IRCA 9000Specimen Paper QMS5 issue 1 TE.docx
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IRCA 9000Specimen Paper QMS5 issue 1 TE.docx
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IRCA9000SpecimenPaperQMS5issue1TE
CONFIDENTIAL
機密
INTERNATIONALREGISTER
OFCERTIFICATEDAUDITORS
國際登錄合格稽核員
SPECIMENEXAMINATIONPAPERQMS5
練習試卷QMS5
ISO9000:
2000Series
Auditor/LeadAuditorTrainingCourse(IRCA/2245)
ISO9000:
2000系列
稽核員/主導稽核員訓練課程
Pleaseprintyournameinthespacebelow:
請將您的中英文正楷寫在下列空格欄內:
CourseNo………………
課程編號
THESESPACESAREFOROFFICIALUSEONLY
Section
Marker1
Marker2
Checkmark/arithmeticcheck.
Deleteasapplicable
Passmark
Maximum
1
6
15
2
10
25
3
12
30
4
12
30
Total
70
100
Nameofmarker
Verified
Result
Theexaminationpaperisinfoursections.Pleaseattemptallsections.
考試題目共分為四大題,請回答所有的大題。
Thetimeallowedistwohours.Thereisnoadditionaltimeallowanceforreadingthequestionpaper.Thereisamaximumof100marksavailable;thepassmarkis70%andyoumustachieveatleast40%ineachofthefoursections.
考試時間二小時,總分為100分,70分以上合格且每大題必須至少答對40%。
Youranswersmustbewrittenonthesheetsthataresupplied.Additionalloosesheetswillnotbeaccepted.
答案必須寫在本答案紙上,自行附加上的答案紙,不計分。
Thephrase"ISO9001"and“standard”alwaysrefertoISO9001:
2000.
Theword"clause"referstoaparagraphorsectionofISO9001thatisidentifiedbyanumbersuchas5.4.1oranumberandlettersuchas7.1b.
題目上若顥示“ISO9001”及“標準”即指ISO/FDIS9001:
2000
你可參考無任何註記的ISO9001條文,其它文件不得參考。
題目上所顯示之“條文”即指標準中,例如:
5.4.1或7.2.1(a)…等。
Section1isworth15marks
第一大題共15分
Comprisesquestionswhichrequireyoueithertoplaceacirclearoundtheletter(a,b,c,dore)toindicatewhichyoujudgetobethebestanswerortostatethenumberofaclausefromISO9001.Youmustonlygiveoneanswerforeachquestion.
選擇題由a、b、c、d、e圈選一個最適合的答案,而填充題寫上適切的條文編號
Section2isworth25marks
第二大題共25分
Comprisesquestionsthatrequireabriefwrittenanswerinthespaceprovided.
請簡單回答,並將答案寫在空白欄位上。
Section3isworth30marks
第三大題共30分
Comprisesquestionsthatrequireadetailedwrittenanswerthatwillnormallyfillthespaceprovided.
請詳細回答,並將答案寫在空白欄位上。
Section4isworth30marks
第四大題30分
Comprisesanumberofsituationsforwhichanonconformityreport(NCR)mayberequired.
依照題意狀況,寫出不符合事項報告或尋找更多的證據來佐證。
Section1worth15marks
第一大題共15分
Thirteenmulti-choicequestionswhichrequireyoutoplaceacirclearoundtheletter(a,b,c,dore)toindicatewhichyoujudgetobethebestanswerandtwoquestionswhichrequireyoutostatethenumberofaclausefromISO9001.Eachquestionisworth1mark.Ifyouchangeyouransweryoushouldclearlycrossouttheanswerthatwasincorrect.
