ASTM C1009-2013a
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 C1009-2013a

发布日期

2013年

实施日期

废止日期

无

国际标准分类号

27.120.01 (Nuclear energy in general); 71.040.01 (

发布单位

US-ASTM

适用范围

4.1x00a0;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.

4.2x00a0;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 laboratoryx0027;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.

4.3x00a0;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.

4.4x00a0;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 Quality Assurance of Analytical Laboratory Data

4.5x00a0;Although the Standard Guide describes x201c;Recommended Practicesx201d; and x201c;Recommendationsx201d; and uses suggestive rather than prescriptive language (for example, x201c;shouldx201d; as opposed to x201c;shallx201d;), 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-