QC+080000+Introduction+English+Version.ppt

ISO9001 2000QMS ISO14001 2004EMS OHSAS18001 QC080000HSPM ISO13485MDD CMDCAS ISO22000 HACCP AS9000 TL9000 ISO IEC27000ISMS ISO IEC20000ITSMS SA8000 SystemCertificationOverview ANAB ISO13485 ISO9000 QS 9000 AS9000 AS9100 TL 9000 TESupplementIATF ISO TS 16949RvA ISO9000 QS9000 ISO27000 ISO20000UKAS ISO9000 ISO13485 ISO14000SCC ISO13485 ISO9000 QS 9000 TESupplement ISO14000 TL 9000IECQ QC080000HSPMSAI SA8000 AccreditedStatus IECQ HSPMQC080000 TheDUTCHministryofenvironment X RayFluorescence X光螢光分析儀 NITON700XRF WhatisRoHS RoHS Directive2002 95 ECoftheEuropeanParliamentandoftheCouncilof27January2003ontheRestrictionoftheuseofcertainHazardousSubstancesinelectricalandelectronicequipment RoHS RestrictionofHazardousSubstances Toreducewasteharmfulness bansthefollowingsixsubstances abovethenotedconcentrationlevels inelectricalandelectronicequipment SubstanceLead PbMercury HgCadmium CdHexavalentChromium Cr VI Polybrominatedbiphenyls PBBPolybrominateddiphenylethers PBDE MaxConcentration0 1 0 1 0 01 0 1 0 1 0 1 KeyDate CompliancebyJuly1 2006 byWeightinHomogenousMaterial WhatisWEEE 什么是WEEE Directive2002 96 ECoftheEuropeanParliamentandoftheCouncilof27January2003onWasteElectricalandElectronicEquipment TrendofBans Restrictions Requirements RoHS WEEEEUAsiaPacificUnitedStatesIndustryGreenProcessProcurementMajorOEMsWorldwide US GlobalHSFLegislation MaineCalifornia10USStateswithPendingLegislationAndgrowingeveryday ChinaJapanAustraliaKorea RecognizedIssues RequirementsarestillbeingdevelopedUSA StatebyState SB 50 SB 20 Prop 65 AB2202JapanJGPSSIKoreaKoreaRoHS WEEEChinaChina slegalrequirementsontherestrictionofTS HSinEIPandWEEEOthers CourtesyofPRTM SONY SS 00259 DELL 6T198 7X435 TI QA 11284 Microsoft H00594 H00642 MOTOROLA 12G02897W18 PioneerGroup GGP 001 A HP A 5951 1745 1 FUTURE QES9401 RoHSDirectiveWEEEDirectiveWastePackageDirectiveCd prohibitionOrdinanceAzo prohibitionOrdinanceBatteryDirectiveCaliforniaUSASB50ChinaRoHSRegulation RegulationandDirective IndustryGreenProcessProcurement GreenProductRequirements Howdoyoumeetthemall Today sMess TestingcapacityandexpertiseinsufficientTestingproductsamplesisprovingproblematicSelf declarationsprovingquestionable BeaManager GotoJail emerging DevelopemntofRestrictedSubstance SpecialSubstancebanned RequirementfromspecialcustomerDeclaration IECQHSPM AllinvolvedRS3rdpartauditTechnicalSpeciationContinualImprovement IEC InternationalElectrotechniqueCommissionIECQ IECQualityAssessmentSystemforElectronicComponentsHSPM ElectricalandElectronicComponentsandProductsHazardousSubstanceProcessManagementSystemRequirements HSPM QC080000IECQHSPM WhatisQC080000IECQHSPM BasedonbeliefthatachievementofHSFproductsCan t testout HSF QC080000IECQHSPM ACommonSenseApproachMovesfromproducttoprocessfocusMovesfromself declarationstothird partyassessmentandcertificationtoaninternationallyacceptedStandardExpandable adaptableframeworkforfuture QC080000IECQHSPM CompatibleandcomplimentarytomanyexistingstandardsandapproachesMakesuseofknownconventions ISO alreadyinwidespreaduseChangesthecurrencyinthesupplychainfromextensive expensivetestingandauditstoacrediblecertificateindicatingwellunderstood controlledprocesses QC080000andISO9001 IECQHPSMisan addon totheISO9001 2000QualityManagementSystem QMS ISO9001providesablueprintforoptimizationofbusinessandqualitymanagementsystemsIECQHSPMwaswrittentofitintothatblueprintIECQHSPMstrengthensadherencetotheprinciplesandpracticesprescribedbytheInternationalOrganizationofStandardization ISO anddirectstheirapplicationtothemanagementofhazardoussubstances BasicProcessforAchievingHSFOperations Continuedonnext BasicProcessforAchievingHSFOperations KeyElementsoftheStandardQC080000HSPM