ISO-9001-Lead-Auditor Test Preparation: ISO 9001 & ISO-9001-Lead-Auditor Best Questions

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

Topic	Details
Topic 1	Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Topic 2	Managing an ISO 9001 audit program: This topic evaluates your abilities to establishing and managing a QMS audit program.
Topic 3	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 4	Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q88-Q93):

NEW QUESTION # 88
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

Answer:

Explanation:

NEW QUESTION # 89
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.

A. Name of the forklift driver that was moving the pallet
B. Batch number of the secondary material
C. The signature of the clean room's supervisor accepting the nonconformity
D. More information in the place within the clean room where secondary material was found
E. Description of any primary material close to this pallet
F. Description of the secondary material
G. The date on which the evidence was identified
H. The type of nonconformity (major or minor)
I. Evidence that the secondary material was approved ready to be used
J. Description of the ISO 9001:2015 requirement not being complied with and the clause number

Answer: B,E,F,G,H,J

NEW QUESTION # 90
An organisation wants to certify their ISO 9001:2015-based QMS for the first time. Arrange the activities in the correct sequence from 2 to 5.
To complete the sequence, click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

Answer:

Explanation:

Explanation:
To certify an organization's ISO 9001:2015-based Quality Management System (QMS) for the first time, the correct sequence of activities would be:
* Establish the management system (already in place).
* Supplier audit
* Internal audit
* Management review
* Initial certification audit - stage 1
* Initial certification audit - stage 2 (already in place).
This sequence follows the typical path for preparing and ensuring that a QMS is functioning as required, leading up to certification.

NEW QUESTION # 91
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements.
The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You are interviewing the Training Manager (TM).
You: "What quality objectives apply to the training process?"
TM: "One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses." You: "How do you measure this objective?" The Training Manager shows you a record on her computer and you see the following:

Which two of the following statements are true?

A. You would raise a nonconformity as a requirement in clause 10.2 has not been fulfilled.
B. You would check the training of personnel.
C. You would determine what corrective action was being taken to address the low pass rates.
D. You would determine the relative difficulty of each training course by reviewing them.
E. You would determine how the exam pass rate figures were analysed.
F. You would raise a nonconformity as a requirement in clause 8.7 has not been fulfilled.

Answer: C,E

Explanation:
In this scenario, the organization has set a quality objective of achieving a 90% minimum exam pass rate for all courses. The auditor's task is to assess whether this objective is being monitored effectively and if appropriate actions are taken when the objective is not met.
B: You would determine how the exam pass rate figures were analysed: ISO 9001:2015, particularly Clause
9.1 (Monitoring, measurement, analysis, and evaluation), requires organizations to evaluate performance data.
The auditor should verify how the organization analyses the pass rate data to ensure trends are identified, and corrective actions are planned based on this analysis.
D: You would determine what corrective action was being taken to address the low pass rates: When performance falls short of the objective, as seen with Course 4 (where the pass rate is below 90% in all months), Clause 10.2 (Nonconformity and corrective action) requires organizations to take corrective actions to address issues. The auditor would need to check if corrective actions have been initiated to address consistently low pass rates.
Statements A, C, E, and F do not directly address the monitoring and corrective action required under ISO
9001:2015 in this context.

NEW QUESTION # 92
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:

A. Present the nonconformities to the managers, inform them that the report will be sent within 10 days, close the meeting and leave the site.
B. Ask the General Manager to have a private conversation in which you present the nonconformities only to him because of their sensitive nature.
C. Present the nonconformities to the whole group and analyse with them how to overcome this situation.
D. Present the nonconformities to the whole group and inform that you will recommend your company to remove them from the approved suppliers list.

Answer: C

Explanation:
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. References: 1: Conducting the Audit Closing Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive Event.

NEW QUESTION # 93
......

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ISO-9001-LEAD-AUDITOR TEST PREPARATION: ISO 9001 & ISO-9001-LEAD-AUDITOR BEST QUESTIONS

ISO-9001-Lead-Auditor Test Preparation: ISO 9001 & ISO-9001-Lead-Auditor Best Questions