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ISO-9001-Lead-Auditor最新受験攻略 & ISO-9001-Lead-Auditor最新な問題集
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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
- ISO 9001 監査の実施: QMS 監査を実施するスキルを評価します。
トピック 2
- 品質管理システム (QMS) 要件: ISO 9001 に基づく品質管理システムのさまざまな要件を指摘し、説明する能力を評価します。
トピック 3
- ISO 9001 監査の準備: このトピックでは、品質管理システム監査の準備に関連するサブトピックについて説明します。
トピック 4
- ISO 9001 監査プログラムの管理: このトピックでは、QMS 監査プログラムを確立および管理する能力を評価します。
トピック 5
- 品質管理システムの基本原則と概念: このドメインの主な目的は、ISO 9001 の原則と概念を説明および適用するスキルを評価することです。
トピック 6
- ISO 9001 監査の終了: このトピックでは、QMS 監査の終了と監査フォローアップ活動の実施に焦点を当てています。
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PECB QMS ISO 9001:2015 Lead Auditor Exam 認定 ISO-9001-Lead-Auditor 試験問題 (Q67-Q72):
質問 # 67
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.
In scenario 4, the audit team determined the audit feasibility by considering only the resources available for the audit. Is this acceptable?
- A. No, because other factors should be considered when determining the audit feasibility, such as information needed to plan the audit, the cooperation of the auditee, duration of the audit, etc.
- B. Yes, because the audit team leader has final authority over audit feasibility.
- C. Yes, considering only the resources available for the audit is sufficient for determining the audit feasibility.
- D. No, the audit feasibility should be determined by TD's top management.
正解:A
解説:
Comprehensive and Detailed In-Depth Explanation:
An audit's feasibility must be assessed using multiple factors, not just resource availability.
Clause References:
* ISO 19011:2018, Clause 5.3 - Establishing the Audit Program: Requires consideration of logistical, technical, and cooperation factors when assessing audit feasibility.
* ISO/IEC 17021-1:2015, Clause 9.1.3 - Determining Feasibility of the Audit: Requires evaluating more than just resources to ensure a successful audit.
Why is the Correct Answer B?
* Audit feasibility should consider:
* Availability of information (documents, records).
* Cooperation from the auditee.
* Operational conditions that might affect the audit.
* Scope and complexity of the QMS being audited.
* Resource availability alone is not enough to determine feasibility.
Why are the Other Options Incorrect?
* A (Top management determines feasibility) # Incorrect because feasibility is determined by the certification body, not the auditee.
* C (Resources alone are sufficient) # Incorrect because other key factors must be evaluated.
* D (Final authority lies with the audit leader) # Incorrect because ISO requires multiple factors to be considered, not just an auditor's decision.
質問 # 68
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements.
While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence.
They observed the company's working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
Which statement below represents the level of responsibility demonstrated by the audit team in scenario 3?
- A. No negligence, the audit team has demonstrated diligence during the audit and followed the best practices.
- B. Gross negligence, the audit team has demonstrated a total lack of diligence.
- C. Ordinary negligence, the audit team has demonstrated lack of diligence.
- D. Willful misconduct, the audit team intentionally disregarded audit procedures.
正解:A
解説:
Comprehensive and Detailed In-Depth Explanation:
ISO 19011:2018 requires auditors to conduct audits professionally and diligently.
Clause References:
* ISO 19011:2018, Clause 4.4 - Professional Care: Auditors must exercise due diligence in conducting audits.
* ISO 9001:2015, Clause 9.2 - Internal Audit: Requires objective and systematic audits to evaluate QMS effectiveness.
Why is the Correct Answer A?
* The audit team followed best practices by gathering verifiable audit evidence through interviews, document reviews, and observations.
* They ensured fair presentation of findings in the final audit report.
* They complied with ISO 9001 and ISO 19011 guidelines for audit procedures.
Why are the Other Options Incorrect?
* B (Ordinary negligence) # No evidence of negligence; the team followed structured audit processes.
* C (Gross negligence) # No indication that the auditors ignored important responsibilities.
* D (Willful misconduct) # The auditors acted professionally and did not intentionally disregard rules.
質問 # 69
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."
正解:
解説:
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.
質問 # 70
In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.
- A. A finding of conformity is reported.
- B. A finding of good practice is reported.
- C. An opportunity for improvement is raised.
- D. A major non-conformity is raised.
- E. A recommendation is given in the report.
- F. A minor non-conformity is raised.
