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| Topic | Details |
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| Topic 1 | - 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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| 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.
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| Topic 3 | - Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.
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| 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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| Topic 5 | - Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q126-Q131):
NEW QUESTION # 126
During a second-party audit of a fruit grower (apples, pears, peaches) by a potential customer complying with ISO 9001:2015, the auditor verifies that there is a large variability in the quality of fruit production. In the last two years, they have noticed an increasing variability in daily production quality. The auditor found a trend of delivered produce showing signs of bruising and over-ripening, which led to an increasing number of customer complaints.
This process has been in operation for decades. The business was founded by the grandfather of the current owners, who did not want to alter the established practices.
The auditor raises a non-conformity against ISO 9001.
Which one of the following options would be acceptable as corrective action by the auditee?
- A. Contract an independent consultant to determine the reasons for the variability of the process.
- B. Apply improved controls to the existing process that align with the customer's criteria.
- C. Retain the current contract and try to sell the rejected fruit to a second customer.
- D. Review the maintenance of the workers' competencies to ensure they meet the daily objective.
Answer: B
Explanation:
Corrective action must eliminate the cause of a nonconformity and prevent recurrence. In this case, the problem is process variability causing bruised and over-ripe fruit and increasing complaints.
Option C is acceptable because applying improved process controls aligned with customer criteria directly addresses the cause and prevents recurrence.
A may help only if competence is the cause, which is not established. B is investigation, not corrective action itself. D disposes of rejected product but does not prevent recurrence.
NEW QUESTION # 127
According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?
- A. Communicating the quality objectives needed for the Quality Management System.
- B. Establishing the Quality Management System quality policy.
- C. Planning actions to address risks and opportunities.
- D. Ensuring customer requirements are consistently met.
Answer: B
Explanation:
Top management is responsible for establishing, implementing, and maintaining the quality policy. The quality policy provides a framework for setting quality objectives and must be compatible with the context of the organization and support its strategic direction. It should also provide a commitment to satisfy applicable requirements and to continuous improvement.
References: ISO 9001:2015, Clause 5.2
NEW QUESTION # 128
Among others, what does Clause 4.4 (Quality Management System and Its Processes) of ISO 9001 require from organizations?
- A. To review the QMS annually
- B. To change the QMS quarterly
- C. To continually improve the QMS
- D. To conduct a QMS gap analysis every two years
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 # 129
In the context of a third-party management system certification audit, which two of the following statements are correct?
- A. The purpose of a Stage 2 audit is to certify an organisation to ISO 9001.
- B. A Stage 2 audit evaluates how efficiently the organisation is implementing its management system
- C. The Stage 2 audit should include an opening meeting at the start of the audit and a closing meeting at the conclusion of the audit.
- D. The purpose of a Stage 2 audit is to evaluate the implementation of the auditee's management system.
- E. The Stage 2 audit cannot include remote access to electronic site(s) that contain information relevant to the audit of the management system.
- F. The Stage 2 audit must be conducted by auditors who have never worked for the auditee
Answer: C,D
NEW QUESTION # 130
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. 80% of complaints originate from five shops in the same region. Most of these complaints relate to customer laundry not being cleaned as customers require. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it now. You learn that the shop managers were told to dismiss most of the complaints because of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
You raised a nonconformity against clause 8.5.1 of ISO 9001.
Based on the scenario, select the three options which best describe the evidence for raising such a nonconformity.
- A. The management failed in planning to replace obsolete equipment.
- B. The organisation failed to control the laundry operations in 5 shops adequately.
- C. The operators did not check the condition of the customer's product upon receipt.
- D. Some equipment used was not suitable for the laundry process.
- E. The operators did not check the laundry before release to the customer.
- F. The organisation failed to maintain all of its equipment to an adequate standard.
- G. Shop managers were told to make excuses to customers with complaints.
- H. Customer complaints are not taken seriously by the organisation.
Answer: B,G,H
NEW QUESTION # 131
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