,"SupplierQualityManagementSystemAuditChecklist(ISO13485)

供應(yīng)商質(zhì)量管理體系審核表(ISO13485)",,,,,,,,

,"AuditDate:

審核時(shí)間:",,"ActralScore:

實(shí)際得分:",312,,"ScoreRate

得分率",,78%(312=/400),

,"Auditor(s):

審核人員:",,"MaxScore:

總分:",400,,"Conclusion:

審核結(jié)論:",,Goodsupplier,

,"Scorerate&supplierlevel:

得分率與供應(yīng)商等級(jí)：","＜60%Poorsupplier,60%～70%Basicsupplier,70%～80%Goodsupplier,80%～90%Verygoodsupplier,90%～100%Excellentsupplier",,,,,,,

,"Audititem

審核項(xiàng)目","Score

得分","Audititem

審核項(xiàng)目","Score

得分",,"Audititem

審核項(xiàng)目",,"Score

得分",

,"1.QualityManagementSystem

質(zhì)量管理體系",/68,"4.PurchasingControls

采購(gòu)管控",/48,,"7.NonconformingProductControls

不合格品控制",,/20,

,"2.Design&DevelopmentControls

設(shè)計(jì)與開(kāi)發(fā)管控",/48,"5.Facilities&Equipment

設(shè)施與設(shè)備",/40,,"8.Corrective&PreventiveAction

糾正預(yù)防措施",,/20,

,"3.DocumentControls

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

生產(chǎn)過(guò)程管控",/48,,"9.Storage&Delivery&After-Sale

倉(cāng)儲(chǔ)/交付/售后",,/72,

,Theadvantage/disadvantageofqualitymanagement供應(yīng)商質(zhì)量管理優(yōu)缺點(diǎn)：,,,,,,,,

,1.Advantage優(yōu)點(diǎn):,,,,,,,,

,2.Disadvantage缺點(diǎn):,,,,,,,,

,,,,,,,,,,

,GeneralInformationofsupplier供應(yīng)商基本信息,,,,,,,,

,"SupplierName:

供應(yīng)商名稱：",,,"FactoryAddress:

工廠地址：",,,,,

,"AuditPurpose:

驗(yàn)廠目的：","tNewsupplier□Self-Assessment□Regularly

新供應(yīng)商評(píng)審供應(yīng)商自評(píng)例行評(píng)審",,"Certifications:

認(rèn)證信息：",tISO13485□MDD□FDA□BSCI□ISO9001□ISO14000□SA8000□SAA,,,,

,"ContactPerson:

聯(lián)系人：",,"ContactTel.&Fax:

聯(lián)系方式：",Tel:Fax:,,,,,

,"RegisteredCapital

注冊(cè)資金：",,"ProductionScope:

產(chǎn)品范圍：",,,,,,

,"EmployeesNumber:

公司人數(shù)：",500,"R&DNumber:

研發(fā)人員：",,"QA/QCNumber:

品質(zhì)人員：",,,"TechnicianNumber:

技術(shù)人員：",

,"MajorCustomers:

主要客戶：",,,"Saleexperience

外銷區(qū)域","□Europe%,□America%,□Japan%,□Asia%,□Australia%,□Africa%",,,,

,"OperationHours:

營(yíng)業(yè)時(shí)間：","8:30-12:00,13:00-17:30,Mon-Fri",,"Others:

其他信息：",,,,,

,,,,,,,,,,

,ScoringCriteria評(píng)分標(biāo)準(zhǔn),,,,,,,,

,Score分值,Definition定義,,,,,,,

,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優(yōu)秀,Fullymeettherequirement(100%)完全符合要求,,,,,,

,,,,,,,,,,

,1.QualityManagementSystem質(zhì)量管理體系,,,,"MaxScore

總分",68,,"ActualScore

實(shí)際得分",

,"Audititem

審核項(xiàng)目","Auditcontent

審核內(nèi)容",,"Auditmethod

審核方法","Comment

評(píng)價(jià)",,,"Score

得分","ISO13485clausebasedon

所依據(jù)的ISO13485條款"

,"Verifythatwhetherthesupplierhasestablishedqualitymanagementsystem.

確認(rèn)供應(yīng)商是否已建立質(zhì)量管理體系。","★1)VerifythatwhetherthesupplierhasobtainedtheISO13485certificate,businesslicense,productionlicense,CEcertificate,etc.,andwhethertheyarewithinthevalidityperiod.

1)確認(rèn)是否已取得ISO13485:2016體系認(rèn)證證書，營(yíng)業(yè)執(zhí)照，生產(chǎn)許可證，CE證書等？證件是否在有效期內(nèi)？",,"ChecktheISO13485certificate,businesslicense,productionlicense,CEcertificate,etc.

查看ISO13485:2016證書、營(yíng)業(yè)執(zhí)照、生產(chǎn)許可證、CE證書。",,,,,4.1.1

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

2)檢查質(zhì)量方針、質(zhì)量目標(biāo)、質(zhì)量手冊(cè)、程序文件、作業(yè)指導(dǎo)書、記錄表單是否已文件化？",,"Checkthedocumentedfilesofqualitymanagementsystem.

查看體系文件。",,,,,"4.1.1

4.2.1"

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

3)查看質(zhì)量管理體系過(guò)程關(guān)系表（輸入、輸出、擁有者、顧客）是否清晰。",,"Checktheflowchartofqualitymanagementsystem.

查看質(zhì)量管理體系過(guò)程關(guān)系表",,,,,4.1.1

,"Qualitymanual

質(zhì)量手冊(cè)","1)Verifythatwhetherthequalitymanualisissuedbythetopmanager.

1)檢查質(zhì)量手冊(cè)是否為最高管理者簽發(fā)。",,"Checkthequalitymanual.

