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1、Orderno.:70198205201Date:Nov.4,2002Page1of55ModularAuditQuestionnaireTOVMANAGEMENTSERVICEPRODUCTSERVICEApplicant:ZhejiangAnjiSunlightMedicinalProductsCo.,Ltd.SunLightIndustry,AnjiCounty,ZhejiangProvince,P.R.China313300Auditedcompany:ZhejiangAnjiSunlightMedicinalProductsCo.,Lltd.SunLigh
2、tIndustry,AnjiCounty,ZhejiangProvince,P.R.China313300Companyrepresent.:Mr.HeqingDongLeadauditor:Mr.XinggangXuTechnologyauditor(s):Mr.LiubaoLi,Mr.JerryJiaAuditrequirements:ISO9002:1994,EN46002:1996EC-Directive93/42/EECAnnexV.3TypeofAudit:CertificationAuditProducts,Category:MedicalBandag
3、eQ-Manual(number,dateofissue:Otherdocuments:Date(s)ofQ-documentinspection:Auditperiod:Nov.8,2002・Nov.9,2002Comments:Orderno.:70198205201Date:Nov.4,2002Page3of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEScopeofthequestionnaireThisquestionnaireisbasedonthestandardsmentio
4、nedbelow・TheAudit-Questionnairecontainsquestionsfromthefollowingareas:•ISO9001•EN46001/ISO13485•MDD/AIMD/IVDDFile:CRT_F_07.33E/Rev.1/23.11.99File:CRT_F_15.30E/Rev.3/1.9.00File:CRT_F_15.31E/Rev.4/2002-04-01TableofcontentsGeneral4ECDirectives54.1:Managementresponsibility174.2:QualitySyst
5、em194.3:Contractreview204.4:Designcontrol214.5:Documentanddatacontrol254.6:Purchasing274.7:Controlofcustomer-suppliedproduct294.8:Productidentificationandtraceability304.9:Processcontrol324.10:Inspectionandtesting364.11:Controlofinspection,measuringandtestequipment404.12:Inspectionandt
6、eststatus424.13:Controlofnonconformingproduct434.14:Correctiveandpreventiveaction454.15:Handling,storage,packaging,preservationanddelivery484.16:Controlofqualityrecords504.17:Internalqualityaudits514.18:Training534.19:Servicing544.20:Statisticaltechniques55Orderno.:70198205201Date:Nov.
7、4,2002Page4of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234567GeneralISO9001Isthefollowingcompanyinformationup-to-date?E.g.•Address•Phone•Fax•E-mail•
