CONFIDENTIAL
機密
INTERNATIONAL REGISTER
OF CERTIFICATED AUDITORS
國際登錄合格稽核員
SPECIMEN EXAMINATION PAPER QMS 5
練習試卷 QMS 5
ISO 9000:2000 Series
Auditor/Lead Auditor Training Course (IRCA/2245)
ISO 9000:2000 系列
稽核員/主導稽核員訓練課程
Please print your name in the space below:
請將您的中英文正楷寫在下列空格欄內：
Course No………………
課程編號
THESE SPACES ARE FOR OFFICIAL USE ONLY
Section Marker 1 Marker 2
Check mark/arithmetic
check.
Delete as applicable
Pass mark Maximum
1 6 15
2 10 25
3 12 30
4 12 30
Total 70 100
Name of
marker
Verified
Result
The examination paper is in four sections. Please attempt all sections.
考試題目共分為四大題，請回答所有的大題。
The time allowed is two hours. There is no additional time allowance for reading the
question paper. There is a maximum of 100 marks available; the pass mark is 70% and
you must achieve at least 40% in each of the four sections.
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%。
Your answers must be written on the sheets that are supplied. Additional loose sheets
will not be accepted.
答案必須寫在本答案紙上，自行附加上的答案紙，不計分。
The phrase "ISO 9001" and “standard” always refer to ISO 9001:2000.
The word "clause" refers to a paragraph or section of ISO 9001 that is identified by a
number such as or a number and letter such as .
題目上若顥示“ISO 9001”及“標準”即指 ISO/FDIS 9001:2000
你可參考無任何註記的 ISO 9001 條文，其它文件不得參考。題目上所顯示之“條文”
即指標準中，例如： 或 (a)…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 the number of a clause
from ISO 9001. You must only give one answer for each question.
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
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.
請簡單回答，並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 detailed written answer that will normally fill the
space provided.
請詳細回答，並將答案寫在空白欄位上。
Section 4 is worth 30 marks
第四大題 30 分
Comprises a number of situations for which a nonconformity report (NCR) may be
required.
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。
Section 1 worth 15 marks
第一大題共 15 分
Thirteen multi-choice questions which 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 questions which
require you to state the number of a clause from ISO 9001. Each question is worth 1
mark. If you change your answer you should clearly cross out the answer that was
incorrect.
十三題單選題，二題填充，每題各 1 分
Quality system audits are used to verify:
品質系統稽核是驗證：
a the number of persons working on a contract 執行合約要求的員工人數
b the extent to which audit criteria are fulfilled 稽核準則被履行的程度
c that all suppliers to the organisation have ISO 9001 certification
組織所有供應商皆具有 ISO 9001 資格
d all of the above 以上皆是
e none of the above 以上皆非
Third party audit is
第三方稽核是
a an internal audit 內部稽核
b an audit by the customer or client 由客戶或委託人的稽核
c an audit by an independent organisation 由獨立機構所執行的稽核
d all of the above 以上皆是
e none of the above 以上皆非
ISO 9001 includes:
ISO 9001 包含：
a health and safety requirements 健康和安全要求
b quality planning 品質規劃
c quality costing 品質成本
d all of the above 以上皆是
e none of the above 以上皆非
preparing for an audit it is important to
稽核的準備是重要在
a plan 計劃
b define the scope of the audit 訂定稽核的範圍
c select a lead auditor and a competent team 選擇主任稽核員及有能力的組員
d all of the above 以上皆是
e none of the above 以上皆非
Which of the following activities must be carried out by someone who does not
perform the activity being evaluated?
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？
a a contract review 合約審查
b an inspection of product 產品的檢驗
c a quality system audit 品質系統稽核
d all of the above 以上皆是
e none of the above 以上皆非
A system based on the requirements of ISO 9001 aims to
某系統基於 ISO 9001 要求，其目的在
a achieve customer satisfaction 達到客戶滿意
b demonstrate an organisation’s ability to consistently supply conforming product
展現組織持續供應合格產品的能力
c prevent non conformity 防止不合格產品
d all of the above 以上皆是
e none of the above 以上皆非
“Data supporting the existence or verify of something” is called:
支持事物存在或真實性的資料，稱之
a objective evidence 客觀證據
b a deficiency 缺點
c a nonconformity report 不符合報告
d all of the above 以上皆是
e none of the above 以上皆非
What information is being sought during a third party audit of a quality system?