查看質(zhì)量手冊(cè)。",,,,,4.2.2

,,"2)Checkwhetherthedescriptionofproductscope,qualitysystemcoverage,documentstructureandclausedeletioncoveredbythequalitymanualareconsistentwiththeactualsituation?

2)檢查質(zhì)量手冊(cè)覆蓋的產(chǎn)品范圍、質(zhì)量體系涵蓋范圍、文件結(jié)構(gòu)、條款刪減的描述與實(shí)際是否相符？",,"Checkthequalitymanual.

查看質(zhì)量手冊(cè)。",,,,,4.2.2

,"Qualitypolicy

質(zhì)量方針","Hasthequalitypolicybeenevaluatedandpublicized?

質(zhì)量方針是否經(jīng)過(guò)評(píng)審、宣貫？",,"Checkrelevantrecords,randomlycheck1~3employeestoconfirmwhethertheyarefamiliarwiththequalitypolicy?

查看相關(guān)記錄，隨機(jī)抽查1~3名員工對(duì)質(zhì)量方針是否熟悉?",,,,,5.3

,"Qualityobjective

質(zhì)量目標(biāo)","1)Isthequalityobjectivemeasurable?Isitconsistentwiththequalitypolicy?

1)質(zhì)量目標(biāo)是否是可測(cè)量的？與質(zhì)量方針是否保持一致？",,"Contrastqualitypolicyandqualityobjective

對(duì)比質(zhì)量方針和質(zhì)量目標(biāo)。",,,,,5.4.1

,,"2)Arethereanycauseanalysisandimprovementmeasuresfortheunachievedqualityobjectives?

2)針對(duì)未達(dá)成的質(zhì)量目標(biāo)是否有對(duì)應(yīng)的原因分析和改進(jìn)措施？",,"Viewthecompletionofqualityobjectivesandrelatedcausesandimprovementmeasuresinthepreviousyearorthisyear.

查看上年度或本年度的質(zhì)量目標(biāo)完成情況及相關(guān)原因分析、改進(jìn)措施。",,,,,5.4.1

,"Responsibilityandauthority

職責(zé)和權(quán)限","Arethepersonnelinthequalityandproductiondepartmentsseparated?

質(zhì)量部門和生產(chǎn)部門的人員是否獨(dú)立分開(kāi)？",,"Viewthepersonnelstructureofthequalitydepartmentandtheproductiondepartment

查看質(zhì)量部門和生產(chǎn)部門的人員架構(gòu)。",,,,,5.5.1

,"Managementrepresentative

管理者代表","Isthereamanagementrepresentativeappointmentdocumentissuedbythetopmanagement?

是否有最高管理者簽發(fā)的管理者代表任命文件？",,"Checkthemanagementrepresentativeappointmentdocument.

查看管代任命文件。",,,,,5.5.2

,"Managementreview

管理評(píng)審","1)Istheredocumentedprocedureformanagementreview?Hasmanagementreviewbeenconductedatthetimespecifiedintheproceduraldocuments?

1)是否有管理評(píng)審的程序文件？是否按程序文件規(guī)定的時(shí)間實(shí)施管理評(píng)審？",,"Checktherelevantdocumentedproceduredocumentsandthemanagementreviewrecordoflastyearorthisyear.

查看相關(guān)程序文件和去年或本年度管理評(píng)審記錄。",,,,,5.6

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

2)管理評(píng)審是否由最高管理者主持？評(píng)審的輸入輸出是否充分(詳見(jiàn)條例)？審核結(jié)果是否經(jīng)過(guò)最高管理者批準(zhǔn)？是否有對(duì)應(yīng)改善措施的記錄？",,"Checkthemanagementreviewrecordsoflastyearorthisyear.

查看去年或本年度管理評(píng)審記錄。",,,,,5.6

,"

Internalaudit

內(nèi)部審核","1)Istheredocumentedprocedureforinternalaudit?

是否有內(nèi)部審核的程序文件？",,"Viewthedocumentedprocedureforinternalaudit.

查看內(nèi)審相關(guān)程序文件。",,,,,8.2.4

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

2)是否編制了內(nèi)審計(jì)劃？?jī)?nèi)審計(jì)劃是否包含：審核目的、范圍、依據(jù)、審核人員？是否有管代簽字批準(zhǔn)？",,"Checktheinternalauditplanforlastyearorthisyear.

查看去年或本年度內(nèi)審計(jì)劃。",,,,,8.2.4

,,"3)Arethereatleasttwointernalauditors?Haveinternalauditorsbeentrainedinthequalitymanagementsystem?Isthereaninternalauditorreviewinghisorherowndepartment?

3)是否至少有2名內(nèi)審員？?jī)?nèi)審員是否經(jīng)過(guò)了質(zhì)量管理體系的相關(guān)培訓(xùn)？是否存在內(nèi)審員審核本部門或本崗位的情況？",,"Checkthecertificatesortrainingrecordsofinternalauditors;Checktheinternalauditrecordsoflastyearorthisyear.

查看內(nèi)審員的證書或培訓(xùn)記錄；查看去年或本年度內(nèi)審記錄。",,,,,8.2.4

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

審核是否充分？不符合項(xiàng)的出具是否具有依據(jù)？審核結(jié)論是否經(jīng)過(guò)管代批準(zhǔn)？",,"Checktheinternalauditchecklistandnon-conformityreportlastyearorthisyear.

查看去年或本年度檢查表和不符合報(bào)告。",,,,,8.2.4

,,"5)Isthereanycorrespondingimprovementmeasuresforinternalauditnon-conformity?

內(nèi)審不符合項(xiàng)是否有對(duì)應(yīng)的改進(jìn)措施？",,"Viewrelevantrecords.

