PECB ISO-9001-Lead-Auditor 問題集

質問 1：
When monitoring customer perceptions, which analysis is helpful to use?
A. Market-share analysis
B. PEST analysis
C. Gap analysis
D. Competitive benchmarking
正解：C
解説: (Topexam メンバーにのみ表示されます)

質問 2：
The Closing meeting of a second-party audit was planned for 6 pm with the general manager and the quality manager.
At 6 pm, when the audit team enters the meeting room, only the Quality Manager is present and walting for them.
The dialogue among them is as follows:
Auditor team leader: "Good evening, could you please inform the general manager that we are ready to start with the closing meeting?" Quality manager: "Good evening. I am sorry to inform you that the general manager will not be able to attend the meeting. He will try to participate virtually to make some closing remarks." Auditor team leader: "OK. We identified seven nonconformities - these are the reports. Could you please review them and sign them?" Quality manager: "OK. As you know, I reviewed them after yesterday's meeting and accept of all them, where shall I sign?" General manager (from speakers in the room and addressing the quality manager): "Hold on! Do not sign the two nonconformities related to ABC Bank! I have just checked, and we did not provide any services to ABC Bank during September! You can sign the remaining five nonconformities." How would you proceed with the audit? Select one.
A. I will discuss this issue with our corporate quality manager and will let you know what we will do
B. I withdraw the two nonconformities related to service to ABC and will present the report with the remaining five nonconformities
C. I will include the seven nonconformities in the report, considering that we identified objective evidence on which all these nonconformities are based
D. I will review this issue at length with the audit team tonight and will phone you tomorrow to let you know our decision
正解：D

質問 3：
Consultancy ABC, which is a subsidiary of a certification body called ABC-CERT, provided consultancy services regarding the implementation of a QMS based on ISO 9001 to an organization.
Considering this, can ABC-CERT provide certification services to the organization which obtained consultancy services from Consultancy ABC?
A. Yes, after a minimum period of two years has passed.
B. Yes, if both parties sign an agreement which states that previous services by Consultancy ABC will not impact the judgment of auditors.
C. No, ABC-CERT is not allowed to provide certification services to that organization ever, as this would be a conflict of interest.
正解：C
解説: (Topexam メンバーにのみ表示されます)

質問 4：
Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.
A. Organisation's processes
B. Organisation's invoicing and profits of the last 5 years
C. Requirements of ISO 9001
D. Requirements of auditee's interested parties other than customers
E. ISO 19011 Audit principles
F. Organisation's market sector
正解：C,E
解説: (Topexam メンバーにのみ表示されます)

質問 5：
In the context of a third-party audit, match the event with the responsibility for conducting it.

正解：

Explanation:
The correct answer is:
Event
Selecting audit team = Individual(s) managing the audit programme
Conducting the audit = Audit team
Preparing the audit plan = Audit team leader
Requesting the audit = Audit client
To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below. Alternatively, drag and drop each option to the appropriate blank section. Responsibility:- Individual(s) managing the audit programme Audit team Audit team leader Audit client According to ISO 19011:2018, clause 5.3, the individual(s) managing the audit programme are responsible for selecting the audit team, taking into account the competence and availability of the auditors and any experts needed. 1 According to clause 6.2, the audit team is responsible for conducting the audit, which includes collecting and verifying audit evidence, evaluating audit findings, and preparing the audit report. 1 According to clause 6.1, the audit team leader is responsible for preparing the audit plan, which includes defining the audit objectives, scope, criteria, and duration, as well as assigning roles and responsibilities to the audit team members. 1 According to clause 5.2, the audit client is the person or organization that requests the audit, which can be the auditee (the person or organization being audited) or any other person or organization that has an interest in the audit results. 1 References:
1: ISO 19011:2018 - Guidelines for auditing management systems

質問 6：
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?" TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry." You: "How is their regulatory competence maintained?" TD: "They are dedicated individuals with lots of contacts in the sector." You: "How does the business enable them to maintain their understanding of current regulatory requirements?" TD: "We leave that up to them."

正解：



質問 7：
You work for organisation A. You are asked to lead an internal audit of A's quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.
Which of the following actions would you consider appropriate when planning the internal audit of A's quality management system?
A. Visit Plant A2 to interview A's security personnel and B's maintenance department
B. Interview the A2 plant manager, now working in Plant A1
C. Visit Plant A2 to interview B's quality manager
D. Visit Plant A2 to interview personnel of company B
正解：B
解説: (Topexam メンバーにのみ表示されます)