在品質系統第三方稽核時，會尋找什麼資訊？
a a list of nonconformities to ISO 9001 不符合 ISO 9001 的清單
b objective evidence of conformity with ISO 9001 符合 ISO 9001 的客觀證據
c a management commitment to quality assurance 品質保證的管理承諾
d all of the above 以上皆是
e none of the above 以上皆非
To act as an auditor of a quality system a person has to
扮演品質系統的稽核員必須
a be registered as a Certificated Auditor 登錄合格的稽核員
b have a detailed knowledge of the product or service of the organisation to be
audited
具有被稽核組織產品或服務的知識
c have been a quality systems manager 是品質系統經理
d all of the above 以上皆是
e none of the above 以上皆非
The process approach to a quality management system seeks to help
organisations:
品質管理系統的過程導向尋求協助組織：
a manage numerous linked activities 管理多個相連的活動
b understand and fulfil requirements 瞭解及履行要求
c continually improve processes 持續改善過程
d all of the above 以上皆是
e none of the above 以上皆非
If the audit team does not find any nonconformity then the audit team leader
should
若稽核小組未發現任何不符合事項，則主任稽核員應
a explain to the management of the audited organisation that the audit only
investigated a sample of activities and that there may be nonconformities which
the sample did not uncover.
向受稽組織管理階層解釋，稽核僅抽樣查核，活動可能有不符合事項，但抽
樣時並未發現
b conclude that there are no nonconformities existing in the quality system.
做出品質系統並未有不符合事項存在的結論
c cancel the closing meeting. 取消結束會議
d all of the above 以上皆是
e none of the above 以上皆非
extent of documentation of the quality system should be determined by:
品質系統文件化的範圍應由下列何者來決定？
a the complexity of processes and their interactions
過程的複雜度及它們相互關係
b the expectations of auditees 受稽者的期望
c the culture of the quality department 品質部門的文化
d all of the above 以上皆是
e none of the above 以上皆非
"degree to which a set of inherent characteristics fulfils requirements” is the
ISO 9000:2000 definition of:
“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 ISO 9000:2000 對何者的定義：
a continual improvement 持續改善
b quality assurance 品質保證
c quality 品質
d all of the above 以上皆是
e none of the above 以上皆非
Indicate fully the clause of ISO 9001 that is applicable to the following:
指出 ISO 9001 的條文：
〝 ensure that personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of quality objectives〞
〝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〞
This is covered by clause ..................這段話在條文……..............
Indicate fully the clause of ISO 9001 that is applicable to the following;
指出 ISO 9001 的條文：
〝 the organisation shall continually improve the effectiveness of the quality
management system〞
〝組織應持續改善品質管理系統的有效性〞
This is covered by clause ...................這段話在條文……...............
Section 2 worth 25 marks
第二大題 每題五分
Write a brief answer to each of the following five questions using only the space
provided. Each question is worth 5 marks.
在下列各題的空白欄位上，寫出簡單答案。每題 5 分
There are three types of quality system audit based on a first, second and third
party involvement. Explain the specific features that distinguish each of them.
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。
What are the objectives and benefits of quality management system
documentation?
品質管理系統文件的目標及效益為何？
Objectives of quality management system documentation:
品質管理系統文件的目標為：
Benefits of quality management system documentation:
品質管理系統文件的效益為：
ISO 9000 identifies a “process approach“ as 1 of the 8 quality principles, which
facilitate achievement of quality objectives. Please explain your understanding of
what is meant by a “process approach” and identify at least four ISO 9001
clauses that support such an approach.
ISO 9000 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 ISO 9001 條文
An auditor is conducting a third party audit. The guide who has been appointed
to accompany the auditor around the various departments is called away by a
senior manager. After five minutes the guide has not returned. What should the
auditor do? What should the auditor not do?