PurposeScopeReferenceDocumentsTermsandDefinitionsGeneralRequirementsManagementResponsibilityPlanningManagementReviewResourceManagementProductRealization DesignandDevelopmentPurchasingVerificationofPurchasedProductProductionandServiceIdentificationandTraceabilityHandlingofHazardousSubstancesPartsMeasurement AnalysisandImprovement QC080000HSPM ReferenceDocuments RoHS Directive2002 95 EConRestrictionoftheUseofCertainHazardousSubstancesinElectricalandElectronicEquipment WEEE Directive2002 96 EConWasteElectricalandElectronicEquipmentISO9001 2000 QualityManagementSystems Requirements QC080000HSPM TermsandDefinitionsShallindicatesamandatoryrequirementtobefollowedinordertoconformtothisdocumentShouldindicatesthat amongseveralpossibilities oneisrecommendedasparticularlysuitable withoutmentioningorexcludingothers orthatacertaincourseofactionispreferredbutnotnecessarilyrequired orthat inthenegativeform acertaincourseofactionisdeprecatedbutnotprohibited Mayindicatesacourseofactionthatispermissiblewithinthelimitsofthisdocument QC080000HSPM TermsandDefinitionsHSFHazardousSubstancesFreereferstothereductionoreliminationofanymaterialaslistedintheWEEEorRoHSdirectivesorotherapplicablestandardsorregulations HSHazardousSubstancereferstoanymaterialaslistedintheWEEEorRoHSasprohibitedfromusageandisinterchangeablewithRestrictedSubstances RestrictedSubstancereferstoanymaterialaslistedintheWEEEorRoHSasprohibitedfromusageandisinterchangeablewithHS QC080000HSPM GeneralRequirementsTheorganizationshall Identifyanddocumentallhazardoussubstancesinuseintheorganization IdentifythespecificprocessestobemanagedrelevanttoitsHSFgoals ImplementactionstoensurecontinuousprocessimprovementinachievingHSF Haveaprocessestablishedtorestrictand oreliminatetheuseofhazardoussubstancesfromproductsandprocesses QC080000HSPM GeneralRequirementsComposealistofallhazardoussubstancesusedwithintheorganization StatementsofHSFpolicyandobjectiveswithinclusionofatimelineforeliminationofuseofallhazardoussubstancesasappropriate Establishintheorganization squalitymanualasectionontheHSFprocessmanagementplanandobjectivesandreferencetoHSFdocumentedprocedures QC080000HSPM ManagementResponsibilityEstablishingtheHSFpolicyEnsuringthatHSFobjectivesareestablishedincludingHSFinmanagementreviews andprovidingresourcestoensureprogresstowardHSFproductsandproductionprocesses Ensuringthelistofhazardoussubstancesiscommunicatedthroughouttheorganization QC080000HSPM PlanningHSFobjectivesshallincludeatimeline asappropriate fortheeliminationofhazardoussubstancesidentifiedandusedinprocessesorproductsincludingprocuredproductsPracticesrequiredtoachieveHSFareintegratedintothequalitymanagementsystemplanningandareelementsinthequalityobjectives QC080000HSPM ManagementReviewTopmanagementshallincludeandreporton duringtheregularmanagementreviews activitiesrelatedtotheHSFplanwithregardstoidentificationof useofhazardoussubstances nonconformance sandcorrectiveactions QC080000HSPM ResourceManagementTheorganizationshalldetermineandprovidetheresourcesneededtoimplementandmaintainHSFprocessesandproductsProvidetrainingspecifictotheHSFplanfortheidentification use andeliminationofhazardoussubstances QC080000HSPM ProductRealizationInplanningHSFproductrealization theorganizationshalldeterminethefollowing asappropriate QualityobjectivesandrequirementsfortheHSFproductEstablishHSFprocesses documents andprovideresourcesspecifictotheHSFproductDocumentedproceduresorworkinstructionsforprocessesthatincludetheuseofrestrictedsubstancestoincludepreventionwherethepossibilityofcontaminationexists QC080000HSPM ProductRealizationReviewofHSFrequirementsanddefinitionofproducts HSFrequirementsAnyuseoforpossibilityofcontaminationormixingofprocessesorproductthatcontainrestrictedsubstancesshallbecommunicatedtothecustomer QC080000HSPM DesignandDevelopmentInplanningthedesign