十三題單選題,二題填充,每題各1分
1.01Qualitysystemauditsareusedtoverify:
品質系統稽核是驗證:
athenumberofpersonsworkingonacontract執行合約要求的員工人數
btheextenttowhichauditcriteriaarefulfilled稽核準則被履行的程度
cthatallsupplierstotheorganisationhaveISO9001certification
組織所有供應商皆具有ISO9001資格
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.02Thirdpartyauditis
第三方稽核是
aaninternalaudit內部稽核
banauditbythecustomerorclient由客戶或委託人的稽核
canauditbyanindependentorganisation由獨立機構所執行的稽核
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.03ISO9001includes:
ISO9001包含:
ahealthandsafetyrequirements健康和安全要求
bqualityplanning品質規劃
cqualitycosting品質成本
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.04Inpreparingforanaudititisimportantto
稽核的準備是重要在
aplan計劃
bdefinethescopeoftheaudit訂定稽核的範圍
cselectaleadauditorandacompetentteam選擇主任稽核員及有能力的組員
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.05Whichofthefollowingactivitiesmustbecarriedoutbysomeonewhodoesnotperformtheactivitybeingevaluated?
下列何者活動必須藉由沒有執行受評估活動的人員來完成?
aacontractreview合約審查
baninspectionofproduct產品的檢驗
caqualitysystemaudit品質系統稽核
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.06AsystembasedontherequirementsofISO9001aimsto
某系統基於ISO9001要求,其目的在
aachievecustomersatisfaction達到客戶滿意
bdemonstrateanorganisation’sabilitytoconsistentlysupplyconformingproduct
展現組織持續供應合格產品的能力
cpreventnonconformity防止不合格產品
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.07“Datasupportingtheexistenceorverifyofsomething”iscalled:
支持事物存在或真實性的資料,稱之
aobjectiveevidence客觀證據
badeficiency缺點
canonconformityreport不符合報告
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.08Whatinformationisbeingsoughtduringathirdpartyauditofaqualitysystem?
在品質系統第三方稽核時,會尋找什麼資訊?
aalistofnonconformitiestoISO9001不符合ISO9001的清單
bobjectiveevidenceofconformitywithISO9001符合ISO9001的客觀證據
camanagementcommitmenttoqualityassurance品質保證的管理承諾
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.09Toactasanauditorofaqualitysystemapersonhasto
扮演品質系統的稽核員必須
aberegisteredasaCertificatedAuditor登錄合格的稽核員
bhaveadetailedknowledgeoftheproductorserviceoftheorganisationtobeaudited
具有被稽核組織產品或服務的知識
chavebeenaqualitysystemsmanager是品質系統經理
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.10Theprocessapproachtoaqualitymanagementsystemseekstohelporganisations:
品質管理系統的過程導向尋求協助組織:
amanagenumerouslinkedactivities管理多個相連的活動
bunderstandandfulfilrequirements瞭解及履行要求
ccontinuallyimproveprocesses持續改善過程
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.11Iftheauditteamdoesnotfindanynonconformitythentheauditteamleadershould
若稽核小組未發現任何不符合事項,則主任稽核員應
aexplaintothemanagementoftheauditedorganisationthattheauditonlyinvestigatedasampleofactivitiesandthattheremaybenonconformitieswhichthesampledidnotuncover.
向受稽組織管理階層解釋,稽核僅抽樣查核,活動可能有不符合事項,但抽樣時並未發現
bconcludethattherearenononconformitiesexistinginthequalitysystem.
做出品質系統並未有不符合事項存在的結論
ccanceltheclosingmeeting.取消結束會議
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.12Theextentofdocumentationofthequalitysystemshouldbedeterminedby:
品質系統文件化的範圍應由下列何者來決定?
athecomplexityofprocessesandtheirinteractions
過程的複雜度及它們相互關係
btheexpectationsofauditees受稽者的期望
cthecultureofthequalitydepartment品質部門的文化
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.13"degreetowhichasetofinherentcharacteristicsfulfilsrequirements”istheISO 9000:
2000definitionof:
“產品系統或過程履行固有特質要求的程度滿足客戶和其他利益團體要求的能力”是ISO9000:
2000對何者的定義:
acontinualimprovement持續改善
bqualityassurance品質保證
cquality品質
dalloftheabove以上皆是
enoneoftheabove以上皆非
1.14IndicatefullytheclauseofISO9001thatisapplicabletothefollowing:
指出ISO9001的條文:
〝ensurethatpersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofqualityobjectives〞
〝確保員工對他們活動的重要性及相關性的認知及他們對品質目標的達成如何貢獻〞
Thisiscoveredbyclause..................這段話在條文……..............