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？
What should the auditor do 稽核員應該做:
What should the auditor not do 稽核員不應該做:
What objective evidence could be available in order to verify compliance with
the requirements of clause of ISO 9001? In your answer, make links to
other ISO 9001 clauses as necessary.
那些客觀證據能提供以證明符合 ISO 9001 條文 的要求？在您的回答中，
與其它 ISO 9001 條文相連結。
Section 3 worth 30 marks
第三大題 每大題 10 分
Attempt each of the following three questions each worth 10 marks. Questions that
require a detailed written answer will normally fill the space provided. Where
appropriate, you should identify the relevant clauses of ISO 9001 in your answer.
詳細回答下列三題，適當時，您應該標示出相關的 ISO 9001 條文
You are planning a process audit of an organisation that supplies electronic
cabling and networking products. The organisation consists of the following
departments:
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：
sales and marketing 行銷和業務
purchasing 採購
warehouse 倉儲
packing and despatch 包裝及運交
support services 支援服務
The top management team consists of the managing director and departmental
managers from each of the above departments.
高階管理團隊包括總經理及上述各部門經理。
What would be your two main considerations in deciding the sequence of activities
for the audit?
舉出 2 個你在決定稽核活動順序的主要考量？
How would you approach the audit of continual improvement in this
organisation?
你如何稽核該公司的持續改善？
Sequence of activities 活動的順序 Maximum 4 marks
Continual improvement in this organisation 企業的持續改善 Maximum 6 marks
Describe the principal actions which should be taken, and by whom, when a
nonconformity has been identified during an audit. A simple flowchart may be
used to answer this question.
當稽核所發現的不符合事項，請陳述主要採取的行動並說明該由誰、何時
來執行？利用簡單流程圖來回答此問題。
You are conducting an audit of a medium sized manufacturing company. The
document review has raised a concern about how the organisation ensures the
competence of staff.
您正在對一中型的製造商進行稽核。文件審查引起你對於該公司如何確保
員工能力的產生質疑。
Prepare a checklist that would guide you through a process audit of this area, and
state the relevant ISO 9001 clauses.
請準備查檢表引導你的過程稽核且寫出相關的 ISO 9001 條文
Section 4 worth 30 marks
第四大題 共 30 分
Three incidents that occur during a third party audit of a supplier, XYZ plc, are
described. They contain situations for which nonconformity reports may be required.
Examine each incident carefully then take one of the following actions:
下列是發生在執行 XYZ 公司第三方稽核的情況，可能要求書寫不符合事項報告。
仔細衡量每種情況並採取下列二者之一的行動：
a) For each incident, if you think that there is sufficient objective evidence of
nonconformity then you should complete a nonconformity report and categorise
it as major or minor.
若您認為已有足夠客觀證據顯示其為不符合事項，則應該完成不符合事項
報告及分類
b) If you do not think that there is sufficient objective evidence of nonconformity
then:
若您不認為有足夠客觀證據顯示其為不符合事項，則：
state why you think there is insufficient evidence of nonconformity
陳述你為何認為不符合事項證據不足
state at least three things you would look for as evidence that the situation
is under control
請寫出至少三點你可能進一步尋找此事件是在管制下的證據
Incident Number 1 事件 1
During an audit of management review activities you notice from the minutes of
management review meetings that the meetings are not attended by any of the top
management team. When you query this, the management representative tells you that
management review has evolved into a two-tier process, as it was proving so difficult
to get all of the departmental and top managers available at the same time. The
process is now that departmental managers meet and conduct the first level of
management review. The management representative prepares a summary report
including actions and recommendations. This is passed round each of the top
management team for comment and the Managing Director finally agrees the action
plan.
10 marks
在稽核管理審查活動中，你由管理審查記錄中發現未有任何最高管理團隊參加此會
議。當你詢問這點，管理代表告訴你，管理審查分為兩個過程，因為，要將所有部
門及高階主管同時召集是有困難的。所以部門主管參與第一階段的管理審查過程。
而管理代表彙整報告，包括措施及建議，再傳閲每位高階管理者提供卓見，最後由
總經理核准行動計劃。
Incident Number 2 事件 2
During an audit you are shown the latest internal audit on the purchasing department.
