供应商质量管理体系审查表(ISO13485)-100项

,"SupplierQualityManagementSystemAuditChecklist(ISO13485)

供应商质量管理体系审核表(ISO13485)",,,,,,,,

,"AuditDate:

审核时间:",,"ActralScore:

实际得分:",312,,"ScoreRate

得分率",,78%(312=/400),

,"Auditor(s):

审核人员:",,"MaxScore:

总分:",400,,"Conclusion:

审核结论:",,Goodsupplier,

,"Scorerate&supplierlevel:

得分率与供应商等级：","＜60%Poorsupplier,60%～70%Basicsupplier,70%～80%Goodsupplier,80%～90%Verygoodsupplier,90%～100%Excellentsupplier",,,,,,,

,"Audititem

审核项目","Score

得分","Audititem

审核项目","Score

得分",,"Audititem

审核项目",,"Score

得分",

,"1.QualityManagementSystem

质量管理体系",/68,"4.PurchasingControls

采购管控",/48,,"7.NonconformingProductControls

不合格品控制",,/20,

,"2.Design&DevelopmentControls

设计与开发管控",/48,"5.Facilities&Equipment

设施与设备",/40,,"8.Corrective&PreventiveAction

纠正预防措施",,/20,

,"3.DocumentControls

文件控制",/36,"6.Production&ProcessControls

生产过程管控",/48,,"9.Storage&Delivery&After-Sale

仓储/交付/售后",,/72,

,Theadvantage/disadvantageofqualitymanagement供应商质量管理优缺点：,,,,,,,,

,1.Advantage优点:,,,,,,,,

,2.Disadvantage缺点:,,,,,,,,

,,,,,,,,,,

,GeneralInformationofsupplier供应商基本信息,,,,,,,,

,"SupplierName:

供应商名称：",,,"FactoryAddress:

工厂地址：",,,,,

,"AuditPurpose:

验厂目的：","þNewsupplier□Self-Assessment□Regularly

新供应商评审供应商自评例行评审",,"Certifications:

认证信息：",þISO13485□MDD□FDA□BSCI□ISO9001□ISO14000□SA8000□SAA,,,,

,"ContactPerson:

联系人：",,"ContactTel.&Fax:

联系方式：",Tel:Fax:,,,,,

,"RegisteredCapital

注册资金：",,"ProductionScope:

产品范围：",,,,,,

,"EmployeesNumber:

公司人数：",500,"R&DNumber:

研发人员：",,"QA/QCNumber:

品质人员：",,,"TechnicianNumber:

技术人员：",

,"MajorCustomers:

主要客户：",,,"Saleexperience

外销区域","□Europe%,□America%,□Japan%,□Asia%,□Australia%,□Africa%",,,,

,"OperationHours:

营业时间：","8:30-12:00,13:00-17:30,Mon-Fri",,"Others:

其他信息：",,,,,

,,,,,,,,,,

,ScoringCriteria评分标准,,,,,,,,

,Score分值,Definition定义,,,,,,,

,0,Fail非常差,Failuretomeettherequirement(0%)完全不符合要求,,,,,,

,1,Poor差,Asmallpartmeettherequirement(30%)小部分符合要求,,,,,,

,2,Fair一般,Partiallymeetstherequirement(50%)部分符合要求,,,,,,

,3,Good良好,Basicallymeettherequirement(80%)基本符合要求,,,,,,

,4,Excellent优秀,Fullymeettherequirement(100%)完全符合要求,,,,,,

,,,,,,,,,,

,1.QualityManagementSystem质量管理体系,,,,"MaxScore

总分",68,,"ActualScore

实际得分",

,"Audititem

审核项目","Auditcontent

审核内容",,"Auditmethod

审核方法","Comment

评价",,,"Score

得分","ISO13485clausebasedon

所依据的ISO13485条款"

,"Verifythatwhetherthesupplierhasestablishedqualitymanagementsystem.

确认供应商是否已建立质量管理体系。","★1)VerifythatwhetherthesupplierhasobtainedtheISO13485certificate,businesslicense,productionlicense,CEcertificate,etc.,andwhethertheyarewithinthevalidityperiod.

1)确认是否已取得ISO13485:2016体系认证证书，营业执照，生产许可证，CE证书等？证件是否在有效期内？",,"ChecktheISO13485certificate,businesslicense,productionlicense,CEcertificate,etc.

查看ISO13485:2016证书、营业执照、生产许可证、CE证书。",,,,,4.1.1

,,"★2)Verifythatwhetherthesupplierhasdocumentedthequalitypolicy,qualityobjectives,qualitymanual,procedures,workinstructions,andchecklists.

2)检查质量方针、质量目标、质量手册、程序文件、作业指导书、记录表单是否已文件化？",,"Checkthedocumentedfilesofqualitymanagementsystem.

