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QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Question 57

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'.

Options:

No quality objectives planned for the top management team

Decisions on improvement action timescales not involving departmental managers.

Evaluation of the results of the improvement action not always documented by the Quality Manager.

Limited knowledge of the content of Quality Improvement Requests by departmental staff.

Quality improvements not aligning with the quality policy.

Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.

Answer:

A, 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.

Question 58

One of the conflict resolution techniques is toning down. How is the conflict managed in that case?

Options:

Following negotiations, each party makes concessions in order to reach a common agreement.

The audit team leader uses their authority to solve the conflict.

The points of agreement are emphasized and the points of disagreement are put into perspective.

Question 59

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

Options:

Manages the performance

Monitors the performance

Dictates the performance

Improves the performance

Answer:

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.

[Reference:Clause 0.1 (General) of ISO 9001:2015 specifies that a QMS enables organizations to achieve better performance by consistently meeting customer needs and improving their processes. It further highlights that continual improvement is a cornerstone of the standard (Clause 10.3)., Option Analysis:, A. Manages the performance:Incorrect. A QMS provides a framework to manage processes, not directly manage performance. The improvement of performance is an outcome of managing processes effectively., B. Monitors the performance:Incorrect. Monitoring is a component of performance evaluation (Clause 9.1) but does not define the overall purpose of the QMS., C. Dictates the performance:Incorrect. ISO 9001 does not "dictate" performance but allows organizations to set their own objectives and improve their operations based on their specific context and goals., D. Improves the performance:Correct. The fundamental purpose of a QMS as per ISO 9001 is continual improvement of the organization’s performance. This includes improving operational efficiency, customer satisfaction, and product/service quality., Why Option D is Correct:ISO 9001:2015 emphasizes the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking, which are designed to drive improvements in organizational performance. Continuous assessment of processes and customer feedback ensures that the organization can adapt, innovate, and improve its effectiveness over time., Relevant Clauses Supporting the Answer:, Clause 0.1: Purpose of the QMS., Clause 10.3: Continual improvement ensures that the QMS remains effective and aligned with organizational objectives., Clause 4.1: Context of the organization, which requires the QMS to align with organizational strategies and improve outcomes., , , ]

Question 60

Takitup is a small fabrication organisation that manufactures steel fencing, stairs and platforms for the construction sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit plan during a surveillance audit covers the organisation's improvement actions and the auditor asks to see the most recent management review meeting minutes.

The auditor finds that the management review report records that none of the improvement actions set by the previous review has been realised for a second time. A new Quality Manager has been brought in at the middle management level to rectify the situation as the organisation is concerned that it might lose its certification.

Select three options that would provide evidence of conformance with clause 10.3 of ISO 9001.

Options:

Outsource more processes to external providers

Removing expensive external providers from the database.

An increase in the number of quality staff.

A quality objective to achieve lower reject rates by quality control.

Considering results from the analysis of the effectiveness of corrective actions to determine improvement opportunities.

The certification body auditor reporting fewer nonconformities.

An enhanced customer satisfaction survey score than in the previous year.

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QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

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