ASTM C1009-13
制定和维护核工业化学分析实验室质量保证计划的标准指南
Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
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- 标准号
- ASTM C1009-13
- 发布
- 2013年
- 发布单位
- 美国材料与试验协会
- 替代标准
- ASTM C1009-13a
- 当前最新
- ASTM C1009-21
- 适用范围
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 product or service will be fulfilled. The quality system is complementary to specific technical requirements. 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.
4.5 Although the Standard 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 should, at minimum, completely and adequately consider and include all elements listed in Sections 5-94个各种实验室常用标准（三）
GB/T22275.1-2008良好实验室规范实施要求第1部分：质量保证与良好实验室规范 GB/T22275《良好实验室规范实施要求》分为7个部分，GB/T22275的本部分规定了GLP原则下质量保证活动的具体内容和要求，包括:质量保证人员的责任、质量保证人员与管理者的联系、质量保证人员资质及参与标准操作程序和研究计划的制定过程的情况、质量保证检查、质量保证活动的计划和对质量保证活动及方法的论证...
