PECB QMS ISO 9001:2015 Lead Auditor ISO-9001-Lead-Auditor Exam Questions

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Total 227 questions
Question 1

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.

Which of the following indicates that Bell has defined its quality objectives?



Answer : A

Comprehensive and Detailed In-Depth

ISO 9001:2015, Clause 6.2 (Quality Objectives and Planning to Achieve Them) states that an organization must establish measurable and relevant quality objectives to improve QMS effectiveness.

Bell's strategy for handling customer complaints aligns with this requirement because it includes specific, measurable goals (biweekly customer surveys) to enhance customer satisfaction and service quality.

Other options are not directly related to defining quality objectives:

Option B (Implementing a QMS) refers to the overall system, not specific objectives.

Option C (Creating a QMS team) is an implementation step, not an objective.

Option D (Assigning responsibilities) is necessary for QMS but does not define objectives.


ISO 9001:2015, Clause 6.2 -- Quality Objectives and Planning to Achieve Them

Question 2

Who would be defined as a witness during a witness audit?

Choose two of the following options:



Answer : B, D

Comprehensive and Detailed = According to the web search results from my internal tool, a witness audit is a technique used during an accreditation audit, where the accreditation body observes the performance and competence of the certification body auditors in conducting an audit12. A witness audit can also be used by a certification body to monitor and evaluate its own auditors3. During a witness audit, the following roles can be defined:

*An auditor: This is the person who is being witnessed by the accreditation body or the certification body. The auditor is responsible for conducting the audit according to the audit plan, criteria, and standards, and for providing audit evidence and findings123.

*An assessor for the accreditation body: This is the person who witnesses the auditor on behalf of the accreditation body. The assessor is responsible for evaluating the auditor's performance and competence, and for providing feedback and recommendations to the accreditation body123.

The other options are not defined as witnesses during a witness audit, according to the web search results from my internal tool. They are:

*Someone with a qualification from the certification body: This is not a specific role in a witness audit, as anyone who is involved in the audit process should have a qualification from the certification body. Moreover, having a qualification does not necessarily mean that the person is a witness or an auditor4.

*An existing member of the audit team: This is not a specific role in a witness audit, as the audit team consists of the auditors who are conducting the audit, not the ones who are witnessing it. The witness audit is a separate activity from the audit itself, and the witness should not interfere with the audit process or influence the audit outcome123.

Therefore, the correct answer is B and D.


Question 3

Which of the following is a record related to the audit program that should be managed and maintained?



Answer : C

Comprehensive and Detailed In-Depth

ISO 19011:2018, Clause 5.4 (Audit Records Management) states that the audit schedule must be maintained as a key record.

Thus, C is the correct answer.


ISO 19011:2018, Clause 5.4 (Audit Records Management)

Question 4

What should the auditor document during the Stage 1 audit?



Answer : C

Comprehensive and Detailed In-Depth

Stage 1 Audit (ISO 9001:2015, Clause 9.2.2) is a documentation review to assess the readiness for a Stage 2 Audit. The auditor must document:

Observations that could lead to nonconformities, ensuring they are addressed before Stage 2.

Areas needing improvement, such as missing documented information or unclear process definitions.

While understanding the auditee's main processes is important, documenting interviews is not a requirement at Stage 1.


ISO 9001:2015, Clause 9.2.2 (Internal Audit Reporting)

Question 5

Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top-notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.

In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.

Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS. They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.

During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS. AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.

Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.

Based on the scenario above, answer the following questio n:

Scenario 1 indicates that AL-TAX did not ensure clear and open communication channels with interested parties. Which quality management principle did the organization not follow in this case?



Answer : B

Comprehensive and Detailed In-Depth

ISO 9001:2015 is based on seven quality management principles, one of which is Relationship Management. This principle emphasizes the importance of maintaining open communication and collaboration with interested parties, including suppliers and customers.

Clause 7.4 (Communication) requires organizations to determine what, when, with whom, and how communication should take place. Since AL-TAX failed to ensure clear communication channels, it did not adhere to this principle. Effective relationship management helps improve supply chain performance, customer satisfaction, and overall QMS effectiveness.


ISO 9001:2015, Clause 7.4 -- Communication

ISO 9001:2015, Quality Management Principles -- Relationship Management

Question 6

According to ISO 19011, what two activities take place during the conduct of a audit follow-up?



Answer : A, B

According to ISO 19011:2018, clause 6.7, the audit follow-up is the process of verifying the completion and effectiveness of corrective actions taken by the auditee as a result of an audit. The audit follow-up can include two main activities:

Verifying the effectiveness of the implemented corrective actions: this means checking whether the actions taken by the auditee have addressed the root causes of the nonconformities and prevented their recurrence or occurrence in other areas. The verification can be done by reviewing documents, records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or remotely.

Verifying corrections taken to fix the reported non-conformities: this means checking whether the auditee has corrected the nonconformities identified during the audit and eliminated their immediate effects. The verification can be done by reviewing documents, records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or remotely.

The audit follow-up can be conducted as a separate audit or as part of a subsequent audit, depending on the audit programme, the audit objectives, the audit criteria, the audit scope, the audit risks, and the audit findings. The audit follow-up should be planned and conducted in accordance with the same principles and processes as the initial audit, and the results should be documented and reported accordingly.Reference:

ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.7

ISO 19011 Management Systems Audit Checklist | Process Street, task 6.7.1 and 6.7.2

Conducting the Audit Follow-Up: When to Verify - The Auditor, section ''Conducting the audit follow-up''


Question 7

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company's working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

ACB sent the audit objectives to the audit team after an agreement was reached. Is this acceptable?



Answer : C

Comprehensive and Detailed In-Depth

Clause Reference:

ISO 19011:2018 (Guidelines for Auditing Management Systems), Clause 5.3 -- Establishing the Audit Objectives

ISO/IEC 17021-1:2015, Clause 9.1.2 -- Audit Planning

Why is the Correct Answer C?

Audit objectives must be clearly defined in the audit offer to ensure that the scope, criteria, and purpose are agreed upon in advance.

ISO/IEC 17021-1:2015 (which governs certification bodies) requires that audit objectives be established before the audit begins to ensure transparency and effectiveness.

Sending audit objectives after an agreement has been reached could lead to misalignment between the auditee's expectations and the audit's purpose.

Why are the Other Options Incorrect?

A (Audit objectives should be known only after agreement) Incorrect because objectives must be pre-defined in the audit offer.

B (Only the auditee should know the objectives) Incorrect because both the auditor and auditee must align on objectives.

D (Approval from the lead auditor is sufficient) Incorrect because audit planning follows formal procedures defined by ISO/IEC 17021-1.


ISO/IEC 17021-1:2015, Clause 9.1.2 -- Audit Planning

ISO 19011:2018, Clause 5.3 -- Establishing the Audit Objectives

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