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

Topic
Details

Topic 1

Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.

Topic 2

Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.

Topic 3

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 4

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 5

Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.

Topic 6

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 (Q199-Q204):

NEW QUESTION # 199
You are carrying out an annual audit at an organisation that has been certificated to ISO 9001 for two years.
The organisation offers home security
services. The scope of the quality management system covers alarm installation, alarm servicing, alarm monitoring and response. The business operates from a single office and employs subcontract installers and service technicians across the country.
You have just completed the opening meeting. You are interviewing the Managing Director (MD).
You: "I would like to gain an understanding of how the quality management system has been supporting your business and its strategic direction." MD: "We are continuing to face difficult times. The market is extremely competitive, and customers typically look for the least expensive option when choosing home security services. We have not yet seen any business benefit from our quality management system." You: "Tell me how you determine external and internal issues." MD: "We use SWOT analysis (Strengths Weaknesses, Opportunities, Threats)." You: "How have the outputs from your SWOT been used?" Select two of the following audit trails would you take to explore the extent to which the SWOT analysis and the outputs from this have been used to enable the business to achieve the intended results(s) of its quality management system according to ISO 9001.

A. Establish what actions were taken to improve the QMS
B. Establish how the organisation reviews information about external and internal issues
C. Establish how the organisation shares information with external interested parties
D. Establish how many interested parties need to be consulted
E. Establish whether the SWOT analysis is focussed solely on the QMS
F. Establish whether the SWOT analysis has been reviewed by the procurement manager

Answer: A,B

Explanation:
According to ISO 9001:2015, clause 4.1, the organisation must determine the external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended results of its quality management system. The organisation must also monitor and review the information about these issues. SWOT analysis is a tool that can help the organisation to identify its strengths, weaknesses, opportunities, and threats. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to review the information periodically and update it as necessary. Therefore, one audit trail would be to establish how the organisation reviews information about external and internal issues, such as how often, by whom, using what criteria, and with what results. 123 According to ISO 9001:2015, clause 10.3, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system. The organisation must also consider the results of analysis and evaluation, and the outputs from management review, to determine if there are any needs or opportunities for improvement. SWOT analysis can help the organisation to identify the areas where improvement is needed or possible, such as addressing the weaknesses and threats, or exploiting the strengths and opportunities. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to take actions to implement the improvement, such as setting objectives, allocating resources, assigning responsibilities, and evaluating the effectiveness. Therefore, another audit trail would be to establish what actions were taken to improve the QMS, such as what, when, by whom, how, and with what results. 124 References:
1: ISO 9001:2015 - Quality management systems - Requirements
2: Advisera, "Context of the organization in ISO 9001:2015 explained", https://advisera.com/9001academy
/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
3: ISO Templates, "ISO 9001 - Clause 4: Context of the organisation explained", https://resources.iso- templates.com/blog/iso-9001-clause-4-context-of-the-organisation-explained
4: Advisera, "How to implement continual improvement in ISO 9001", https://advisera.com/9001academy
/knowledgebase/how-to-implement-continual-improvement-in-iso-9001/

NEW QUESTION # 200
How much time is usually spent on the Stage 1 audit?

A. 20% of the total audit time
B. 40% of the total audit time
C. 30% of the total audit time

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015 (Conformity Assessment - Requirements for Certification Bodies), Clause 9.3.1.2, the Stage 1 Audit typically consumes around 30% of the total audit time.
This time is allocated to:
* Reviewing documented information.
* Assessing the readiness for Stage 2.
* Identifying potential nonconformities.
A 20% allocation (Answer A) is too low, and 40% (Answer C) is excessive, as the majority of the audit should be spent on Stage 2 (on-site verification).

NEW QUESTION # 201
Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
"The scope of the QMS includes all activities related to food processing." Leslie established a quality policy and presented it to the team for review before top management approval
. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
In scenario 2, the team determined the QMS scope by taking into account only the requirements of top management. Is this compliant with ISO 9001?

A. No, the QMS scope must take into account only those directly involved in QMS implementation.
B. Yes, as long as the top management defines the scope, it meets ISO 9001 requirements.
C. Yes, ISO 9001 does not specify whether any interested party should be considered when determining QMS scope.
D. No, the QMS scope must be determined by considering the needs and expectations of relevant interested parties.

Answer: D

Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015, Clause 4.3 (Determining the Scope of the Quality Management System) states that when determining the QMS scope, an organization must consider:
* External and internal issues (Clause 4.1)
* The needs and expectations of interested parties (Clause 4.2)
* The products and services provided by the organization
In the scenario, Bell only considered top management's input, which fails to address Clause 4.2 (interested parties' expectations)-such as customers, suppliers, and regulatory authorities.
Reference:
ISO 9001:2015, Clause 4.3 - Determining the Scope of the QMS
ISO 9001:2015, Clause 4.2 - Understanding the Needs and Expectations of Interested Parties

NEW QUESTION # 202
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
The audit team members were selected based on their knowledge of the legal and other regulations that TD is subject to. Is this acceptable?

A. No, because there is no need to have knowledge of the legal and other requirements that TD is subject to.
B. Yes, to ensure effective conduct of the audit, each audit team member should have knowledge of legal and other requirements that TD is subject to.
C. Yes, but only the lead auditor needs to have knowledge of legal and other regulatory requirements.
D. No, because only one audit team member is required to have knowledge of legal and other regulatory requirements that TD is subject to.

