PECB ISO-9001-Lead-Auditor Exam Questions Instant Access

Question 1

Select which one of the following statements is true.

AThe team leader shall be an auditor that is qualified in the scheme.

BAn audit team can include non-qualified auditors.

CA technical expert can replace a qualified auditor on an audit team.

DAudits leading to auditor qualification are undertaken annually.

Answer : A

According to the ISO 19011:2018 standard, which provides guidelines for auditing management systems, the team leader of an audit team should be an auditor who has demonstrated the competence to manage an audit of the relevant management system scheme. This means that the team leader should have the appropriate knowledge, skills, and experience to plan, conduct, report, and follow-up an audit of the specific management system, such as ISO 9001 for quality management systems. The other options are false because: B. An audit team can include non-qualified auditors, but only as observers or trainees who do not contribute to the audit findings or conclusions. C. A technical expert can assist a qualified auditor on an audit team, but cannot replace them, as a technical expert does not have the competence to perform audits. D. Audits leading to auditor qualification are not undertaken annually, but rather as part of a certification process that involves meeting certain criteria, such as education, work experience, audit experience, and examination. Reference: ISO 19011:2018, PECB Certified ISO 9001 Lead Auditor Exam Preparation Guide, ISO 9001:2015 Quality Management Systems Lead Auditor Training Course

Question 2

Even though past audits have highlighted a consistently large number of nonconformities within an organisation's design team, the organisation has not varied the frequency or duration of audits on its audit plan.

The decision for whether this situation is acceptable or not should be governed by which of the following?

AA risk-based approach to the audit programme

BThe authority of the audit team leader

CThe availability of competent internal auditors

DThe organisation's reasoning behind the lack of change to the audit plan

Answer : A

Question 3

An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer

manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001

certificate to cover the new contract.

Which one of the options is the correct response by the auditor?

ADo you realise that this involves an extension to the scope of the audit and will require an application process?

BHow can we audit this area when we do not have an IT specialist in the team?

CWould you like a separate certificate for the IT packages to show your new client?

DWould you mind writing to my programme manager with this request?

Answer : A

When an organization wishes to extend the scope of their current certification to include new services or activities, such as the printing and compilation of computer documentation packages, it requires an extension to the scope of the audit.This involves a formal application process with the certification body to ensure that the new activities are included in the audit plan and that the organization's quality management system encompasses these new processes12.Reference: = The answer is based on the ISO 9001 Auditing Practices Group guidance on scope and applicability, which outlines the need for a formal application process when there is a change in the scope of the quality management system that affects the certification1.Additionally, the UKAS guide on the extension to scope (ETS) process provides information on how changes to the scope, including the addition of new services, require a formal application2.

Question 4

What is the responsibility of the audit committee during an internal audit?

ATo define the audit schedule

BTo supervise all audit functions and activities

CTo establish an internal audit program

Answer : C

Comprehensive and Detailed In-Depth

According to ISO 19011:2018, Clause 5.2 (Audit Program Management):

The audit committee is responsible for establishing the internal audit program.

The audit schedule (A) is determined within the program, but it is not the main role of the committee.

Thus, C is the correct answer.

ISO 19011:2018, Clause 5.2 (Audit Program Management)

Question 5

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.

The quality policy was established by Leslie and approved by top management. Is this acceptable? Please refer to scenario 2.

ANo, the quality policy must be established and approved by top management.

BYes, the quality policy can be established by the QMS implementation team and be approved by top management.

CNo, the quality policy must be established and approved only by the quality manager.

DYes, as long as top management is informed, the policy can be established by any responsible employee.

Answer : A

Comprehensive and Detailed In-Depth

ISO 9001:2015, Clause 5.2.1 (Establishing the Quality Policy) states that top management must establish, implement, and maintain a quality policy.

In the scenario, the quality manager (Leslie) created the policy, but top management did not establish it themselves, which violates Clause 5.2.1. While the policy can be drafted by a team, top management must take full ownership of its development and approval.

ISO 9001:2015, Clause 5.2.1 -- Establishing the Quality Policy

Question 6

Which of the options below is an example of minor nonconformity?

ASome of the nonconformities were not closed as planned (on time) and no justification was provided or documented

BLack of commitment from the top management

CLack of corrective actions to address recurrent incidents

Answer : A

Comprehensive and Detailed In-Depth

Minor nonconformities are isolated issues that do not significantly impact the QMS but still require correction.

Failure to close nonconformities on time (Answer A) is a procedural issue and is considered minor unless it leads to repeated failures.

Major nonconformities include:

Lack of top management commitment (Answer B), which affects leadership and strategic direction.

Failure to take corrective actions for recurrent issues (Answer C), which indicates systemic failure.

ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action)

Question 7

Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.

A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.

In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.

Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.

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

Is it acceptable for the certification body and Eva to make the certification decision together?

AYes, because the audit team leader must be involved in the certification decision

BNo, only the audit team leader must make the certification decision

CNo, auditors that take part in the audit should never take part in the certification decision

Answer : C

Comprehensive and Detailed In-Depth

According to ISO 17021-1:2015, Clause 9.5.1 (Certification Decision):

Auditors who conduct the audit cannot be involved in the certification decision to ensure impartiality.

The certification body alone is responsible for making the certification decision based on the audit report and findings.

The audit team leader (Eva) must not take part in the certification decision.

Thus, C is the correct answer.

ISO 17021-1:2015, Clause 9.5.1 (Certification Decision)

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