1.15IndicatefullytheclauseofISO9001thatisapplicabletothefollowing;
指出ISO9001的條文:
〝theorganisationshallcontinuallyimprovetheeffectivenessofthequalitymanagementsystem〞
〝組織應持續改善品質管理系統的有效性〞
Thisiscoveredbyclause...................這段話在條文……...............
Section2worth25marks
第二大題每題五分
Writeabriefanswertoeachofthefollowingfivequestionsusingonlythespaceprovided.Eachquestionisworth5marks.
在下列各題的空白欄位上,寫出簡單答案。
每題5分
2.01Therearethreetypesofqualitysystemauditbasedonafirst,secondandthirdpartyinvolvement.Explainthespecificfeaturesthatdistinguisheachofthem.
有三種品質系統稽核的型式,分別是第一、第二及第三方參與。
請解釋其不同的特徵。
2.02Whataretheobjectivesandbenefitsofqualitymanagementsystemdocumentation?
品質管理系統文件的目標及效益為何?
Objectivesofqualitymanagementsystemdocumentation:
品質管理系統文件的目標為:
Benefitsofqualitymanagementsystemdocumentation:
品質管理系統文件的效益為:
2.03ISO9000identifiesa“processapproach“as1ofthe8qualityprinciples,whichfacilitateachievementofqualityobjectives.Pleaseexplainyourunderstandingofwhatismeantbya“processapproach”andidentifyatleastfourISO9001clausesthatsupportsuchanapproach.
ISO9000所言之”過程導向”是八大品質理之一,促使品質目標的達成。
就您所瞭解請解釋”過程導向”的意義,並至少舉出4個相關的ISO9001條文
2.04Anauditorisconductingathirdpartyaudit.Theguidewhohasbeenappointedtoaccompanytheauditoraroundthevariousdepartmentsiscalledawaybyaseniormanager.Afterfiveminutestheguidehasnotreturned.Whatshouldtheauditordo?
Whatshouldtheauditornotdo?
某位稽核員正執行第三方稽核,原被指派隌同稽核的引導者突然被主管叫去。
過了5分鍾,引導者還未回來。
稽核員應該怎麼做?
稽核員不應做什麼?
Whatshouldtheauditordo稽核員應該做:
Whatshouldtheauditornotdo稽核員不應該做:
2.05Whatobjectiveevidencecouldbeavailableinordertoverifycompliancewiththerequirementsofclause7.2.3ofISO9001?
Inyouranswer,makelinkstootherISO9001clausesasnecessary.
那些客觀證據能提供以證明符合ISO9001條文7.2.3的要求?
在您的回答中,
與其它ISO9001條文相連結。
Section3worth30marks
第三大題每大題10分
Attempteachofthefollowingthreequestionseachworth10marks.Questionsthatrequireadetailedwrittenanswerwillnormallyfillthespaceprovided.Whereappropriate,youshouldidentifytherelevantclausesofISO9001inyouranswer.
詳細回答下列三題,適當時,您應該標示出相關的ISO9001條文
3.01Youareplanningaprocessauditofanorganisationthatsupplieselectroniccablingandnetworkingproducts.Theorganisationconsistsofthefollowingdepartments:
您計劃以過程導向的方式為一家供應電子線纜和網路產品的公司稽核。
此公司包括下列部門:
∙salesandmarketing行銷和業務
∙purchasing採購
∙warehouse倉儲
∙packinganddespatch包裝及運交
∙supportservices支援服務
Thetopmanagementteamconsistsofthemanagingdirectoranddepartmentalmanagersfromeachoftheabovedepartments.
高階管理團隊包括總經理及上述各部門經理。
3.01aWhatwouldbeyourtwomainconsiderationsindecidingthesequenceofactivitiesfortheaudit?
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- IRCA 9000Specimen Paper QMS5 issue TE 9000 Specimen