ISOIEC 17025质量指南1.docx

ISOIEC 17025质量指南1.docx

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ISOIEC17025质量指南1

ISOIEC17025质量指南

（1）

ACB

COMPNAY

1800NW169THPI,BEAVERTON,OR97006

ISO/IEC17025QUALITYMANUAL

Revision1

Date:

4/16/04

UNCONTROLLEDCOPY□

CONTROLLEDCOPY□

Serial#_________

IssuedTo:

___________________________Date:

___________

ABCCompany

ISO/IEC17025QUALITYMANUAL

REV.1DATE:

4/16/04PAGE2OF17

TABLEOFCONTENTS

Introduction………………………….……………………………………………………………4

QualityManualDistributionandApproval…………………………………………………….4

QualityPolicyStatement…………….…………………………………………………………5

4.0ManagementRequirements.......................................................................................6

4.1Organization..............................................................................................................6

4.2QualitySystem..........................................................................................................8

4.3DocumentControl.....................................................................................................8

4.4ReviewofRequests,Tenders,andContracts...........................................................9

4.5SubcontractingofTestsandCalibrations...............................................................10

4.6PurchasingServicesandSupplies..........................................................................10

4.7ServicetotheCustomer..........................................................................................11

4.8Complaints..............................................................................................................11

4.9ControlofNonconformingTestingand/orCalibrationWork....................................11

4.10CorrectiveAction.....................................................................................................12

4.11PreventiveAction....................................................................................................12

4.12ControlofRecords..................................................................................................13

4.13InternalAudits.........................................................................................................14

4.14ManagementReviews.............................................................................................14

5.0TechnicalRequirements........................................................................................15

5.1TechnicalRequirements–General.........................................................................15

5.2Personnel................................................................................................................15

5.3AccommodationsandEnvironmentalConditions....................................................16

5.4TestandCalibrationMethodsandMethodValidation.............................................17

5.5Equipment...............................................................................................................20

5.6MeasurementTraceability.......................................................................................22

5.7Sampling.................................................................................................................23

5.8HandlingandTransportationofTestand/orCalibrationItems................................23

5.9AssuringtheQualityofTestandCalibrationResults.............................................24

5.10ReportingtheResults..............................................................................................24

ABCCompany

ISO/IEC17025QUALITYMANUAL

REV.1DATE:

4/16/04PAGE3OF17

INTRODUCTION

ABCCompanyrecognizesitsresponsibilityasaproviderofqualitytestingservices.Tothisend,ABCCompanyhasdevelopedanddocumentedaqualitymanagementsystemtobettersatisfytheneedsofitscustomersandtoimprovemanagementofthecompany.ThequalitysystemcomplieswiththeinternationalstandardISO/IEC17025,1999andISO9001:

2000.Thismanualhasbeenpreparedtodefinethequalitysystem,establishresponsibilitiesofthepersonnelaffectedbythesystem,andtoprovidegeneralproceduresforallactivitiescomprisingthequalitysystem.Inaddition,thismanualisutilizedforthepurposeofinformingourcustomersofthequalitysystem,andwhatspecificcontrolsareimplementedtoassureservicequality.

QUALITYMANUALDISTRIBUTIONANDAPPROVAL

Thismanualwillberevisedasnecessarytoreflectthequalitysystemcurrentlyinuse.Itisissuedonacontrolledcopybasistoallinternalfunctionsaffectedbythequalitysystemandonanuncontrolledcopybasistocustomersandsuppliers;although,itcanbeissuedtocustomersonacontrolledcopybasisuponcustomerrequest.ThemethodsforcontrolanddistributionofmanualsareexplainedinControlofMPSQualityManual,procedure#QA-001.

TheQualityManagerandCEOapprovechangestotheQualityManual.ABCCompanyrecordstherevisionlevel,issuedateandauthorizedsignaturesinthemasterQualityManual.

ABCCompany

ISO/IEC17025QUALITYMANUAL

REV.1DATE:

4/16/04PAGE4OF17

QUALITYPOLICYSTATEMENT

ABCCompanyiscommittedtothecontinuousimprovementofprocessesandproductstoachievecustomersatisfaction.Itisthereforeourpolicyto:

∙Consistentlyprovidequalityproductsandservicesthatconformtocustomerrequirements.

∙Deliverourtestingserviceswithaccurateandquicktestresults,whilemaintainingan

economicalvaluetothecustomer.

