ISO-9001-Lead-Auditor Exam Dumps - PECB ISO 9001 Questions and Answers

Question # 64

Select six tasks you would expect to be completed at the audit team meeting of a third-party audit team leader and his audit team in preparation for a Closing meeting for a four-day initial certification audit.

Options:

Audit team leader informs the individual(s) managing the audit programme that the closing meeting is ready to be held.

Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the audit for other team members.

Final audit team meeting to agree findings and categories including clarification of any uncertainties.

Agree the roles of each audit team member for the closing meeting.

Audit team review any points raised by the auditee nominated representative.

Audit team agree final audit outcome recommendation.

Audit team leader completes final report, including individual findings and certification recommendation.

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Answer:

C, D, E, F, H, I

Explanation:

The tasks that are expected to be completed at the audit team meeting of a third-party audit team leader and his audit team in preparation for a Closing meeting for a four-day initial certification audit are:

•Option C: Final audit team meeting to agree findings and categories including clarification of any uncertainties. This option is correct because the audit team meeting is an opportunity for the audit team leader and the audit team members to review and consolidate the audit findings, to ensure that they are clear, accurate, objective, and supported by sufficient audit evidence. The audit team should also agree on the categories of the findings, such as nonconformity, observation, or opportunity for improvement, and resolve any uncertainties or disagreements among the audit team members.

•Option D: Agree the roles of each audit team member for the closing meeting. This option is correct because the audit team meeting is an opportunity for the audit team leader to assign the roles and responsibilities of each audit team member for the closing meeting, such as presenting the audit findings, answering questions, or taking notes. The audit team leader should also ensure that the audit team members are prepared and confident to perform their roles and to communicate effectively with the auditee.

•Option E: Audit team review any points raised by the auditee nominated representative. This option is correct because the audit team meeting is an opportunity for the audit team to review any points raised by the auditee nominated representative during the audit, such as requests for clarification, feedback, or complaints. The audit team should consider the validity and relevance of the points raised and decide how to address them in the closing meeting or in the audit report.

•Option F: Audit team agree final audit outcome recommendation. This option is correct because the audit team meeting is an opportunity for the audit team to agree on the final audit outcome recommendation, based on the audit findings and the audit criteria. The audit team should also consider the implications and consequences of the audit outcome recommendation for the auditee and the certification body, and ensure that the recommendation is consistent and justified.

•Option H: Audit team complete final version of their individual findings. This option is correct because the audit team meeting is an opportunity for the audit team to complete the final version of their individual findings, based on the agreement and feedback from the audit team meeting. The audit team should ensure that their individual findings are written in a clear, concise, and factual manner, and that they include the audit criteria, the audit evidence, and the audit conclusion. The audit team should also submit their individual findings to the audit team leader for review and approval.

•Option I: Re-audit corrective actions taken to correct findings found during the audit. This option is correct because the audit team meeting is an opportunity for the audit team to re-audit the corrective actions taken by the auditee to correct the findings found during the audit, if applicable and feasible. The audit team should verify the effectiveness and adequacy of the corrective actions and update the audit findings accordingly. The audit team should also document the results of the re-audit and communicate them to the auditee.

The following options are not correct:

•Option A: Audit team leader informs the individual(s) managing the audit programme that the closing meeting is ready to be held. This option is not correct because this task is not part of the audit team meeting, but part of the communication between the audit team leader and the individual(s) managing the audit programme. The audit team leader should inform the individual(s) managing the audit programme that the closing meeting is ready to be held after the audit team meeting, when the audit team has completed all the tasks and is ready to present the audit results to the auditee.

•Option B: Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the audit for other team members. This option is not correct because this task is not part of the final audit team meeting, but part of the daily audit team meetings that are held during the audit. The daily audit team meetings are opportunities for the audit team to review the progress and performance of the audit, to identify and resolve any issues or problems, and to coordinate and adjust the audit plan and activities as needed.

