1、Designation:C100913aStandard Guide forEstablishing and Maintaining a Quality Assurance Programfor Analytical Laboratories Within the Nuclear Industry1This standard is issued under the fixed designation C1009;the number immediately following the designation indicates the year oforiginal adoption or,i
2、n the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide covers the establishment and maintenance ofa quality assurance(QA)program for
3、 analytical laboratorieswithin the nuclear industry.References to key elements ofASME NQA-1 and ISO 9001 provide guidance to the func-tional aspects of analytical laboratory operations.When imple-mented as recommended,the practices presented in this guidewill provide a comprehensive QA program for t
4、he laboratory.The practices are grouped by functions,which constitute thebasic elements of a laboratory QA program.1.2 The essential,basic elements of a laboratory QA pro-gram appear in the following order:SectionOrganization5Quality Assurance Program6Training and Qualification7Procedures8Laboratory
5、 Records9Control of Records10Control of Procurement11Control of Measuring Equipment and Materials12Control of Measurements13Deficiencies and Corrective Actions142.Referenced Documents2.1 ASTM Standards:2C859 Terminology Relating to Nuclear MaterialsC1068 Guide for Qualification of Measurement Method
6、s bya Laboratory Within the Nuclear IndustryC1128 Guide for Preparation of Working Reference Materi-als for Use in Analysis of Nuclear Fuel Cycle MaterialsC1156 Guide for Establishing Calibration for a Measure-ment Method Used to Analyze Nuclear Fuel Cycle Mate-rialsC1210 Guide for Establishing a Me
7、asurement System Qual-ity Control Program for Analytical Chemistry Laborato-ries Within the Nuclear IndustryC1215 Guide for Preparing and Interpreting Precision andBias Statements in Test Method Standards Used in theNuclear IndustryC1297 Guide for Qualification of Laboratory Analysts forthe Analysis
8、 of Nuclear Fuel Cycle MaterialsD1193 Specification for Reagent WaterD4840 Guide for Sample Chain-of-Custody ProceduresE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE178 Practice for Dealing With Outlying ObservationsE542 Practice for Calibration o
9、f Laboratory VolumetricApparatusE617 Specification for Laboratory Weights and PrecisionMass StandardsE694 Specification for Laboratory Glass Volumetric Appa-ratusE1578 Guide for Laboratory Informatics2.2 Other Standards:ISO 9001 Quality Management SystemsRequirementsISO 1042 Laboratory GlasswareOne-
10、Mark VolumetricFlasksISO/IEC 17020 General Criteria for the Operation of Vari-ous Types of Bodies Performing InspectionISO/IEC 17025 General Requirements for the Competenceof Testing and Calibration LaboratoriesANSIN15.41 DerivationofMeasurementControlProgramsGeneral PrinciplesANSI N15.51 Measuremen
11、t Control ProgramNuclear Ma-terials Analytical Chemistry LaboratoryJCGM 20:2008 International Vocabulary of MetrologyBasic and General Concepts and Associated Terms(VIM)ASME NQA-1 QualityAssurance Requirements for NuclearFacility Applications33.Terminology3.1 For definitions of pertinent terms not l
12、isted here,seeTerminology C859.1This guide is under the jurisdiction of ASTM Committee C26 on Nuclear FuelCycle and is the direct responsibility of Subcommittee C26.08 on QualityAssurance,Statistical Applications,and Reference Materials.Current edition approved April 1,2013.Published May 2013.Origin
13、allyapproved in 1996.Last previous edition approved in 2013 as C1009 13.DOI:10.1520/C1009-13a.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summ
14、ary page onthe ASTM website.3Available from American Society of Mechanical Engineers(ASME),ASMEInternational Headquarters,Three Park Ave.,New York,NY 10016-5990.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2 Definitions of Terms Spec
15、ific to This Standard:3.2.1 condition adverse to quality,nan all-inclusive termused in reference to any of the following:failures,malfunctions,deficiencies,defectiveitems,andnon-conformances.ASME NQA-13.2.2 custody,nphysical possession or control.A sampleis under custody if it is in possession or un
16、der control so as toprevent tampering or alteration of its characteristics.D48403.2.3 customer,nthe entity requesting analytical servicesfrom the laboratory.3.2.3.1 DiscussionA customer may be a person or anorganization,and may be internal to the organization of whichthe laboratory is a part,or may be an external entity.3.2.4 laboratory,nan organization established to provideanalyses of materials.3.2.5 laboratory quality assurance,nall those plannedand systematic actions necessary to provide ade