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

Topic	Details
Topic 1	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.
Topic 2	Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.
Topic 3	Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
Topic 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.
Topic 5	Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q59-Q64):

NEW QUESTION # 59
You are conducting a third-party audit to ISO 9001 and the next item on your audit plan is 'internal auditing'.
When reviewing a sample of audit records up to 5 years previously, you find that many contain non-conformance reports and no actions have been taken. You interview the Quality Manager.
You: "I have noted that many of the older files contain non-conformances that have not had any corrective action taken." Quality Manager: "Because the business is always changing, the departmental managers tell me that the non-conformances are no longer applicable. I made a decision that any non-conformance over 3 years old is automatically closed" You: "Do you obtain any confirmation beforehand from the appropriate departments that the non-conformances are no longer applicable." Quality Manager: " No, because they are so old I consider that they are no longer appropriate. Please remember that we take a risk-based approach which means we audit where and when it is considered important to do so.
Select one course of action you would now take from the options.

A. Interview Top management to determine whether they were aware of and agreed the actions of the Quality Manager
B. Review all non-conformances reports related to clause 9.2 of ISO 9001
C. Interview relevant Departmental managers to assess whether the older non-conformances are still valid.
D. Raise a non-conformance report against clause 9.2.2.e of ISO 9001

Answer: D

Explanation:
According to ISO 9001:2015, clause 9.2.2.e, the organization is required to retain documented information as evidence of the implementation of the audit programme and the audit results. This includes the records of the nonconformities identified during the internal audits and the corrective actions taken to address them. The organization is also required to verify the effectiveness of the corrective actions, as per clause 10.2.2.
Therefore, in the scenario given, the Quality Manager's decision to automatically close any nonconformance over 3 years old without obtaining any confirmation from the relevant departments or verifying the effectiveness of the corrective actions is a clear violation of the requirements of clause 9.2.2.e. This indicates a lack of control and follow-up of the internal audit process, as well as a potential risk of recurrence or occurrence of the nonconformities in other areas. This also undermines the credibility and value of the internal audit programme, as well as the risk-based approach claimed by the Quality Manager.
Hence, the best course of action to take is D, to raise a nonconformance report against clause 9.2.2.e of ISO
9001, and to communicate the audit findings to the relevant management. The other options are either insufficient or irrelevant to address the issue, as they do not directly relate to the noncompliance with clause
9.2.2.e.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 9.2.2 and 10.2.2 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6

NEW QUESTION # 60
According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?

A. Establishing the Quality Management System quality policy.
B. Communicating the quality objectives needed for the Quality Management System.
C. Planning actions to address risks and opportunities.
D. Ensuring customer requirements are consistently met.

Answer: A

Explanation:
Top management is responsible for establishing, implementing, and maintaining the quality policy. The quality policy provides a framework for setting quality objectives and must be compatible with the context of the organization and support its strategic direction. It should also provide a commitment to satisfy applicable requirements and to continuous improvement.
References: ISO 9001:2015, Clause 5.2

NEW QUESTION # 61
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management. The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
How would you respond with the following options? Select three.

A. Suggest asking the certification body for guidance on this matter.
B. Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.
C. Indicate that ISO 9001 requires a minimum of two quality objectives.
D. Inform the Quality Manager that you will comment on the subject in your audit report.
E. Suggest that the Quality Manager obtains external consultancy on the use of quality objectives.
F. Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organisation's requirements.
G. Advise the Quality Manager that, as an auditor, you cannot provide advice to the organisation on how it should operate its QMS.
H. Suggest that all employees undertake a training course on ISO 9001.

Answer: B,D,F

Explanation:
According to the ISO 9001:2015 standard, clause 6.2.1 requires organizations to establish quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The quality objectives must also be measurable, monitored, communicated, and updated as appropriate.
In this scenario, the Quality Manager of XYZ Corporation has set quality objectives for every employee in the organization except top management. This has created a lot of resistance to the QMS, and the Chief Executive is asking questions about the cost and the method of setting objectives. The Quality Manager asks for your opinion as an auditor on whether this is the correct method of setting objectives.
As an auditor, you cannot provide advice to the organization on how it should operate its QMS. Your role is to assess the conformity and effectiveness of the QMS against the requirements of the standard and the organization's own policies and objectives. Therefore, you should respond with the following options:
B: Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization's requirements: You can suggest that the Quality Manager should familiarize himself with the requirements of clause 6.2.1 and understand how they apply to his organization. He should also consider the context and the needs and expectations of interested parties when setting quality objectives. He should ensure that the quality objectives are aligned with the quality policy and the strategic direction of the organization.
C: Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly: You can inform the Quality Manager that you will evaluate the quality objectives during the audit and check whether they meet the requirements of clause 6.2.1. If you find any gaps or weaknesses in the quality objectives, you will raise an opportunity for improvement to help the organization improve its QMS. You will also verify whether the quality objectives are monitored, communicated, and updated as appropriate.
D: Inform the Quality Manager that you will comment on the subject in your audit report: You can inform the Quality Manager that you will document your findings and observations on the quality objectives in your audit report. You will also provide a summary of the audit results and any recommendations for improvement.
You will also indicate the level of conformity and effectiveness of the QMS.
These three options would help you to maintain your impartiality and professionalism as an auditor and to provide constructive feedback to the organization

NEW QUESTION # 62
An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
"The reject rate of 'finished' product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%." Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells the audit team leader that a member of the audit team was seen taking photographs of the factory on his phone during the day and wants him suspended from the Closing meeting with any nonconformities raised by him rescinded. The issue of photographs was not discussed during the opening meeting.
Select the three options for how the audit team leader might deal with this situation.

A. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered
B. State that the auditor will take no further part in the audit and all his photographs will be deleted
C. Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting
D. Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office
E. Advise the Quality Manager that the auditor will be reported to Head Office
F. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done

Answer: A,B,F

Explanation:
The audit team leader should deal with this situation in a professional and ethical manner, while maintaining the integrity and credibility of the audit process and the audit findings. The audit team leader should also try to resolve the conflict with the Quality Manager in a constructive and respectful way, without compromising the audit objectives or the audit team's independence and impartiality. According to the ISO 9001 Lead Auditor Reference Materials guides and documents, the possible actions that the audit team leader might take are:
*A. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered. This action is consistent with the principle of evidence-based approach, which states that the audit team should collect and verify information that is appropriate, sufficient, and reliable to support the audit findings and conclusions. The audit team leader should explain to the Quality Manager that the nonconformities are not based solely on the photographs, but on other audit evidence that corroborates them.
The audit team leader should also remind the Quality Manager that the nonconformities are subject to review and approval by the certification body, and that any attempt to influence or interfere with the audit results would be considered a breach of the audit agreement and the certification rules.
*D. State that the auditor will take no further part in the audit and all his photographs will be deleted. This action is consistent with the principle of confidentiality, which states that the audit team should exercise discretion in the use and protection of information acquired during the audit. The audit team leader should acknowledge that the auditor's behavior was inappropriate and unprofessional, and that he violated the audit rules and the auditee's rights. The audit team leader should apologize for the inconvenience and the discomfort caused by the auditor, and assure the Quality Manager that the auditor will be removed from the audit team and that his photographs will be erased from his phone and any other device or media. The audit team leader should also inform the auditor of his misconduct and the consequences, and report the incident to the audit program manager and the certification body.
*F. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done. This action is consistent with the principle of communication, which states that the audit team should exchange information with the auditee in a timely, open, honest, and respectful manner. The audit team leader should express his concern and his willingness to address the issue with the auditor, and ask for the Quality Manager's patience and cooperation. The audit team leader should also explain that the audit process is not finished yet, and that the Closing meeting is an opportunity to present and discuss the audit findings and conclusions, and to seek feedback and clarification from the auditee. The audit team leader should then speak to the auditor privately, and follow the steps described in action D.
The other options are not appropriate or effective ways to deal with this situation, because they either:
*B. Delay the Closing meeting until the audit team leader has consulted his audit program manager at Head Office. This action would disrupt the audit schedule and the audit plan, and create unnecessary delays and costs for both the audit team and the auditee. It would also show a lack of leadership and decision-making skills from the audit team leader, and undermine his authority and credibility. The audit team leader should be able to handle the situation on site, and consult his audit program manager only if the situation escalates or becomes unmanageable.
*C. Advise the Quality Manager that the auditor will be reported to Head Office. This action would escalate the conflict and create a hostile and defensive atmosphere between the audit team and the auditee. It would also imply that the audit team leader is not capable or willing to resolve the issue himself, and that he is threatening or punishing the auditee for raising a legitimate concern. The audit team leader should try to defuse the tension and restore the trust and the rapport with the Quality Manager, and report the auditor to Head Office only after the audit is completed and the audit report is submitted.
*E. Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting. This action would not address the root cause of the problem, and would not prevent the auditor from taking more photographs or using them for other purposes. It would also expose the audit team and the auditee to unnecessary risks and liabilities, and compromise the confidentiality and the security of the audit information. The audit team leader should delete the photographs as soon as possible, and not wait until the Closing meeting.
References: ISO 9001:2015, ISO 19011:2018, PECB Certified ISO 9001 Lead Auditor, Common Audit Problems and How to Deal with Them, The Auditor's Guide to Conflict Resolution, Conflict Resolution in your Audit Career, How to Be a Good Auditor as a Team Leader

NEW QUESTION # 63
A Health Trust has contracted with Servitup, a catering services organisation that has been certified to ISO
9001 for one year. It provides services to
10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals, and loading heated trolleys for Ward Service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff." You: "I see. It really shouldn't affect the QMS so the audit can progress as normal." DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is." You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?" DCM: "Give me a minute. I need to look at the Quality Policy on the noticeboard in his office." As the audit progresses, it is clear that the DCM has a very low knowledge of the QMS. He continually has to look up the answers to your questions or ask staff members about their processes. You decide to raise a nonconformity.
Select one of the following options that best describes the nonconformity.

A. The Deputy Catering Manager is not competent to manage the QMS.
B. The effectiveness of the QMS depends on the Catering Manager being present on site.
C. The Quality Policy only exists as a document in the Catering Manager's office.
D. As a member of the management team, the Deputy Catering Manager is not sufficiently aware of the QMS.

Answer: D

NEW QUESTION # 64
......

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Latest updated New ISO-9001-Lead-Auditor Exam Bootcamp & Leader in Qualification Exams & Excellent ISO-9001-Lead-Auditor Valid Learning Materials

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

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q59-Q64):

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