ISO系列稽核員主導(dǎo)稽核員訓(xùn)練課程

1、CONFIDENTIAL機(jī)密INTERNATIONAL REGISTEROF CERTIFICATED AUDITORS國(guó)際登錄合格稽核員SP ECIMEN EXAMINATION PAPER QMS 5練習(xí)試卷QMS 5ISO 9000:2000 SeriesAuditor/Lead Auditor Training Course (IRCA/2245)ISO 9000:2000系列稽核員/主導(dǎo)稽核員訓(xùn)練課程PI ease print your n ame in the sp ace below: 請(qǐng)將您的中英文正楷寫在下列空格欄內(nèi)：Course No.課程編號(hào)THESE SP ACES A

2、RE FOR OFFICIAL USE ONLYSectio nMarker 1Marker 2Check mark/arithmetic check.Delete as app licableP ass markMaximum1615210253123041230Total70100NameofmarkerVerifiedResultThe examination paper is in four sections. Please attempt all sections.考試題目共分為四大題，請(qǐng)回答所有的大題。The time allowed is two hours. There is

3、no additional time allowance for readingthe question paper. There is a maximumof 100 marks available; the pass mark is 70%and you must achieve at least 40% in each of the four sections.考試時(shí)間二小時(shí)，總分為 100 分，70 分以上合格且每大題必須至少答對(duì) 40%。Your answers must be written on the sheets that are supplied. Additional l

4、oose sheetswill not be accepted. 答案必須寫在本答案紙上，自行附加上的答案紙，不計(jì)分。The phrase ISO 9001 and “standard ” always refer to ISO 9001:2000. The wordclause refers to a paragraph or section of ISO 9001 that is identified by a numbersuch as 5.4.1 or a number and letter such as . 題目上若顥示“ ISO 9001”及“標(biāo)準(zhǔn)”即指 ISO/FDIS 900

5、1:2000 你可參考無任何注記的 ISO 9001 條文，其它文件不得參考。題目上所顯示之“條 文”即指標(biāo)準(zhǔn)中，例如：541 或等。Section 1 is worth 15 marks 第一大題共 15 分Comprises questions which require you either to place a circle around the letter(a, b, c, d or e) to indicate which you judge to be the best answer or to state thenumber of a clause from ISO 9001

6、. You must only give one answer for each question.選擇題由a、b、c、d、e圈選一個(gè)最適合的答案，而填充題寫上適切的條文編號(hào)Section 2 is worth 25 marks 第二大題共 25 分Comprises questions that require a brief written answer in the space provided.請(qǐng)簡(jiǎn)單回答，并將答案寫在空白欄位上。Section 3 is worth 30 marks 第三大題共 30 分Comprises questions that require a detail

7、ed written answer that will normally fillthe space provided.請(qǐng)?jiān)敿?xì)回答，并將答案寫在空白欄位上。Section 4 is worth 30 marks第四大題 30 分Comprises a numberof situations for which a nonconformity report (NCR) may berequired.依照題意狀況，寫出不符合事項(xiàng)報(bào)告或?qū)ふ腋嗟淖C據(jù)來佐證。Section 1 worth 15 marks第一大題共 15 分Thirteen multi-choice questions which

8、require you to place a circle around the letter(a, b, c, d or e) to indicate which you judge to be the best answer and two questionswhich require you to state the number of a clause from ISO 9001. Each question isworth 1 mark. If you change your answer you should clearly cross out the answer thatwas

9、 incorrect.十三題單選題，二題填充，每題各1分1.02abcdeQuality system audits are used to verify:品質(zhì)系統(tǒng)稽核是驗(yàn)證：the number of persons working on a contract 數(shù)the extent to which audit criteria are fulfilled 的程度 that allsuppliers to the organisation have ISO 9001 certification 組織所有供應(yīng)商皆具有 ISO 9001 資格 all of the above以上皆是none

10、of the above 以上皆非Third party auditis 第三方稽核是執(zhí)行合約要求的員工人稽核準(zhǔn)則被履行an internal audit內(nèi)部稽核an audit by the customer or client由客戶或委托人的稽核an audit by an independent organisation由獨(dú)立機(jī)構(gòu)所執(zhí)行的稽核all of the above以上皆是none of the above 以上皆非ISO 9001 includes:ISO 9001 包含：health and safety requirementsquality planning 品質(zhì)規(guī)劃健康

