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PECB ISO-9001-Lead-Auditor 考試大綱：

主題
簡介

主題 1

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

主題 2

Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.

主題 3

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

主題 4

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 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.

最新的 ISO 9001 ISO-9001-Lead-Auditor 免費考試真題 (Q22-Q27):

問題 #22
Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
"The scope of the QMS includes all activities related to food processing." Leslie established a quality policy and presented it to the team for review before top management approval
. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
Which statement related to the last paragraph of scenario 2 is correct?

A. Top management demonstrated leadership and commitment with respect to customer satisfaction.
B. Customer satisfaction is only measured through complaints, making surveys unnecessary.
C. Customer surveys are the best method for obtaining and monitoring customer perceptions.
D. Customer surveys should be conducted every week to have a clear understanding of the needs and expectations of customers.

答案：A

解題說明：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015, Clause 5.1.2 (Customer Focus) states that top management must ensure customer satisfaction by monitoring customer perceptions.
In scenario 2, top management initiated customer surveys, demonstrating their commitment to customer focus as required by Clause 5.1.2.
Reference:
ISO 9001:2015, Clause 5.1.2 - Customer Focus

問題 #23
Select the two statements that are true.

A. Where the available audit evidence indicates that the audit objectives are unattainable, the individual(s) managing the audit programme shall be immediately informed.
B. During the audit, the audit team leader shall periodically assess audit progress.
C. An immediate and significant risk to the audit shall be informed to the auditee and if possible to the certification body.
D. Inform the general manager if the auditor finds uncontrolled documents.
E. Changes to the audit scope, which become apparent during the audit, shall be approved with the auditee.
F. The audit team leader shall only communicate any concerns to the auditee during the closing meeting.

答案：A,B

解題說明：
* Analyzing Each Statement:
* A.Incorrect. The audit team leader must communicate concerns as they arise, not just during the closing meeting. Per ISO 19011:2018 Clause 6.4.9, significant concerns should be shared promptly with the auditee and audit client during the audit process to allow for immediate understanding and potential resolution.
* B.Incorrect. The auditor or team leader is not specifically required to inform the general manager about uncontrolled documents. Instead, the issue is communicated within the framework of the audit findings to the audit client or auditee, as appropriate.
Reference: ISO 19011:2018, Clause 6.6.2.
D:Incorrect. Changes to the audit scope require the approval of the audit client (e.g., the certification body), not just the auditee. The scope is agreed upon in advance, and significant changes must be communicated with all stakeholders.
E:Correct. The audit team leader is responsible for periodically assessing the audit progress to ensure it aligns with the audit objectives and planned scope.Reference: ISO 19011:2018, Clause 6.4.5.
F:Incorrect. While immediate and significant risks should be communicated to the auditee, notifying the certification body is not an immediate responsibility of the audit team leader. The communication process depends on the procedures defined by the audit programme manager.
Why Options C and E Are Correct:
C: Communicating unattainable audit objectives ensures the audit remains effective and prevents unnecessary effort or misalignment with goals.
E: Periodic assessments by the team leader help in maintaining alignment with the scope, objectives, and time constraints, ensuring the audit's success.
Relevant References from ISO Standards:
ISO 19011:2018, Clause 6.6.2: Describes procedures for when audit objectives are unattainable.
ISO 19011:2018, Clause 6.4.5: Emphasizes the audit team leader's responsibility for ongoing assessment of audit progress.

問題 #24
For a third-party, match the Activity with the Responsibility for conducting it.