查看相關(guān)記錄。",,,,,8.2.4

,2.Design&DevelopmentControls設(shè)計(jì)與開(kāi)發(fā)管控,,,,"MaxScore

總分",48,,"ActualScore

實(shí)際得分",

,"Audititem

審核項(xiàng)目","Auditcontent

審核內(nèi)容",,"Auditmethod

審核方法","Comment

評(píng)價(jià)",,,"Score

得分","ISO13485clausebasedon

所依據(jù)的ISO13485條款"

,"Documentedprocedurefordesign&development

設(shè)計(jì)開(kāi)發(fā)程序文件","IstheredocumentedprocedureforDesign&Development?

是否有設(shè)計(jì)開(kāi)發(fā)程序文件？",,"CheckthedocumentedprocedureforDesign&Development.

查看程序文件。",,,,,7.3.1

,"Design&developmentplanning

設(shè)計(jì)和開(kāi)發(fā)策劃","Isthereadesignanddevelopmentplan(theresultoftheplan)?Doestheplanpresenttherequiredresources,includingthenecessarypersonnelcapacity?Istheresponsibilityandauthorityofpersonnel(includinginterfacepersonnelofdifferentdepartments)andthedivisionofeachstageclear?Doestheplanchangeasthedesignprogresses?

是否編制了設(shè)計(jì)開(kāi)發(fā)計(jì)劃（策劃的結(jié)果）？計(jì)劃是否提出了所需的資源，包括必要的人員能力？人員（包括不同部門的接口人）職責(zé)權(quán)限、各階段劃分是否明確？并確認(rèn)計(jì)劃是否隨設(shè)計(jì)的進(jìn)展而適時(shí)修改？",,"CheckthedesignanddevelopmentplanofproductssuppliedtoXXXcompany.

查看供應(yīng)給XXX公司的產(chǎn)品的設(shè)計(jì)開(kāi)發(fā)計(jì)劃。",,,,,7.3.2

,"Design&developmentinputs

設(shè)計(jì)和開(kāi)發(fā)輸入","1)Istherearecordofdesignanddevelopmentinputs?Istherearecordofreviewingtheadequacy/suitabilityofdesignanddevelopmentinputs?Hasthereviewconclusionbeenapproved?

1)是否有設(shè)計(jì)開(kāi)發(fā)輸入的記錄？是否有對(duì)設(shè)計(jì)開(kāi)發(fā)輸入的充分性/適宜性進(jìn)行評(píng)審的記錄？評(píng)審結(jié)論是否得到批準(zhǔn)？",,"Checkthedesignanddevelopmentinputrecordsoftheprojectsabove.

查看上述項(xiàng)目的設(shè)計(jì)開(kāi)發(fā)輸入相關(guān)記錄。",,,,,7.3.3

,,"2)Toconfirmtheadequacyofdesignanddevelopmentinputs,thefollowingshouldbeincluded:

①Accordingtotheexpecteduse:function,performance,availabilityandsafetyrequirements;

②Applicablestatutoryrequirementsandstandards;

③Outputofriskmanagement(e.g.riskanalysisreportorFMEA);

④Informationprovidedbyprevioussimilardesigns.

2)確認(rèn)設(shè)計(jì)開(kāi)發(fā)輸入是否充分，應(yīng)包括以下內(nèi)容：

①根據(jù)預(yù)期用途：功能、性能、可用性和安全要求；

②適用的法規(guī)要求和標(biāo)準(zhǔn)；

③風(fēng)險(xiǎn)管理輸出（例如風(fēng)險(xiǎn)分析報(bào)告或FMEA）；

④以前類似設(shè)計(jì)提供的信息。",,"Checkthedesignanddevelopmentinputrecordsoftheprojectsabove.(FocusonriskanalysisreportsorFMEA).

查看上述項(xiàng)目的設(shè)計(jì)開(kāi)發(fā)輸入相關(guān)記錄（重點(diǎn)關(guān)注風(fēng)險(xiǎn)分析報(bào)告或FMEA）。",,,,,7.3.3

,"Design&developmentoutputs

設(shè)計(jì)和開(kāi)發(fā)輸出","Istherearecordofdesignanddevelopmentoutput?Isthedesignoutputdocumentapprovedbeforerelease?Toconfirmthecompletenessofthedesignanddevelopmentoutputdata,thefollowingshouldbeincluded:

①Relevantinformationprovidedbyprocurement/production/service;

②Productacceptancecriteria;

③Importantcharacteristicstoensureproductsafety/normaluse.

是否有設(shè)計(jì)開(kāi)發(fā)輸出的記錄？設(shè)計(jì)輸出文件放行前是否得到批準(zhǔn)？確認(rèn)設(shè)計(jì)開(kāi)發(fā)輸出資料是否完整，應(yīng)包括以下內(nèi)容：

①采購(gòu)/生產(chǎn)/服務(wù)提供的相關(guān)信息；

②產(chǎn)品驗(yàn)收準(zhǔn)則；

③確保產(chǎn)品安全/正常使用的重要特性。",,"Checkthedesignanddevelopmentoutputrecordsoftheprojectsabove.

查看上述項(xiàng)目的設(shè)計(jì)開(kāi)發(fā)輸出相關(guān)記錄",,,,,7.3.4

,"Design&developmentreview

設(shè)計(jì)和開(kāi)發(fā)評(píng)審","Arereviewsconductedinaccordancewiththereviewpointssetupinthedesignanddevelopmentplan?Hasthereviewconclusionbeenapproved?Arethereanyevidenceofimprovementatthereviewpoint?Isthereasituationwherethereviewisnotqualifiedandisstillreleasedtothenextstage?