正解:D、F
解説:
According to ISO 19011:2018, clause 6.6.2, a nonconformity is the non-fulfilment of a requirement. A nonconformity can be classified as either major or minor, depending on the nature and extent of the deviation from the audit criteria. A major nonconformity is a nonconformity that affects the ability or the integrity of the organization's management system to achieve the intended results. A minor nonconformity is a nonconformity that does not affect the ability or the integrity of the organization's management system to achieve the intended results, but is a deviation from the audit criteria1.
According to ISO/IEC 17021-1:2015, clause 9.4.9, the organization is required to analyze the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time. The organization is also required to provide the certification body with records and evidence of the implementation and effectiveness of the correction and corrective actions taken. The certification body will then verify the correction and corrective actions taken by the organization and decide on the certification status2.
Therefore, the two options of when the organization is required to act in response to reported findings are D and F, as they indicate the presence of nonconformities that need to be corrected and prevented from recurring. The other options are not correct, as they do not require the organization to act in response to reported findings:
*A. A recommendation is given in the report: A recommendation is a suggestion for improvement that is not related to a nonconformity. A recommendation is not binding for the organization and does not affect the certification status. The organization may choose to accept or reject the recommendation, but it is not required to act on it.
*B. A finding of good practice is reported: A finding of good practice is a positive observation that indicates a strength or a best practice of the organization's management system. A finding of good practice is not related to a nonconformity and does not affect the certification status. The organization may choose to acknowledge or share the finding of good practice, but it is not required to act on it.
*C. An opportunity for improvement is raised: An opportunity for improvement is a potential area where the organization's management system can be enhanced or optimized. An opportunity for improvement is not related to a nonconformity and does not affect the certification status. The organization may choose to pursue or ignore the opportunity for improvement, but it is not required to act on it.
*E. A finding of conformity is reported: A finding of conformity is a confirmation that the organization's management system fulfils the audit criteria. A finding of conformity is not related to a nonconformity and does not affect the certification status. The organization may choose to celebrate or communicate the finding of conformity, but it is not required to act on it.
References: ISO 19011:2018(en), Guidelines for auditing management systems, ISO/IEC 17021-1:2015(en), Conformity assessment - Requirements for bodies providing audit and certification of management systems
- Part 1: Requirements
質問 # 71
The following are stages of an audit, put them in the order they would be conducted.
正解:
解説:
Explanation:
Establishing the audit programme objectives
Determining and evaluating the audit programme risks and opportunities
Establishing the audit programme
Initiating the audit
Preparing all audit activity
Conducting the audit activities
According to ISO 19011:2018, clause 5, the audit programme is a set of one or more audits planned for a specific time frame and directed towards a specific purpose. The audit programme includes all activities necessary to plan, organize, and conduct the audits. The audit programme management involves the following steps1:
Establishing the audit programme objectives: The audit programme objectives define the intended outcomes of the audit programme, such as verifying conformity, evaluating performance, identifying improvement opportunities, etc. The audit programme objectives should be aligned with the strategic direction and policies of the organization and the needs and expectations of the interested parties.
Determining and evaluating the audit programme risks and opportunities: The audit programme risks and opportunities are the factors that can affect the achievement of the audit programme objectives, such as changes in the internal or external context, availability of resources, competence of auditors, etc. The audit programme risks and opportunities should be identified, analyzed, and evaluated to determine the appropriate actions to address them.
Establishing the audit programme: The audit programme is established by defining the audit programme scope, criteria, methods, and resources. The audit programme scope defines the extent and boundaries of the audit programme, such as the processes, functions, sites, activities, etc. that will be audited. The audit programme criteria are the set of policies, procedures, or requirements used as a reference for the audits. The audit programme methods are the techniques used to conduct the audits, such as interviews, observations, document review, sampling, etc. The audit programme resources are the human, technical, and financial resources needed to implement the audit programme.
Initiating the audit: The audit initiation is the process of formally establishing the arrangements for an individual audit within the audit programme. The audit initiation involves contacting the auditee and the audit client, confirming the audit objectives, scope, and criteria, and obtaining the necessary information and access for the audit.
Preparing all audit activity: The audit preparation is the process of developing the audit plan and the audit work documents for an individual audit. The audit plan is a document that provides the basis for agreement regarding the conduct of the audit, such as the audit schedule, the audit team, the audit methods, the audit language, the audit report, etc. The audit work documents are the records that provide evidence of the audit activities, such as the audit checklist, the audit notes, the audit findings, etc.
Conducting the audit activities: The audit activities are the processes of collecting and verifying audit evidence and evaluating it against the audit criteria to make the audit conclusions. The audit activities include the opening meeting, the communication during the audit, the roles and responsibilities of the audit team and the auditee, the audit evidence collection and verification, the audit findings generation and recording, the closing meeting, and the audit report preparation and distribution.
References: ISO 19011:2018(en), Guidelines for auditing management systems
質問 # 72
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