ASTM C1009-21
(Guide)Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
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
4.5 Althoug...
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 Tra...
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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.
Designation: C1009 − 21
Standard Guide for
Establishing and Maintaining a Quality Assurance Program
1
for Analytical Laboratories Within the Nuclear Industry
This standard is issued under the fixed designation C1009; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This guide covers the establishment and maintenance of
mendations issued by the World Trade Organization Technical
a quality assurance (QA) program for analytical laboratories
Barriers to Trade (TBT) Committee.
within the nuclear industry. References to key elements of
ASME NQA-1 and ISO/IEC 17025 provide guidance to the
2. Referenced Documents
functional aspects of analytical laboratory operations. When
2
implemented as recommended, the practices presented in this 2.1 ASTM Standards:
guide will provide a comprehensive QA program for the C859 Terminology Relating to Nuclear Materials
laboratory. The practices are grouped by functions, which C1068 Guide for Qualification of Measurement Methods by
constitute the basic elements of a laboratory QA program. a Laboratory Within the Nuclear Industry
C1108 Test Method for Plutonium by Controlled-Potential
1.2 The essential, basic elements of a laboratory QA pro-
Coulometry
gram appear in the following order:
C1128 Guide for Preparation of Working Reference Materi-
Section
als for Use in Analysis of Nuclear Fuel Cycle Materials
Organization 5
Quality Assurance Program 6
C1156 Guide for Establishing Calibration for a Measure-
Training and Qualification 7
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
Procedures 8
rials
Laboratory Records 9
Control of Records 10
C1210 Guide for Establishing a Measurement System Qual-
Management of Customer Requests and Commitments to Custom- 11
ity Control Program for Analytical Chemistry Laborato-
ers
ries Within the Nuclear Industry
Control of Procurement 12
Control of Measuring Equipment and Materials 13
C1215 Guide for Preparing and Interpreting Precision and
Control of Measurements 14
Bias Statements in Test Method Standards Used in the
Control of Nonconforming Work 15
Nuclear Industry
Candidate Actions 16
Preventative Actions 17
C1297 Guide for Qualification of Laboratory Analysts for
the Analysis of Nuclear Fuel Cycle Materials
1.3 Collection of samples and associated sampling proce-
D1193 Specification for Reagent Water
dures are outside the scope of this guide.The user may refer to
D4840 Guide for Sample Chain-of-Custody Procedures
sampling practices developed by Subcommittee C26.02.
E29 Practice for Using Significant Digits in Test Data to
1.4 Nuclear laboratories are required to handle a variety of
Determine Conformance with Specifications
hazardous materials, including but not limited to radioactive
E178 Practice for Dealing With Outlying Observations
samples and materials. The need for proper handling of these
E542 Practice for Calibration of Laboratory Volumetric
materialsisdiscussedin13.2.4.Whilethisguidefocusesonthe
Apparatus
nuclear laboratory QA program, proper handling of nuclear
E617 Specification for Laboratory Weights and Precision
materials is essential for proper function of the QA program.
Mass Standards
1.5 This international standard was developed in accor-
E694 Specification for Laboratory Glass Volumetric Appa-
dance with internationally recognized principles on standard-
ratus
E1578 Guide for Laboratory Informatics
1
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality
2
Assurance, Statistical Applications, and Reference Materials. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Feb. 1, 2021. Published March 2021. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1996. Last previous edition approved in 2013 as C1009 – 13a. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/C1009-21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
C1009 − 21
3
2.2 ISO Standards: 3.1.4.1 Discussion—The calibration relationship can be ex-
ISO 9000 Quality Management Systems—Fundamentals pressed by a stateme
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: C1009 − 13a C1009 − 21
Standard Guide for
Establishing and Maintaining a Quality Assurance Program
1
for Analytical Laboratories Within the Nuclear Industry
This standard is issued under the fixed designation C1009; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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-1ASME NQA-1 and ISO 9001ISO/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
Control of Procurement 11
Control of Measuring Equipment and Materials 12
Control of Measurements 13
Deficiencies and Corrective Actions 14
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
This guide is under the jurisdiction of ASTM Committee C26 on Nuclear Fuel Cycle and is the direct responsibility of Subcommittee C26.08 on Quality Assurance,
Statistical Applications, and Reference Materials.
Current edition approved April 1, 2013Feb. 1, 2021. Published May 2013March 2021. Originally approved in 1996. Last previous edition approved in 2013 as
C1009 – 13.C1009 – 13a. DOI: 10.1520/C1009-13a.10.1520/C1009-21.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
C1009 − 21
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
2
2.1 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 Laborato
...
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