是否按照設(shè)計(jì)開(kāi)發(fā)計(jì)劃設(shè)置的評(píng)審點(diǎn)實(shí)施評(píng)審？評(píng)審結(jié)論是否得到批準(zhǔn)？評(píng)審問(wèn)題點(diǎn)是否有改善證據(jù)？是否存在評(píng)審不合格仍放行到下一個(gè)階段的情況？",,"Checkthedesignanddevelopmentreviewrecordsoftheprojectsabove.

查看上述項(xiàng)目的設(shè)計(jì)開(kāi)發(fā)評(píng)審相關(guān)記錄。",,,,,7.3.5

,"Design&developmentverification(Whethertheoutputsatisfiestheinput)

設(shè)計(jì)和開(kāi)發(fā)驗(yàn)證(輸出是否滿足輸入)","Isthereverificationconductedaccordingtotheverificationpointsspecifiedinthedesignanddevelopmentplan(suchastheverificationofpackaging)?Arethereverificationguidelines(validationmethods/acceptancecriteria)?Arethereanynecessaryimprovementstotheproblemsidentified?

項(xiàng)目是否按設(shè)計(jì)和開(kāi)發(fā)計(jì)劃規(guī)定的驗(yàn)證點(diǎn)進(jìn)行驗(yàn)證(比如包裝的驗(yàn)證)？是否有驗(yàn)證的指導(dǎo)文件(驗(yàn)證方法/接收準(zhǔn)則)？針對(duì)驗(yàn)證發(fā)現(xiàn)的問(wèn)題是否有必要的改進(jìn)措施？",,"Checkthedesignanddevelopmentverificationrecordsoftheprojectsabove.

查看上述項(xiàng)目的設(shè)計(jì)開(kāi)發(fā)驗(yàn)證相關(guān)記錄。",,,,,7.3.6

,"Design&developmentvalidation(Whetherthedesignanddevelopmentresultsmeettheneedsofusers)

設(shè)計(jì)和開(kāi)發(fā)確認(rèn)(設(shè)計(jì)開(kāi)發(fā)結(jié)果是否滿足用戶需求)","Arethereplansorinstructionsfordesignanddevelopmentvalidation(suchasclinicalevaluationorperformanceevaluation)?Arethereanyrecordsofconfirmedresults/conclusionsandnecessarymeasures?

是否有設(shè)計(jì)和開(kāi)發(fā)確認(rèn)(比如臨床評(píng)價(jià)或性能評(píng)價(jià))的計(jì)劃或相關(guān)說(shuō)明？是否有確認(rèn)的結(jié)果/結(jié)論以及必要措施的記錄？",,"Checkthedesignanddevelopmentvalidationrecordsoftheprojectsabove.

查看上述項(xiàng)目的設(shè)計(jì)開(kāi)發(fā)確認(rèn)相關(guān)記錄。",,,,,7.3.7

,"Design&developmenttransfer

設(shè)計(jì)和開(kāi)發(fā)轉(zhuǎn)換","Isthereadocumentedprocedurefortheconversionfromdesignanddevelopmentoutputtomassproduction?Isthereanyrecordofthetransitionprocessandconclusions?

是否有從設(shè)計(jì)開(kāi)發(fā)輸出轉(zhuǎn)換到量產(chǎn)的程序文件？是否有轉(zhuǎn)換的過(guò)程和結(jié)論的記錄？",,"Checkrelevantdocumentedprocedure.Checkthedesignanddevelopmentvalidationrecordsoftheprojectsabove.

查看相關(guān)程序文件；查看上述項(xiàng)目的設(shè)計(jì)開(kāi)發(fā)確認(rèn)相關(guān)記錄。",,,,,7.3.8

,"Controlofdesignanddevelopmentchanges

設(shè)計(jì)和開(kāi)發(fā)更改的控制","1)Isthereadocumentedprocedurefordesignanddevelopmentchanges?

1)是否有設(shè)計(jì)和開(kāi)發(fā)變更的程序文件？",,"Checkrelevantdocumentedprocedure.

查看設(shè)計(jì)開(kāi)發(fā)變更的程序文件。",,,,,7.3.9

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

變更是否經(jīng)過(guò)了評(píng)審/驗(yàn)證/批準(zhǔn)？是否有對(duì)變更的影響進(jìn)行評(píng)價(jià)？",,"Check3~5designanddevelopmentchanges.

抽查3~5份變更。",,,,,7.3.9

,"Designanddevelopmentfiles(DHF)

設(shè)計(jì)和開(kāi)發(fā)文件（DHF）","Accordingtothedesignanddevelopmentplanandprogramfiles,checkwhethertheDHFfilesarecompleteornot?Doesitincluderecordsofdesignanddevelopmentchanges?

根據(jù)設(shè)計(jì)開(kāi)發(fā)計(jì)劃及程序文件，查看其DHF文件是否完整？是否包括設(shè)計(jì)與開(kāi)發(fā)變更的記錄？",,"ChecktheDHFoftheprojectsabove.

查看上述項(xiàng)目的DHF。",,,,,7.3.10

,3.DocumentControls文件控制,,,,"MaxScore

總分",36,,"ActualScore

實(shí)際得分",

,"Audititem

審核項(xiàng)目","Auditcontent

審核內(nèi)容",,"Auditmethod

審核方法","Comment

評(píng)價(jià)",,,"Score

得分","ISO13485clausebasedon

所依據(jù)的ISO13485條款"

,"Documentscontrol

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

1)是否有程序文件規(guī)定文件（包含電子媒體形式的文件）的審核、發(fā)放、修訂、保存、作廢等過(guò)程?",,"Checkrelevantdocumentedprocedure.

查看相關(guān)程序文件。",,,,,4.2.4

,,"2)Verifythatwhetherthelistofdocumentsandrecordsofdocumentdistribution/cancellationareclear.

