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>> ISO-9001-Lead-Auditor資料的中率 <<
PECB ISO-9001-Lead-Auditor試験の準備方法|信頼できるISO-9001-Lead-Auditor資料的中率試験|素晴らしいQMS ISO 9001:2015 Lead Auditor Exam模擬試験
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PECB QMS ISO 9001:2015 Lead Auditor Exam 認定 ISO-9001-Lead-Auditor 試験問題 (Q61-Q66):
質問 # 61
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. Quality improvements not aligning with the quality policy.
- B. Decisions on improvement action timescales not involving departmental managers.
- C. Evaluation of the results of the improvement action not always documented by the Quality Manager.
- D. Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.
- E. No quality objectives planned for the top management team
- F. Limited knowledge of the content of Quality Improvement Requests by departmental staff.
正解:A、E
解説:
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.
質問 # 62
Which one of the following options is the definition of the context of an organisation?
- A. Comparison of internal and external issues that can have an effect on an organisation's desire to achieve its objectives.
- B. Complexity of internal and external issues that can have an effect on an organisation's approach to developing and achieving its purpose.
- C. Coordination of internal and external issues that can have a positive or negative effect on an organisation's success.
- D. Combination of internal and external issues that can have an effect on an organisation's approach to developing and achieving its objectives.
正解:D
解説:
Understanding "Context of the Organization":
The term "context of the organization" is defined in ISO 9001:2015 Clause 4.1, which states:
"The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system." The definition emphasizes identifying both internal and external issues that influence the organization's approach to developing and achieving its objectives.
Option Analysis:
Option A:Correct. This option aligns with the standard definition as it explicitly mentions the combination of internal and external issues that affect the organization's approach to achieving its objectives, which is the essence of Clause 4.1.
Option B:Incorrect. The term "comparison of internal and external issues" does not reflect the ISO 9001 requirements. The standard does not require a comparison but rather an understanding of these issues.
Option C:Incorrect. Although it mentions "complexity," the focus of ISO 9001:2015 is on identifying relevant issues rather than the complexity of those issues.
Option D:Incorrect. This option mentions "coordination" and focuses only on the positive or negative effects.
ISO 9001 requires identifying issues but does not emphasize coordination.
Clause Reference and Relevance:
ISO 9001:2015 requires organizations to understand their context because internal and external factors can influence the Quality Management System's effectiveness. Understanding this context helps in:
Addressing risks and opportunities (Clause 6.1).
Aligning the QMS with the organization's strategic direction.
Why A is Correct:
"Combination of internal and external issues" captures the essence of Clause 4.1, making it the accurate definition of the context of the organization.
質問 # 63
Who maintains ownership of the audit report?
- A. The auditee
- B. The audit team leader
- C. The certification body
正解:C
解説:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting):
* The certification body retains ownership of the audit report as it is responsible for the certification decision.
* The auditee may receive a copy, but it does not own the report.
* The audit team leader compiles the report but does not own it.
Thus, C is the correct answer.
Reference:
ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting)
質問 # 64
You have been nominated audit team leader of a third-party audit. Which of the following could be the two most relevant objectives of this audit?
- A. Evaluate the satisfaction interested parties
- B. Evaluate the benefits obtained since the implementation of the management system
- C. Evaluate the capability of the management system to establish and achieve objectives
- D. Evaluate the effectiveness of the management system
- E. Identify opportunities for improvement
- F. Identify the need of resources
正解:C、D
質問 # 65
Match the process descriptions below to the process names:
正解:
解説:
Explanation:
A white background with black text Description automatically generated
質問 # 66
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