查看体系文件。",,,,,"4.1.1

4.2.1"

,,"3)Verifythatwhetherthequalitymanagementsystemprocessdiagram(input,output,owner,customer)isclear.

3)查看质量管理体系过程关系表（输入、输出、拥有者、顾客）是否清晰。",,"Checktheflowchartofqualitymanagementsystem.

查看质量管理体系过程关系表",,,,,4.1.1

,"Qualitymanual

质量手册","1)Verifythatwhetherthequalitymanualisissuedbythetopmanager.

1)检查质量手册是否为最高管理者签发。",,"Checkthequalitymanual.

查看质量手册。",,,,,4.2.2

,,"2)Checkwhetherthedescriptionofproductscope,qualitysystemcoverage,documentstructureandclausedeletioncoveredbythequalitymanualareconsistentwiththeactualsituation?

2)检查质量手册覆盖的产品范围、质量体系涵盖范围、文件结构、条款删减的描述与实际是否相符？",,"Checkthequalitymanual.

查看质量手册。",,,,,4.2.2

,"Qualitypolicy

质量方针","Hasthequalitypolicybeenevaluatedandpublicized?

质量方针是否经过评审、宣贯？",,"Checkrelevantrecords,randomlycheck1~3employeestoconfirmwhethertheyarefamiliarwiththequalitypolicy?

查看相关记录，随机抽查1~3名员工对质量方针是否熟悉?",,,,,5.3

,"Qualityobjective

质量目标","1)Isthequalityobjectivemeasurable?Isitconsistentwiththequalitypolicy?

1)质量目标是否是可测量的？与质量方针是否保持一致？",,"Contrastqualitypolicyandqualityobjective

对比质量方针和质量目标。",,,,,5.4.1

,,"2)Arethereanycauseanalysisandimprovementmeasuresfortheunachievedqualityobjectives?

2)针对未达成的质量目标是否有对应的原因分析和改进措施？",,"Viewthecompletionofqualityobjectivesandrelatedcausesandimprovementmeasuresinthepreviousyearorthisyear.

查看上年度或本年度的质量目标完成情况及相关原因分析、改进措施。",,,,,5.4.1

,"Responsibilityandauthority

职责和权限","Arethepersonnelinthequalityandproductiondepartmentsseparated?

质量部门和生产部门的人员是否独立分开？",,"Viewthepersonnelstructureofthequalitydepartmentandtheproductiondepartment

查看质量部门和生产部门的人员架构。",,,,,5.5.1

,"Managementrepresentative

管理者代表","Isthereamanagementrepresentativeappointmentdocumentissuedbythetopmanagement?

是否有最高管理者签发的管理者代表任命文件？",,"Checkthemanagementrepresentativeappointmentdocument.

查看管代任命文件。",,,,,5.5.2

,"Managementreview

管理评审","1)Istheredocumentedprocedureformanagementreview?Hasmanagementreviewbeenconductedatthetimespecifiedintheproceduraldocuments?

1)是否有管理评审的程序文件？是否按程序文件规定的时间实施管理评审？",,"Checktherelevantdocumentedproceduredocumentsandthemanagementreviewrecordoflastyearorthisyear.

查看相关程序文件和去年或本年度管理评审记录。",,,,,5.6

,,"2)Isthemanagementreviewconductedbythetopmanagement?Aretheinputandoutputofthereviewsufficient?Hastheauditresultbeenapprovedbythetopmanagement?Isthereanyrecordsofcorrespondingimprovementmeasure?

2)管理评审是否由最高管理者主持？评审的输入输出是否充分(详见条例)？审核结果是否经过最高管理者批准？是否有对应改善措施的记录？",,"Checkthemanagementreviewrecordsoflastyearorthisyear.

查看去年或本年度管理评审记录。",,,,,5.6

,"

Internalaudit

内部审核","1)Istheredocumentedprocedureforinternalaudit?

是否有内部审核的程序文件？",,"Viewthedocumentedprocedureforinternalaudit.

查看内审相关程序文件。",,,,,8.2.4

,,"2)Hasaninternalauditplanbeenprepared?Doestheinternalauditplanincludethepurpose,scope,basisandpersonneloftheaudit?Isthereanysignatureforapprovalbythemanagementrepresentative?

2)是否编制了内审计划？内审计划是否包含：审核目的、范围、依据、审核人员？是否有管代签字批准？",,"Checktheinternalauditplanforlastyearorthisyear.

查看去年或本年度内审计划。",,,,,8.2.4

,,"3)Arethereatleasttwointernalauditors?Haveinternalauditorsbeentrainedinthequalitymanagementsystem?Isthereaninternalauditorreviewinghisorherowndepartment?