11、和安全要求quality costing 品質(zhì)成本 all ofthe above以上皆是none of the above 以上皆非1.04In preparing for an audit it is importantto 稽核的準(zhǔn)備是重要在plan 計(jì)劃define the scope of the audit訂定稽核的范圍select a lead auditor and a competent team選擇主任稽核員及有能力的組員all of the above以上皆是none of the above 以上皆非Which of the following activities m

12、ust be carried out by someonewho does notperform the activity being evaluated 下列何者活動(dòng)必須藉由沒有執(zhí)行受評(píng)估活動(dòng)的人員來完成abcdea contract review 合約審查an inspection of product 產(chǎn)品的檢驗(yàn)aquality system audit 品質(zhì)系統(tǒng)稽核 all ofthe above以上皆是none of the above 以上皆非1.06A system based on the requirements of ISO 9001 aims to 某系統(tǒng)基於 ISO 9

13、001 要求，其目的在achieve customer satisfaction達(dá)到客戶滿意demonstrate an organisation s ability to consistently supply conformingproduct 展現(xiàn)組織持續(xù)供應(yīng)合格產(chǎn)品的能力 prevent non conformity all of theabove none of the above防止不合格產(chǎn)品以上皆是 以上皆非1.07“Data supporting支持事物存在或真實(shí)性的資料，稱之the existence or verifyof something ” is called:abc

14、deobjective evidence a deficiency 缺點(diǎn) anonconformity report不符合報(bào)告all of the above以上皆是none of the above 以上皆非客觀證據(jù)1.08What information is being sought during a third party audit ofa quality system 在品質(zhì)系統(tǒng)第三方稽核時(shí)，會(huì)尋找什麼資訊a list of nonconformities to ISO 9001 objectiveevidence of conformity with ISO 9001 觀證據(jù)a

15、management commitment to quality assurance allof the above 以上皆是 none of the above 以上皆非不符合 ISO 9001 的清單符合 ISO 9001 的客品質(zhì)保證的管理承諾To act as an auditor of a quality system a person hasto 扮演品質(zhì)系統(tǒng)的稽核員必須be registered as a Certificated Auditorhave a detailed knowledge of theorganisation to be audited 具有被稽核組織產(chǎn)品

16、或服務(wù)的知識(shí) have been a qualitysystems manager all of the above 以上皆是 none of the above 以上皆非登錄合格的稽核員 product orservice of the是品質(zhì)系統(tǒng)經(jīng)理The process approach to a quality management system seeks to helporganisations:品質(zhì)管理系統(tǒng)的過程導(dǎo)向?qū)で髤f(xié)助組織：abcdemanage numerous linked activitiesunderstand and fulfil requirementsconti

17、nually improve processes allof the above 以上皆是 none of theabove 以上皆非管理多個(gè)相連的活動(dòng)了解及履行要求 持續(xù)改善過程by:品質(zhì)系統(tǒng)文件化的范圍應(yīng)由下列何者來決定bcdethe complexity of processes and their interactions 過程的復(fù)雜度及它們相互關(guān)系the expectations of auditees受稽者的期望the culture of the quality department 品質(zhì)部門的文化 all ofthe above以上皆是none of the above 以上皆

18、非1.13degree to which a set of inherent characteristics fulfils requirements ”is the ISO?9000:2000 definition of:“產(chǎn)品系統(tǒng)或過程履行固有特質(zhì)要求的程度滿足客戶和其他利益團(tuán)體要求 的能力” 是 ISO 9000:2000 對(duì)何者的定義：abcdecontinual improvement持續(xù)改善品質(zhì)保證quality assurancequality 品質(zhì) all ofthe above none ofthe above以上皆是以上皆非Indicate fully the clause

19、 of ISO 9001 that is applicable to thefollowing:指出 ISO 9001 的條文：ensure that personnel are aware of the relevance and importanceof their activities and how they contribute to the achievement ofquality objectives If the audit team does not find any nonconformity then leadershould 若稽核小組未發(fā)現(xiàn)任何不符合事項(xiàng)，則主任稽核

