实验室检定一般规定Word文档格式.docx

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thisisencouragedforaccreditationpurposes.

January1997

GENERALREQUIREMENTSFORACCREDITATIONOFLABORATORIES

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.Measurementtraceabilityandcalibration.......................22

10.Calibrationandtestmethods.............................25

11.Handlingofcalibrationandtestitems........................28

12.Records.......................................29

13.Certificatesandreports...............................30

14.Sub-contractingofcalibrationortesting......................33

15.Outsidesupportandsupplies.............................34

16.Complaints......................................35

PartB.CONDITIONSFORACCREDITATION............................36

PartC.ACCREDITATIONPROCESS...............................38

I.Application.....................................38

II.On-siteAssessment.................................38

III.Deficiencies....................................39

IV.AccreditationAnniversaryDate...........................40

V.ProficiencyTesting.................................40

VI.AccreditationDecisions...............................41

VII.AnnualReview....................................41

VIII.ReassessmentandRenewalofAccreditation......................42

IX.AddingtotheScopeofAccreditation........................42

X.LaboratoryReferencetoA2LAAccreditedStatus...................42

XI.MisuseoftheA2LAAccreditationLogo........................43

XII.AdverseAccreditationDecisions...........................44

XIII.SuspensionofAccreditation.............................44

XIV.WithdrawalofAccreditation.............................45

XV.AppealsProcedure..................................45

XVI.ConfidentialityPolicy...............................46

XVII.ConflictofInterestPolicy.............................46

DiagramoftheAccreditationProcess........................48

DiagramoftheAppealsProcess...........................49

PARTA

GENERALREQUIREMENTSFORTHECOMPETENCEOFCALIBRATION

ANDTESTINGLABORATORIES（ISO/IECGuide25-1990）

WITHEXPLANATORYNOTES

IntroductionbyA2LA

AlllaboratoriesaccreditedbytheAmericanAssociationforLaboratoryAccreditation（A2LA）arerequiredtocomplywithISO/IECGuide25--1990,"

unlessthereissomeunusualcircumstanceinthelaboratorywhichmightmakecompliancewithaspecificprovisionnotappropriate.

InthisGuideattentionispaidtotheactivitiesofbothcalibrationandtestinglaboratoriesandaccountistakenofotherrequirementsforlaboratorycompetencesuchasthoselaiddownintheOECDCodeofGoodLaboratoryPractice（GLP）andtheISO9000seriesofqualityassurancestandards.

AccordingtotheGuide'

sownIntroduction（paragraph7）,laboratoriesmeetingtherequirementsofthisGuidecomply,forcalibrationandtestingactivities,withtherelevantrequirementsoftheISO9000seriesofstandards,includingthoseofthemodeldescribedinISO9002whentheyareactingassuppliersproducingcalibrationandtestresults.

Forlaboratoriesengagedinspecificfieldsoftestingsuchasthechemical（toxicology）field（seeforexampletheOECDCodeofGoodLaboratoryPractice）ortheenvironmentalfield,theserequirementsmayneedamplificationwithspecificcriteriawhichincludeadditionalrequirements.

Thetextthatfollows,includingtheNOTES,comedirectlyfromGuide25（ingothicprint）.A2LAExplanatoryNotes（sectionsinitalics）areinterpretativeguidanceonparticularrequirementsinthetext.Theseexplanatorynotesarenottobeinterpretedasadditionalrequirements.

Guide25coversbothcalibrationandtestinglaboratories,sothepairingof"

calibrationandtest"

isfrequentlyrepeated.Inthiscontext,testlaboratoriesshouldignoretheword"

calibration"

（withtheexceptionofsection9）andcalibrationlaboratoriesshouldignoretheword"

test."

1.Scope

1.1ThisGuidesetsoutthegeneralrequirementsinaccordancewithwhichalaboratoryhastodemonstratethatitoperates,ifitistoberecognizedascompetenttocarryoutspecificcalibrationsortests.

1.2Additionalrequirementsandinformationwhichhavetobedisclosedforassessingcompetenceorfordeterminingcompliancewithothercriteriamaybespecifiedby