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

Topic	Details
Topic 1	Fundamental principles and concepts of a quality management system: The main objective of this domain is to evaluate your skills of explaining and applying ISO 9001 principles and concepts.
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	Managing an ISO 9001 audit program: This topic evaluates your abilities to establishing and managing a QMS audit program.
Topic 5	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 6	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 (Q132-Q137):

NEW QUESTION # 132
Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
"The scope of the QMS includes all activities related to food processing." Leslie established a quality policy and presented it to the team for review before top management approval
. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
Which situation presented in scenario 2 is NOT compliant with ISO 9001?

A. The responsibilities and authorities for QMS roles were assigned by Leslie, the quality manager.
B. The QMS implementation team did not include a representative from top management.
C. The quality policy was reviewed by the implementation team before top management approval.
D. The QMS implementation team comprised five middle managers.

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015 Clause 5.1.1 (Leadership and Commitment) states that top management must demonstrate leadership and commitment to the QMS by actively participating in QMS implementation, integration, and effectiveness.
In scenario 2, top management refused to be directly involved in the QMS implementation team, which violates Clause 5.1.1 because leadership involvement is essential for the system's success.
Other options do not indicate nonconformance:
* Option A (Middle managers in the QMS team) is acceptable.
* Option C (Leslie assigning roles) is valid if competence is ensured (Clause 5.3 - Organizational Roles, Responsibilities, and Authorities).
* Option D (Team reviewing the policy before approval) aligns with best practices.

NEW QUESTION # 133
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. Dictates the performance
B. Monitors the performance
C. Improves the performance
D. Manages the performance

Answer: C

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 # 134
What does the application of the process approach in a QMS enable?

A. The achievement of effective process performance
B. The consideration of processes in terms of financial value
C. The reduction of resource consumption
D. The improvement of processes based on the needs and expectations of interested parties

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015 promotes the process approach, which allows organizations to structure their activities into interrelated processes. This approach helps ensure that processes effectively achieve intended results.
Clause 0.3.1 (Process Approach) states that "The application of the process approach in a quality management system enables understanding and consistency in meeting requirements, considering processes in terms of added value, and achieving effective process performance." This aligns directly with option C, making it the correct answer. The other options are either partially correct or do not fully capture the purpose of the process approach:
* Option A (Improvement based on interested parties) is a benefit but does not define the main goal.
* Option B (Financial value) is not the primary focus of the process approach.
* Option D (Reduction of resource consumption) may be an indirect benefit but is not a core objective.

NEW QUESTION # 135
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months?" Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products in house." You: "That sounds like quite a significant change. What has been the impact of that?" Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging time." You: "I'm sure. What were the reasons for making the change?" Auditee: "Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices that made our product uncompetitive." You: "How did you go about the change?" In relation to the auditor's question about how the change was managed, the auditee mentions the steps listed below. Match the ISO 9001 clauses to the steps.
To complete the table, click on the blank section you want to complete so it is highlighted in red and then click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which step the requirement applies to.

Answer:

Explanation:

Explanation:

Here is the correct matching of ISO 9001:2015 clauses to the steps mentioned in the change management process:
* We identified risks and opportunities and fed these into our risk management processes.
* Clause 6.1 (Actions to address risks and opportunities)
* We found a suitable supplier.
* Clause 8.4 (Control of externally provided processes, products, and services)
* We monitored customer feedback and noticed an increase in negative feedback about lead times.
* Clause 9.1.2 (Customer satisfaction)
* We put together a plan for implementation.
* Clause 6.2.2 (Planning to achieve quality objectives)
* We monitored the performance of the new supplier.
* Clause 8.4.2 (Type and extent of control of external providers)
* We noticed that productivity targets were being missed.
* Clause 9.1.1 (Monitoring, measurement, analysis, and evaluation)
* We communicated the plan internally.
* Clause 7.4 (Communication)
* We looked at the data at the management review and decided we needed to do something different.
* Clause 9.3.2 (Management review inputs)
* We reorganised the staffing and implemented redundancies.
* Clause 7.1.2 (People)
* We set an objective to effectively implement the transition and outsource manufacturing.
* Clause 6.2.1 (Quality objectives and planning to achieve them)
This aligns the steps of the change process with relevant ISO 9001:2015 clauses related to risk, planning, communication, and monitoring.

NEW QUESTION # 136
Technical experts must operate under the supervision of:

A. The auditee
B. The audit team leader only
C. An auditor

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence), technical experts:
* Provide specialized knowledge in an audit.
* Must operate under the supervision of an auditor to ensure compliance with audit protocols.
* Cannot work independently or under the auditee's supervision, as they are not responsible for the audit's findings.
The audit team leader has overall responsibility, but technical experts are supervised by an auditor during the audit process.

NEW QUESTION # 137
......

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Exam ISO-9001-Lead-Auditor Prep, Latest ISO-9001-Lead-Auditor Test Report

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

Pass Guaranteed Quiz ISO-9001-Lead-Auditor - QMS ISO 9001:2015 Lead Auditor Exam –Reliable Exam Prep

PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q132-Q137):

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