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

Topic
Details

Topic 1

Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.

Topic 2

Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.

Topic 3

Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.

Topic 4

Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.

Topic 5

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.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q22-Q27):

NEW QUESTION # 22
Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit?

A. A list of interested parties
B. An evidence sampling strategy
C. An organization's financial statement
D. A checklist
E. A career history of the quality manager
F. An audit plan

Answer: C,E

NEW QUESTION # 23
XYZ Corporation is an organisation that employs 100 people. As the 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.
How would you respond with the following options? Select three.

A. Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organisation's requirements.
B. Suggest asking the certification body for guidance on this matter.
C. Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.
D. Inform the Quality Manager that you will comment on the subject in your audit report.
E. Indicate that ISO 9001 requires a minimum of two quality objectives.
F. Suggest that the Quality Manager obtains external consultancy on the use of quality objectives.
G. Suggest that all employees undertake a training course on ISO 9001.
H. Advise the Quality Manager that, as an auditor, you cannot provide advice to the organisation on how it should operate its QMS.

Answer: A,C,D

Explanation:
According to the ISO 9001:2015 standard, clause 6.2.1 requires organizations to establish quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The quality objectives must also be measurable, monitored, communicated, and updated as appropriate.
In this scenario, the Quality Manager of XYZ Corporation has set quality objectives for every employee in the organization except top management. This has created a lot of resistance to the QMS, and the Chief Executive is asking questions about the cost and the method of setting objectives. The Quality Manager asks for your opinion as an auditor on whether this is the correct method of setting objectives.
As an auditor, you cannot provide advice to the organization on how it should operate its QMS. Your role is to assess the conformity and effectiveness of the QMS against the requirements of the standard and the organization's own policies and objectives. Therefore, you should respond with the following options:
B: Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization's requirements: You can suggest that the Quality Manager should familiarize himself with the requirements of clause 6.2.1 and understand how they apply to his organization. He should also consider the context and the needs and expectations of interested parties when setting quality objectives. He should ensure that the quality objectives are aligned with the quality policy and the strategic direction of the organization.
C: Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly: You can inform the Quality Manager that you will evaluate the quality objectives during the audit and check whether they meet the requirements of clause 6.2.1. If you find any gaps or weaknesses in the quality objectives, you will raise an opportunity for improvement to help the organization improve its QMS. You will also verify whether the quality objectives are monitored, communicated, and updated as appropriate.
D: Inform the Quality Manager that you will comment on the subject in your audit report: You can inform the Quality Manager that you will document your findings and observations on the quality objectives in your audit report. You will also provide a summary of the audit results and any recommendations for improvement.
You will also indicate the level of conformity and effectiveness of the QMS.
These three options would help you to maintain your impartiality and professionalism as an auditor and to provide constructive feedback to the organization

NEW QUESTION # 24
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

Answer:

Explanation:

Explanation:
The quality system failed to control the laundry services provided for customers in five shops.
The equipment used was not capable of consistently producing the required service.

NEW QUESTION # 25
Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.

A. To support the operation of the processes of the quality management system.
B. To facilitate auditing for proof of conformity to the standard.
C. To provide confidence in the effectiveness of the quality management system.
D. To safeguard the integrity of the quality management system.

Answer: A

Explanation:
Documented information is a means by which an organization demonstrates compliance. It communicates what we do and how we do things, it communicates what happened and what results were achieved. It is, essentially, a tool for communication. ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. The standard states that the organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. Therefore, the purpose of retaining documented information is to support the operation of the processes of the QMS, not to facilitate auditing, provide confidence or safeguard integrity, which are secondary benefits of documented information.
References: Guidance on the requirements for Documented Information of ISO 9001:2015, ISO 9001:2015 documented information | CQI | IRCA, Documented Information Required by ISO 9001:2015 - 9000 Store

NEW QUESTION # 26
A Health Trust has contracted with Servitup, a catering services organisation that has been certified to ISO
9001 for one year. It provides services to
10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals, and loading heated trolleys for Ward Service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff." You: "I see. It really shouldn't affect the QMS so the audit can progress as normal." DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is." You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?" DCM: "Give me a minute. I need to look at the Quality Policy on the noticeboard in his office." As the audit progresses, it is clear that the DCM has a very low knowledge of the QMS. He continually has to look up the answers to your questions or ask staff members about their processes. You decide to raise a nonconformity.
Select one of the following options that best describes the nonconformity.

A. The effectiveness of the QMS depends on the Catering Manager being present on site.
B. The Deputy Catering Manager is not competent to manage the QMS.
C. The Quality Policy only exists as a document in the Catering Manager's office.
D. As a member of the management team, the Deputy Catering Manager is not sufficiently aware of the QMS.

Answer: D

NEW QUESTION # 27
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