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試験の準備方法-効果的なISO-9001-Lead-Auditor資格認定試験試験-実際的なISO-9001-Lead-Auditor認定テキスト
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PECB QMS ISO 9001:2015 Lead Auditor Exam 認定 ISO-9001-Lead-Auditor 試験問題 (Q145-Q150):
質問 # 145
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. Manages the performance
- B. Monitors the performance
- C. Dictates the performance
- D. Improves the performance
正解:D
解説:
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.
質問 # 146
Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled.
The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team.
Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Based on Scenario 7, the team worked together to draft the final audit report. Is this acceptable?
- A. No, audit team members should draft separate reports for their findings and conclusions
- B. No, it is the responsibility of the audit team leader to draft the audit report
- C. Yes, audit team members should contribute to drafting one general report for the findings and conclusions
正解:C
解説:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 6.4.9 (Audit Conclusions & Reporting):
* One consolidated audit report should be drafted based on all team members' findings.
* Each auditor does not draft separate reports (B) unless explicitly required.
Thus, A is the correct answer.
質問 # 147
Match the process descriptions below to the process names:
正解:
解説:
Explanation:
Match the process descriptions below to the process names:
The process by which the accuracy of test equipment is checked against a known standard. = Calibration The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation The process by which data is examined in detail to reach a specific answer or answers. = Analysis The process by which a parameter of a product or service is examined to determine a specific value. = Measurement According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, the definitions of the process names are as follows:
Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Analysis: detailed examination of the elements or structure of something.
Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.
Therefore, the process descriptions can be matched to the process names based on these definitions.
References:
ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary
質問 # 148
Select the word that best completes the sentence:
正解:
解説:
Explanation:
According to the ISO - Management system standards page, the key benefits of an effective management system include improved operational effectiveness and efficiency, improved risk management and protection of people and the environment, and enhanced drive for innovation. The Integrated Use of Management System Standards (IUMSS) handbook also states that the purpose and objectives of management system standards are to help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives.
Therefore, the complete sentence is:
"The purpose of a management system standard is to improve the performance of an organisation."
質問 # 149
The certification body has not been able to verify the implementation of corrective actions for any identified major nonconformity within six months after the last day of the Stage 2 audit. What must the certification body do in this case?
- A. It must issue an unfavorable recommendation of certification
- B. It must conduct all audit activities from the beginning
- C. It must conduct another Stage 2 audit before granting certification
正解:A
解説:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015, Clause 9.4.10 (Corrective Actions for Major Nonconformities):
* If a major nonconformity is not corrected within six months, the certification body must reject the certification request.
* Another Stage 2 audit (C) is not required unless the organization reapplies for certification.
* Restarting all audit activities (B) is unnecessary; instead, certification is denied.
Thus, A is the correct answer.
質問 # 150
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