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to ensure that auditors have the necessary competence and knowledge to conduct audits effectively.
Clause References:
* ISO 19011:2018, Clause 7.2.1 - Determining Competence of Auditors: Auditors must have knowledge of applicable legal and regulatory requirements that affect the scope of the audit.
* ISO/IEC 17021-1:2015, Clause 7.1.2 - Competence Requirements: Certification bodies must ensure that auditors assigned to the audit team possess relevant knowledge in areas such as legal and regulatory compliance.
Why is the Correct Answer C?
* Each audit team member should have sufficient knowledge of relevant legal and regulatory requirements to ensure compliance.
* This helps auditors identify gaps or nonconformities related to compliance obligations.
* Having multiple team members with knowledge reduces reliance on a single expert and ensures a comprehensive assessment.
Why are the Other Options Incorrect?
* A (Only one team member needs knowledge) # Incorrect because audits involve various aspects, and all auditors should have basic awareness of legal and regulatory requirements.
* B (Legal knowledge is not necessary) # Incorrect because compliance is essential for QMS effectiveness.
* D (Only the lead auditor needs legal knowledge) # Incorrect because ISO requires all auditors to be competent in applicable laws, not just the leader.

NEW QUESTION # 203
A Health Trust has contracted with Servitup, a catering services organisation which has been certified to ISO
9001 for 1 year. It provides services to ten, small rural
hospitals in remote locations involving purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. An auditor is conducting the first sole surveillance audit at one site with the Deputy Catering Manager (DCM).
At the closing meeting attended solely by the DCM, the auditor informs him that he has found numerous gaps in the QMS processes which lead him to consider recommending suspension of the organisation's certification. He is particularly concerned with the evidence that patient health is being adversely affected by produce stored beyond its safe consumption date, poor kitchen hygiene and undercooked meals. The DCM says that he cannot make any decisions about these issues in the absence of the Catering Manager due to illness but will write everything down and report to the Catering Manager.
Which two actions should you take in the context of the audit?

A. Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body.
B. Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course.
C. Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit.
D. Recommend that all personnel should be given urgent in-depth training in the QMS.
E. Thank the DCM for his time and express an expectation that improvements will be made in the QMS.
F. Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work.

Answer: A,B

Explanation:
The actions that should be taken in the context of the audit are:
*Option B: Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body. This option is correct because the auditor has found serious and significant gaps in the QMS processes that affect the health and safety of the patients, which is a major nonconformity that may warrant suspension of certification. The auditor should inform the individual(s) managing the audit programme of the situation and the audit findings, and recommend immediate suspension of certification to protect the integrity of the Certification Body and the credibility of the certification scheme. The auditor should also follow the Certification Body's procedures and rules for suspension of certification and communicate the decision and the consequences to the auditee.
*Option C: Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course. This option is correct because the auditor should not terminate or postpone the closing meeting due to the absence of the Catering Manager, as the DCM is the auditee's nominated representative for the audit. The auditor should continue with the meeting, present the audit conclusions and the audit findings, and inform the DCM that the organisation will receive the audit report in due course. The auditor should also explain the audit outcome recommendation and the suspension of certification, and request the DCM to acknowledge the receipt and understanding of the audit results.
The following options are not correct:
*Option A: Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit. This option is not correct because the auditor should not close the meeting without presenting the audit conclusions and the audit findings, as this would violate the audit principles of fairness and transparency. The auditor should also not advise that the issues will be addressed at the next surveillance visit, as this would imply that the auditor is accepting the auditee's delay and inaction, and that the auditor is not taking the major nonconformity seriously.
*Option D: Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work. This option is not correct because the auditor should not conclude the meeting early or reschedule it due to the absence of the Catering Manager, as this would disrupt the audit process and the audit schedule. The auditor should also not wait for the Catering Manager to return to work, as this would delay the communication and resolution of the major nonconformity, and potentially compromise the health and safety of the patients.
*Option E: Recommend that all personnel should be given urgent in-depth training in the QMS. This option is not correct because the auditor should not recommend or prescribe specific corrective actions to the auditee, as this would violate the audit principles of independence and objectivity. The auditor should only report the audit findings and the audit outcome recommendation, and leave the responsibility and authority for determining and implementing the corrective actions to the auditee.
*Option F: Thank the DCM for his time and express an expectation that improvements will be made in the QMS. This option is not correct because the auditor should not thank the DCM for his time and express an expectation that improvements will be made in the QMS, as this would imply that the auditor is satisfied and optimistic with the auditee's performance and response, and that the auditor is not taking the major nonconformity seriously. The auditor should instead express the concern and dissatisfaction with the auditee's QMS processes and the impact on the health and safety of the patients, and communicate the suspension of certification and the need for urgent and effective corrective actions.
References:
*ISO 19011:2018 Guidelines for auditing management systems, Clause 6.4.2: Conducting audit activities, Subclause k) and l)
*ISO 9001 Lead Auditor Course Material, Module 5: Conducting an Audit, Slide 20: Closing Meeting
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 5.5: Closing 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

NEW QUESTION # 204
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