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| Section | Weight | Objectives |
|---|
| Topic 1: Preparing an ISO 9001 audit | 12.5% | - Audit feasibility - Steps and activities to prepare a QMS audit - Roles and responsibilities of the audit team leader and members - Evidence types and their characteristics
|
| Topic 2: Managing an ISO 9001 audit program | 12.5% | - Audit program monitoring and improvement - Audit program management
|
| Topic 3: Fundamental principles and concepts of a quality management system (QMS) | 12.5% | - Advantages of implementing a QMS based on ISO 9001 - Applicability and scope of ISO 9001 - Connection between ISO 9001 and other standards (ISO 9001, ISO/TS 9002, ISO 9004)
|
| Topic 4: Closing an ISO 9001 audit | 13.75% | - Audit report preparation - Management of audit records - Audit completion and follow-up
|
| Topic 5: Conducting an ISO 9001 audit | 22.5% | - Audit findings and conclusions - Audit techniques and evidence collection - Audit conducting process
|
| Topic 6: Fundamental audit concepts and principles | 12.5% | - Audit concepts and principles - Personal attributes and behaviors of a professional auditor - Management of combined audits
|
| Topic 7: Quality management system (QMS) and ISO 9001 requirements | 13.75% | - Structure of the standard - Leadership and commitment, quality policy, roles and responsibilities (clause 5) - Risks and opportunities - Context of the organization, interested parties, and QMS scope (clause 4)
|
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q65-Q70):
NEW QUESTION # 65
Match the process descriptions below to the process names:

Answer:
Explanation:

Explanation:
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NEW QUESTION # 66
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).

Answer:
Explanation:

Explanation:
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According to the ISO 9000:2015 document, the seven quality management principles are:
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management
For each principle, the document provides a statement, a rationale, key benefits, and actions you can take to apply the principle in your organization.
Based on the document, here is a possible way to match a potential benefit to each of the four quality management principles you mentioned:
Table
Quality management principle
Potential benefit
Customer focus
Increased revenue and market share
Engagement of people
Enhanced trust and collaboration throughout the organization
Improvement
Enhanced drive for innovation
Evidence-based decision making
Increased ability to demonstrate effectiveness of past actions
NEW QUESTION # 67
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 comprised five middle managers.
- C. The quality policy was reviewed by the implementation team before top management approval.
- D. The QMS implementation team did not include a representative from top management.
Answer: D
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 # 68
What is the responsibility of the audit committee during an internal audit?
- A. To establish an internal audit program
- B. To supervise all audit functions and activities
- C. To define the audit schedule
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 5.2 (Audit Program Management):
* The audit committee is responsible for establishing the internal audit program.
* The audit schedule (A) is determined within the program, but it is not the main role of the committee.
Thus, C is the correct answer.
NEW QUESTION # 69
The ISO 9001 clause 5.1.1 states top management shall demonstrate leadership and commitment with respect to the quality management system.
In the context of the ISO 9001 management system certification, select the one correct description of top management's responsibilities.
- A. Top management shall ensure that all requirements are fulfilled.
- B. Depending on the organization's available resources, top management can comply with one or more of the 5.1.1 requirements.
- C. Top management needs only to comply with 50% of the 5.1.1 requirements.
- D. Depending on the size, complexity and business context, some of the 5.1.1 requirements can be excluded.
Answer: A
NEW QUESTION # 70
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