2)確認(rèn)文件清單、文件發(fā)放/作廢記錄是否清晰?",,"Checkthelistofdocumentsandrecordsofdocumentdistribution/cancellation.

查看文件清單及文件發(fā)放/作廢記錄。",,,,,4.2.4

,,"3)Isthereanyuseofelectronicmediaorotherformsofdocuments?Isitcontrolled?

3)是否有使用電子媒體或其他形式的文件？是否已經(jīng)受控？",,"Inquirerelevantpersonnelorcheckonsite.

詢問(wèn)相關(guān)人員，或現(xiàn)場(chǎng)檢查。",,,,,4.2.4

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

4)現(xiàn)場(chǎng)是否可以得到有關(guān)文件，文件是否受控，是否有相關(guān)人員批準(zhǔn)，文件版本和數(shù)量是否與發(fā)放記錄一致？",,"Checkdocumentsonsiteasperreleaserecord.

根據(jù)發(fā)放記錄核對(duì)現(xiàn)場(chǎng)文件。",,,,,4.2.4

,,"5)Checkthelistofforeigndocuments,check3pcsforeigndocumentstoconfirmthattheirissuancerecordsandidentificationareclear,andverifythattheyarethelatestversion.

5)查看外來(lái)文件清單，抽查3份外來(lái)文件確認(rèn)其發(fā)放記錄和標(biāo)識(shí)是否清晰，并確定是否為最新版本。",,"Checkthelistofforeigndocumentsandselect3pcsforeigndocumentsforconfirmation.

查看外來(lái)文件清單，抽查3份外來(lái)文件進(jìn)行確認(rèn)。",,,,,4.2.4

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

6)查看作廢文件清單（至少保存一份作廢文件），抽查1～3份作廢技術(shù)文檔，確認(rèn)是否有作廢標(biāo)識(shí)，核對(duì)保存期限是否正確（保存期限至少在醫(yī)療器械的使用壽命期限之內(nèi)，且不得短于醫(yī)療器械通過(guò)入市審批后的2年）。",,"Checkthelistofobsoletedocuments,select1~3pcsobsoletedocumentsforconfirmation.

查看作廢文件清單,抽查1~3份作廢文件進(jìn)行確認(rèn)。",,,,,4.2.4

,"Recordscontrol

記錄控制","1)thereisadocumentedproceduretospecifytheidentification,filling,storage,safetyandintegrity,retrieval,preservationperiodandothercontrolrequirementsforrecords(includingrecordsinelectronicmediaform)?

1)是否有程序文件規(guī)定記錄（包含電子媒體形式的記錄）的標(biāo)識(shí)、填寫、貯存、安全和完整性、檢索、保存期限和處置所需的控制?",,"Checkrelevantdocumentedprocedure.

查看相關(guān)程序文件。",,,,,4.2.5

,,"2)Istherecordcompleteandclear,isthealterationstandard?

2)記錄的填寫是否完整、清晰，涂改是否規(guī)范？",,"Verifyonsite.

現(xiàn)場(chǎng)確認(rèn)。",,,,,4.2.5

,,"3)Isthearchive,identificationandstorageoftherecordformeasytoretrieve?

3)記錄表單的歸檔、標(biāo)識(shí)和儲(chǔ)存是否便于檢索？",,"Determineifthedocumentcanbepresentedquickly.

判斷是否能迅速出示文件。",,,,,4.2.5

,4.PurchasingControls采購(gòu)管控,,,,"MaxScore

總分",48,,"ActualScore

實(shí)際得分",

,"Audititem

審核項(xiàng)目","Auditcontent

審核內(nèi)容",,"Auditmethod

審核方法","Comment

評(píng)價(jià)",,,"Score

得分","ISO13485clausebasedon

所依據(jù)的ISO13485條款"

,"Documentedprocedureforpurchasing

采購(gòu)程序文件","Isthereadocumentedprocedureforpurchasing?Doesitincluderequirementsforsupplierevaluationandre-evaluation,specialprocurement?

是否有采購(gòu)的程序文件？是否包括供應(yīng)商的評(píng)價(jià)和再評(píng)價(jià)、特殊采購(gòu)的相關(guān)要求？",,"Checkthedocumentedprocedureforpurchasing

查看采購(gòu)程序文件。",,,,,7.4.1

,"Supplierevaluation

供應(yīng)商評(píng)價(jià)","1)Isthereasupplierevaluationandarecordofthecorrespondingimprovementmeasures?Isthesupplierre-evaluatedwithinthespecifiedtime?Arecorrectiveactionstakenagainstvendorswithpoorperformanceandfollow-upvalidation?

1)是否有相應(yīng)的供應(yīng)商評(píng)價(jià)和對(duì)應(yīng)改進(jìn)措施的記錄？是否在規(guī)定時(shí)間內(nèi)按準(zhǔn)則要求對(duì)供應(yīng)商進(jìn)行重新評(píng)價(jià)？針對(duì)表現(xiàn)較差的供應(yīng)商是否采取糾正措施并跟蹤驗(yàn)證？",,"Checkthelistofqualifiedsuppliers,randomlyselect3suppliers,andchecktheirrecordsofevaluation,re-evaluationandimprovement.

查看合格供應(yīng)商清單，從中隨機(jī)抽查3家供應(yīng)商，查看其評(píng)價(jià)、再評(píng)價(jià)和改進(jìn)記錄。",,,,,7.4.1

,,"2)Spotchecktherecentinspectionformstoconfirmwhetherthesuppliersareallqualifiedsuppliers.

2)抽查近期報(bào)驗(yàn)單，確認(rèn)供應(yīng)商是否都是評(píng)價(jià)合格的供應(yīng)商？",,"Checktheinspectionreportatthewarehousesite.

