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ISO-9001-Lead-Auditor Valid Exam Pattern | ISO-9001-Lead-Auditor Reliable Test Prep

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

Topic
Details

Topic 1

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

Topic 2

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

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 (Q13-Q18):

NEW QUESTION # 13
Among others, what does Clause 4.4 (Quality Management System and Its Processes) of ISO 9001 require from organizations?

A. To conduct a QMS gap analysis every two years
B. To change the QMS quarterly
C. To continually improve the QMS
D. To review the QMS annually

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 emphasizes continual improvement as a fundamental requirement of an effective Quality Management System (QMS).
Clause Reference:
* Clause 4.4.1 (Quality Management System and Its Processes) states that organizations must:
* Determine processes needed for the QMS
* Establish criteria and methods for process effectiveness
* Ensure continual improvement of the system
Why is the Correct Answer C?
* Continual improvement is a core principle of ISO 9001.
* Organizations must regularly assess and enhance their QMS to adapt to new challenges and maintain effectiveness.
Why are the Other Options Incorrect?
* A (To change the QMS quarterly) # ISO 9001 does not mandate a specific frequency for system changes.
* B (To review the QMS annually) # QMS reviews must be conducted as needed, not strictly annually.
* D (To conduct a QMS gap analysis every two years) # Gap analysis is useful but is not a mandatory requirement under Clause 4.4.
Reference:
ISO 9001:2015, Clause 4.4 - Quality Management System and Its Processes

NEW QUESTION # 14
Which of the options below is an example of minor nonconformity?

A. Lack of commitment from the top management
B. Some of the nonconformities were not closed as planned (on time) and no justification was provided or documented
C. Lack of corrective actions to address recurrent incidents

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:
Minor nonconformities are isolated issues that do not significantly impact the QMS but still require correction.
* Failure to close nonconformities on time (Answer A) is a procedural issue and is considered minor unless it leads to repeated failures.
Major nonconformities include:
* Lack of top management commitment (Answer B), which affects leadership and strategic direction.
* Failure to take corrective actions for recurrent issues (Answer C), which indicates systemic failure.
Reference:
ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action)

NEW QUESTION # 15
Select which one of the following statements is true.

A. A technical expert can replace a qualified auditor on an audit team.
B. The team leader shall be an auditor that is qualified in the scheme.
C. An audit team can include non-qualified auditors.
D. Audits leading to auditor qualification are undertaken annually.

Answer: B

Explanation:
According to the ISO 19011:2018 standard, which provides guidelines for auditing management systems, the team leader of an audit team should be an auditor who has demonstrated the competence to manage an audit of the relevant management system scheme. This means that the team leader should have the appropriate knowledge, skills, and experience to plan, conduct, report, and follow-up an audit of the specific management system, such as ISO 9001 for quality management systems. The other options are false because: B. An audit team can include non-qualified auditors, but only as observers or trainees who do not contribute to the audit findings or conclusions. C. A technical expert can assist a qualified auditor on an audit team, but cannot replace them, as a technical expert does not have the competence to perform audits. D. Audits leading to auditor qualification are not undertaken annually, but rather as part of a certification process that involves meeting certain criteria, such as education, work experience, audit experience, and examination. References:
ISO 19011:2018, PECB Certified ISO 9001 Lead Auditor Exam Preparation Guide, ISO 9001:2015 Quality Management Systems Lead Auditor Training Course

NEW QUESTION # 16
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. Decisions on improvement action timescales not involving departmental managers.
B. Evaluation of the results of the improvement action not always documented by the Quality Manager.
C. Quality improvements not aligning with the quality policy.
D. Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.
E. No quality objectives planned for the top management team
F. Limited knowledge of the content of Quality Improvement Requests by departmental staff.

Answer: C,E

Explanation:
According to the ISO 9001:2015 standard, clause 10.2.1 defines nonconformity as the non-fulfilment of a requirement. A requirement can be related to the quality management system, the products and services, the customer expectations, or the applicable statutory and regulatory requirements. Nonconformities can be detected through various sources, such as audits, inspections, tests, customer complaints, or internal reviews.
Nonconformities must be addressed by taking appropriate actions to correct them and prevent their recurrence.
In this scenario, the auditee has shown several issues that indicate nonconformities in their quality management system. Two statements that apply to the term nonconformity are:
A: No quality objectives planned for the top management team: According to ISO 9001, clause 6.2.1, the organization must establish quality objectives at relevant functions, levels, and processes. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The top management team is responsible for providing leadership and direction for the quality management system and ensuring its alignment with the organization's purpose and context. Therefore, the absence of quality objectives for the top management team is a nonconformity as it violates the requirement of clause 6.2.1.
E: Quality improvements not aligning with the quality policy: According to ISO 9001, clause 5.2.1, the quality policy is a statement of the organization's intentions and direction regarding quality, as formally expressed by top management. The quality policy must provide a framework for setting quality objectives and be compatible with the context and strategic direction of the organization. The quality policy must also be communicated, understood, and applied within the organization. Therefore, if the quality improvements are not aligned with the quality policy, it is a nonconformity as it violates the requirement of clause 5.2.1.

NEW QUESTION # 17
You are conducting a third-party audit to ISO 9001 and the next item on your audit plan is 'internal auditing'.
When reviewing a sample of audit records up to 5 years previously, you find that many contain non-conformance reports and no actions have been taken. You interview the Quality Manager.
You: "I have noted that many of the older files contain non-conformances that have not had any corrective action taken." Quality Manager: "Because the business is always changing, the departmental managers tell me that the non-conformances are no longer applicable. I made a decision that any non-conformance over 3 years old is automatically closed" You: "Do you obtain any confirmation beforehand from the appropriate departments that the non-conformances are no longer applicable." Quality Manager: " No, because they are so old I consider that they are no longer appropriate. Please remember that we take a risk-based approach which means we audit where and when it is considered important to do so.
Select one course of action you would now take from the options.

A. Raise a non-conformance report against clause 9.2.2.e of ISO 9001
B. Interview relevant Departmental managers to assess whether the older non-conformances are still valid.
C. Interview Top management to determine whether they were aware of and agreed the actions of the Quality Manager
D. Review all non-conformances reports related to clause 9.2 of ISO 9001

Answer: A

Explanation:
According to ISO 9001:2015, clause 9.2.2.e, the organization is required to retain documented information as evidence of the implementation of the audit programme and the audit results. This includes the records of the nonconformities identified during the internal audits and the corrective actions taken to address them. The organization is also required to verify the effectiveness of the corrective actions, as per clause 10.2.2.
Therefore, in the scenario given, the Quality Manager's decision to automatically close any nonconformance over 3 years old without obtaining any confirmation from the relevant departments or verifying the effectiveness of the corrective actions is a clear violation of the requirements of clause 9.2.2.e. This indicates a lack of control and follow-up of the internal audit process, as well as a potential risk of recurrence or occurrence of the nonconformities in other areas. This also undermines the credibility and value of the internal audit programme, as well as the risk-based approach claimed by the Quality Manager.
Hence, the best course of action to take is D, to raise a nonconformance report against clause 9.2.2.e of ISO
9001, and to communicate the audit findings to the relevant management. The other options are either insufficient or irrelevant to address the issue, as they do not directly relate to the noncompliance with clause
9.2.2.e.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 9.2.2 and 10.2.2 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6

NEW QUESTION # 18
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