3)是否至少有2名内审员？内审员是否经过了质量管理体系的相关培训？是否存在内审员审核本部门或本岗位的情况？",,"Checkthecertificatesortrainingrecordsofinternalauditors;Checktheinternalauditrecordsoflastyearorthisyear.

查看内审员的证书或培训记录；查看去年或本年度内审记录。",,,,,8.2.4

,,"4)Istheinternalauditsufficient?Isthereanybasisfortheissuanceofnon-conformities?Istheauditconclusionapprovedbymanagementrepresentative？

审核是否充分？不符合项的出具是否具有依据？审核结论是否经过管代批准？",,"Checktheinternalauditchecklistandnon-conformityreportlastyearorthisyear.

查看去年或本年度检查表和不符合报告。",,,,,8.2.4

,,"5)Isthereanycorrespondingimprovementmeasuresforinternalauditnon-conformity?

内审不符合项是否有对应的改进措施？",,"Viewrelevantrecords.

查看相关记录。",,,,,8.2.4

,2.Design&DevelopmentControls设计与开发管控,,,,"MaxScore

总分",48,,"ActualScore

实际得分",

,"Audititem

审核项目","Auditcontent

审核内容",,"Auditmethod

审核方法","Comment

评价",,,"Score

得分","ISO13485clausebasedon

所依据的ISO13485条款"

,"Documentedprocedurefordesign&development

设计开发程序文件","IstheredocumentedprocedureforDesign&Development?

是否有设计开发程序文件？",,"CheckthedocumentedprocedureforDesign&Development.

查看程序文件。",,,,,7.3.1

,"Design&developmentplanning

设计和开发策划","Isthereadesignanddevelopmentplan(theresultoftheplan)?Doestheplanpresenttherequiredresources,includingthenecessarypersonnelcapacity?Istheresponsibilityandauthorityofpersonnel(includinginterfacepersonnelofdifferentdepartments)andthedivisionofeachstageclear?Doestheplanchangeasthedesignprogresses?

是否编制了设计开发计划（策划的结果）？计划是否提出了所需的资源，包括必要的人员能力？人员（包括不同部门的接口人）职责权限、各阶段划分是否明确？并确认计划是否随设计的进展而适时修改？",,"CheckthedesignanddevelopmentplanofproductssuppliedtoXXXcompany.

查看供应给XXX公司的产品的设计开发计划。",,,,,7.3.2

,"Design&developmentinputs

设计和开发输入","1)Istherearecordofdesignanddevelopmentinputs?Istherearecordofreviewingtheadequacy/suitabilityofdesignanddevelopmentinputs?Hasthereviewconclusionbeenapproved?

1)是否有设计开发输入的记录？是否有对设计开发输入的充分性/适宜性进行评审的记录？评审结论是否得到批准？",,"Checkthedesignanddevelopmentinputrecordsoftheprojectsabove.

查看上述项目的设计开发输入相关记录。",,,,,7.3.3

,,"2)Toconfirmtheadequacyofdesignanddevelopmentinputs,thefollowingshouldbeincluded:

①Accordingtotheexpecteduse:function,performance,availabilityandsafetyrequirements;

②Applicablestatutoryrequirementsandstandards;

③Outputofriskmanagement(e.g.riskanalysisreportorFMEA);

④Informationprovidedbyprevioussimilardesigns.

2)确认设计开发输入是否充分，应包括以下内容：

①根据预期用途：功能、性能、可用性和安全要求；

②适用的法规要求和标准；

③风险管理输出（例如风险分析报告或FMEA）；

④以前类似设计提供的信息。",,"Checkthedesignanddevelopmentinputrecordsoftheprojectsabove.(FocusonriskanalysisreportsorFMEA).

查看上述项目的设计开发输入相关记录（重点关注风险分析报告或FMEA）。",,,,,7.3.3

,"Design&developmentoutputs

设计和开发输出","Istherearecordofdesignanddevelopmentoutput?Isthedesignoutputdocumentapprovedbeforerelease?Toconfirmthecompletenessofthedesignanddevelopmentoutputdata,thefollowingshouldbeincluded:

①Relevantinformationprovidedbyprocurement/production/service;

②Productacceptancecriteria;

③Importantcharacteristicstoensureproductsafety/normaluse.

是否有设计开发输出的记录？设计输出文件放行前是否得到批准？确认设计开发输出资料是否完整，应包括以下内容：

①采购/生产/服务提供的相关信息；

②产品验收准则；

③确保产品安全/正常使用的重要特性。",,"Checkthedesignanddevelopmentoutputrecordsoftheprojectsabove.

查看上述项目的设计开发输出相关记录",,,,,7.3.4

,"Design&developmentreview

设计和开发评审","Arereviewsconductedinaccordancewiththereviewpointssetupinthedesignanddevelopmentplan?Hasthereviewconclusionbeenapproved?Arethereanyevidenceofimprovementatthereviewpoint?Isthereasituationwherethereviewisnotqualifiedandisstillreleasedtothenextstage?