倉(cāng)庫(kù)現(xiàn)場(chǎng)查看報(bào)驗(yàn)單。",,,,,7.4.1

,"Qualityagreement

質(zhì)量協(xié)議","Hasaqualityagreementbeensignedwiththesupplier?Doesthequalityagreementincludetherequirementsofthequalitymanagementsystem,outsourcingmanagement,changecontrol,exceptionhandling,qualityrequirements,acceptancerequirements,lawsandregulations,cargosafetyrequirements,poorqualityhandlingmethods,etc?

是否和供應(yīng)商簽訂了質(zhì)量協(xié)議？質(zhì)量協(xié)議中是否包括：質(zhì)量管理體系的要求、外包管理、變更控制、異常處理、質(zhì)量要求、驗(yàn)收要求、法律法規(guī)要求、貨物安全要求、質(zhì)量不良處理方式等？",,"Checkthequalityagreementswiththeabove3suppliers.

查看與上述3家供應(yīng)商簽訂的質(zhì)量協(xié)議。",,,,,7.4.2

,"Purchasingprocess

采購(gòu)過(guò)程","1)Arepurchasedocumentsandpurchaseordersexaminedandapprovedbeforetheyareissued?

1)采購(gòu)文件、采購(gòu)單發(fā)出前是否經(jīng)過(guò)審批？",,"Spotcheckthepurchasedocumentsandpurchaseordersoftherecent3～5batchesofproductssuppliedtoXXXcompany.

抽查近期3～5批供應(yīng)給XXX公司的產(chǎn)品的采購(gòu)文件和采購(gòu)單。",,,,,7.4.1

,,"2)Doesthepurchaseorder(orcontract)includethequalityrequirementsandacceptancerequirementsofthepurchasedproducts?

2)采購(gòu)訂單(或合同)中是否包括所采購(gòu)產(chǎn)品的質(zhì)量要求、驗(yàn)收要求？",,"Checkthepurchaseorder(orcontract).

查看采購(gòu)訂單(或合同)。",,,,,7.4.1

,,"3)Isthereahierarchicalmanagementofsuppliersandmatrerials?Howaretheygraded?Howtomanage?

3)是否對(duì)供應(yīng)商和物料進(jìn)行分級(jí)管理？如何分級(jí)？如何管理？",,"Checkrelatedfiles.

查看相關(guān)文件。",,,,,7.4.1

,,"4)Howtocontrolspecialpurchases?Isittraceable?

4)特殊采購(gòu)如何控制？是否可追溯？",,"Checkcorrespondingcontrolrecordsandevidence.

查看相應(yīng)控制記錄與證據(jù)。",,,,,7.4.2

,"Verificationofpurchasedproducts

采購(gòu)產(chǎn)品的驗(yàn)證","1)ArethereOQCreportsfromsub-suppliersforincomingmaterials?Havethesub-suppliersprovidetestreportsofRoHSandothertests?

1)來(lái)料是否有原供應(yīng)商的出廠報(bào)告？供應(yīng)商是否有提供RoHS等相關(guān)測(cè)試報(bào)告？",,"Checktherelevantrecords.

抽查相關(guān)記錄。",,,,,7.4.3

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

2)查看來(lái)料是否有相應(yīng)的來(lái)料檢驗(yàn)SIP/圖紙/檢驗(yàn)設(shè)備?SIP/圖紙是否詳細(xì)正確？是否按照SIP要求進(jìn)行檢驗(yàn)？檢驗(yàn)記錄是否具有可追溯性？檢驗(yàn)設(shè)備是否有相應(yīng)的操作規(guī)程？",,"ChecktheSIPof3incomingbatches,andchecktheinspectionrecordsof3～5incomingbatchesandcomparewithSIP.ChecktheSOPofinspectionequipment.

查看3個(gè)來(lái)料的SIP，并抽查其近期1~3批次來(lái)料的檢查記錄并和SIP對(duì)照。核對(duì)檢驗(yàn)設(shè)備的操作規(guī)程。",,,,,7.4.3

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

3)當(dāng)所采購(gòu)的物料有變化(比如重新選型或設(shè)計(jì)變更)時(shí)，是否進(jìn)行了相關(guān)的驗(yàn)證以證明該變化不會(huì)對(duì)過(guò)程和產(chǎn)品構(gòu)成影響？",,"Checktherelevantrecords.

抽查相關(guān)記錄。",,,,,7.4.3

,,"4)Aretheredocumentedproceduresformaterialcertificationandrelevantrecordsformaterialcertification?

4)是否有物料認(rèn)證的程序文件和物料認(rèn)證的相關(guān)記錄？",,"Checktherelevantdocumentedproceduresandrecords.

抽查相關(guān)程序文件和記錄。",,,,,7.4.3

,5.Facilities&Equipment設(shè)施與設(shè)備,,,,"MaxScore

總分",40,,"ActualScore

實(shí)際得分",

,"Audititem

審核項(xiàng)目","Auditcontent

審核內(nèi)容",,"Auditmethod

審核方法","Comment

評(píng)價(jià)",,,"Score

得分","ISO13485clausebasedon

所依據(jù)的ISO13485條款"

,"Documentedproceduresforfacilities&equipment

設(shè)施設(shè)備程序文件","Aretheredocumentedproceduresthatspecifyrequirementsforinfrastructure(includinglocations,equipment,transportation,supportingservicessuchascommunicationsorinformationsystems)?Arethereproceduresforcalibration,verification,maintenanceanduseofgaugeequipment?

