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    ASTM C1009 - 21

    Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry

    Active Standard ASTM C1009 | Developed by Subcommittee: C26.08

    Book of Standards Volume: 12.01


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    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

     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.

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    1. Scope

    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.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    C859 Terminology Relating to Nuclear Materials

    C1068 Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear Industry

    C1108 Test Method for Plutonium by Controlled-Potential Coulometry

    C1128 Guide for Preparation of Working Reference Materials for Use in Analysis of Nuclear Fuel Cycle Materials

    C1156 Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials

    C1210 Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry

    C1215 Guide for Preparing and Interpreting Precision and Bias Statements in Test Method Standards Used in the Nuclear Industry

    C1297 Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials

    D1193 Specification for Reagent Water

    D4840 Guide for Sample Chain-of-Custody Procedures

    E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications

    E178 Practice for Dealing With Outlying Observations

    E542 Practice for Calibration of Laboratory Volumetric Apparatus

    E617 Specification for Laboratory Weights and Precision Mass Standards

    E694 Specification for Laboratory Glass Volumetric Apparatus

    E1578 Guide for Laboratory Informatics

    ANSI Standards

    ANSI N15.41

    ANSI N15.51 Measurement Control ProgramNuclear Materials Analytical Chemistry Laboratory

    BIPM Standards

    JCGM 200:2008

    ASME Standard

    ASME NQA-1 Quality Assurance Requirements for Nuclear Facility Applications

    ISO Standards

    ISO 1042 Laboratory GlasswareOne-Mark Volumetric Flasks

    ISO 9000 Quality Management SystemsFundamentals and Vocabulary

    ISO 9001 Quality Management SystemsRequirements

    ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories


    ICS Code

    ICS Number Code 27.120.01 (Nuclear energy in general); 71.040.01 (Analytical chemistry in general)

    UNSPSC Code

    UNSPSC Code 81111819(Quality assurance services); 15131500(Nuclear fuel)


    Referencing This Standard
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    DOI: 10.1520/C1009-21

    Citation Format

    ASTM C1009-21, Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry, ASTM International, West Conshohocken, PA, 2021, www.astm.org

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