20、員應(yīng)explain to the managementof the audited organisation onlyinvestigated a sampleof activities and thatnonconformities which the sample did not uncover. 向受稽組織管理階層解釋，稽核僅抽樣查核，活動(dòng)可能有不符合事項(xiàng)，但 抽樣時(shí)并未發(fā)現(xiàn)conclude that there are no nonconformities existing in the quality system.做出品質(zhì)系統(tǒng)并未有不符合事項(xiàng)存在的結(jié)論 cancel the clo

21、sing meeting.取消結(jié)束會(huì)議all of the above以上皆是none of the above 以上皆非The extent of documentation of the quality system should be determinedthe audit teamthat the auditthere may be確保員工對(duì)他們活動(dòng)的重要性及相關(guān)性的認(rèn)知及他們對(duì)品質(zhì)目標(biāo)的達(dá)成 如何貢獻(xiàn)This is covered by clause文.Indicate fully the clause of ISO 9001 that is applicable to the fo

22、llowing;指出 ISO 9001 的條文：the organisation shall continually improve the effectiveness of the qualitymanagement system 組織應(yīng)持續(xù)改善品質(zhì)管理系統(tǒng)的有效性This is covered by clause文.這段話在條這段話在條 H H HH H H H H H H Secti on 2 worth 25 marks第二大題每題五分 H H HH H H H H H H Write a brief answer to each of the following five quest

23、ions using only the sp ace provided. Each questi on is worth 5 marks.在下列各題的空白欄位上，寫出簡(jiǎn)單答案。每題5分There are three types of quality system audit based on a first, second and thirdparty invo Iveme nt. Expl ai n the sp ecific features that dist in guish each ofthem.有三種品質(zhì)系統(tǒng)稽核的型式，分別是第一、第二及第三方參與。請(qǐng)解釋其 不同的特徵 H H

24、H HH H H H H H H H HH H H H H H H H H HH H H H H H H H H HH H H H H H H H H HH H H H H H H H H HH H H H H H H H H HH H H H H H H H H HH H H H H H H H H HH H H H H H H 2.02 What are the objectives and ben efits of quality man ageme nt systemdocume ntati on品質(zhì)管理系統(tǒng)文件的目標(biāo)及效益為何Objectives of quality man age

25、me nt system docume ntati on:品質(zhì)管理系統(tǒng)文件的目標(biāo)為:Ben efits of quality man ageme nt system docume ntati on:品質(zhì)管理系統(tǒng)文件的效益為:p rocess app roach “ as 1 of the 8 qualityPI ease explain your un dersta nding of what is mea nt by aapproach ” and identify at least four suchprinciples.whichfacilitateachievement of qual

26、ity objectives.2.03 ISO 9000 ide ntifies ap rocessISO 9001 clauses that support就您所了解請(qǐng)解釋”過程導(dǎo)向”的意義，并至少舉出 4 個(gè)相關(guān)的 ISO 9001 B H H H H H H H H H an app roach.ISO 9000 所言之”過程導(dǎo)向”是八大品質(zhì)理之一，促使品質(zhì)目標(biāo)的達(dá)成。條文 H H H HH HH H H H H H H HH H H H H H H H H HH H H H H H H H H HH H H H H H H An auditor is con duct ing a th

27、ird p arty audit. The guide who has bee n appoin tedto acco mpany the auditor around the various dep artme nts is called away by a seniormanager. After five minutes the guide hasnot returned. What should the auditor do What should the auditor notdo 某位稽核員正執(zhí)行第三方稽核，原被指派隌同稽核的引導(dǎo)者突然被主管叫 去。過了 5 分鍾，引導(dǎo)者還未回來。

28、稽核員應(yīng)該怎麼做稽核員不應(yīng)做什麼What should the auditor do H H H H H HH H H H H BH H H H H HH H H What should the auditor not do H H H H H HH H H H H H H H H H HH H H H H H H H H H HH H H H H H H HH H HH H H H H H H HH H HH H H H H H H HH H H H H H H B H H H H H H H H H complianee with the requirements of clause 7.