是否有程序文件規(guī)定基礎(chǔ)設(shè)施（包括：場(chǎng)所，設(shè)備，運(yùn)輸、通訊或信息系統(tǒng)等支持性服務(wù)）的相關(guān)要求？是否有程序文件規(guī)定量?jī)x設(shè)備的校準(zhǔn)、驗(yàn)證、維護(hù)和使用？",,"Checktherelevantdocumentedprocedures.

查看相關(guān)程序文件。",,,,,6.3

,"Regiondivision

區(qū)域劃分","1)Doeseachareahaveacorrespondingareaidentifier?Aretheitemsplacedineachareaconsistentwiththeareaidentification?Isthereachemicalcabinet?

1)各區(qū)域是否有相應(yīng)的區(qū)域標(biāo)識(shí)？各區(qū)域內(nèi)擺放的物品是否與區(qū)域標(biāo)識(shí)相符？是否有化學(xué)品柜？",,"Verifyonsite.

現(xiàn)場(chǎng)確認(rèn)。",,,,,"6.3

7.5.11"

,"Facilities&equipment

設(shè)施與設(shè)備","1)Canproductionequipment/inspectionequipment/testequipmentmeetproductionandR&Dneeds(FocusonwhetherthereisanXRFdevice)?Doesfactoryhaveacalibrationplanformeasuringequipment?

1)生產(chǎn)設(shè)備/檢驗(yàn)設(shè)備/測(cè)試設(shè)備是否可以滿足生產(chǎn)和設(shè)計(jì)開(kāi)發(fā)的需要(重點(diǎn)關(guān)注是否有XRF設(shè)備)？是否有量?jī)x的校準(zhǔn)計(jì)劃？",,"Checkthedevicemasterlistandcalibrationplan.

查看設(shè)備總表和校準(zhǔn)計(jì)劃",,,,,"6.1

6.3"

,,"2)Doesthemeasuringequipmenthavethecalibrationmarkofthemeasuringorganization?Isitwithinthevalidityperiodofcalibration?

2)計(jì)量設(shè)備是否有計(jì)量機(jī)構(gòu)的校準(zhǔn)標(biāo)識(shí)？是否在校準(zhǔn)有效期內(nèi)？",,"Verifyonsite.

現(xiàn)場(chǎng)確認(rèn)。",,,,,7.6

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

3)不需移動(dòng)的設(shè)備、量?jī)x是否配置有容易獲取的操作規(guī)程？是否有點(diǎn)檢表？點(diǎn)檢表是否按時(shí)填寫點(diǎn)檢記錄？",,"Verifyonsite.

現(xiàn)場(chǎng)確認(rèn)。",,,,,6.3

,,"4)Aretherestatusidentificationsforequipmentwithcertainhazardsorlargerequipment?Areoperatorstrainedandcertified?

4)具有一定危險(xiǎn)性的設(shè)備或較大型設(shè)備是否有狀態(tài)標(biāo)識(shí)？操作員是否經(jīng)過(guò)培訓(xùn)考核并持證上崗？",,"Verifyonsite.

現(xiàn)場(chǎng)確認(rèn)。",,,,,6.3

,,"5)Aresamplesandtoolingequipmentprovidedbycustomersverified,identifiedandmaintained?Isthereasamplelendingregistrationrecord?

5)對(duì)顧客提供的樣品、工裝設(shè)備，是否有進(jìn)行驗(yàn)證、標(biāo)識(shí)和保管？是否有樣品借出登記記錄？",,"Verifyonsite.

現(xiàn)場(chǎng)確認(rèn)。",,,,,7.5.10

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

車間和倉(cāng)庫(kù)是否配備了必要的消防設(shè)施（如消防栓、滅火器）和防蟲害設(shè)施？是否定期點(diǎn)檢維護(hù)？",,"Verifyonsite.

現(xiàn)場(chǎng)確認(rèn)。",,,,,6.3

,"validationofomputersoftware

計(jì)算機(jī)軟件的確認(rèn)","Whichcomputersoftwareneedstobecontrolled?Arethereanyvalidations(re-validatedifnecessary)?

需要控制的計(jì)算機(jī)軟件有哪些？是否有經(jīng)過(guò)確認(rèn)(必要時(shí)需進(jìn)行再確認(rèn))？",,"Checkthevalidationreport.

查看驗(yàn)證記錄。",,,,,7.6

,6.Production&ProcessControls生產(chǎn)過(guò)程管控,,,,"MaxScore

總分",48,,"ActualScore

實(shí)際得分",

,"Audititem

審核項(xiàng)目","Auditcontent

審核內(nèi)容",,"Auditmethod

審核方法","Comment

評(píng)價(jià)",,,"Score

得分","ISO13485clausebasedon

所依據(jù)的ISO13485條款"

,"Personnelandtraining

人員與培訓(xùn)","1)Isthereanyappointmentdocumentforqualitydirector,technicaldirector,productiondirector,etc?Dotheyknowthelawsandregulationsofmedicaldevices?

1)質(zhì)量負(fù)責(zé)人、技術(shù)負(fù)責(zé)人、生產(chǎn)負(fù)責(zé)人等是否有任命文件？是否了解醫(yī)療器械的法律法規(guī)？",,"Viewtheappointmentdocuments.Checkjobrequirements,personnelfilesandtrainingrecords,andfocusonwhetherthesepersonsinchargeunderstandthelawsandregulationsofmedicaldevices.

查看任命文件。查看崗位任職要求、人事檔案和培訓(xùn)記錄，重點(diǎn)關(guān)注這些負(fù)責(zé)人是否了解醫(yī)療器械的法律法規(guī)。",,,,,6.1

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

2)生產(chǎn)人員和檢驗(yàn)人員是否經(jīng)過(guò)培訓(xùn)？培訓(xùn)后是否有進(jìn)行考核？是否取得了上崗資格證（不能以培訓(xùn)代替上崗資格認(rèn)可）？",,"Inquireattheproductionsite,andcheckthequalificationcertificateandtrainingrecords.

