安规认证产品管理办法

ThisdocumentandinformationhereinisthepropertyofUSIandallunauthorizeduseandreproductionisprohibited.CopyrightbyUniversalScientificIndustrialCo.,Ltd.機密等級:機密USIControlledDocumentConfidentialLevel:ConfidentialDocumentTitle(文件名稱):安規認證產品管理辦法OperationProcedureforSafetycertifiedproductDocumentNumber(文件編號):AG-0801-R206Revision(文件版本):A2ReviseDate(改版日期):2012/10/16Preparedby(撰寫者):張鶴騰CreatedbywhichFunction(制定單位):CE/DQD/SafetyAG-0801-M006-F2Rev.:A1ThisdocumentandinformationhereinisthepropertyofUSIandallunauthorizeduseandreproductionisprohibited.CopyrightbyUniversalScientificIndustrialCo.,Ltd.AmendmentRecordsItem:Date:Revision:Page:ChangeDescription:Changedby:12010/3/25A1ALLNewIssue張鶴騰22012/10/16A22,3AddMaintaintheregulationsupgradeandproductcertifications.張鶴騰AG-0801-M006-F3Rev.:A1SourceOrganization：USI/Taiwan安規認證產品管理辦法OperationProcedureforSafetycertifiedproductDOCNO.:AG-0801-R206-A2OriginalEffectiveDate：2010/3/25PAGE1OF3ThisdocumentandinformationhereinisthepropertyofUSIandallunauthorizeduseandreproductionisprohibited.CopyrightbyUniversalScientificIndustrialCo.,Ltd.1.1.11.21.2.11.2.2適用範圍及時機Applicablescopeandoccasion目的利用系統的管理，降低公司安規認證之量產產品與其安規驗證報告發生不符的機率，以避免於在驗證單位稽核人員到廠檢驗時，發現缺失，而導致禁止出貨的可能。PurposeReducethenon-conformityopportunitiesbetweenaproductanditssafetyreportinmassproductionphasebymanagementsystemtoavoidanydefectsbeingfoundbytheauditorsofcertifiedbodieswhiletheirfactoryauditandresultinginthepossibilityofstoppedshipment.範圍產品：產品標籤上有安規標誌例如UL、CSA、GS、TUV、CE、CCC、NOM或其他國家之安規認證之量產產品。ScopeProduct:Productswithsafetylogos,suchasUL、CSA、GS、TUV、CE、CCC、NOMorothercountries’safetylogos.部門：1.PE2.HWRD3.MD4.SafetyDepartment：1.PE2.HWRD3.MD4.SafetySourceOrganization：USI/Taiwan安規認證產品管理辦法OperationProcedureforSafetycertifiedproductDOCNO.:AG-0801-R206-A2OriginalEffectiveDate：2010/3/25PAGE2OF3ThisdocumentandinformationhereinisthepropertyofUSIandallunauthorizeduseandreproductionisprohibited.CopyrightbyUniversalScientificIndustrialCo.,Ltd.2.2.12.22.3作業規定要點OperationruleSSR作業程序OperationprocessforissuingSSR當PE/HWRD要在已量產品的BOM加入或變更元件，須先發行SSR，安規人員在收到SSR後，針對此變更進行評估是否影響安規報告，若有影響，則提出變更安規報告所需測試及費用，若BD同意此費用，則安規人員依據變更向認證機構申報並完成安規報告更新，完成更新後方可導入此變更。WhenPE/HWRDwanttoaddormodifythecomponentsfortheproductswhichhavebeenmassproduction,itisnecessarytoissuetheSSR,theSafetypersonneedtocheckwhetherthechangeimpactSafetycertifications/reports,ifyes,SafetypersonneedtoprovidethetestitemsandcostforupdatingtheSafetycertifications/reports,ifBDagreethefee,SafetypersonwillupdatetheSafetycertifications/reportsforthechange,afterthat,thechangejustcanbeimplemented.ECN作業程序OperationprocessforissuingECN當MD/HWRD要對已量產品作任何結構上或線路上的變更須先發行ECN，安規人員在收到ECN後，針對此變更進行評估是否影響安規報告，若有影響，則提出變更安規報告所需測試及費用，若BD同意此費用，則安規人員依據變更向認證機構申報並完成安規報告更新，完成更新後方可導入此變更。WhenMD/HWRDwanttomodifythemechanicsorcircuitsfortheproductswhichhavebeenmassproduction,itisnecessarytoissuetheECN,theSafetypersonneedtocheckwhetherthechangeimpactSafetycertifications/reports,ifyes,SafetypersonneedtoprovidethetestitemsandcostforupdatingtheSafetycertifications/reports,ifBDagreethefee,SafetypersonwillupdatetheSafetycertifications/reportsforthechange,afterthat,thechangejustcanbeimplemented.法規更新及產品證書維護Maintaintheregulationsupgradeandproductcertifications安規人員應收集國際產品相關安規標準及要求，並追縱其變動。將新增或變更之國際產品相關安規標準及要求，通知Site/安規人員並上傳至USI內部網站。SafetypersonshallcollecttheinternationalSafetyrelateddirectives/regulationsofproduct,andmonitorifanyupdateorrevision,anddelivertoSite/SafetypersonanduploadonUSIintranetwebsite.安規人員應進行宣導與公告，以將接收之資訊或執行程序展開導入至相關單位。SourceOrganization：USI/Taiwan安規認證產品管理辦法OperationProcedureforSafetycertifiedproductDOCNO.:AG-0801-R206-A2OriginalEffectiveDate：2010/3/25PAGE3OF3ThisdocumentandinformationhereinisthepropertyofUSIandallunauthorizeduseandreproductionisprohibited.CopyrightbyUniversalScientificIndustrialCo.,Ltd.Safetypersonshallpublicizeandannouncetheinformationorworkingflowtoallrelatedstaffs.安規人員應確保產品證書之有效性，在證書失效日期前兩個月前知會相關單位，確認是否要繼續保留該證書，若要，則須在失效前完成更新取證。Safetypersonshallmakesurethevalidityofproductcertifications,informrelateddepartmentsbeforetwomonthsofexpirationofcertificates,andconfirmthatwhethertocontinuekeepingthevalidityofcertificates,ifyes,finishtorenewthecertificatesbeforelosingefficiency.