theuseofanyrestrictedsubstanceshallbeidentifiedinthedocumentationandaplanforcontrolandeventualreplacement eliminationofthepart Whenthedesignrequirestheuseofarestrictedsubstanceadocumentedprocedureshallbedevelopedforthecontrol identification monitoringandmeasurementoftheprocess producttoincludesubcontractedproduct QC080000HSPM PurchasingTheorganizationshallensurethatanyHSFpart materialisfreefrompossiblecontaminationwitharestrictedsubstance Procurementofrestrictedsubstancesshallbeclearlyidentifiedonthepurchasedocumentanduponreceiptofthematerial QC080000HSPM VerificationofPurchasedProductTheprocurementrouteofpurchasedgoodsshallbefullyunderstoodandanyprocessthathasthepossibilityofcontaminationbyrestrictedhazardoussubstancesshallbefullyidentified AdocumentedprocedureshalloutlinetheprocurementactivitiesrelatedtotheHSFprocess QC080000HSPM VerificationofPurchasedProductEstablishadocumentedprocedurefortheinspectionandidentificationofHazardoussubstancesincludedinpurchasedgoods Thehazardoussubstanceshallbeidentifiedbythetypeintheinspectiondata Includedshallbeaprocesstohandleanabnormality nonconformance Iftheprocessesarecombinedwitheachotheradocumentedprocedureshallbeestablishedtodifferentiatebetweenparts QC080000HSPM ProductionandServiceProvisionProcessesthathavethepossibilityofcontaminationareidentifiedanddocumented Operationalproceduresaredocumentedanddefinepreventivemeasurestopreventpossiblecontamination QC080000HSPM Identification TraceabilityProcessesthatincludeanyrestrictedsubstanceshallbeuniquelyidentifiedandsegregatedtopreventcombinationwithHSFproduct QC080000HSPM HandlingofHazardousSubstancesPartsThereshallbeadocumentedprocedureforthehandlingandstorageofhazardoussubstancesThisprocedureshallincluderecordsofreceivingandshipping andrecordsshowinghazardoussubstancesaresegregatedandmanagedseparately QC080000HSPM Measurement AnalysisandImprovementTheorganizationshallconductinternalassessmentsatplannedintervalstodeterminewhethertheorganization sHazardousSubstanceFreeprocessesconformtotherequirementsofthisstandardandtocustomerspecifications andareeffectivelyimplementedandmaintained QC080000HSPM Measurement AnalysisandImprovementTheorganizationshallestablishadocumentedproceduretomonitorandmeasuretheRestrictedSubstancesoftheproducttoverifythatproductrequirementshavebeenmet ThisshallbecarriedoutatappropriatestagesoftheproductrealizationprocessinaccordancewiththeHSFplan QC080000HSPM Measurement AnalysisandImprovementThereshallbeaclearproceduretohandlesituationswhennonconformingproductsthatcontainrestrictedsubstancesaredetectedTopreventproductsthatcontainrestrictedsubstancesfrombeingshippedunlessotherwiseallowedRecordsofthenatureofnonconformitiesandsubsequentactionstakenshallbemaintainedandclearlyidentifiedastowhatrestrictedsubstancewasdetected QC080000HSPM Measurement AnalysisandImprovementTheanalysisofdatashallprovideinformationrelatingtocontinuousimprovementeffortsfortheeliminationoftheallhazardoussubstances asapplicable QC080000HSPM Measurement AnalysisandImprovementAHSFdocumentedprocedureshallbeestablishedtodefinerequirementsforReviewingHSFnonconformities includingcustomercomplaints Determiningthecausesofnonconformities EvaluatingtheneedforactiontoensurethatHSFnonconformitiesdonotrecur QC080000HSPM Measurement AnalysisandImprovementCorrectiveActionDeterminingandimplementingactionneededRecordsoftheresultsofactiontakenReviewingcorrectiveactiontakenReportingthestatusofallHSFcorrectiveactionsformanagementreview CertificationAdvantages CompaniesachievingIECQHSPMCertificationwill ImproveoperationalresultsReducecompliancecostsPreserveaccesstoglobalmarketsImprovesupplychainmanagementPerhapsimprovesuppliersReducelegalliabilityGaincompetitiveadvantageAssurecompliancewithlawsandhighestindustrystandardsIndicatecompany sdesiretobeworld classandto