证计划由组织设计和实施，以确保满足过程、产品或服务的质量要求。 质量体系是对工艺或分析方法特定的技术要求的补充。每个实验室应确定适用的计划要求，并使用标准来实施符合适当要求的质量计划。本指南可用于制定和实施分析实验室质量保证计划。第节列出了其他有用的实施标准和文件 2. 和 附录X1 . 4.4 核燃料循环内分析实验室的质量保证指南旨在为实验室的每项主要活动提供指导，并显示在 图1 . 以下各节说明了每个主题的适用标准。 图1 分析实验室质量保证体系的基本要素 4.5 尽管本指南描述了“推荐做法”和“建议”，并使用了暗示性而非规定性语言（例如，“应该”而不是“应该”），但所涉及的要素不应解释为可选。有效和全面的实验室质量保证/质量控制计划充分考虑并包括第节中列出的所有要素 5 – 17 本指南的。

1.1 This guide covers the establishment and maintenance of a quality assurance (QA) program for analytical laboratories within the nuclear industry. References to key elements of ASME NQA-1 and ISO/IEC 17025 provide guidance to the functional aspects of analytical laboratory operations. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA program. 1.2 The essential, basic elements of a laboratory QA program appear in the following order: Section Organization 5 Quality Assurance Program 6 Training and Qualification 7 Procedures 8 Laboratory Records 9 Control of Records 10 Management of Customer Requests and Commitments to Customers 11 Control of Procurement 12 Control of Measuring Equipment and Materials 13 Control of Measurements 14 Control of Nonconforming Work 15 Candidate Actions 16 Preventative Actions 17 1.3 Collection of samples and associated sampling procedures are outside the scope of this guide. The user may refer to sampling practices developed by Subcommittee C26.02. 1.4 Nuclear laboratories are required to handle a variety of hazardous materials, including but not limited to radioactive samples and materials. The need for proper handling of these materials is discussed in 13.2.4 . While this guide focuses on the nuclear laboratory QA program, proper handling of nuclear materials is essential for proper function of the QA program. 1.5 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 The mission of an analytical laboratory is to provide quality analyses on nuclear fuel cycle materials. An analytical laboratory QA program is comprised of planned and systematic actions needed to provide confidence that this mission is conducted in an acceptable and consistent manner. 4.2 The analytical laboratories involved in the analysis of nuclear fuel cycle materials are required to implement a documented QA program. Regulatory agencies may mandate some form of control requirements for all or a part of a laboratory's operation. A documented QA program is also necessary for those laboratory operations required to comply with ASME NQA-1 or ISO/IEC 17025, or the requirements of many accreditation bodies. Even when not mandated, laboratory QA programs should be established as a sound and scientific technical practice. This guide provides guidance for establishing and maintaining a QA program to control those analytical operations vital to ensuring the quality of chemical analyses. 4.3 Quality assurance programs are designed and implemented by organizations to assure that the quality requirements for a process, product or service will be fulfilled. The quality system is complementary to technical requirements that may be specific to a process or analytical method. Each laboratory should identify applicable program requirements and use standards to implement a quality program that meets the appropriate requirement. This guide may be used to develop and implement an analytical laboratory QA program. Other useful implementation standards and documents are listed in Section 2 and Appendix X1 . 4.4 The guides for QA in the analytical laboratory within the nuclear fuel cycle have been written to provide guidance for each of the major activities in the laboratory and are displayed in Fig. 1 . The applicable standard for each subject is noted in the following sections. FIG. 1 Essential Elements of Analytical Laboratory Quality Assurance System 4.5 Although this guide describes “Recommended Practices” and “Recommendations” and uses suggestive rather than prescriptive language (for example, “should” as opposed to “shall”), the elements being addressed should not be interpreted as optional. An effective and comprehensive laboratory quality assurance/quality control program completely and adequately considers and includes all elements listed in Sections 5 – 17 of this guide.