ISO系列稽核员主导稽核员训练课程

1、CONFIDENTIAL机密INTERNATIONAL REGISTEROF CERTIFICATED AUDITORS国际登录合格稽核员SP ECIMEN EXAMINATION PAPER QMS 5练习试卷QMS 5ISO 9000:2000 SeriesAuditor/Lead Auditor Training Course (IRCA/2245)ISO 9000:2000系列稽核员/主导稽核员训练课程PI ease print your n ame in the sp ace below: 请将您的中英文正楷写在下列空格栏内：Course No.课程编号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.考试题目共分为四大题，请回答所有的大题。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.考试时间二小时，总分为 100 分，70 分以上合格且每大题必须至少答对 40%。Your answers must be written on the sheets that are supplied. Additional l

4、oose sheetswill not be accepted. 答案必须写在本答案纸上，自行附加上的答案纸，不计分。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 . 题目上若颢示“ ISO 9001”及“标准”即指 ISO/FDIS 900

5、1:2000 你可参考无任何注记的 ISO 9001 条文，其它文件不得参考。题目上所显示之“条 文”即指标准中，例如：541 或等。Section 1 is worth 15 marks 第一大题共 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.选择题由a、b、c、d、e圈选一个最适合的答案，而填充题写上适切的条文编号Section 2 is worth 25 marks 第二大题共 25 分Comprises questions that require a brief written answer in the space provided.请简单回答，并将答案写在空白栏位上。Section 3 is worth 30 marks 第三大题共 30 分Comprises questions that require a detail

7、ed written answer that will normally fillthe space provided.请详细回答，并将答案写在空白栏位上。Section 4 is worth 30 marks第四大题 30 分Comprises a numberof situations for which a nonconformity report (NCR) may berequired.依照题意状况，写出不符合事项报告或寻找更多的证据来佐证。Section 1 worth 15 marks第一大题共 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.十三题单选题，二题填充，每题各1分1.02abcdeQuality system audits are used to verify:品质系统稽核是验证：the number of persons working on a contract 数the extent to which audit criteria are fulfilled 的程度 that allsuppliers to the organisation have ISO 9001 certification 组织所有供应商皆具有 ISO 9001 资格 all of the above以上皆是none

10、of the above 以上皆非Third party auditis 第三方稽核是执行合约要求的员工人稽核准则被履行an internal audit内部稽核an audit by the customer or client由客户或委托人的稽核an audit by an independent organisation由独立机构所执行的稽核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 品质规划健康

11、和安全要求quality costing 品质成本 all ofthe above以上皆是none of the above 以上皆非1.04In preparing for an audit it is importantto 稽核的准备是重要在plan 计划define the scope of the audit订定稽核的范围select a lead auditor and a competent team选择主任稽核员及有能力的组员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 下列何者活动必须藉由没有执行受评估活动的人员来完成abcdea contract review 合约审查an inspection of product 产品的检验aquality system audit 品质系统稽核 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 某系统基於 ISO 9

13、001 要求，其目的在achieve customer satisfaction达到客户满意demonstrate an organisation s ability to consistently supply conformingproduct 展现组织持续供应合格产品的能力 prevent non conformity all of theabove none of the above防止不合格产品以上皆是 以上皆非1.07“Data supporting支持事物存在或真实性的资料，称之the existence or verifyof something ” is called:abc

14、deobjective evidence a deficiency 缺点 anonconformity report不符合报告all of the above以上皆是none of the above 以上皆非客观证据1.08What information is being sought during a third party audit ofa quality system 在品质系统第三方稽核时，会寻找什麽资讯a list of nonconformities to ISO 9001 objectiveevidence of conformity with ISO 9001 观证据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 的清单符合 ISO 9001 的客品质保证的管理承诺To act as an auditor of a quality system a person hasto 扮演品质系统的稽核员必须be registered as a Certificated Auditorhave a detailed knowledge of theorganisation to be audited 具有被稽核组织产品

16、或服务的知识 have been a qualitysystems manager all of the above 以上皆是 none of the above 以上皆非登录合格的稽核员 product orservice of the是品质系统经理The process approach to a quality management system seeks to helporganisations:品质管理系统的过程导向寻求协助组织：abcdemanage numerous linked activitiesunderstand and fulfil requirementsconti

17、nually improve processes allof the above 以上皆是 none of theabove 以上皆非管理多个相连的活动了解及履行要求 持续改善过程by:品质系统文件化的范围应由下列何者来决定bcdethe complexity of processes and their interactions 过程的复杂度及它们相互关系the expectations of auditees受稽者的期望the culture of the quality department 品质部门的文化 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:“产品系统或过程履行固有特质要求的程度满足客户和其他利益团体要求 的能力” 是 ISO 9000:2000 对何者的定义：abcdecontinual improvement持续改善品质保证quality assurancequality 品质 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 的条文：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 若稽核小组未发现任何不符合事项，则主任稽核

20、员应explain to the managementof the audited organisation onlyinvestigated a sampleof activities and thatnonconformities which the sample did not uncover. 向受稽组织管理阶层解释，稽核仅抽样查核，活动可能有不符合事项，但 抽样时并未发现conclude that there are no nonconformities existing in the quality system.做出品质系统并未有不符合事项存在的结论 cancel the clo