是否按照设计开发计划设置的评审点实施评审？评审结论是否得到批准？评审问题点是否有改善证据？是否存在评审不合格仍放行到下一个阶段的情况？",,"Checkthedesignanddevelopmentreviewrecordsoftheprojectsabove.

查看上述项目的设计开发评审相关记录。",,,,,7.3.5

,"Design&developmentverification(Whethertheoutputsatisfiestheinput)

设计和开发验证(输出是否满足输入)","Isthereverificationconductedaccordingtotheverificationpointsspecifiedinthedesignanddevelopmentplan(suchastheverificationofpackaging)?Arethereverificationguidelines(validationmethods/acceptancecriteria)?Arethereanynecessaryimprovementstotheproblemsidentified?

项目是否按设计和开发计划规定的验证点进行验证(比如包装的验证)？是否有验证的指导文件(验证方法/接收准则)？针对验证发现的问题是否有必要的改进措施？",,"Checkthedesignanddevelopmentverificationrecordsoftheprojectsabove.

查看上述项目的设计开发验证相关记录。",,,,,7.3.6

,"Design&developmentvalidation(Whetherthedesignanddevelopmentresultsmeettheneedsofusers)

设计和开发确认(设计开发结果是否满足用户需求)","Arethereplansorinstructionsfordesignanddevelopmentvalidation(suchasclinicalevaluationorperformanceevaluation)?Arethereanyrecordsofconfirmedresults/conclusionsandnecessarymeasures?

是否有设计和开发确认(比如临床评价或性能评价)的计划或相关说明？是否有确认的结果/结论以及必要措施的记录？",,"Checkthedesignanddevelopmentvalidationrecordsoftheprojectsabove.

查看上述项目的设计开发确认相关记录。",,,,,7.3.7

,"Design&developmenttransfer

设计和开发转换","Isthereadocumentedprocedurefortheconversionfromdesignanddevelopmentoutputtomassproduction?Isthereanyrecordofthetransitionprocessandconclusions?

是否有从设计开发输出转换到量产的程序文件？是否有转换的过程和结论的记录？",,"Checkrelevantdocumentedprocedure.Checkthedesignanddevelopmentvalidationrecordsoftheprojectsabove.

查看相关程序文件；查看上述项目的设计开发确认相关记录。",,,,,7.3.8

,"Controlofdesignanddevelopmentchanges

设计和开发更改的控制","1)Isthereadocumentedprocedurefordesignanddevelopmentchanges?

1)是否有设计和开发变更的程序文件？",,"Checkrelevantdocumentedprocedure.

查看设计开发变更的程序文件。",,,,,7.3.9

,,"2)Hasthechangebeenreviewed/verified/approved?Isthereanassessmentoftheimpactofthechange?

变更是否经过了评审/验证/批准？是否有对变更的影响进行评价？",,"Check3~5designanddevelopmentchanges.

抽查3~5份变更。",,,,,7.3.9

,"Designanddevelopmentfiles(DHF)

设计和开发文件（DHF）","Accordingtothedesignanddevelopmentplanandprogramfiles,checkwhethertheDHFfilesarecompleteornot?Doesitincluderecordsofdesignanddevelopmentchanges?

根据设计开发计划及程序文件，查看其DHF文件是否完整？是否包括设计与开发变更的记录？",,"ChecktheDHFoftheprojectsabove.

查看上述项目的DHF。",,,,,7.3.10

,3.DocumentControls文件控制,,,,"MaxScore

总分",36,,"ActualScore

实际得分",

,"Audititem

审核项目","Auditcontent

审核内容",,"Auditmethod

审核方法","Comment

评价",,,"Score

得分","ISO13485clausebasedon

所依据的ISO13485条款"

,"Documentscontrol

文件控制","1)Verifythatwhetherthereisadocumentedprocedureforthereview,issuance,modification,preservationandabolitionofdocuments(includingthoseintheformofelectronicmedia)

1)是否有程序文件规定文件（包含电子媒体形式的文件）的审核、发放、修订、保存、作废等过程?",,"Checkrelevantdocumentedprocedure.

查看相关程序文件。",,,,,4.2.4

,,"2)Verifythatwhetherthelistofdocumentsandrecordsofdocumentdistribution/cancellationareclear.

2)确认文件清单、文件发放/作废记录是否清晰?",,"Checkthelistofdocumentsandrecordsofdocumentdistribution/cancellation.

查看文件清单及文件发放/作废记录。",,,,,4.2.4

,,"3)Isthereanyuseofelectronicmediaorotherformsofdocuments?Isitcontrolled?

3)是否有使用电子媒体或其他形式的文件？是否已经受控？",,"Inquirerelevantpersonnelorcheckonsite.

