文稿2015 tms 2c審核類型auditcriteria

TypeofAudit1.SurveillanceTPS:ENISO13485:2012+AC:2012withoutdesign,MDD93/42/EECAx.V.3TAM:ISO9001:2008withoutdesignDefinedprocessesanddocumentationoftheAuditee’smanagementsystem.受審核方管理體系所規(guī)定的過程及文件Auditperiod(on Auditee(s)/ShandongYixingMedicalDevicesCo.,Ltd.,Governmentheadquarters,PangjiaTown,BoxingCounty,Shandong256500,P.R.China(77317)AuditLead-auditor/Mr.FengGao高峰先生TechnicalExpert/AuditorReg.審核員注冊號Mr.FengGao高峰：2013-1-NQ22143Translator/QMManual:Revision/AuditFirstreleaseofauditplan/TobesignedbyauditWeherebyconfirmthatduringthelastfiveyearswehavenotgivenanyadvicewhatsoevertotheclient,itsrepresentatives,itssuppliersorcompetitorsinrelationtodesign,construction,marketingormaintenanceofproductsorinrelationtotheestablishmentandarrangementofqualitymanagementsystems.Furthermoreweconfirmthatweareindependentoftheauditee/client.Wehaveread,understoodandacceptedthe“Independence,Impartiality,ConflictofInterest我們已經(jīng)閱讀，理解并接受了程序文件MED_P_09.09(TMSCRT_F_05.22中規(guī)定的“獨立性、公正性、利益LeadAuditor:Iconfirmthattheauditplanisreleasedpriortothe審核員/專家/實習(xí)審核員（簽名，日期TobesignedbyWeconfirmthatqualitymanagementsystemcertificationmarksarenotusedinanyadvertisingthatimpliesthattheyapplytoproducts.WeconfirmthatthisAuditPlanincludingauditobjectivesareWeconfirmthattheauditors/technicalexperts/translatorareIncludingthefactthatthefollowingperson(s)is/areemployedbythelocalTüVSüDProductServicecompany:Mr.FengGaoandMr.YongquanLiu,)Aroomfortheauditteamshouldbeprovidedtoensureundisturbedcommunicationaswellassafekeepingofdocuments.Theauditorsareaccompaniedbytheauditresponsibleduringtheaudit.TheAuditPlancanbeadjustedduringtheaudit.Openingandclosingmeetingarefixed.Pleasenote:Thecompanyandtheleadauditorshoulddiscussanypersonalprotectiveequipmentneededfortheauditwellinadvancebeforethestartoftheaudit.Protectiveequipment(helmet,safetyshoes,safetygoggles,cleanroomclothes)mustbeprovidedbytheauditedcompany.目鏡、潔凈室衣物等)應(yīng)由受審核公司準(zhǔn)備。AuditAuditObjectivesTheobjectivesofthisauditDetermineconformanceofthemanagementsystemwiththeAuditCriteria(seeEvaluatetheeffectivenessofthemanagementsysteminmeetingitsspecifiedqualityEvaluatethecapabilityofthemanagementsystemtoensurecompliancewithrelevantstatutory,regulatoryandcontractualrequirements(asapplicable)Evaluatetheeffectivenessofthemanagementsystemtoensurethatagreedrequirementsforproductsand/orservicesaremetIdentifyareasforpotentialimprovementofthemanagementEvaluatetheeffectivenessofthecorrectiveactionsrelatedtotheNonconformitiesandMinorNonconformitiesofthepreviousaudit(ifapplicable)審核目的Plannedproducts,elements/processesaccordingto(EN)ISO13485–Location:(ifmulti45123451234CertinXXXXXXXXXXXXXXXXXXXXXXXNBOG-code(s):MD010131,MD010225,MDS70061stInXXXXXXXXXXXXXXXXXXIfmultiplesite,notesitespecificdifferencesforNBOGcodesor2ndXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXAuditScopeJul.08,9:00–Opening9:15–4.1Generalrequirements質(zhì)量管理體系總要求,4.2.1General文件總要求,4.2.2QualityManual質(zhì)量手冊5ManagementAuditScoperesponsibility管理職責(zé)6.1Provisionofresources資源提供7.1Planningofproductrealization產(chǎn)品實現(xiàn)計劃,8.1General測量、分析和改進(jìn)的總要求,8.2.1&8.5.1feedback&ImprovmentGeneral改進(jìn)(complainthandlingandcustomersatisfaction)4.2.3Controlofdocuments文件控制,4.2.4Controlofrecords記錄控制12:00–13:00–Sales14:00–Controlofproductionandserviceprovision生產(chǎn)與服務(wù)的提Validationofprocessesforproducttionandservice7.5.4Customerproperty顧客財產(chǎn),8.2.4Monitoringandmeasurementofproductin-process16:00–QCand8.2.4Monitoringandmeasurementofproductincomingandfinalinspection),產(chǎn)品的監(jiān)視測量(進(jìn)貨檢驗和成品檢驗)9:00–10:0010:00–QCand11:00–QCand8.3Controlofnonconformingproduct不合格品的控制8.4