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PECB ISO-9001-Lead-Auditor日本語認定、ISO-9001-Lead-Auditorミシュレーション問題

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IT業の多くの人がいくつか認証試験にパスしたくて、それなりの合格証明書が君に最大な上昇空間を与えます。この競争の激しい業界でとんとん拍子に出世させるのはPECBのISO-9001-Lead-Auditor認定試験ですが、簡単にパスではありません。でもたくさんの方法があって、最も少ない時間をエネルギーをかかるのは最高です。

毎年のISO-9001-Lead-Auditor試験問題は、テストの目的に基づいてまとめられています。すべての回答はテンプレートであり、2つのパートの主観的および客観的なISO-9001-Lead-Auditor試験があります。この目的のために、認定試験のISO-9001-Lead-Auditorトレーニング資料では、問題解決スキルを要約し、一般的なテンプレートを紹介しています。ユーザーは、提供された回答テンプレートに基づいて回答をスカウトし、スコアをスカウトできます。そのため、ユニバーサルテンプレートは、ユーザーがISO-9001-Lead-Auditor試験を勉強して合格するための貴重な時間を大幅に節約できます。

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ISO-9001-Lead-Auditorミシュレーション問題 & ISO-9001-Lead-Auditor専門知識内容

市場には試験に関する多くの学習資料があるため、当社からISO-9001-Lead-Auditor準備ガイドを選択する決定を下すことは容易ではありません。ただし、当社からISO-9001-Lead-Auditorテストプラクティスファイルを購入することに決めた場合は、ここ数年で行った最良の決定の1つになることをお知らせします。私たちに知られているように、当社のISO-9001-Lead-Auditor準備資料は、この分野の有名な専門家や教授の多くによって設計されています。 ISO-9001-Lead-Auditor準備ガイドが想像を超えた高品質であることは間違いありません。

PECB ISO-9001-Lead-Auditor 認定試験の出題範囲：トピック出題範囲トピック 1

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

トピック 2

Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.

トピック 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.

トピック 4

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

トピック 5

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.

トピック 6

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

PECB QMS ISO 9001:2015 Lead Auditor Exam 認定 ISO-9001-Lead-Auditor 試験問題 (Q129-Q134):

質問 # 129
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
The audit team members were selected based on their knowledge of the legal and other regulations that TD is subject to. Is this acceptable?

A. Yes, but only the lead auditor needs to have knowledge of legal and other regulatory requirements.
B. Yes, to ensure effective conduct of the audit, each audit team member should have knowledge of legal and other requirements that TD is subject to.
C. No, because only one audit team member is required to have knowledge of legal and other regulatory requirements that TD is subject to.
D. No, because there is no need to have knowledge of the legal and other requirements that TD is subject to.

正解：B

解説：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to ensure that auditors have the necessary competence and knowledge to conduct audits effectively.
Clause References:
* ISO 19011:2018, Clause 7.2.1 - Determining Competence of Auditors: Auditors must have knowledge of applicable legal and regulatory requirements that affect the scope of the audit.
* ISO/IEC 17021-1:2015, Clause 7.1.2 - Competence Requirements: Certification bodies must ensure that auditors assigned to the audit team possess relevant knowledge in areas such as legal and regulatory compliance.
Why is the Correct Answer C?
* Each audit team member should have sufficient knowledge of relevant legal and regulatory requirements to ensure compliance.
* This helps auditors identify gaps or nonconformities related to compliance obligations.
* Having multiple team members with knowledge reduces reliance on a single expert and ensures a comprehensive assessment.
Why are the Other Options Incorrect?
* A (Only one team member needs knowledge) # Incorrect because audits involve various aspects, and all auditors should have basic awareness of legal and regulatory requirements.
* B (Legal knowledge is not necessary) # Incorrect because compliance is essential for QMS effectiveness.
* D (Only the lead auditor needs legal knowledge) # Incorrect because ISO requires all auditors to be competent in applicable laws, not just the leader.
Reference:
ISO 19011:2018, Clause 7.2.1 - Competence of Auditors
ISO/IEC 17021-1:2015, Clause 7.1.2 - Competence Requirements

質問 # 130
Technical experts must operate under the supervision of:

A. The audit team leader only
B. An auditor
C. The auditee

正解：B

解説：
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence), technical experts:
* Provide specialized knowledge in an audit.
* Must operate under the supervision of an auditor to ensure compliance with audit protocols.
* Cannot work independently or under the auditee's supervision, as they are not responsible for the audit's findings.
The audit team leader has overall responsibility, but technical experts are supervised by an auditor during the audit process.
Reference:
ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence)

質問 # 131
Which two of the following auditors would not participate in a first-party audit?

A. An auditor from a customer
B. An auditor certified by IRCA
C. An auditor from an interested party
D. An auditor employed by an external consultancy organisation
E. An auditor trained in-house
F. An auditor trained in the IRCA scheme

