100% PASS QUIZ 2025 PECB LATEST ISO-9001-LEAD-AUDITOR: VALID QMS ISO 9001:2015 LEAD AUDITOR EXAM EXAM VCE

100% Pass Quiz 2025 PECB Latest ISO-9001-Lead-Auditor: Valid QMS ISO 9001:2015 Lead Auditor Exam Exam Vce

100% Pass Quiz 2025 PECB Latest ISO-9001-Lead-Auditor: Valid QMS ISO 9001:2015 Lead Auditor Exam Exam Vce

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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

TopicDetails
Topic 1
  • Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Topic 2
  • 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.
Topic 3
  • Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q62-Q67):

NEW QUESTION # 62
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?

  • A. Reviews the client's management system documented information
  • B. Evaluates the conditions of all sites
  • C. Verifies the compliance with legal requirements
  • D. Reviews the processes with high level of risk
  • E. Evaluates the results of the last management review
  • F. During the Stage 1 audit, the audit team:
  • G. Verifies the degrees of customer satisfaction

Answer: A,D

Explanation:
* Reviews the client's management system documented information: This activity involves checking the documentation of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team also evaluates the client's understanding and implementation of the standard, and identifies any gaps or nonconformities that need to be addressed before the Stage 2 audit123.
*Reviews the processes with high level of risk: This activity involves assessing the processes that have a significant impact on the quality of the products or services, or that pose a high risk of nonconformity or customer dissatisfaction123. The audit team also verifies the client's risk management approach, and evaluates the effectiveness of the controls and actions taken to mitigate the risks123.
The other options are not statements that are true for the Stage 1 audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is D and G.
References: 1: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit
| NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit


NEW QUESTION # 63
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?" GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience." You: "Did you document these issues?" GM: "No. Jack said that ISO 9001 does not require us to document these issues." You: "How did you determine the risks associated with the issues and did you plan actions to address them?" GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence." Select two options for how you would respond to the General Manager's suggestion:

  • A. I would ask the consultant to leave the meeting since he is not an employee of the organisation.
  • B. I would ask for a different guide instead of the legal compliance expert.
  • C. I would not accept the legal compliance expert answering the question.
  • D. I would ask to audit the Technical Manager by phone.
  • E. I would look for evidence that the actions resulting from the risk assessment had been taken.
  • F. I would delay the audit until the return of the technical manager

Answer: C,E

Explanation:
According to clause 4.1 of ISO 9001:2015, the organization should determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended results of its quality management system. The organization should monitor and review these issues and update them as necessary. Although the standard does not explicitly require documented information of these issues, it does require documented information as evidence of the implementation of the actions taken to address risks and opportunities, as per clause 6.1. The organization should also retain documented information as evidence of the results of the monitoring, measurement, analysis and evaluation of its QMS, as per clause 9.1. Therefore, the auditor should not accept the legal compliance expert answering the question, as he is not the person responsible for the process and may not have the necessary competence or knowledge of the QMS. The auditor should also look for evidence that the actions resulting from the risk assessment had been taken, as this is a requirement of the standard and a way to verify the effectiveness of the QMS. The other options are not appropriate courses of action for the auditor, because they do not address the audit objective or criteria, or they may compromise the audit integrity or impartiality. For example, option B may not be feasible or reliable, as the Technical Manager may not be available or able to provide the necessary evidence by phone. Option C may cause unnecessary delay and inconvenience for the audit process and the auditee. Option E may not solve the problem, as the guide is not the main source of evidence or information for the audit. Option F may be disrespectful or unprofessional, as the consultant may have a legitimate role or interest in the audit.
References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Context of the Organization, ISO 9001 Auditing Practices Group Guidance on Audit Evidence


NEW QUESTION # 64
What does the application of the process approach in a QMS enable?

  • A. The reduction of resource consumption
  • B. The consideration of processes in terms of financial value
  • C. The improvement of processes based on the needs and expectations of interested parties
  • D. The achievement of effective process performance

Answer: D

Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015 promotes the process approach, which allows organizations to structure their activities into interrelated processes. This approach helps ensure that processes effectively achieve intended results.
Clause 0.3.1 (Process Approach) states that "The application of the process approach in a quality management system enables understanding and consistency in meeting requirements, considering processes in terms of added value, and achieving effective process performance." This aligns directly with option C, making it the correct answer. The other options are either partially correct or do not fully capture the purpose of the process approach:
* Option A (Improvement based on interested parties) is a benefit but does not define the main goal.
* Option B (Financial value) is not the primary focus of the process approach.
* Option D (Reduction of resource consumption) may be an indirect benefit but is not a core objective.


NEW QUESTION # 65
Select the two statements that are true.

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

Answer: B,F

Explanation:
* 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.


NEW QUESTION # 66
TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit team discussed and agreed both nonconformities with TIX's quality manager. The Closing meeting was planned for 6pm with the general manager, quality manager and service manager at the meeting room.
At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the warehouse supervisor. Neither have participated in the audit.
The dialogue among them is as follows:
Audit team leader: "Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?" 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 the emergency." Warehouse supervisor: "They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed." Which one of the following options would be your preferred response to the final comment made by the warehouse manager?

  • A. We will hear what you were asked to tell us and will then leave. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to carry out the Closing meeting.
  • B. Sorry, but we cannot proceed with the Closing meeting. So, we are leaving now, and please tell the quality manager that I will phone him tomorrow early in the morning.
  • C. We will hear what you were asked to tell us and will ask you to sign the nonconformity reports as evidence that you have accepted them. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to complete the Closing meeting.
  • D. We will hear what you were asked to tell us and will leave copies of the nonconformity reports that have been agreed with the quality manager. Please tell the managers that we will consider this as the Closing meeting and that the individual(s) managing the audit programme will send the full report in five days.

Answer: A


NEW QUESTION # 67
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