【国外标准】 Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry

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 System4.5 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.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:  SectionOrganization 5Quality Assurance Program 6Training and Qualification 7Procedures 8Laboratory Records 9Control of Records 10Management of Customer Requests and Commitments to Customers 11Control of Procurement 12Control of Measuring Equipment and Materials 13Control of Measurements 14Control of Nonconforming Work 15Candidate Actions 16Preventative Actions 171.3 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.