PECB ISO-9001-Lead-Auditor 問題集

質問 1：
You are conducting a third-party audit to ISO 9001 and interviewing the Training Manager. She explains that training is more important than ever because the organisation has had to reduce the number of staff employed. Many of the remaining staff are now required to be 'multi-skilled'. You ask to see plans for the multi-skilling training and are shown plans that look comprehensive, and include both 'on the job" training and internal and external training courses.
The records indicate that several staff required parts of their training to be repeated one month after the first training was provided. You ask why this was needed and are told that an investigation of customer complaints identified that several staff members did not complete certain tasks in the correct manner. The extra training was therefore recommended as a corrective action.
Based on this interview, which two of the tollowing audit trails would be the most appropriate to follow?
Select the two most appropriate audit trails from the following.
A. Assess whether Quality objectives are being met.
B. Determine whether customers were consulted about the risks associated with the multi-skilling training.
C. Ask the members of staff whether they found the training received useful.
D. Review records to assess if all planned training has been completed.
E. Ask if customer complaints had ceased since the multi-skilled training finished.
F. Determine whether management has assessed the impact of staff reduction on the organisation's ability to meet its objectives.
正解：D,E
解説: (Topexam メンバーにのみ表示されます)

質問 2：
Match the process descriptions below to the process names:

正解：

Explanation:
Match the process descriptions below to the process names:
The process by which the accuracy of test equipment is checked against a known standard. = Calibration The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation The process by which data is examined in detail to reach a specific answer or answers. = Analysis The process by which a parameter of a product or service is examined to determine a specific value. = Measurement According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, the definitions of the process names are as follows:
Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Analysis: detailed examination of the elements or structure of something.
Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.
Therefore, the process descriptions can be matched to the process names based on these definitions.
References:
ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary

質問 3：
ABC is a worldwide fast-food organisation. One of the branches, in downtown Cape Town, decided to implement an ISO 9001 quality management system and you are the audit team leader (with two other auditors) that will carry out the certification audits, Stage 2.
ABC receive the orders by phone or internet; some of the employees deliver the ordered food to indicated addresses. The normal menu includes 15 different types of hamburgers; however, in the last two weeks, due to a shortage of a special type of meat, they can only prepare six of the 15 varieties.
During the internal meeting of the audit team, you ask one of the auditors to describe what she has observed. She audited the reception of orders from customers (via phone or internet) and the communication of the orders to the kitchen. She noticed that the menu offering food on the website is still the normal one, with 15 different hamburgers, and during a 30-minute period, she observed many customers reluctantly accepting something other than the hamburger they preferred.
You, as audit team leader, inform the Quality Manager of your concern about the major nonconformity, since you consider this a serious breach of the basic principles of quality that lasted two weeks without action being taken.
Right at the beginning of the Closing meeting, you discuss the nonconformity with the General Manager.
She got quite upset and said she was going to make a complaint to the certification body and left the room; the Quality Manager was the only member of ABC left with the audit team. The Quality Manager said the General Manager would not come back to the meeting.
What would you do? Choose the best from the following options:
A. Inform the Quality Manager that you consider the meeting closed, and that you will report to the Certification Body for instructions.
B. Ask the Quality Manager for a break to discuss the issue with the members of the audit team.
C. Ask the Quality Manager to listen to the nonconformity the auditor will present and continue with the meeting until its closure.
D. Inform the Quality Manager that the certification process is put on hold and leave the room.
正解：C

質問 4：
XYZ Corporation is an organisation that employs 100 people. As audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality objectives for all employees and replaced them with a single objective for himself. This states that "The Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates that this gives him the authority to issue instructions to department managers when quality improvement is needed. He says that this approach has the full backing of senior management. He shows you the latest Quality Improvement Request that was included in the last management review.

After further auditing, the issues below were found. Select two statements that apply to the term
`nonconformity'.
A. Evaluation of the results of the improvement action not always documented by the Quality Manager.
B. Limited knowledge of the content of Quality Improvement Requests by departmental staff.
C. Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.
D. No quality objectives planned for the top management team
E. Quality improvements not aligning with the quality policy.
F. Decisions on improvement action timescales not involving departmental managers.
正解：D,E
解説: (Topexam メンバーにのみ表示されます)

質問 5：
Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?
A. Procedures
B. Checklist / Prompts
C. Risk Matrices
D. Findings
E. Audit Plan
F. Audit Report
正解：B,E
解説: (Topexam メンバーにのみ表示されます)

質問 6：
TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit team discussed and agreed both nonconformities with TIX's quality manager. The Closing meeting was planned for 6pm with the general manager, quality manager and service manager at the meeting room.
At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the warehouse supervisor. Neither have participated in the audit.
The dialogue among them is as follows:
Audit team leader: "Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?" Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and the other two managers have had to leave urgently to attend the emergency." Warehouse supervisor: "They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed." Which one of the following options would be your preferred response to the final comment made by the warehouse manager?
A. Sorry, but we cannot proceed with the Closing meeting. So, we are leaving now, and please tell the quality manager that I will phone him tomorrow early in the morning.
B. We will hear what you were asked to tell us and will ask you to sign the nonconformity reports as evidence that you have accepted them. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to complete the Closing meeting.
C. We will hear what you were asked to tell us and will then leave. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to carry out the Closing meeting.
D. We will hear what you were asked to tell us and will leave copies of the nonconformity reports that have been agreed with the quality manager. Please tell the managers that we will consider this as the Closing meeting and that the individual(s) managing the audit programme will send the full report in five days.
正解：C

質問 7：
Audit criteria are a set of requirements used as a reference against which objective evidence is compared.
Which two of the following are not potential audit criteria?
A. Organisation's documented information
B. Verbal agreements with interested parties
C. Claims made on the organisation's website
D. Verbal statements by the general manager
E. Written agreements with interested parties
F. Health and safety notices
G. Commercial advertisements
H. Commitment to follow principles issued by an NGO
I. Environmental aspects register
J. ISO management system standards
正解：C,G
解説: (Topexam メンバーにのみ表示されます)