询问相关人员，或现场检查。",,,,,4.2.4

,,"4)Verifythatwhetherthedocumentscanbeeasilyobtainedonsite,whetherthedocumentsarecontrolled,approvedbyrelevantpersonnel,andwhethertheversionandquantityofthedocumentsareconsistentwiththereleaserecords.

4)现场是否可以得到有关文件，文件是否受控，是否有相关人员批准，文件版本和数量是否与发放记录一致？",,"Checkdocumentsonsiteasperreleaserecord.

根据发放记录核对现场文件。",,,,,4.2.4

,,"5)Checkthelistofforeigndocuments,check3pcsforeigndocumentstoconfirmthattheirissuancerecordsandidentificationareclear,andverifythattheyarethelatestversion.

5)查看外来文件清单，抽查3份外来文件确认其发放记录和标识是否清晰，并确定是否为最新版本。",,"Checkthelistofforeigndocumentsandselect3pcsforeigndocumentsforconfirmation.

查看外来文件清单，抽查3份外来文件进行确认。",,,,,4.2.4

,,"6)Checkthelistofobsoletedocuments(saveatleastoneobsoletedocument),check1-3obsoletedocumentsbyrandomtoconfirmwhetherthereisanobsoletemarkandcheckthepreservationperiodiscorrect.

6)查看作废文件清单（至少保存一份作废文件），抽查1～3份作废技术文档，确认是否有作废标识，核对保存期限是否正确（保存期限至少在医疗器械的使用寿命期限之内，且不得短于医疗器械通过入市审批后的2年）。",,"Checkthelistofobsoletedocuments,select1~3pcsobsoletedocumentsforconfirmation.

查看作废文件清单,抽查1~3份作废文件进行确认。",,,,,4.2.4

,"Recordscontrol

记录控制","1)thereisadocumentedproceduretospecifytheidentification,filling,storage,safetyandintegrity,retrieval,preservationperiodandothercontrolrequirementsforrecords(includingrecordsinelectronicmediaform)?

1)是否有程序文件规定记录（包含电子媒体形式的记录）的标识、填写、贮存、安全和完整性、检索、保存期限和处置所需的控制?",,"Checkrelevantdocumentedprocedure.

查看相关程序文件。",,,,,4.2.5

,,"2)Istherecordcompleteandclear,isthealterationstandard?

2)记录的填写是否完整、清晰，涂改是否规范？",,"Verifyonsite.

现场确认。",,,,,4.2.5

,,"3)Isthearchive,identificationandstorageoftherecordformeasytoretrieve?

3)记录表单的归档、标识和储存是否便于检索？",,"Determineifthedocumentcanbepresentedquickly.

判断是否能迅速出示文件。",,,,,4.2.5

,4.PurchasingControls采购管控,,,,"MaxScore

总分",48,,"ActualScore

实际得分",

,"Audititem

审核项目","Auditcontent

审核内容",,"Auditmethod

审核方法","Comment

评价",,,"Score

得分","ISO13485clausebasedon

所依据的ISO13485条款"

,"Documentedprocedureforpurchasing

采购程序文件","Isthereadocumentedprocedureforpurchasing?Doesitincluderequirementsforsupplierevaluationandre-evaluation,specialprocurement?

是否有采购的程序文件？是否包括供应商的评价和再评价、特殊采购的相关要求？",,"Checkthedocumentedprocedureforpurchasing

查看采购程序文件。",,,,,7.4.1

,"Supplierevaluation

供应商评价","1)Isthereasupplierevaluationandarecordofthecorrespondingimprovementmeasures?Isthesupplierre-evaluatedwithinthespecifiedtime?Arecorrectiveactionstakenagainstvendorswithpoorperformanceandfollow-upvalidation?

1)是否有相应的供应商评价和对应改进措施的记录？是否在规定时间内按准则要求对供应商进行重新评价？针对表现较差的供应商是否采取纠正措施并跟踪验证？",,"Checkthelistofqualifiedsuppliers,randomlyselect3suppliers,andchecktheirrecordsofevaluation,re-evaluationandimprovement.

查看合格供应商清单，从中随机抽查3家供应商，查看其评价、再评价和改进记录。",,,,,7.4.1

,,"2)Spotchecktherecentinspectionformstoconfirmwhetherthesuppliersareallqualifiedsuppliers.

2)抽查近期报验单，确认供应商是否都是评价合格的供应商？",,"Checktheinspectionreportatthewarehousesite.

仓库现场查看报验单。",,,,,7.4.1

,"Qualityagreement

质量协议","Hasaqualityagreementbeensignedwiththesupplier?Doesthequalityagreementincludetherequirementsofthequalitymanagementsystem,outsourcingmanagement,changecontrol,exceptionhandling,qualityrequirements,acceptancerequirements,lawsandregulations,cargosafetyrequirements,poorqualityhandlingmethods,etc?

