ASTM_D_6808_-_02_2012.pdf

Designation:D680802(Reapproved 2012)Standard Practice forCompetency Requirements of Reference Material Producersfor Water Analysis1This standard is issued under the fixed designation D6808;the number immediately following the designation indicates the year oforiginal adoption or,in 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 practice establishes the general requirements withwhich a reference materials(RM)producer has to demonstratethat it operates,if it is to be recognized as competent toproduce RMs used for water analysis.1.2 This practice establishes the quality system require-ments in accordance with which waters RMs shall be pro-duced.It is intended to be used as part of a RM producersgeneral QA procedures.RM producers shall define their scopein terms of the application,the measurement methods used inthe homogeneity,stability and characterization studies.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D1129 Terminology Relating to WaterD6362 Practice for Certificates of Reference Materials forWater Analysis2.2 ISO Documents:3ISO/IEC 17025:1999 General Requirements for the Compe-tence of Calibration and Testing LaboratoriesISO8402:1994 QualityManagementandQualityAssuranceVocabularyISO 10012-1:1992 Quality Assurance Requirements forMeasuring EquipmentPart 1:Metrological Confirma-tion Systems for Measuring EquipmentISO/IECGuide2:1996 StandardizationandRelatedActivitiesGeneral VocabularyISO Guide 30:1992 Terms and Definitions used in Connec-tion with Reference MaterialsISO Guide 31:2000 Contents of Certificates and Labels ofReference MaterialsISO/IEC Guide 32:1997 Calibration inAnalytical Chemistryand Use of Certified Reference MaterialsISO Guide 34:2000 General Requirements for the Compe-tency of Reference Material ProducersISO Guide 35:1989 Certification of Reference MaterialsGeneral and Statistical PrinciplesISO 3534 Series:1993 StatisticsVocabulary and SymbolsVIM:1993 International Vocabulary of Basic and GeneralTerms in Metrology(issued by ISO,IEC,BIPM,IFCC,IUPAC,IUPAP and OIML)ISO Guide to the Expression of Uncertainty in Measure-ment:1995(issued by ISO,IEC,BIPM,IFCC,IUPAC,IUPAP and OIML)3.Terminology3.1 Definitions:3.1.1 For the purposes of this practice,the definitions givenin Terminology D1129,ISO/IEC Guide 2,ISO/IEC 17025,ISOGuide 30,ISO 8402,ISO 3534,VIM and the followingdefinitions apply.3.1.2 collaboratortechnically competent body(organiza-tion or firm,public or private)that undertakes aspects of themanufacture,or characterization,of the(certified)RM onbehalf of the RM producer,either on a contractual(as asub-contractor)or voluntary basis.3.1.3 reference material producertechnically competentbody(organization or firm,public or private)that is fullyresponsible for assigning the certified or other property valuesof the RMs it produces and supplies,which have beenproduced in accordance with ISO Guide 35,Practice D6362,and ISO Guide 31.4.Significance and Use4.1 This practice is for the use by RM producers in thedevelopment and implementation of their quality system andby those concerned with assessing the competence of RM1This practice is under the jurisdiction of ASTM Committee D19 on Water andis the direct responsibility of Subcommittee D19.02 on Quality Systems,Specification,and Statistics.Current edition approved June 1,2012.Published June 2012.Originallyapproved in 2002.Last previous edition approved in 2007 as D6808 02R07.DOI:10.1520/D6808-02R12.2For 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 Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 producers.It should be recognized that a RM needs to becharacterized mainly to the level of accuracy required for itsintended purpose(that is,appropriate measurement uncer-tainty).The RM producer shall describe the procedure forestablishing the quality of materials as a component of thequality system.4.2 This practice is for the use of RM users in the estab-lishment if a RM producer has a quality system adequate toproduce high quality RMs.It can be used by users to determineif the scientific and technical competence of a RMs producer isadequate to ensure the quality of RMs.This practice isconsistent with the requirements for RM producers establishedin ISO G