实验室检定一般规定英文.docx
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实验室检定一般规定英文
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实验室检定一般规定(英文)
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PRIVATE
General
Requirements
for
Accreditation
ofLaboratories
[PartAincludesallISO/IECGuide25requirements]
Thisdocumentisreproducibleand
thisisencouragedforaccreditationpurposes.
January1997
GENERALREQUIREMENTSFORACCREDITATIONOFLABORATORIES
January1997
Foreword
TheAMERICANASSOCIATIONFORLABORATORYACCREDITATION(A2LA)isanon-profit,nongovernmental,publicservice,membershiporganizationdedicatedtooperatinganationwide,broadspectrumlaboratoryaccreditationsystem.Accreditationisdefinedasaformalrecognitionofcompetencethatalaboratorycanperformspecifictestsortypesoftests.Accreditationisavailabletoanytypeoftestinglaboratory,beitintheprivatesector(independentorin-house)orinthegovernmentsector.
A2LAwasformedin1978,asapracticalandefficientorganizationtodevelopandmanageasystemtoverifyandrecognizecompetenttestinglaboratories.Accreditationisavailableforvirtuallyalltypesoftests,calibrations,measurementsandobservationswhicharereproducibleandproperlydocumented.
Theaccreditationoflaboratoriesisofferedinthefollowingfieldsoftesting:
BiologicalMechanicalAcoustical&VibrationNondestructive
ChemicalEnvironmentalConstructionMaterialsGeotechnical
ElectricalThermalCalibration
Specialprogramsaredevelopedinresponsetouserneedsandmaycutacrossmorethanonefieldoftesting.Ifonlyafewtestsfromasecondfieldaretobeincludedandalltestingismanagedinonefacilityunderonequalitysystem,thesetestsmaybeaddedtothescopeofaccreditationintheprimaryfieldatnochargeforasecondfield.Iftherearetwomanagersofequivalentstatusresponsibleforthetestingineachfield,accreditationwillbenecessaryinbothfields.
UsersofaccreditedlaboratoriesareadvisedtoseektheScope(s)ofAccreditationfromanyaccreditedlaboratoryorfromA2LA.TheScope(s)ofAccreditationidentifiesthespecifictestsortypesoftestsorcalibrationcapabilityforwhichthelaboratoryisaccredited.
Thegeneralrequirements(generalcriteria)foraccreditationusedbyA2LAarefromtheinternationalstandard,ISO/IECGuide25-1990,"Generalrequirementsforthecompetenceofcalibrationandtestinglaboratories"whichfollowinpartA.Additionalprogramrequirements(specificcriteria)forspecificfieldsoftesting(e.g.environmental)orspecificprograms(e.g.fasteners)whicharenecessarytomeetparticularuserneeds(e.g.USEPA,PL101-592:
FastenerQualityAct)complementthesegeneralrequirementsinparticularareas.
Ineffect,A2LAaccreditationatteststhatalaboratoryhasdemonstratedthat:
a)itiscompetenttoperformspecifictestsorspecifictypesoftests;
b)itsqualitysystemaddressesandconformstoallelementsofISO/IECGuide25,isdocumentedperGuide25,andisfullyoperational;
c)itconformstoanyadditionalrequirementsofA2LAorspecificfieldsoftestingorprogramsnecessarytomeetparticularuserneeds.
ItisA2LApolicynottoaccreditorrenewaccreditationofalaboratorythatfailstomeettheabovecriteria[seepartB,ConditionsforAccreditationandpartC,AccreditationProcess,sectionsondeficiencies,accreditationdecisionsandsuspensionorwithdrawalofaccreditation.]
F:
\WP\MAN\REQ\GENERAL.REQ012297,President
GENERALREQUIREMENTSFORACCREDITATION
TableofContents
Page
CoverPage.........................................1
Foreword..........................................2
TableofContents......................................3
PartA.GENERALREQUIREMENTSFORTHECOMPETENCEOFCALIBRATIONANDTESTINGLABORATORIES
(ISO/IECGuide25-1990)withexplanatorynotes..................4
IntroductionbyA2LA.................................4
1.Scope........................................4
2.References......................................5
3.Definitions.....................................5
4.Organizationandmanagement.............................7
5.Qualitysystem,auditandreview...........................9
6.Personnel......................................17
7.AccommodationandEnvironment............................19
8.Equipmentandreferencematerials..........................20
9.Measurementtraceabilityandcalibra