正解：A、D

解説：
A first-party audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited1. The purpose of a first-party audit is to assess the conformity of the organization's quality management system to the requirements of ISO 9001 and to identify opportunities for improvement2. Therefore, the two auditors who would not participate in a first-party audit are:
*A. An auditor employed by an external consultancy organization: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit (if the external consultancy organization is a customer or supplier of the organization being audited) or a third-party audit (if the external consultancy organization is a certification body or registrar).
*F. An auditor from a customer: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit, as a customer is an interested party that has specific requirements for the organization being audited.
The other options are not correct, as they could participate in a first-party audit, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited:
*B. An auditor from an interested party: This auditor could be a first-party auditor, as long as the interested party is within the organization being audited. For example, an auditor from the finance department could audit the production department, as long as they are not involved in the production process or affected by its outcomes.
*C. An auditor trained in-house: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The source of the auditor's training is not relevant for determining the type of audit, as long as the auditor is competent and qualified to perform the audit.
*D. An auditor trained in the IRCA scheme: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The IRCA scheme is a professional certification scheme for auditors of management systems, which provides recognition of the auditor's competence and credibility3. However, being trained in the IRCA scheme does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.
*E. An auditor certified by IRCA: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. Being certified by IRCA means that the auditor has met the requirements of the IRCA scheme and has demonstrated their competence and credibility as an auditor of management systems3. However, being certified by IRCA does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.
References: First Party Audits: The 5 Steps to Success - Sync Resource Inc, ISO 9001 Auditing Practices Group, IRCA - International Register of Certificated Auditors

質問 # 132
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top- notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS.
They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS.
AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
Scenario 1 indicates that AL-TAX did not ensure clear and open communication channels with interested parties. Which quality management principle did the organization not follow in this case?

A. Leadership
B. Evidence-based decision making
C. Relationship management

正解：C

解説：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 is based on seven quality management principles, one of which is Relationship Management. This principle emphasizes the importance of maintaining open communication and collaboration with interested parties, including suppliers and customers.
Clause 7.4 (Communication) requires organizations to determine what, when, with whom, and how communication should take place. Since AL-TAX failed to ensure clear communication channels, it did not adhere to this principle. Effective relationship management helps improve supply chain performance, customer satisfaction, and overall QMS effectiveness.
Reference:
ISO 9001:2015, Clause 7.4 - Communication
ISO 9001:2015, Quality Management Principles - Relationship Management

質問 # 133
A Health Trust has contracted with Servitup, a catering services organisation which has been certified to ISO
9001 for 1 year. It provides services to ten, small rural
hospitals in remote locations involving purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. An auditor is conducting the first sole surveillance audit at one site with the Deputy Catering Manager (DCM).
At the closing meeting attended solely by the DCM, the auditor informs him that he has found numerous gaps in the QMS processes which lead him to consider recommending suspension of the organisation's certification. He is particularly concerned with the evidence that patient health is being adversely affected by produce stored beyond its safe consumption date, poor kitchen hygiene and undercooked meals. The DCM says that he cannot make any decisions about these issues in the absence of the Catering Manager due to illness but will write everything down and report to the Catering Manager.
Which two actions should you take in the context of the audit?

A. Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course.
B. Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit.
C. Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work.
D. Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body.
E. Thank the DCM for his time and express an expectation that improvements will be made in the QMS.
F. Recommend that all personnel should be given urgent in-depth training in the QMS.

正解：A、D

解説：
The actions that should be taken in the context of the audit are:
*Option B: Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body. This option is correct because the auditor has found serious and significant gaps in the QMS processes that affect the health and safety of the patients, which is a major nonconformity that may warrant suspension of certification. The auditor should inform the individual(s) managing the audit programme of the situation and the audit findings, and recommend immediate suspension of certification to protect the integrity of the Certification Body and the credibility of the certification scheme. The auditor should also follow the Certification Body's procedures and rules for suspension of certification and communicate the decision and the consequences to the auditee.
*Option C: Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course. This option is correct because the auditor should not terminate or postpone the closing meeting due to the absence of the Catering Manager, as the DCM is the auditee's nominated representative for the audit. The auditor should continue with the meeting, present the audit conclusions and the audit findings, and inform the DCM that the organisation will receive the audit report in due course. The auditor should also explain the audit outcome recommendation and the suspension of certification, and request the DCM to acknowledge the receipt and understanding of the audit results.
The following options are not correct:
*Option A: Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit. This option is not correct because the auditor should not close the meeting without presenting the audit conclusions and the audit findings, as this would violate the audit principles of fairness and transparency. The auditor should also not advise that the issues will be addressed at the next surveillance visit, as this would imply that the auditor is accepting the auditee's delay and inaction, and that the auditor is not taking the major nonconformity seriously.
*Option D: Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work. This option is not correct because the auditor should not conclude the meeting early or reschedule it due to the absence of the Catering Manager, as this would disrupt the audit process and the audit schedule. The auditor should also not wait for the Catering Manager to return to work, as this would delay the communication and resolution of the major nonconformity, and potentially compromise the health and safety of the patients.
*Option E: Recommend that all personnel should be given urgent in-depth training in the QMS. This option is not correct because the auditor should not recommend or prescribe specific corrective actions to the auditee, as this would violate the audit principles of independence and objectivity. The auditor should only report the audit findings and the audit outcome recommendation, and leave the responsibility and authority for determining and implementing the corrective actions to the auditee.
*Option F: Thank the DCM for his time and express an expectation that improvements will be made in the QMS. This option is not correct because the auditor should not thank the DCM for his time and express an expectation that improvements will be made in the QMS, as this would imply that the auditor is satisfied and optimistic with the auditee's performance and response, and that the auditor is not taking the major nonconformity seriously. The auditor should instead express the concern and dissatisfaction with the auditee's QMS processes and the impact on the health and safety of the patients, and communicate the suspension of certification and the need for urgent and effective corrective actions.
References:
*ISO 19011:2018 Guidelines for auditing management systems, Clause 6.4.2: Conducting audit activities, Subclause k) and l)
*ISO 9001 Lead Auditor Course Material, Module 5: Conducting an Audit, Slide 20: Closing Meeting
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 5.5: Closing Meeting
*Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection
3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies

質問 # 134
......

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