ASTM_E_1691_-_95_2001.pdf

Designation:E 1691 95(Reapproved 2001)Standard Guide forEvaluation and Assessment of Analytical ChemistryLaboratories1This standard is issued under the fixed designation E 1691;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(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide sets the minimum requirements which ananalytical chemistry laboratory should meet to be recognizedas competent to carry out specific analytical procedures.1.2 Additional requirements and information which have tobe disclosed for assessing competence or for determiningcompliance with other criteria may be specified by the orga-nization or authority granting the accreditation,dependingupon the specific character of the task of the laboratory.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:E 50 Practices for Apparatus,Reagents,and Safety Consid-erations for Chemical Analysis of Metals,Ores,andRelated Materials2E 416 Practice for Planning and Safe Operation of a Spec-trochemical Laboratory2E 548 Guide for Generic Criteria for Evaluating LaboratoryCompetence3E 876 Practice for Use of Statistics in the Evaluation ofSpectrometric Data2E 882 Guide for Accountability and Quality Control in theChemical Analysis Laboratory2E 994 Guide for Calibration and Testing Laboratory Ac-creditation Systems General Requirements for Operationand Recognition3E 1187 Terminology Relating to Conformaity Assessment3E 1329 Practice for Verification and the Use of ControlCharts in Spectrochemical Analysis2E 1581 Practice for Using Pre-Control in the InstrumentalAnalysis Laboratory42.2Other Documents:ANSI/ASQCQ90 Quality Management and Quality Assur-ance StandardsGuidelines for Selection and Use5ISO/IECGuide 25 General Requirements for the Compe-tence of Calibration and Testing Laboratories53.Terminology3.1 DefinitionsFor definitions of terms used in this guide,refer to Terminology E 1187.3.2 Definitions of Terms Specific to This Standard:3.2.1 auditan examination of a laboratorys operation andquality control to ascertain that it is able to obtain validanalyses.3.2.2 authorityan organization that evaluates the perfor-mance of a laboratory;the authority may be a company thatmaintains the laboratory for its own analytical requirements.3.2.3 clientan organization that requires a laboratorysservice.3.2.4 protocola set of procedures which must be followedto obtain acceptable analytical results.3.2.5 traceabilitythe property of a result of a measure-ment where it can be related to appropriate standards,generallyinternational or national standards,through an unbroken chainof comparisons.3.2.6 valid analysisanalytical results obtained when aprocedure follows proper protocol and statistical control isverified.4.Significance and Use4.1 This guide provides a mechanism for promoting confi-dence in analytical chemistry laboratories by demonstratingthat they operate in accordance with the guides requirements.4.2 This guide is for use by analytical chemistry laboratoriesin the development and implementation of their quality sys-tems.It may also be used by accreditation bodies,certificationbodies,and others concerned with the competence of labora-tories.4.3 It is intended that analytical chemistry laboratoriesmeeting the requirements of this guide will be in conformitywith the relevant requirements of the ISO 9000 series of1This guide is under the jurisdiction of ASTM Committee E01 on AnalyticalChemistry for Metals,Ores,and Related Materials and is the direct responsibility ofSubcommittee E01.22 on Statistics and Quality Control.Current edition approved March 15,1995.Published May 1995.2Annual Book of ASTM Standards,Vol 03.05.3Annual Book of ASTM Standards,Vol 14.02.4Discontinued 1998;see 1997 Annual Book of ASTM Standards,Vol 03.06.5Available from American National Standards Institute,11 W.42nd Street,13thFloor,New York,NY 10036.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.standards,including those of the model described in ISO 9002when they are acting as suppliers producing test results.TheISO 9000 and ISO 9002 standards are identical to the standardsappearing in the ANSI/ASQC Q90 Series.4.4 This guide follows criteria of ISO/IEC Guide 25-1990,and Guides E 548 and E 994.It is intended as a generic guidefor analytical chemistry laboratories.Specific analytical tech-niques or instruments,or both,may require additional specificcriteria.5.Organization and Management5.1 The laboratory shall be legally identifiable,and orga-nized and operate