1.1 本指南为制定和维护测量系统质量控制计划提供了指导。为一般项目考虑事项、质量控制样品的制备、质量控制样品的分析、质量控制数据分析、分析员资格鉴定、测量系统校准、测量方法资格鉴定和测量系统维护提供指导。 1.2 本指南在以下章节中提供: 部分 一般质量控制计划注意事项 5. 质量控制样品 6. 质量控制样品分析 7. 质量控制数据分析 8. 分析师资格 9 测量系统校准 10 测量方法和系统的鉴定 11 测量系统维护 12 1.3 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 实验室质量保证计划是核工业实验室的基本计划。指导 C1009 为核工业内的分析实验室制定质量保证计划提供指导。 本指南涉及实验室质量保证计划的测量控制方面。 图1 显示了测量控制与实验室质量保证计划其他基本方面的关系。 图1 分析实验室数据的质量保证 4.2 测量控制程序的基本目的是提供 使用 保证（实时控制）测量系统的性能令人满意，并提供量化测量系统性能所需的数据。这个 使用 通常通过对质量控制样品（分析员已知或未知的参考值）进行满意的分析来提供保证。 量化测量系统性能所需的数据通常通过质量控制样本的分析或过程样本的重复分析，或两者都提供。除了分析质量控制样品外，实验室质量控制计划还应解决( 1. )标准品和试剂的制备和验证( 2. )数据分析程序和文件( 3. )校准和校准程序( 4. )测量方法鉴定( 5. )分析师资格，以及( 6. )其他一般计划注意事项。实验室质量保证的其他要素也会影响实验室质量控制计划。 这些要素或要求包括( 1. )化学分析程序和程序控制( 2. )记录存储和检索要求( 3. )内部审计要求( 4. )组织考虑，以及( 5. )培训/资格要求。在可能的情况下，本标准将主要处理质量控制要求，而不是指南中提出的总体质量保证要求 C1009 . 4.3 尽管本指南使用暗示性而非规定性语言（例如，“应该”而非“应该”），但所述要素不应解释为可选。有效和全面的实验室质量控制计划至少应全面、充分地考虑并包括第节中列出的所有要素 1. 并在本指南的相应参考章节中。

1.1 This guide provides guidance for establishing and maintaining a measurement system quality control program. Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification, and measurement system maintenance. 1.2 This guidance is provided in the following sections: Section General Quality Control Program Considerations 5 Quality Control Samples 6 Analysis of Quality Control Samples 7 Quality Control Data Analysis 8 Analyst Qualification 9 Measurement System Calibration 10 Qualification of Measurement Methods and Systems 11 Measurement System Maintenance 12 1.3 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 A laboratory quality assurance program is an essential program for laboratories within the nuclear industry. Guide C1009 provides guidance for establishing a quality assurance program for an analytical laboratory within the nuclear industry. This guide deals with the control of measurements aspect of the laboratory quality assurance program. Fig. 1 shows the relationship of measurement control with other essential aspects of a laboratory quality assurance program. FIG. 1 Quality Assurance of Analytical Laboratory Data 4.2 The fundamental purposes of a measurement control program are to provide the with-use assurance (real-time control) that a measurement system is performing satisfactorily and to provide the data necessary to quantify measurement system performance. The with-use assurance is usually provided through the satisfactory analysis of quality control samples (reference value either known or unknown to the analyst). The data necessary to quantify measurement system performance is usually provided through the analysis of quality control samples or the duplicate analysis of process samples, or both. In addition to the analyses of quality control samples, the laboratory quality control program should address ( 1 ) the preparation and verification of standards and reagents, ( 2 ) data analysis procedures and documentation, ( 3 ) calibration and calibration procedures, ( 4 ) measurement method qualification, ( 5 ) analyst qualification, and ( 6 ) other general program considerations. Other elements of laboratory quality assurance also impact the laboratory quality control program. These elements or requirements include ( 1 ) chemical analysis procedures and procedure control, ( 2 ) records storage and retrieval requirements, ( 3 ) internal audit requirements, ( 4 ) organizational considerations, and ( 5 ) training/qualification requirements. To the extent possible, this standard will deal primarily with quality control requirements rather than overall quality assurance requirements, which are addressed in Guide C1009 . 4.3 Although this guide 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 control program should, at minimum, completely and adequately consider and include all elements listed in Section 1 and in the corresponding referenced sections of this guide.