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2025 PECB ISO-9001-Lead-Auditor: QMS ISO 9001:2015 Lead Auditor Exam Unparalleled New Cram Materials
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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
- 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 3
- 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 (Q95-Q100):
NEW QUESTION # 95
Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit?
- A. An audit plan
- B. An organisation's financial statement
- C. A list of interested parties
- D. A career history of the quality manager
- E. A checklist
- F. An evidence sampling strategy
Answer: B,D
NEW QUESTION # 96
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. Evaluation of the results of the improvement action not always documented by the Quality Manager.
- B. Decisions on improvement action timescales not involving departmental managers.
- C. Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.
- D. No quality objectives planned for the top management team
- E. Limited knowledge of the content of Quality Improvement Requests by departmental staff.
- F. Quality improvements not aligning with the quality policy.
Answer: D,F
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 # 97
Consultancy ABC, which is a subsidiary of a certification body called ABC-CERT, provided consultancy services regarding the implementation of a QMS based on ISO 9001 to an organization.
Considering this, can ABC-CERT provide certification services to the organization which obtained consultancy services from Consultancy ABC?
- A. Yes, after a minimum period of two years has passed.
- B. Yes, if both parties sign an agreement which states that previous services by Consultancy ABC will not impact the judgment of auditors.
- C. No, ABC-CERT is not allowed to provide certification services to that organization ever, as this would be a conflict of interest.
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Certification bodies must remain independent and impartial. If a certification body (ABC-CERT) provides consulting services to an organization through its subsidiary (Consultancy ABC), it cannot later certify the same organization.
Clause References:
* ISO/IEC 17021-1:2015, Clause 5.2.5 - Impartiality Requirements:
* A certification body must not certify an organization to which it has provided consultancy services.
* ISO/IEC 17021-1:2015, Clause 5.2.6:
* Subsidiaries of certification bodies must not provide consulting services to prevent conflicts of interest.
Why is the Correct Answer C?
* Certifying a client after providing consultancy creates a conflict of interest and violates ISO/IEC
17021-1:2015 impartiality rules.
* The certification body (ABC-CERT) and consultancy firm (Consultancy ABC) are related entities
, making it impossible to remain objective and independent.
Why are the Other Options Incorrect?
* A (Waiting two years) # ISO does not specify a time frame; the issue is impartiality, not just time.
* B (Signing an agreement to ensure objectivity) # Conflicts of interest cannot be resolved through an agreement; independence is required.
Reference:
ISO/IEC 17021-1:2015, Clause 5.2.5 - Impartiality Requirements
NEW QUESTION # 98
Which one of the following is not an ISO 9000:2015 quality management principle?
- A. Leadership
- B. Process approach
- C. Evidence-based decision-making
- D. Risk-based approach
Answer: D
Explanation:
According to the ISO 9000:2015 quality management principles document1, risk-based approach is not one of the seven quality management principles that ISO 9000, ISO 9001 and other related quality management standards are based on. The seven quality management principles are:
* Customer focus
* Leadership
* Engagement of people
* Process approach
* Improvement
* Evidence-based decision making
* Relationship management
Therefore, risk-based approach is not a quality management principle under ISO 9001:2015.
References: ISO - Quality management principles
NEW QUESTION # 99
How can an organization ensure the objectivity and impartiality of the internal audit function?
- A. By always outsourcing the internal audit function to a third party
- B. By having a representative of top management involved during the internal audit process
- C. By assigning internal auditors that do not have operational roles related to the QMS
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.1 (Impartiality):
* Internal auditors must not audit areas where they have direct responsibilities to avoid conflicts of interest.
* Outsourcing (C) is not required, as long as impartiality is maintained internally.
Thus, B is the correct answer.
Reference:
ISO 19011:2018, Clause 5.1 (Impartiality)
NEW QUESTION # 100
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