29、2.3 of ISO 9001 In youran swer, make links to other ISO 9001 clauses as n ecessary那些客觀證據(jù)能提供以證明符合 ISO 9001 條文 7.2.3 的要求在您的回答中稽核員應(yīng)該做稽核員不應(yīng)該做What objectiveevidenee could be availablein order to verify與其它 ISO 9001 條文相連結(jié)。Secti on 3 worth 30 marks第三大題每大題 10 分Attempt each of the following three questions ea

30、ch worth 10 marks. Questions thatrequire a detailed written answer will normally fill the space provided. Where appropriate, you should ide ntify the releva nt clauses of ISO 9001 in your an swer.詳細(xì)回答下列三題，適當(dāng)時(shí)，您應(yīng)該標(biāo)示出相關(guān)的 ISO 9001 條文3.01 You are planning a p rocess audit of an orga ni satio n that supp

31、 lies electroniccablingand networkingproducts.The organisationcon sists of the follow ing dep artme nts:您計(jì)劃以過程導(dǎo)向的方式為一家供應(yīng)電子線纜和網(wǎng)路產(chǎn)品的公司稽核。此 公司包括下列部門：sales and marketi ng行銷和業(yè)務(wù)pu rchas ing 采購(gòu)warehouse 倉(cāng)儲(chǔ)p ack ing and des patch包裝及運(yùn)交support services支援服務(wù)The top management team consists of the managing direc

32、tor and dep artme ntalman agers from each of the above dep artme nts.高階管理團(tuán)隊(duì)包括總經(jīng)理及上述各部門經(jīng)理。3.01a What would be your two main con sideratio ns in decidi ng the seque nee ofactivities for the audit舉出 2 個(gè)你在決定稽核活動(dòng)順序的主要考量How would you app roach the audit of continual impro veme nt in this organi sati on你如何

33、稽核該公司的持續(xù)改善Seque nee of activities活動(dòng)的順序Con ti nual impro veme nt in this orga ni sati on續(xù)改善Maximum 4 marks企業(yè)的持Maximum 6 marks3.02 Describe the principal acti ons which should be take n, and by whom, when anoncon formity has bee n ide ntified duri ng an audit. A simple flowchartmay be used to an swer

34、this questi on.當(dāng)稽核所發(fā)現(xiàn)的不符合事項(xiàng)，請(qǐng)陳述主要采取的行動(dòng)并說明該由誰(shuí)、何時(shí) 來執(zhí)行利用簡(jiǎn)單流程圖來回答此問題。3.03 You are con duct ing an audit of a mediumsized manu facturi ng company. Thedocume nt review has raised a concern about how the orga ni sati on en suresthe comp ete nee of staff.您正在對(duì)一中型的制造商進(jìn)行稽核。文件審查引起你對(duì)於該公司如何確保 員工能力的產(chǎn)生質(zhì)疑。Prepare a

35、checklist that would guide you through a p rocess audit of thisarea, and state the releva nt ISO 9001 clauses.請(qǐng)準(zhǔn)備查檢表引導(dǎo)你的過程稽核且寫出相關(guān)的 ISO 9001 條文Secti on 4 worth 30 marks第四大題共 30 分Three in cide nts that occur duri ng a third p arty audit of a supp lier, XYZpic, are described. They contain situationsfor

36、 which nonconformity reportsmay be required. Exam ine each in cide nt carefully the n take one of the followi ng actions:下列是發(fā)生在執(zhí)行 XYZ 公司第三方稽核的情況，可能要求書寫不符合事項(xiàng)報(bào)告。仔 細(xì)衡量每種情況并采取下列二者之一的行動(dòng)：For each in cide nt, if you thi nk that there is sufficie nt objective evide neeof noncon formity the n you should comp

37、 lete a noncon formity report and categoriseit as major or minor.若您認(rèn)為已有足夠客觀證據(jù)顯示其為不符合事項(xiàng)，則應(yīng)該完成不符合事項(xiàng) 報(bào)告及分類If you do not thi nk that there is sufficie nt objective evide nee of noncon formitythe n:若您不認(rèn)為有足夠客觀證據(jù)顯示其為不符合事項(xiàng)，貝 U:state why you think there isinsufficientevidenee ofnoncon formity陳述你為何認(rèn)為不符合事項(xiàng)證據(jù)不足

38、state at least three things you would look for as evidenee that the situation is un der con trol請(qǐng)寫出至少三點(diǎn)你可能進(jìn)一步尋找此事件是在管制下的證據(jù)During an audit of man ageme nt review activities you no tice from the minutes ofmanagementreview meetings that the meetings are not attended by any of the top man agement team.

