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Most Recent PECB ISO-9001-Lead-Auditor Exam Questions & Answers


Prepare for the PECB QMS ISO 9001:2015 Lead Auditor exam with our extensive collection of questions and answers. These practice Q&A are updated according to the latest syllabus, providing you with the tools needed to review and test your knowledge.

QA4Exam focus on the latest syllabus and exam objectives, our practice Q&A are designed to help you identify key topics and solidify your understanding. By focusing on the core curriculum, These Questions & Answers helps you cover all the essential topics, ensuring you're well-prepared for every section of the exam. Each question comes with a detailed explanation, offering valuable insights and helping you to learn from your mistakes. Whether you're looking to assess your progress or dive deeper into complex topics, our updated Q&A will provide the support you need to confidently approach the PECB ISO-9001-Lead-Auditor exam and achieve success.

The questions for ISO-9001-Lead-Auditor were last updated on Nov 23, 2024.
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Question No. 1

You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist

laboratory equipment and furniture.

You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say,

over the last 12 months?"

Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products

in house."

You: "That sounds like quite a significant change. What has been the impact of that?"

Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced

manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff

redundant. This represents about 20% of our workforce, so this has been quite a challenging time."

This scenario presents a number of audit trails to different ISO 9001 requirements.

Which three of the following requirements would be relevant audit trails for this scenario?

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Correct Answer: B, C, D

Question No. 2

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

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Correct Answer: D, G

*

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.


Question No. 3

You work as an external quality consultant for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', to ISO 9001 which provides packaging materials to your organisation. It is 4 pm and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled at 5 pm.

You, as Audit Team Leader, audited top management. You explain to the audit team that you identified two nonconformities:

a. There is no documented information on Top Management Reviews, as required in clause 9.3 of ISO 9001:2015.

b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO 9001:2015. (e.g., not ensuring the availability of resources

to operate the QMS, not ensuring the establishment of objectives, no promotion of improvement, no promotion of the process approach).

All agreed to present these two nonconformities. They went to meet the Top Management of 'B' and noticed that the General Manager and three other managers (Production, Human Resources, and Sales) were present in the meeting room.

Considering the seriousness of the two nonconformities to Top Management, as audit team leader, from the following select the best option:

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Correct Answer: D

According to the guidance on conducting the audit closing meeting1, the audit team leader should provide a summary of the audit findings and conclusions, invite discussions, and agree on timelines for any corrective actions. The audit team leader should also be respectful, constructive, and objective when presenting the nonconformities, and avoid any personal or emotional comments. The audit team leader should also consider the impact of the disruptive event (such as the Covid-19 pandemic) on the auditee's context, interested parties, and risks2, and acknowledge any good practices or improvements observed during the audit. Therefore, option D is the best option, as it follows the best practices for the closing meeting and allows the auditee to understand the nonconformities and their implications, and to participate in the analysis and resolution of the issues. Option A is not correct, as it is not respectful, constructive, or objective, and it does not invite any discussion or feedback from the auditee. It also assumes that the audit team leader has the authority to recommend the removal of the supplier from the approved list, which may not be the case. Option B is not correct, as it does not provide enough information or explanation to the auditee, and it does not allow any discussion or feedback from the auditee. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, acknowledging any good practices, and agreeing on timelines for corrective actions. Option C is not correct, as it does not involve the other managers who are responsible for the functions or processes that were audited, and who may have valuable input or information to share. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, inviting discussions, and agreeing on timelines for corrective actions. Reference: 1: Conducting the Audit Closing Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive Event.


Question No. 4

Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

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Correct Answer: B

According to the ISO 9000:2015 - Quality management systems --- Fundamentals and vocabulary, correction is defined as ''action to eliminate a detected nonconformity''. A nonconformity is defined as ''non-fulfilment of a requirement''. Therefore, the process of modifying a non-conforming product to bring it within acceptance criteria is a correction, as it eliminates the non-fulfilment of the product specification. The other options are not correct, as they have different definitions and purposes:

* Concession: permission to release or use a nonconforming product, service or process

* Corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence

* Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation


Question No. 5

Which two of the following are included in the objectives of the 'Stage 1 initial certification audit'?

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Correct Answer: B, D

* To evaluate the preparedness of the organisation for a Stage 2 audit: This objective involves assessing the readiness of the organisation to undergo the Stage 2 audit, where the conformity and effectiveness of the quality management system will be verified123. The audit team will check the level of implementation and understanding of the quality management system, identify any major gaps or nonconformities, and confirm the audit scope, criteria, and plan123.

* To review the quality manual: This objective involves reviewing the documented information 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 will also evaluate the organisation's understanding and application of the standard, and identify any areas of improvement or concern123.

The other options are not included in the objectives of the Stage 1 initial certification 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 B and D.


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