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

Topic
Details

Topic 1

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 2

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

Topic 3

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 4

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

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q154-Q159):

NEW QUESTION # 154
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 three statements that apply to the term 'audit trail'

A. Quality improvements not aligning with the quality policy.
B. Decisions on improvement action timescales not involving departmental managers.
C. The single quality objective set for the organisation by the Quality Manager.
D. Limited knowledge of the content of Quality Improvement Requests by departmental staff.
E. Evaluation of the results of the improvement action not always documented by the Quality Manager.
F. Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.

Answer: B,D,E

Explanation:
Based on the scenario and the concept of an 'audit trail' within the context of ISO 9001, the three statements that apply would likely be:
A: Decisions on improvement action timescales not involving departmental managers. This indicates a lack of involvement and communication with those responsible for implementing the improvements, which is a key part of an effective audit trail1.
B: Evaluation of the results of the improvement action not always documented by the Quality Manager.
Proper documentation is essential for an audit trail, as it provides evidence that actions have been evaluated and are effective1.
C: Limited knowledge of the content of Quality Improvement Requests by departmental staff. An audit trail should ensure that all relevant parties are aware of and understand the actions being taken, which is not the case here1.
These points suggest issues with the communication, documentation, and involvement of relevant personnel in the quality management system processes, which are crucial for maintaining an effective audit trail and, by extension, a robust quality management system.

NEW QUESTION # 155
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers.
You are interviewing the Quality Systems Manager (QSM).
You: "What risks and opportunities have the business identified?"
QSM: "I'1l show you. This was discussed with the Managing Director at the latest management review." Narrative: The QSM shows you the latest management review record and points to the following table:

You: "How is the business planning to address these risks and opportunities?" QSM: "The MD said that they already knew about them so it was not necessary."

Answer:

Explanation:

Explanation:
Non-Conformity Report:
ISO 9001 Clause Number
Nature of Problem
ISO 9001 Requirement That Has Not Been Fulfilled
6.1.1
Several risks and opportunities have not been determined.
"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."
6.1.2 (a)
Actions to address risks and opportunities not planned.
"The organization shall plan actions to address risks and opportunities." Step-by-Step Reasoning:
* Clause 6.1.1 - Determining Risks and Opportunities:
* Requirement: The organization must determine risks and opportunities that are relevant to its Quality Management System (QMS). This ensures that the QMS achieves intended results and prevents undesired effects.
* Problem Identified: While some risks and opportunities were discussed, the organization did not perform a systematic evaluation of all risks (e.g., health and safety legislation changes, retiring trainers).
* Clause 6.1.2 (a) - Planning Actions for Risks and Opportunities:
* Requirement: The organization must plan actions to address identified risks and opportunities.
These actions should be integrated into the QMS processes to ensure continuous improvement.
* Problem Identified: The Quality Systems Manager confirmed that no plans were made to address the risks and opportunities because the Managing Director deemed it unnecessary. This violates the requirement to plan actions.
* Correct Options Selected:
* Clause 6.1.1 with the nature of the problem as: "Several risks and opportunities have not been determined."
* Clause 6.1.2 (a) with the nature of the problem as: "Actions to address risks and opportunities not planned."
* ISO 9001 Requirements Not Fulfilled:
* For 6.1.1:"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."
* For 6.1.2 (a):"The organization shall plan actions to address risks and opportunities."

NEW QUESTION # 156
Who is responsible for the development of surveillance activities?

A. The audit team leader
B. The certification body
C. A representative of the auditee's top management

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.6.2 (Surveillance Activities):
* The certification body is responsible for planning and conducting surveillance audits to ensure continued compliance.
* The auditee's top management (A) does not develop surveillance activities, but they must participate.
* The audit team leader (C) conducts the surveillance audit, but they do not develop the program.
Thus, B is the correct answer.
Reference:
ISO 17021-1:2015, Clause 9.6.2 (Surveillance Activities)

NEW QUESTION # 157
You work as an external quality consultant for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', to ISO
9001 which provides packaging materials to your organisation. It is 4 pm and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled at 5 pm.
You, as Audit Team Leader, audited top management. You explain to the audit team that you identified two nonconformities:
a. There is no documented information on Top Management Reviews, as required in clause 9.3 of ISO
9001:2015.
b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO 9001:2015. (e.g., not ensuring the availability of resources to operate the QMS, not ensuring the establishment of objectives, no promotion of improvement, no promotion of the process approach).
All agreed to present these two nonconformities. They went to meet the Top Management of 'B' and noticed that the General Manager and three other managers (Production, Human Resources, and Sales) were present in the meeting room.
Considering the seriousness of the two nonconformities to Top Management, as audit team leader, from the following select the best option:

A. Present the nonconformities to the managers, inform them that the report will be sent within 10 days, close the meeting and leave the site.
B. Ask the General Manager to have a private conversation in which you present the nonconformities only to him because of their sensitive nature.
C. Present the nonconformities to the whole group and inform that you will recommend your company to remove them from the approved suppliers list.
D. Present the nonconformities to the whole group and analyse with them how to overcome this situation.

Answer: D

Explanation:
According to the guidance on conducting the audit closing meeting1, the audit team leader should provide a summary of the audit findings and conclusions, invite discussions, and agree on timelines for any corrective actions. The audit team leader should also be respectful, constructive, and objective when presenting the nonconformities, and avoid any personal or emotional comments. The audit team leader should also consider the impact of the disruptive event (such as the Covid-19 pandemic) on the auditee's context, interested parties, and risks2, and acknowledge any good practices or improvements observed during the audit. Therefore, option D is the best option, as it follows the best practices for the closing meeting and allows the auditee to understand the nonconformities and their implications, and to participate in the analysis and resolution of the issues. Option A is not correct, as it is not respectful, constructive, or objective, and it does not invite any discussion or feedback from the auditee. It also assumes that the audit team leader has the authority to recommend the removal of the supplier from the approved list, which may not be the case. Option B is not correct, as it does not provide enough information or explanation to the auditee, and it does not allow any discussion or feedback from the auditee. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, acknowledging any good practices, and agreeing on timelines for corrective actions. Option C is not correct, as it does not involve the other managers who are responsible for the functions or processes that were audited, and who may have valuable input or information to share. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, inviting discussions, and agreeing on timelines for corrective actions. References: 1: Conducting the Audit Closing Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive Event.

NEW QUESTION # 158
Will the auditee be subject to an audit follow-up if a minor nonconformity has been reported by the audit team leader in the audit conclusions?

A. No, the audit team should suggest a recommendation only, in which it suggests an adequate corrective action for the nonconformity
B. No, the auditee will be subject to an audit follow-up only if a major nonconformity is detected
C. Yes, there should be an audit follow-up regardless of the type of nonconformities that are detected during the audit

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions):
* Minor nonconformities do not require a follow-up audit but must be corrected before the next surveillance audit.
* Follow-up audits are required only for major nonconformities.
* The audit team should recommend corrective actions, not enforce immediate follow-ups for minor nonconformities.
Thus, A is the correct answer.
Reference:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions for Minor Nonconformities)

NEW QUESTION # 159
......

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