答案：

解題說明：

Explanation:

* Approve Certification Body: Accreditation Body
* Award certification: Certification Body
* Recommend certification: Audit Team Leader
* Maintain certification:
Comprehensive Detailed ExplanationIn the context of a third-party ISO 9001 audit, different entities play specific roles in the certification process. Here's a detailed explanation of the responsibilities:
* Approve Certification Body: Accreditation BodyThe Accreditation Body is responsible for approving Certification Bodies. Accreditation Bodies are independent entities that evaluate the competence of Certification Bodies, ensuring they meet international standards like ISO/IEC 17021, which sets out the criteria for bodies providing audit and certification of management systems. In this role, they confirm that the Certification Body is capable of conducting ISO 9001 audits and granting certifications in accordance with international guidelines.
* Award Certification: Certification BodyThe Certification Body is the entity that ultimately awards the certification to an organization after verifying that it meets the ISO 9001 standards. Certification Bodies conduct audits, either directly or through a team of auditors, and based on the audit outcomes, they issue the certification, indicating that the organization complies with ISO 9001.
* Recommend Certification: Audit Team LeaderThe Audit Team Leader is responsible for leading the audit and making a recommendation to the Certification Body. This recommendation is based on the audit findings-whether the organization meets the ISO 9001 requirements or if there are areas of non- compliance that need corrective action. The final decision on certification is not made by the Audit Team Leader but by the Certification Body.
* Maintain Certification: Certification BodyMaintaining certification refers to the ongoing process of ensuring that an organization continues to comply with ISO 9001 requirements. The Certification Body conducts regular surveillance audits (e.g., annually) and may also perform recertification audits (typically every three years). This ongoing monitoring ensures that the certified organization continues to adhere to the quality management standards over time.
This breakdown clearly assigns responsibility based on the defined roles of Accreditation Bodies, Certification Bodies, and Audit Teams in the ISO 9001 certification process.

問題 #25
Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
"The scope of the QMS includes all activities related to food processing." Leslie established a quality policy and presented it to the team for review before top management approval
. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
Which situation presented in scenario 2 is NOT compliant with ISO 9001?

A. The QMS implementation team did not include a representative from top management.
B. The quality policy was reviewed by the implementation team before top management approval.
C. The QMS implementation team comprised five middle managers.
D. The responsibilities and authorities for QMS roles were assigned by Leslie, the quality manager.

答案：A

解題說明：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 Clause 5.1.1 (Leadership and Commitment) states that top management must demonstrate leadership and commitment to the QMS by actively participating in QMS implementation, integration, and effectiveness.
In scenario 2, top management refused to be directly involved in the QMS implementation team, which violates Clause 5.1.1 because leadership involvement is essential for the system's success.
Other options do not indicate nonconformance:
* Option A (Middle managers in the QMS team) is acceptable.
* Option C (Leslie assigning roles) is valid if competence is ensured (Clause 5.3 - Organizational Roles, Responsibilities, and Authorities).
* Option D (Team reviewing the policy before approval) aligns with best practices.
Reference:
ISO 9001:2015, Clause 5.1.1 - Leadership and Commitment
ISO 9001:2015, Clause 5.3 - Organizational Roles, Responsibilities, and Authorities

問題 #26
At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only two people are present and waiting for them: the Health and Safety supervisor and the administrative officer. Neither has participated in the audit. However, the team had previously agreed with the auditee Quality Manager on two nonconformities identified during the audit (NC1 and NC2).
They said:
Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and the other two managers have had to leave urgently to attend to the emergency." Administration officer: "Our quality manager, before leaving, left a written message about 'NC2'. He declares that the correction and corrective action have been already implemented and has attached some documents to the message as evidence of these actions. Therefore, he expects that 'NC2' will not be included in the report." Which one of the following would be your preferred answer to the Quallty Manager's request?

A. Let me review the message and documents, and I will give you my answer in a few minutes
B. The scope of the audit does not allow auditors to review actions taken in response to the nonconformity.There would not be enough time for the full cycle of corrective action to take effect
C. OK. Let's all go to the workshop to see the supervisor. I hope he will be able to explain what they did to correct the nonconformity and prevent its recurrence
D. OK. I will record in the audit report that 'nonconformity 2' was closed during the Closing meeting

答案：A

問題 #27
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