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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

Topic	Details
Topic 1	Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Topic 2	Quality management system (QMS) requirements: It assesses your abilities to point out and explain different requirements for a quality management system based on ISO 9001.
Topic 3	Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
Topic 4	Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q111-Q116):

NEW QUESTION # 111
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 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.
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 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.

Answer: C

NEW QUESTION # 112
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."

Answer:

Explanation:

Explanation:
A screenshot of a computer Description automatically generated

NEW QUESTION # 113
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top- notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS.
They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS.
AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
Which of the following misconceptions about ISO 9001 was present in scenario 1?

A. A QMS based on ISO 9001 requires many resources and is time-consuming.
B. A QMS based on ISO 9001 is only applicable to organizations producing tangible goods.
C. A QMS based on ISO 9001 is a complex task and requires a lot of documentation.

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:
One of the common misconceptions about ISO 9001 is that it only applies to manufacturing companies producing tangible goods. However, ISO 9001:2015 is designed for all types of organizations, including service providers such as financial, healthcare, and IT companies.
Clause 1 (Scope) clearly states that ISO 9001 is applicable to any organization, regardless of type, size, or the products and services it provides. AL-TAX, being a financial services company, is equally eligible for implementing a QMS under ISO 9001.
Reference:
ISO 9001:2015, Clause 1 - Scope

NEW QUESTION # 114
You have been just hired as the Internal Lead Auditor of a large organisation, responsible for internal audits.
Your first job is to analyse the answers to nonconformities included in the report of a recent internal audit to Top Management.
The report contained one nonconformity as follows:
There is no evidence of Top Management ensuring the availability of resources to operate the QMS, the establishment of objectives, the promotion of continual improvement, and the promoting of the process approach.
Which four of the following Top Management actions can be considered 'corrections to the nonconformity'?

A. Improvement action has been promoted
B. All these actions will be reviewed during the Top Management meetings
C. Top Management completed a course on ISO 9001
D. Top Management appoints a senior manager to oversee the quality manangement system
E. Process approach has been communicated to the personnel
F. Objectives have been established
G. Top Management review will be carried out every six months instead of annually
H. Resources have been provided

Answer: A,E,F,H

NEW QUESTION # 115
Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.

A. Manages the performance
B. Improves the performance
C. Dictates the performance
D. Monitors the performance

Answer: B

Explanation:
* Understanding the Purpose of a Quality Management System (QMS):The primary objective of ISO 9001:2015 is to improve the overall performance of the organization by:
* Ensuring consistent delivery of products and services that meet customer and regulatory requirements.
* Focusing on enhancing customer satisfaction.
* Promoting continual improvement of the organization's processes and practices.

NEW QUESTION # 116
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