21、sing meeting.取消结束会议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确保员工对他们活动的重要性及相关性的认知及他们对品质目标的达成 如何贡献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 的条文：the organisation shall continually improve the effectiveness of the qualitymanagement system 组织应持续改善品质管理系统的有效性This is covered by clause文.这段话在条这段话在条 H H HH H H H H H H Secti on 2 worth 25 marks第二大题每题五分 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.在下列各题的空白栏位上，写出简单答案。每题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.有三种品质系统稽核的型式，分别是第一、第二及第三方参与。请解释其 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品质管理系统文件的目标及效益为何Objectives of quality man age

25、me nt system docume ntati on:品质管理系统文件的目标为:Ben efits of quality man ageme nt system docume ntati on:品质管理系统文件的效益为: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就您所了解请解释”过程导向”的意义，并至少举出 4 个相关的 ISO 9001 B H H H H H H H H H an app roach.ISO 9000 所言之”过程导向”是八大品质理之一，促使品质目标的达成。条文 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 某位稽核员正执行第三方稽核，原被指派隌同稽核的引导者突然被主管叫 去。过了 5 分锺，引导者还未回来。

28、稽核员应该怎麽做稽核员不应做什麽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那些客观证据能提供以证明符合 ISO 9001 条文 7.2.3 的要求在您的回答中稽核员应该做稽核员不应该做What objectiveevidenee could be availablein order to verify与其它 ISO 9001 条文相连结。Secti on 3 worth 30 marks第三大题每大题 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.详细回答下列三题，适当时，您应该标示出相关的 ISO 9001 条文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:您计划以过程导向的方式为一家供应电子线缆和网路产品的公司稽核。此 公司包括下列部门：sales and marketi ng行销和业务pu rchas ing 采购warehouse 仓储p ack ing and des patch包装及运交support services支援服务The top management team consists of the managing direc

32、tor and dep artme ntalman agers from each of the above dep artme nts.高阶管理团队包括总经理及上述各部门经理。3.01a What would be your two main con sideratio ns in decidi ng the seque nee ofactivities for the audit举出 2 个你在决定稽核活动顺序的主要考量How would you app roach the audit of continual impro veme nt in this organi sati on你如何

33、稽核该公司的持续改善Seque nee of activities活动的顺序Con ti nual impro veme nt in this orga ni sati on续改善Maximum 4 marks企业的持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.当稽核所发现的不符合事项，请陈述主要采取的行动并说明该由谁、何时 来执行利用简单流程图来回答此问题。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.您正在对一中型的制造商进行稽核。文件审查引起你对於该公司如何确保 员工能力的产生质疑。Prepare a

35、checklist that would guide you through a p rocess audit of thisarea, and state the releva nt ISO 9001 clauses.请准备查检表引导你的过程稽核且写出相关的 ISO 9001 条文Secti on 4 worth 30 marks第四大题共 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:下列是发生在执行 XYZ 公司第三方稽核的情况，可能要求书写不符合事项报告。仔 细衡量每种情况并采取下列二者之一的行动：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.若您认为已有足够客观证据显示其为不符合事项，则应该完成不符合事项 报告及分类If you do not thi nk that there is sufficie nt objective evide nee of noncon formitythe n:若您不认为有足够客观证据显示其为不符合事项，贝 U:state why you think there isinsufficientevidenee ofnoncon formity陈述你为何认为不符合事项证据不足

38、state at least three things you would look for as evidenee that the situation is un der con trol请写出至少三点你可能进一步寻找此事件是在管制下的证据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 在稽核管理审查活动中 ，你由管理审查记录中发现未有任何最高管

41、理团队参加此会 议。当你询问这点，a)b)Incident Number 1事件1管理代表告诉你，管理审查分为两个过程，因为，要将所有部 门及高阶主管同时召集是有困难的 。所以部门主管参与第一阶段的管理审查过程。 而管理代表汇整报告，包括措施及建议，再传閲每位高阶管理者提供卓见，最後由 总经理核准行动计划。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 稽核内部稽核时，你查阅上次内部稽核有关采购部门的报告 。其中有个不符合事项 陈述有 3 位采购部门的员工未被训练如何使用合格供应商名册 ，而矫正措施是对这 3 位员工进行训练。并且这报告已结案。管理代表告诉你并未进一步的调查因为矫 正措施是显而易见的。内部稽核员在结案前已经查检此 3 个员工的训练记录。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 在采购部门，稽核员问到 TMX10 物品的新供应商是如何选择的。采购承办员解释 一般供应商无法满足交货日期且订单是被我们从未交易过的供应商取得 ，因为他的 报价非常的低。承办员说并没有采取其他评估。If you thi nk there is evide nee of a noncon formity, comp lete this report:假如你认为有不符合项的证据，完成下列报告：假若你不认为有足够的不符合事项的证据，陈述你的理由。并且说明稽核员应该采取那些进一步的行动。MAJOR* 主要 MINOR* 次要 * delete one 划去其一No neo nformity （不符合事项）Auditor稽核员Or 或