是否和供应商签订了质量协议？质量协议中是否包括：质量管理体系的要求、外包管理、变更控制、异常处理、质量要求、验收要求、法律法规要求、货物安全要求、质量不良处理方式等？",,"Checkthequalityagreementswiththeabove3suppliers.

查看与上述3家供应商签订的质量协议。",,,,,7.4.2

,"Purchasingprocess

采购过程","1)Arepurchasedocumentsandpurchaseordersexaminedandapprovedbeforetheyareissued?

1)采购文件、采购单发出前是否经过审批？",,"Spotcheckthepurchasedocumentsandpurchaseordersoftherecent3～5batchesofproductssuppliedtoXXXcompany.

抽查近期3～5批供应给XXX公司的产品的采购文件和采购单。",,,,,7.4.1

,,"2)Doesthepurchaseorder(orcontract)includethequalityrequirementsandacceptancerequirementsofthepurchasedproducts?

2)采购订单(或合同)中是否包括所采购产品的质量要求、验收要求？",,"Checkthepurchaseorder(orcontract).

查看采购订单(或合同)。",,,,,7.4.1

,,"3)Isthereahierarchicalmanagementofsuppliersandmatrerials?Howaretheygraded?Howtomanage?

3)是否对供应商和物料进行分级管理？如何分级？如何管理？",,"Checkrelatedfiles.

查看相关文件。",,,,,7.4.1

,,"4)Howtocontrolspecialpurchases?Isittraceable?

4)特殊采购如何控制？是否可追溯？",,"Checkcorrespondingcontrolrecordsandevidence.

查看相应控制记录与证据。",,,,,7.4.2

,"Verificationofpurchasedproducts

采购产品的验证","1)ArethereOQCreportsfromsub-suppliersforincomingmaterials?Havethesub-suppliersprovidetestreportsofRoHSandothertests?

1)来料是否有原供应商的出厂报告？供应商是否有提供RoHS等相关测试报告？",,"Checktherelevantrecords.

抽查相关记录。",,,,,7.4.3

,,"2)CheckwhethertheincomingmaterialhasthecorrespondingincomingmaterialtoverifySIP?IsSIPdetailedandcorrect?Areinspectionrecordstraceable?Isthereaprocedureforinspectionequipment?AretheyinspectedinaccordancewithSIPrequirements?

2)查看来料是否有相应的来料检验SIP/图纸/检验设备?SIP/图纸是否详细正确？是否按照SIP要求进行检验？检验记录是否具有可追溯性？检验设备是否有相应的操作规程？",,"ChecktheSIPof3incomingbatches,andchecktheinspectionrecordsof3～5incomingbatchesandcomparewithSIP.ChecktheSOPofinspectionequipment.

查看3个来料的SIP，并抽查其近期1~3批次来料的检查记录并和SIP对照。核对检验设备的操作规程。",,,,,7.4.3

,,"3)Whenthepurchasedmaterialchanges(e.g.re-selectionordesignchanges),arerelevantvalidationsconductedtoprovethatthechangesdonotaffecttheprocessandproduct?

3)当所采购的物料有变化(比如重新选型或设计变更)时，是否进行了相关的验证以证明该变化不会对过程和产品构成影响？",,"Checktherelevantrecords.

抽查相关记录。",,,,,7.4.3

,,"4)Aretheredocumentedproceduresformaterialcertificationandrelevantrecordsformaterialcertification?

4)是否有物料认证的程序文件和物料认证的相关记录？",,"Checktherelevantdocumentedproceduresandrecords.

抽查相关程序文件和记录。",,,,,7.4.3

,5.Facilities&Equipment设施与设备,,,,"MaxScore

总分",40,,"ActualScore

实际得分",

,"Audititem

审核项目","Auditcontent

审核内容",,"Auditmethod

审核方法","Comment

评价",,,"Score

得分","ISO13485clausebasedon

所依据的ISO13485条款"

,"Documentedproceduresforfacilities&equipment

设施设备程序文件","Aretheredocumentedproceduresthatspecifyrequirementsforinfrastructure(includinglocations,equipment,transportation,supportingservicessuchascommunicationsorinformationsystems)?Arethereproceduresforcalibration,verification,maintenanceanduseofgaugeequipment?

是否有程序文件规定基础设施（包括：场所，设备，运输、通讯或信息系统等支持性服务）的相关要求？是否有程序文件规定量仪设备的校准、验证、维护和使用？",,"Checktherelevantdocumentedprocedures.

查看相关程序文件。",,,,,6.3

,"Regiondivision

区域划分","1)Doeseachareahaveacorrespondingareaidentifier?Aretheitemsplacedineachareaconsistentwiththeareaidentification?Isthereachemicalcabinet?