∙ComplywithISO17025standardsatalltimestoensurequalityproductandtesting

services.ItisABCCompanygoaltoencourageactiveparticipationofallemployeesinqualityplanningandcontinuousimprovementeffortstomeetallquality,serviceandcostobjectives.

__________________________________

ChuckWeitzel,President/CEO

DonHarring,QualityManager

ABCCompany

ISO/IEC17025QUALITYMANUAL

REV.1DATE:

4/16/04PAGE5OF17

4.0ManagementRequirements

4.1OrganizationandManagement

4.1.1ABCCompany（MPS）isaregisteredCorporationintheStateofOregonandholdslegalresponsibilityforitsoperation.

4.1.2MPSisorganizedtooperateinaccordancewiththerequirementsofISO/IEC17025.TheQualityManagerhastheresponsibilitytomaintaintheQualitySystemtooperateinaccordancewiththerequirementsofISO/IEC17025.Itistheresponsibilityofallemployeestoworkinaccordancewiththequalitypolicies,andtosatisfytheneedsofourcustomers.

4.1.3MPSisorganizedtooperateinaccordancewiththerequirementsofISO/IEC

17025,whethercarryingoutworkinitspermanentfacilitiesoronlocation,atcustomersites.

4.1.4MPSisnotpartofanorganizationperformingactivitiesotherthantestingand/orcalibration;therefore,thereisnopotentialconflictofinterestamongstitspersonnel.

4.1.5TheorganizationofABCCompanyisillustratedbelowinFigure1.

Figure1

4.1.5cont.

a）.TheTestEngineerisresponsibleforbeingfamiliarwiththetestmethods,procedures,testobjectivesandtheassessmentoftestresults.TheQualityManagerhastheresponsibilitytomaintaintheQualityManagementSystemstoISO/IEC17025andhastheauthoritytoinstitutecorrectiveactionandproceduresconsistentwiththesequalitygoals.TheprocessforupdatingtheQualityManual,andmethodsfordeterminingtherevisionhistoryandresponsibilitiesaredetailedinControlofMPSQualityManual,procedure#QA-001.TheQualityManagerreportsdirectlytotheChiefExecutiveOfficer.b）.Giftsorfavorsfromsuppliers,customersorinternalactivitiesthatmaybenefitfrom“in-spec”testresultsareprohibitedtoavoidanyperceptionofconflictofinterest,seeCustomerConfidentialityandCodeofEthics,procedure#QA-002.

ABCCompany

ISO/IEC17025QUALITYMANUAL

REV.1DATE:

4/16/04PAGE6OF17

c）ProprietaryrightsandconfidentialinformationforbothMPSandit’scustomersareadequatelysecured（CustomerConfidentialityProcedure#QA-002）.

d）.ItshallbetheresponsibilityofallMPSemployeestoconductthemselvesinamannerthatdoesnotdiminishtheconfidenceinourcompetence,impartiality,judgmentoroperationalintegrityasviewedbybothMPSemployeesandourcustomers.ThisresponsibilityincludesactivitiesbothinandoutsideofnormaloperationsatMPS.

e）.TheorganizationalchartismaintainedandstoredbytheQualityManagerandispartofthismanual.MPSisaprivatelyheldcompany,notpartofanyothercompanyororganization.IntheabsenceoftheQualityManager,theTestEngineerorCEOwillassumethedutiesoftheQualityManager.IntheabsenceoftheTestEngineertheQualityManagerorCEOwillassumethedutiesoftheTestEngineer.IntheeventofboththeQualityManagerandtheTestEngineer’sabsence,theCEO,havingknowledgeoftestingmethodsandsystemsforMPS,willassumethesenecessarymanagementpositionsuntilthereturnofthesekeypersonnel.

f）.Jobdescriptionswillbemaintainedforallpersonneldetailingresponsibility,authority,andeducationandtrainingrequirements（ref.:

JobDescriptionandTrainingProgram,Procedure#QA-003）.

4.2.1.1TheQualityManualistheprincipaldocumentthatdefinesthequalitysystematABCCompany.TheQualityManualandalldocumentedproceduresareavailabletoallpersonnelontheQualitySystemsDirectory.TheQualitySystemsDirectory,managedbytheQualityManager,maintainstheQualityManualand

allrelevantdocumentsperDocumentControlProcedure#QA-004andControlofMPSQualityManual,procedure#QA-001.

4.2.1.2QualitySystemProceduresaredocumentedtoestablishandmaintaincontinuityofeachactivityorfunctionaffectingquality.Qualityprocedureswillbereadilyavailablet