ASTM_E_1580_-_93_2002.pdf

Designation:E 1580 93(Reapproved 2002)An American National StandardStandard Guide forSurveillance of Accredited Laboratories1This standard is issued under the fixed designation E 1580;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 covers a number of procedures that may beused by a laboratory accrediting body,either singly or ascomplementary activities,to provide ensurance that accreditedlaboratories continue to satisfy criteria and conditions foraccreditation required by the accrediting body.1.2 This standard does not purport to address all of thesafety problems,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 548 Guide for General Criteria Used for EvaluatingLaboratory Competence2E 994 Guide for Calibration and Testing Laboratory Ac-creditation Systems General Requirements for Operationand Recognition2E 1187 Terminology Relating to Conformity Assessment2E 1224 Guide for Categorizing Fields of Capability forLaboratory Accreditation Purposes2E 1301 Guide for the Proficiency Testing by InterlaboratoryComparisons2E 1323 Guide for Evaluating Laboratory MeasurementPractices and the StatisticalAnalysis of the Resulting Data23.Terminology3.1 DefinitionsThe terms and definitions used in thisguide are based on those in Terminology E 1187.3.2 Definitions of Terms Specific to This Standard:3.2.1 assessment,nof a laboratory,the activity of evalu-ating a laboratorys compliance with accreditation criteria.3.2.2 surveillance,n of a laboratory,a set of activities(for example,on-site assessment,proficiency testing,question-naire,quality audit)performed or reviewed by an accreditingbody to ensure that accredited laboratories demonstrate ongo-ing compliance with accreditation requirements.4.Significance and Use4.1 This guide is intended to be used by laboratory accred-iting bodies to apply a variety of surveillance procedures thatare appropriate in the maintenance of accreditation.It supple-ments and expands on the information related to surveillanceprovided in Guide E 994.4.2 None of the surveillance procedures used alone provideensurance on all elements of laboratory competence,but takentogether,they can provide confidence for the accrediting bodyas to the continuing compliance of a laboratory with accredi-tation criteria.4.3 Surveillance procedures establish documentary evi-dence as to the continuing competence of an accreditedlaboratory.4.4 Confidentiality shall be maintained by the accreditingbody,its staff,and its contractors for all confidential andproprietary laboratory information.5.Surveillance Elements5.1 Scope of AccreditationAlaboratory may be accreditedfor less than the full range of work it undertakes(see GuideE 1224).Accordingly,surveillance procedures usually addressonly laboratory work performed within the formally definedscope of accreditation,unless other activities of the laboratorycan affect the work covered by the accreditation or areconsidered likely to bring the accrediting body into disrepute.5.2 CriteriaAn accrediting body shall ensure that anychanges to its accreditation criteria(see Guide E 548)areunderstood and implemented by accredited laboratories.6.Surveillance Procedures6.1 Information Updating:6.1.1 An accredited laboratory should provide informationto the accrediting body on matters affecting its accreditation.6.1.2 Questionnaires may be used to solicit updated infor-mation between routine assessments and usually just prior to anassessment.Significant changes in personnel,facilities,equip-ment,or management may precipitate an assessment,morefrequent proficiency tests,or other surveillance activity by theaccrediting body.6.2 Routine Assessment:6.2.1 Regularly scheduled routine on-site assessments areone of the means of surveillance of accredited laboratories.1This guide is under the jurisdiction of ASTM Committee E36 on Laboratoryand Inspection Agency Evaluation and Accreditation and is the direct responsibilityof Subcommittee E36.50 on Directories of Accredited Laboratories and Scopes ofAccreditation.Current edition approved Nov.15,1993.Published April 1994.2Annual Book of ASTM Standards,Vol 14.02.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.6.2.2 Such visits to each laboratory should normally followthe procedures adopted for initial assessments,but may em-phasize particular attention to new testing techniques ormethods,changes in the scope of accreditation,changes inpersonnel,adherence to an agreed quality system,performancein proficiency testing programs,previo