1)各区域是否有相应的区域标识？各区域内摆放的物品是否与区域标识相符？是否有化学品柜？",,"Verifyonsite.

现场确认。",,,,,"6.3

7.5.11"

,"Facilities&equipment

设施与设备","1)Canproductionequipment/inspectionequipment/testequipmentmeetproductionandR&Dneeds(FocusonwhetherthereisanXRFdevice)?Doesfactoryhaveacalibrationplanformeasuringequipment?

1)生产设备/检验设备/测试设备是否可以满足生产和设计开发的需要(重点关注是否有XRF设备)？是否有量仪的校准计划？",,"Checkthedevicemasterlistandcalibrationplan.

查看设备总表和校准计划",,,,,"6.1

6.3"

,,"2)Doesthemeasuringequipmenthavethecalibrationmarkofthemeasuringorganization?Isitwithinthevalidityperiodofcalibration?

2)计量设备是否有计量机构的校准标识？是否在校准有效期内？",,"Verifyonsite.

现场确认。",,,,,7.6

,,"3)Arethereeasy-to-accessoperatingproceduresfordevicesandgaugesthatdonotneedtobemoved?Arethereanyequipmentchecklists?Doinspectionrecordsarefilledinthechecklistsontime?

3)不需移动的设备、量仪是否配置有容易获取的操作规程？是否有点检表？点检表是否按时填写点检记录？",,"Verifyonsite.

现场确认。",,,,,6.3

,,"4)Aretherestatusidentificationsforequipmentwithcertainhazardsorlargerequipment?Areoperatorstrainedandcertified?

4)具有一定危险性的设备或较大型设备是否有状态标识？操作员是否经过培训考核并持证上岗？",,"Verifyonsite.

现场确认。",,,,,6.3

,,"5)Aresamplesandtoolingequipmentprovidedbycustomersverified,identifiedandmaintained?Isthereasamplelendingregistrationrecord?

5)对顾客提供的样品、工装设备，是否有进行验证、标识和保管？是否有样品借出登记记录？",,"Verifyonsite.

现场确认。",,,,,7.5.10

,,"6)Aretheworkshopsandwarehousesequippedwithnecessaryfirefightingfacilities(suchasfirehydrants,fireextinguishers)andpestcontrolfacilities?Aretheycheckedandmaintainedregularly?

车间和仓库是否配备了必要的消防设施（如消防栓、灭火器）和防虫害设施？是否定期点检维护？",,"Verifyonsite.

现场确认。",,,,,6.3

,"validationofomputersoftware

计算机软件的确认","Whichcomputersoftwareneedstobecontrolled?Arethereanyvalidations(re-validatedifnecessary)?

需要控制的计算机软件有哪些？是否有经过确认(必要时需进行再确认)？",,"Checkthevalidationreport.

查看验证记录。",,,,,7.6

,6.Production&ProcessControls生产过程管控,,,,"MaxScore

总分",48,,"ActualScore

实际得分",

,"Audititem

审核项目","Auditcontent

审核内容",,"Auditmethod

审核方法","Comment

评价",,,"Score

得分","ISO13485clausebasedon

所依据的ISO13485条款"

,"Personnelandtraining

人员与培训","1)Isthereanyappointmentdocumentforqualitydirector,technicaldirector,productiondirector,etc?Dotheyknowthelawsandregulationsofmedicaldevices?

1)质量负责人、技术负责人、生产负责人等是否有任命文件？是否了解医疗器械的法律法规？",,"Viewtheappointmentdocuments.Checkjobrequirements,personnelfilesandtrainingrecords,andfocusonwhetherthesepersonsinchargeunderstandthelawsandregulationsofmedicaldevices.

查看任命文件。查看岗位任职要求、人事档案和培训记录，重点关注这些负责人是否了解医疗器械的法律法规。",,,,,6.1

,,"2)Aretheproductionandinspectionpersonneltrained?Hastherebeenanassessmentafterthetraining?Haveyouobtainedaqualificationcertificate(whichcannotbereplacedbytrainingforqualification)?

2)生产人员和检验人员是否经过培训？培训后是否有进行考核？是否取得了上岗资格证（不能以培训代替上岗资格认可）？",,"Inquireattheproductionsite,andcheckthequalificationcertificateandtrainingrecords.

生产现场询问，并检查其上岗资格证和培训记录。",,,,,7.5.1

,"Productioncontrols

生产管控","1)Isthereaprocessflowchartoraqualitycontrolplan(CP)?Doestheprocessflowchartdefinetheinspectionpointsorkeyprocesses?Aretherecorrespondingverificationrecordsforkeyprocessesandspecialprocesses?