生產(chǎn)現(xiàn)場(chǎng)詢問(wèn)，并檢查其上崗資格證和培訓(xùn)記錄。",,,,,7.5.1

,"Productioncontrols

生產(chǎn)管控","1)Isthereaprocessflowchartoraqualitycontrolplan(CP)?Doestheprocessflowchartdefinetheinspectionpointsorkeyprocesses?Aretherecorrespondingverificationrecordsforkeyprocessesandspecialprocesses?

1)是否制定了工藝流程圖或質(zhì)量控制計(jì)劃(CP)？工藝流程圖是否明確了檢驗(yàn)點(diǎn)或關(guān)鍵工序？關(guān)鍵工序和特殊工序是否有對(duì)應(yīng)的驗(yàn)證記錄？",,"Checktheprocessflowchartandqualitycontrolplan(CP)ofproductssuppliedtoXXXcompany.Checktheverificationrecords.

抽查供應(yīng)給XXX公司的產(chǎn)品的工藝流程圖和質(zhì)量控制計(jì)劃(CP)。查看驗(yàn)證記錄。",,,,,7.5.1

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

2)生產(chǎn)過(guò)程是否有計(jì)劃管制（如投入、在制、產(chǎn)出的日?？刂疲?。",,"AsktherelevantpersonorviewthePMCrecord.

詢問(wèn)相關(guān)人員或查看PMC記錄。",,,,,7.5.1

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

3)產(chǎn)線文件(表單/圖紙/SIP/SOP)是否齊全/詳細(xì)/正確？是否為受控文件？是否方便獲??？檢查生產(chǎn)人員作業(yè)是否符合SOP作業(yè)要求？",,"Verifyonsite.

現(xiàn)場(chǎng)確認(rèn)。",,,,,7.5.1

,,"4)Isthereaspecificationforsamplinginspection?Isitimplemented?

4)是否有抽樣檢驗(yàn)的規(guī)范？是否得到執(zhí)行？",,"Checkthesamplinginspectionrequirements,andinquireonsiteorchecktherecentinspectionrecords.

查看抽樣檢驗(yàn)要求，并現(xiàn)場(chǎng)詢問(wèn)或查看近期的檢驗(yàn)記錄。",,,,,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？產(chǎn)品是否有相應(yīng)的來(lái)料檢驗(yàn)、過(guò)程檢驗(yàn)、成品檢驗(yàn)記錄?記錄是否規(guī)范？是否記錄了所使用的測(cè)試設(shè)備信息？",,"Checktherecent3-5batchesofDHRoftheproductssuppliedtoXXXcompany.

查看供應(yīng)給XXX公司的產(chǎn)品的近期3~5批次的DHR。",,,,,8.2.6

,"Identification

標(biāo)識(shí)","1)Checkifthereisadocumentedprocedureforidentification?Aretheidentificationrequirementsforthewholeprocessofproductrealizationspecified?

是否有標(biāo)識(shí)的程序文件？是否明確了產(chǎn)品實(shí)現(xiàn)全過(guò)程的標(biāo)識(shí)要求？",,"Checktherelevantdocumentedprocedure.

查看相關(guān)程序文件。",,,,,7.5.8

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

2)檢查現(xiàn)場(chǎng)的物料、產(chǎn)品是否都有相應(yīng)的標(biāo)識(shí)？標(biāo)識(shí)的方法是否和文件規(guī)定一致？標(biāo)識(shí)填寫是否完整？是否按要求進(jìn)行涂改？",,"Verifyonsite.

現(xiàn)場(chǎng)確認(rèn)。",,,,,7.5.8

,"Exceptionhandling

異常處理","Isthereacorrespondingcorrectiveandpreventivemeasuresfortheproductionanomalies?

生產(chǎn)過(guò)程異常是否有對(duì)應(yīng)的糾正預(yù)防措施？",,"Checktherecordsofproductionprocessexceptions.

查看生產(chǎn)過(guò)程異常的記錄。",,,,,8.2.5

,"Productrelease

產(chǎn)品放行","Isthereadocumentedproceduresforproductrelease?Hasitbeenimplemented?Isthereleasepersonamanagementrepresentativeoristhereleasepersonauthorizedbythemanagementrepresentative?

是否有產(chǎn)品放行的相關(guān)程序文件？是否得到執(zhí)行？放行人員是否為管代或是否有管代的授權(quán)？",,"Checktherelevantdocumentedprocedure,checkrecent3~5batchreleaserecordsofproductssuppliedtoXXXcompany,andconfirmtheauthorityofreleasepersonnel.

查看相關(guān)程序文件，查看供應(yīng)給XXX公司的產(chǎn)品近期3~5批次的放行記錄，確認(rèn)放行人員權(quán)限。",,,,,7.5.1

,"Typeinspection

型式檢驗(yàn)","Areproducttypeinspectionsconductedregularlytoensureproductconformity?

是否有定期進(jìn)行產(chǎn)品的型式檢驗(yàn)以確保產(chǎn)品的符合性？",,"CheckthetypeinspectionsrecordslastyearorcurrentyearofproductssuppliedtoXXXcompany.

查看供應(yīng)給XXX公司的產(chǎn)品去年或本年度的型式檢驗(yàn)記錄。",,,,,8.1

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

總分",20,,"ActualScore

實(shí)際得分",

,"Audititem

審核項(xiàng)目","Auditcontent

審核內(nèi)容",,"Auditmethod

審核方法","Comment

評(píng)價(jià)",,,"Score

得分","ISO13485clausebasedon

所依據(jù)的ISO13485條款"

,"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