39、Whe n you query this, the man ageme nt representative tells you that managementreview has evolved into a two-tier process, as it was proving so difficultto get allof thedepartmental and top managers available at the same time. The process is now that dep artmental man agers meet and con duct the fir

40、st level of man ageme nt review. The man agement rep rese ntativeprep ares a summaryreport in clud ing acti ons and recomme ndati ons. This is p assed round each of the topman ageme nt team for comme nt and the Managing Director fin ally agrees the action plan.10 marks 在稽核管理審查活動(dòng)中 ，你由管理審查記錄中發(fā)現(xiàn)未有任何最高管

41、理團(tuán)隊(duì)參加此會(huì) 議。當(dāng)你詢問這點(diǎn)，a)b)Incident Number 1事件1管理代表告訴你，管理審查分為兩個(gè)過程，因?yàn)?，要將所有?門及高階主管同時(shí)召集是有困難的 。所以部門主管參與第一階段的管理審查過程。 而管理代表匯整報(bào)告，包括措施及建議，再傳閲每位高階管理者提供卓見，最後由 總經(jīng)理核準(zhǔn)行動(dòng)計(jì)劃。Incident Number 2 事件 2During an audit you are shown the latest internal audit on the purchasing department. Thisincludes a nonconformity report st

42、ating that three people in the purchasing departmenthad not been trained in the use of the approved supplier list. The corrective action takenwas to train the three members of staff. The audit report has been closed. The managementrepresentative tells you that there was no further investigation as t

43、he corrective actionwas obvious. The internal auditor had checked the training records of the staff concernedbefore closing the report.10 marks 稽核內(nèi)部稽核時(shí)，你查閱上次內(nèi)部稽核有關(guān)采購(gòu)部門的報(bào)告 。其中有個(gè)不符合事項(xiàng) 陳述有 3 位采購(gòu)部門的員工未被訓(xùn)練如何使用合格供應(yīng)商名冊(cè) ，而矯正措施是對(duì)這 3 位員工進(jìn)行訓(xùn)練。并且這報(bào)告已結(jié)案。管理代表告訴你并未進(jìn)一步的調(diào)查因?yàn)槌C 正措施是顯而易見的。內(nèi)部稽核員在結(jié)案前已經(jīng)查檢此 3 個(gè)員工的訓(xùn)練記錄。Inci

44、dent Number 3In the purchasing department the auditor asks how the new supplier for TMX101items wasselected. The purchasing clerk explains that the regular supplier could not meet thedelivery date and the order was placed with a new supplier which they had never used before,only because the price qu

45、oted was extremely low. The clerk states that no other evaluationwas conducted.10 marks 在采購(gòu)部門，稽核員問到 TMX10 物品的新供應(yīng)商是如何選擇的。采購(gòu)承辦員解釋 一般供應(yīng)商無法滿足交貨日期且訂單是被我們從未交易過的供應(yīng)商取得 ，因?yàn)樗?報(bào)價(jià)非常的低。承辦員說并沒有采取其他評(píng)估。If you thi nk there is evide nee of a noncon formity, comp lete this report:假如你認(rèn)為有不符合項(xiàng)的證據(jù)，完成下列報(bào)告：假若你不認(rèn)為有足夠的不符合事項(xiàng)的證據(jù)，陳述你的理由。并且說明稽核員應(yīng)該采取那些進(jìn)一步的行動(dòng)。MAJOR* 主要 MINOR* 次要 * delete one 劃去其一No neo nformity （不符合事項(xiàng)）Auditor稽核員Or 或