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利用ISO-9001-Lead-Auditor在線題庫 -跟QMS ISO 9001:2015 Lead Auditor Exam考試困擾說再見

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PECB ISO-9001-Lead-Auditor 考試大綱：

主題
簡介

主題 1

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.

主題 2

Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.

主題 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.

主題 4

Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.

主題 5

Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.

>> ISO-9001-Lead-Auditor在線題庫 <<

ISO-9001-Lead-Auditor考試心得 & ISO-9001-Lead-Auditor下載

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最新的 ISO 9001 ISO-9001-Lead-Auditor 免費考試真題 (Q186-Q191):

問題 #186
In the context of a third-party management system certification audit, which two of the following statements are correct?

A. The Stage 2 audit cannot include remote access to electronic site(s) that contain information relevant to the audit of the management system.
B. The purpose of a Stage 2 audit is to evaluate the implementation of the auditee's management system.
C. A Stage 2 audit evaluates how efficiently the organisation is implementing its management system
D. The purpose of a Stage 2 audit is to certify an organisation to ISO 9001.
E. 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.
F. The Stage 2 audit must be conducted by auditors who have never worked for the auditee

答案：B,E

問題 #187
Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

A. Preventive action
B. Correction
C. Concession
D. Corrective action

答案：B

解題說明：
According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, correction is defined as "action to eliminate a detected nonconformity". A nonconformity is defined as "non-fulfilment of a requirement". Therefore, the process of modifying a non-conforming product to bring it within acceptance criteria is a correction, as it eliminates the non-fulfilment of the product specification. The other options are not correct, as they have different definitions and purposes:
*Concession: permission to release or use a nonconforming product, service or process
*Corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence
*Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation References: ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, ISO 9001 nonconforming product: How to understand dispositions - Advisera

問題 #188
Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.

A. Monitors the performance
B. Manages the performance
C. Improves the performance
D. Dictates the performance

答案：C

解題說明：
* 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.
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.

問題 #189
You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM) You: "Would you tell me about your management review process?" QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained." You: "May I see the records from the last two management reviews?" Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."

答案：

解題說明：

Explanation:

Nonconformity report
ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "Top management shall review the organization's quality management system at planned intervals." Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.

問題 #190
(As the audit team leader, you are planning an audit at an organisation that is seeking certification to ISO 9001. You have confirmed and agreed on the audit scope and audit date with the auditee. The audit team comprises of you and one other auditor. The auditee has two sites and one of these sites is the Head Office where the top management team are based.
The other site is referred to as Site 1, which is located in another country. Apart from that, each site is essentially similar in terms of customer service provision. The other auditor has been selected to audit Site 1 as she lives nearby.
Select four issues you need to finalise before documenting the audit plan.)

A. I would need to consider whether any processes were not operating at the time of the audit and determine how these could be audited.
B. I would need to plan for a follow-up audit to close the findings.
C. I would need to determine what IT infrastructure is available to enable the auditor to attend the opening and closing meetings remotely.
D. I would need to determine when I would moderate the grade of any audit non-conformities raised by the auditor at Site 1.
E. I would need to consider how best to structure the audit plan to account for audit trails throughout the audit.
F. I would need to arrange the translation of the audit report in case of language difficulties at Site 1.
G. I would need to find out the names of the auditees to be interviewed.
H. I would need to determine when the auditor and I will communicate after the end of the audit.

答案：A,C,E,F

解題說明：
ISO 9001:2015 requires audits to be planned and conducted to ensure the quality management system conforms to requirements and is effectively implemented. While ISO 9001 sets the requirement, it explicitly refers auditors to ISO 19011 for detailed guidance on audit planning and execution.
ISO 9001:2015, Clause 9.2.2 (NOTE) states that guidance for auditing management systems is provided in ISO 19011 .
Based on ISO 19011:2018 (Clause 6.3 - Initiating and preparing for the audit), the audit team leader is responsible for finalising key planning issues before documenting the audit plan, especially for multi-site and multi-country audits.
Explanation of the selected options:
A). Arrangement of translation of the audit report
ISO 19011 requires consideration of communication and language arrangements during audit preparation.
Where sites are located in different countries, potential language difficulties must be addressed during planning, including translation needs for reports and communications.
C). Structuring the audit plan to account for audit trails
ISO 19011 requires audits to follow audit trails across processes, functions, and interfaces. The audit plan must be structured to allow logical progression through interrelated processes, which must be decided before the plan is documented.
D). Determining available IT infrastructure for remote participation
ISO 19011 allows the use of remote auditing techniques. When audit team members are located in different countries, the audit team leader must confirm the availability of IT infrastructure to support remote participation in opening and closing meetings as part of audit planning.
E). Considering processes not operating at the time of the audit
ISO 19011 requires the audit team leader to consider process availability. If some processes are not operating during the audit period, alternative audit methods (such as records review or rescheduling) must be planned in advance and reflected in the audit plan.
Explanation of why the other options are not selected:
* B: ISO 19011 requires identification of roles and functions to be audited, not specific names, at the audit planning stage.
* F: Moderation or grading of nonconformities is performed after audit findings are raised, not during audit planning.
* G: Post-audit communication arrangements are addressed during reporting and follow-up activities, not before documenting the audit plan.
* H: Follow-up audits are planned only if required after audit results are known, not during initial audit planning.

問題 #191
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