ISO-9001-Lead-Auditor시험문제집즉덤프가지니고있는장점 - QMS ISO 9001:2015 Lead Auditor Exam

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PECB ISO-9001-Lead-Auditor 시험요강:

주제소개
주제 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.
주제 2
  • Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
주제 3
  • Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
주제 4
  • Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.

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최신 ISO 9001 ISO-9001-Lead-Auditor 무료샘플문제 (Q181-Q186):

질문 # 181
When should the certification body accept the audit?

정답：A

설명：
Comprehensive and Detailed In-Depth Explanation:
Before accepting an audit, the certification body must assess the integrity of the auditee and the nature of its operations to ensure compliance feasibility.
Clause References:
* ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning:
* The certification body must review the auditee's background, reputation, and operational complexity before accepting the audit.
Why is the Correct Answer C?
* The auditee's integrity and reputation impact the credibility of certification.
* The nature of operations determines audit complexity and resource allocation.
Why are the Other Options Incorrect?
* A (Integrity and reputation only) # Correct but incomplete; nature of operations is equally important.
* B (Nature of operations only) # Integrity is also a factor, not just operations.
* D (No previous major nonconformities required) # Auditees with past major nonconformities can still be audited if corrective actions are taken.


질문 # 182
Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.

정답：A

설명：
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.


질문 # 183
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented. 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.
Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?

정답：A,B

설명：
According to ISO 9001:2015, clause 6.2.1, the organization is required to establish quality objectives at relevant functions, levels, and processes for the quality management system (QMS). The quality objectives must be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate.
The organization is also required to maintain documented information on the quality objectives, as per clause
7.5.1.
Therefore, in the scenario given, the quality objectives defined by the external consultant are not in alignment with the organization's quality policy, as they are based on those of a competitor, rather than the organization' s own purpose, strategic direction, and customer requirements. This creates a mismatch between the organization's vision and goals, and the quality objectives that are supposed to guide and measure the QMS performance. Moreover, the quality objectives are not maintained as documented information, which makes it difficult to communicate, monitor, and update them, as well as to demonstrate evidence of their implementation and achievement.
Hence, the circumstances in which a nonconformity against clause 6.2 of ISO 9001 could be raised are B and C, as they indicate a failure to comply with the requirements of clause 6.2.1. The other options are either irrelevant or not directly related to clause 6.2, as they do not pertain to the establishment and documentation of quality objectives.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 6.2.1 and 7.5.1 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6


질문 # 184
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.
The quality policy was established by Leslie and approved by top management. Is this acceptable?
Please refer to scenario 2.

정답：D

설명：
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015, Clause 5.2.1 (Establishing the Quality Policy) states that top management must establish, implement, and maintain a quality policy.
In the scenario, the quality manager (Leslie) created the policy, but top management did not establish it themselves, which violates Clause 5.2.1. While the policy can be drafted by a team, top management must take full ownership of its development and approval.


질문 # 185
You work for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', which provides packaging materials to your organisation. It is 4 p.m. and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting.
The Closing meeting was scheduled
for 5 p.m.
You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.
Auditor 1 audited the two manufacturing lines and dispatch areas.
You to Auditor 1: "What findings would you report?"
Auditor 1: "When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at
11.30 am. Procedure P-02 Rev.3 says
that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device." You: "OK, what do you think?" Auditor 2: "I think that this is a nonconformity." You: "OK. How would you describe the evidence on which the nonconformity will be based"?
Identify which one of the following statements best describes the identified nonconformity.

정답：D

설명：
According to the definition in ISO 9000, a nonconformity is "non-fulfillment of a requirement". There are three parts to a well-documented nonconformity: the audit evidence to support auditor findings; a record of the requirement against which the nonconformity is detected; and the statement of nonconformity1. In this case, the audit evidence is the dispatch records that show the same batch number of the product being delivered by two different trucks at different times. The requirement is the procedure P-02 Rev.3 that says that trucks should carry a complete batch. The statement of nonconformity is that the batch 33555 was delivered split in two different trucks (011 and 025), which does not conform to the procedure. Therefore, option C best describes the identified nonconformity, as it includes all three parts of a well-documented nonconformity.
Option A is not correct, as it does not state the audit evidence or the requirement. Option B is not correct, as it does not specify the audit evidence or the statement of nonconformity. Option D is not correct, as it does not match the audit evidence or the requirement. References: 1: ISO 9001 Auditing Practices Group Guidance on Nonconformity - Documenting.


질문 # 186
......

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