•Option G: Audit team leader completes final report, including individual findings and certification recommendation. This option is not correct because this task is not part of the audit team meeting, but part of the audit reporting process. The audit team leader should complete the final report, including the individual findings and the certification recommendation, after the closing meeting, when the audit team has received and considered the feedback and comments from the auditee. The audit team leader should also ensure that the final report is reviewed and approved by the appropriate authorities before issuing it to the auditee and the certification body.

•Option J: Write the audit finding report out when detected and obtain signature of the auditee. This option is not correct because this task is not part of the audit team meeting, but part of the audit evidence collection and documentation process. The audit team should write the audit finding report out when detected and obtain the signature of the auditee during the audit, when the audit team has observed and verified the audit evidence and has communicated the audit finding to the auditee. The signature of the auditee does not indicate acceptance or agreement with the audit finding, but only acknowledgement of receipt.

[References:, •ISO 19011:2018 Guidelines for auditing management systems, Clause 6.4.2: Conducting audit activities, Subclause i) and j), •ISO 9001 Lead Auditor Course Material, Module 5: Conducting an Audit, Slide 19: Audit Team Meeting, •ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 5.4: Audit Team 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, , ]

Question # 65

The procedures of an organisation require that all purchase orders have to be signed by the Purchasing Manager, or, in her absence, by the Production Manager. During an audit carried out in November 2020, an auditor determined that during three weeks in February 2020, the purchase orders were not signed. You raise a nonconformance under Clause 8.4.3 of ISO 9001:2015.

Which one of the following answers would you accept as a 'correction' from the Purchasing Manager?

Options:

All products related to those purchase orders have already been successfully used during the first quarter of 2020, therefore there is no need for correction. We will only take corrective action.

During those weeks, as I was on holiday, the production manager should have signed those purchase orders. As a correction to this particular nonconformity, I will ask him to sign them.

I do not accept the nonconformity. Anything I may ask my employees to do will be seen as another piece of evidence that complying with ISO 9001 requirements is a bureaucratic valueless burden.

I will sign all the purchase orders now. It will take some time to print them since they are on a backup disk, but I will get them done before the end of the audit.

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Question # 66

Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.

Options:

Manages the performance

Monitors the performance

Dictates the performance

Improves the performance

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Answer:

Explanation:

Understanding the Purpose of a Quality Management System (QMS):The primary objective of ISO 9001:2015 is to improve the overall performance of the organization by:

Ensuring consistent delivery of products and services that meet customer and regulatory requirements.

Focusing on enhancing customer satisfaction.

Promoting continual improvement of the organization’s processes and practices.

[Reference:Clause 0.1 (General) of ISO 9001:2015 specifies that a QMS enables organizations to achieve better performance by consistently meeting customer needs and improving their processes. It further highlights that continual improvement is a cornerstone of the standard (Clause 10.3)., Option Analysis:, A. Manages the performance:Incorrect. A QMS provides a framework to manage processes, not directly manage performance. The improvement of performance is an outcome of managing processes effectively., B. Monitors the performance:Incorrect. Monitoring is a component of performance evaluation (Clause 9.1) but does not define the overall purpose of the QMS., C. Dictates the performance:Incorrect. ISO 9001 does not "dictate" performance but allows organizations to set their own objectives and improve their operations based on their specific context and goals., D. Improves the performance:Correct. The fundamental purpose of a QMS as per ISO 9001 is continual improvement of the organization’s performance. This includes improving operational efficiency, customer satisfaction, and product/service quality., Why Option D is Correct:ISO 9001:2015 emphasizes the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking, which are designed to drive improvements in organizational performance. Continuous assessment of processes and customer feedback ensures that the organization can adapt, innovate, and improve its effectiveness over time., Relevant Clauses Supporting the Answer:, Clause 0.1: Purpose of the QMS., Clause 10.3: Continual improvement ensures that the QMS remains effective and aligned with organizational objectives., Clause 4.1: Context of the organization, which requires the QMS to align with organizational strategies and improve outcomes., , ]

Question # 67

You work for an organisation, 'ABC', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other

auditors) to audit an external provider, 'XYZ', which provides packaging materials to your organisation. It is 4 pm, and the audit is dlose 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 for 5 pm.