1)是否制定了工艺流程图或质量控制计划(CP)？工艺流程图是否明确了检验点或关键工序？关键工序和特殊工序是否有对应的验证记录？",,"Checktheprocessflowchartandqualitycontrolplan(CP)ofproductssuppliedtoXXXcompany.Checktheverificationrecords.

抽查供应给XXX公司的产品的工艺流程图和质量控制计划(CP)。查看验证记录。",,,,,7.5.1

,,"2)Whethertheproductionprocessisplannedandcontrolled(e.g.dailycontrolofinput,in-processandoutput)?

2)生产过程是否有计划管制（如投入、在制、产出的日常控制）。",,"AsktherelevantpersonorviewthePMCrecord.

询问相关人员或查看PMC记录。",,,,,7.5.1

,,"3)Arethedocuments(form/drawing/SIP/SOP)onlinecomplete/detailed/correct?HavetheybeencontrolledbyDCC?Aretheyeasytoaccess?CheckwhethertheoperationofproductionpersonnelconformstoSOPoperationrequirements?

3)产线文件(表单/图纸/SIP/SOP)是否齐全/详细/正确？是否为受控文件？是否方便获取？检查生产人员作业是否符合SOP作业要求？",,"Verifyonsite.

现场确认。",,,,,7.5.1

,,"4)Isthereaspecificationforsamplinginspection?Isitimplemented?

4)是否有抽样检验的规范？是否得到执行？",,"Checkthesamplinginspectionrequirements,andinquireonsiteorchecktherecentinspectionrecords.

查看抽样检验要求，并现场询问或查看近期的检验记录。",,,,,8.2.6

,"Traceability

可追溯性","Isthereatraceabilitydocumentedprocedure?Arethereanyrecordsofincominginspection,processinspection,finishedproductinspection?Arerecordsstandardized?Havetheinformationofthetestequipmentusedbeenrecorded?

是否有可追溯性的程序文件？产品是否有相应的来料检验、过程检验、成品检验记录?记录是否规范？是否记录了所使用的测试设备信息？",,"Checktherecent3-5batchesofDHRoftheproductssuppliedtoXXXcompany.

查看供应给XXX公司的产品的近期3~5批次的DHR。",,,,,8.2.6

,"Identification

标识","1)Checkifthereisadocumentedprocedureforidentification?Aretheidentificationrequirementsforthewholeprocessofproductrealizationspecified?

是否有标识的程序文件？是否明确了产品实现全过程的标识要求？",,"Checktherelevantdocumentedprocedure.

查看相关程序文件。",,,,,7.5.8

,,"2)Arematerialsandproductsidentifiedonsite?Isthemethodofidentificationconsistentwiththedocumentation?Istheidentificationcompleted?Arealterationsmadeasrequired?

2)检查现场的物料、产品是否都有相应的标识？标识的方法是否和文件规定一致？标识填写是否完整？是否按要求进行涂改？",,"Verifyonsite.

现场确认。",,,,,7.5.8

,"Exceptionhandling

异常处理","Isthereacorrespondingcorrectiveandpreventivemeasuresfortheproductionanomalies?

生产过程异常是否有对应的纠正预防措施？",,"Checktherecordsofproductionprocessexceptions.

查看生产过程异常的记录。",,,,,8.2.5

,"Productrelease

产品放行","Isthereadocumentedproceduresforproductrelease?Hasitbeenimplemented?Isthereleasepersonamanagementrepresentativeoristhereleasepersonauthorizedbythemanagementrepresentative?

是否有产品放行的相关程序文件？是否得到执行？放行人员是否为管代或是否有管代的授权？",,"Checktherelevantdocumentedprocedure,checkrecent3~5batchreleaserecordsofproductssuppliedtoXXXcompany,andconfirmtheauthorityofreleasepersonnel.

查看相关程序文件，查看供应给XXX公司的产品近期3~5批次的放行记录，确认放行人员权限。",,,,,7.5.1

,"Typeinspection

型式检验","Areproducttypeinspectionsconductedregularlytoensureproductconformity?

是否有定期进行产品的型式检验以确保产品的符合性？",,"CheckthetypeinspectionsrecordslastyearorcurrentyearofproductssuppliedtoXXXcompany.

查看供应给XXX公司的产品去年或本年度的型式检验记录。",,,,,8.1

,7.NonconformingProductControl不合格品控制,,,,"MaxScore

总分",20,,"ActualScore

实际得分",

,"Audititem

审核项目","Auditcontent

审核内容",,"Auditmethod

审核方法","Comment

评价",,,"Score

得分","ISO13485clausebasedon

所依据的ISO13485条款"

,"Documentedprocedurefornonconformingproductcontrol

不合格品控制的程序文件","Isthereadocumentedprocedurefornonconformingproductcontrol？

是否有不合格品控制的程序文件？",,"Checktherelevantprocedure.

查看程序文件。",,,,,8.3.1

,"Responsemeasures