This includes a nonconformity report stating that three people in the purchasing
department had not been trained in the use of the approved supplier list. The corrective
action taken was to train the three members of staff. The audit report has been closed.
The management representative tells you that there was no further investigation as the
corrective action was obvious. The internal auditor had checked the training records of
the staff concerned before closing the report.
10 marks
稽核內部稽核時，你查閱上次內部稽核有關採購部門的報告。其中有個不符合事項
陳述有 3 位採購部門的員工未被訓練如何使用合格供應商名冊，而矯正措施是對
這 3 位員工進行訓練。並且這報告已結案。管理代表告訴你並未進一步的調查因為
矯正措施是顯而易見的。內部稽核員在結案前已經查檢此 3 個員工的訓練記錄。
Incident Number 3
In the purchasing department the auditor asks how the new supplier for TMX101
items was selected. The purchasing clerk explains that the regular supplier could not
meet the delivery date and the order was placed with a new supplier which they had
never used before, only because the price quoted was extremely low. The clerk states
that no other evaluation was conducted.
10 marks
在採購部門，稽核員問到 TMX101 物品的新供應商是如何選擇的。採購承辦員解
釋一般供應商無法滿足交貨日期且訂單是被我們從未交易過的供應商取得，因為他
的報價非常的低。
承辦員說並沒有採取其他評估。
If you think there is evidence of a nonconformity, complete this report:
假如你認為有不符合項的證據，完成下列報告：
IRCA QUALITY AUDIT (IRCA 品質系統稽核)
NONCONFORMITY REPORT 不符合事項報告
Company under Audit: XYZ plc Nonconformity Number ...................
稽核公司 不符合事項編號
Area under review: ISO 9001 Clause Number ...............
查檢的部門 ISO 9001 條文編號
Category 分類 MAJOR* 主要 MINOR* 次要 * delete one 劃去其一
Nonconformity (不符合事項)
Auditor 稽核員
Or 或
If you do not think that there is sufficient evidence of nonconformity, state the reasons
for your decision and state also what further actions the auditor should take.
假若你不認為有足夠的不符合事項的證據，陳述你的理由。並且說明稽核員應該採
取那些進一步的行動。
If you think there is evidence of a nonconformity, complete this report:
假如你認為有不符合項的證據，完成下列報告：
IRCA QUALITY AUDIT (IRCA 品質系統稽核)
NONCONFORMITY REPORT 不符合事項報告
Company under Audit: XYZ plc Nonconformity Number ...................
稽核公司 不符合事項編號
Area under review: ISO 9001 Clause Number ...............
查檢的部門 ISO 9001 條文編號
Category 分類 MAJOR* 主要 MINOR* 次要 * delete one 劃去其一
Nonconformity (不符合事項)
Auditor 稽核員
Or 或
If you do not think that there is sufficient evidence of nonconformity, state the reasons
for your decision and state also what further actions the auditor should take.
假若你不認為有足夠的不符合事項的證據，陳述你的理由。並且說明稽核員應該採
取那些進一步的行動。
If you think there is evidence of a nonconformity, complete this report:
假如你認為有不符合項的證據，完成下列報告：
IRCA QUALITY AUDIT (IRCA 品質系統稽核)
NONCONFORMITY REPORT 不符合事項報告
Company under Audit: XYZ plc Nonconformity Number ...................
稽核公司 不符合事項編號
Area under review: ISO 9001 Clause Number ...............
查檢的部門 ISO 9001 條文編號
Category 分類 MAJOR* 主要 MINOR* 次要 * delete one 劃去其一
Nonconformity (不符合事項)
Auditor 稽核員
Or 或
If you do not think that there is sufficient evidence of nonconformity, state the reasons
for your decision and state also what further actions the auditor should take.
假若你不認為有足夠的不符合事項的證據，陳述你的理由。並且說明稽核員應該採
取那些進一步的行動。