'XYZ' has two manufacturing lines: M1 is a clean room for primary packaging materials (i.e. will be in direct contact with the food), and M2 is for

secondary materials (i.e. will not be in direct contact with food).

Auditor 1 audited the two manufacturing lines.

You: "What findings would you report?"

Auditor 1: "I have one issue. Earlier today in the morning I saw some secondary material stocked in the clean room. I would propose raising a

nonconformity."

You: "How would you write the nonconformity?"

Auditor 1: "In the clean room, there was a pallet with secondary materials."

What additional information would you add to this text to complete the nonconformity report? Select six.

Options:

Batch number of the secondary material

Description of any primary material close to this pallet

Description of the ISO 9001:2015 requirement not being complied with and the clause number

Description of the secondary material

Evidence that the secondary material was approved ready to be used

More information in the place within the clean room where secondary material was found

Name of the forklift driver that was moving the pallet

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Question # 68

You are conducting an ISO 9001 audit of a Materials Recycling Facility. The organisation processes

waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line

where operators are removing contaminant materials from incoming products, such as plastic bags,

plastic film and badly contaminated items that would compromise the recycling process. You

interview the line supervisor.

You: "Why are these plastic items being rejected at this stage?"

Auditee: "They do not meet our processing standards."

You: "What is the reason for that?"

Auditee: "These items are likely to damage the machinery down the line. They can also

compromise our quality standards. We need to protect our reputation for good quality output

materials."

You: "What happens to the rejected items?"

Auditee: "Some get melted down in another process later on, and some are disposed of as waste

products that cannot be recycled."

You: "What happens to the waste products?"

Auditee: "I'm not sure. I suppose they go to landfill."

After further auditing, you have gathered additional evidence. Match the following

statements to the correct ISO 9001 standard clause shown.

To complete the table, click on the blank section you want to complete so that it is

highlighted in red, and then click on the applicable text from the options below.

Alternatively, drag and drop each option to the appropriate blank section.

Options:

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Answer:

Explanation:

A → 8.4.3.a

B → 7.2.b

C → 10.2.2

D → 10.2.1

E → 6.2

F → 5.2.2.c

8.4.3.a – No specification is issued to the suppliers of waste plastic:This clause refers to the information provided to external providers, including requirements for products and services. If no specification is issued, it means the organization is not complying with this clause, which states:

“The organization shall ensure that the requirements for the products and services to be provided are adequately defined prior to communication to the external provider.”

7.2.b – The picking operators have been trained:This falls under Competence requirements. Clause 7.2(b) requires that persons are competent on the basis of education, training, or experience:

“Ensure that these persons are competent on the basis of appropriate education, training, or experience.”

10.2.2 – No documentation is retained for rejected materials:This relates to corrective action documentation. Clause 10.2.2 requires organizations to retain documented information as evidence of nonconformities and actions taken:

“The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken…”

10.2.1 – The rejected materials are segregated:This links to the treatment of nonconforming outputs. Clause 10.2.1 discusses actions such as containment or segregation for nonconforming outputs:

“Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment…”

6.2 – Management has set an objective for the level of recycling:This refers to quality objectives. Clause 6.2 requires that measurable quality objectives be established, and this includes setting performance targets:

“The organization shall establish quality objectives at relevant functions… The quality objectives shall be measurable…”

5.2.2.c – The quality policy appears in promotional material:Clause 5.2.2(c) requires the quality policy to be available to relevant interested parties. Using it in promotional material ensures that it is communicated externally:

“The quality policy shall be… available to relevant interested parties, as appropriate.”

[References:, ISO 9001:2015, Clause 8.4.3 – Information for external providers, Clause 7.2 – Competence, Clause 10.2.2 – Corrective action documentation, Clause 10.2.1 – Nonconforming outputs, Clause 6.2 – Quality objectives, Clause 5.2.2 – Communicating the quality policy, ]