PECB ISO-9001-Lead-Auditor Exam Practice Test Instant Access

Question 1

Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.

AManages the performance

BMonitors the performance

CDictates the performance

DImproves the performance

Answer : D

Understanding the Purpose of a Quality Management System (QMS):

The primary objective of ISO 9001:2015 is to improve the overall performance of the organization by:

Ensuring consistent delivery of products and services that meet customer and regulatory requirements.

Focusing on enhancing customer satisfaction.

Promoting continual improvement of the organization's processes and practices.

Clause 0.1 (General) of ISO 9001:2015 specifies that a QMS enables organizations to achieve better performance by consistently meeting customer needs and improving their processes. It further highlights that continual improvement is a cornerstone of the standard (Clause 10.3).

Option Analysis:

A . Manages the performance:

Incorrect. A QMS provides a framework to manage processes, not directly manage performance. The improvement of performance is an outcome of managing processes effectively.

B . Monitors the performance:

Incorrect. Monitoring is a component of performance evaluation (Clause 9.1) but does not define the overall purpose of the QMS.

C . Dictates the performance:

Incorrect. ISO 9001 does not 'dictate' performance but allows organizations to set their own objectives and improve their operations based on their specific context and goals.

D . Improves the performance:

Correct. The fundamental purpose of a QMS as per ISO 9001 is continual improvement of the organization's performance. This includes improving operational efficiency, customer satisfaction, and product/service quality.

Why Option D is Correct:

ISO 9001:2015 emphasizes the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking, which are designed to drive improvements in organizational performance. Continuous assessment of processes and customer feedback ensures that the organization can adapt, innovate, and improve its effectiveness over time.

Relevant Clauses Supporting the Answer:

Clause 0.1: Purpose of the QMS.

Clause 10.3: Continual improvement ensures that the QMS remains effective and aligned with organizational objectives.

Clause 4.1: Context of the organization, which requires the QMS to align with organizational strategies and improve outcomes.

Question 2

In the context of a third-party certification audit, how can the auditor demonstrate confidentiality? Select two.

AAdhere to the CQI Professional Code of Conduct.

BConfirm the confidentiality arrangements with the auditee regarding the use of mobile devices/cameras.

CDiscuss sensitive personal information with the guides appointed by the auditee.

DRemove audit evidence without the permission of the auditee.

EShare audit conclusions with competitor organisations.

Answer : A, B

In a third-party certification audit, auditors are responsible for maintaining confidentiality as part of their professional duties. Here's how they can demonstrate it:

A . Adhere to the CQI Professional Code of Conduct: The CQI (Chartered Quality Institute) Code of Conduct outlines ethical principles, including confidentiality. Auditors must adhere to professional standards, ensuring sensitive information is protected and not disclosed improperly.

B . Confirm the confidentiality arrangements with the auditee regarding the use of mobile devices/cameras: Before using mobile devices or cameras, auditors must seek explicit permission from the auditee and agree on confidentiality terms, preventing unauthorized recording or sharing of sensitive information.

Options C, D, and E involve breaching confidentiality and are not acceptable practices in an ISO 9001:2015 certification audit. Sharing sensitive information, removing evidence without consent, or discussing it with unauthorized parties violates audit principles and the standard's confidentiality requirements.

Question 3

You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below;

Head Office and Site 1 - Day 1

Site 2 (150 Km from HQ) - Days 2 and 3

During Day 1 of the audit, the dient informs you that the laboratory at Site 2 has been dosed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.

As the audit team leader, what would you do?

Choose the best acceptable action you could take:

Ask the audit Programme Manager for direction.

Complete the audit on day 3 and report back to the certification body for a certification decision.

Continue the audit on days 2 and 3 and return later to audit the Site 2 laboratory.

Immediately cancel the audit since the audit plan cannotbecompleted.

Who has the responsibility for assigning work to the audit team?

AThe audit team leader

BThe audit team member

CThe auditee organisation

DThe certification body

Answer : A

In the context of ISO 9001:2015 audits, it is the audit team leader who holds the responsibility for assigning work to the audit team. According to ISO 19011:2018 (Guidelines for auditing management systems, which complements ISO 9001:2015), the audit team leader is responsible for the organization and direction of the audit, including assigning specific roles and responsibilities to audit team members. This includes preparation of the audit plan, leading the audit, and ensuring that each team member understands their tasks.

Question 4

The following actions need to be carried out during a third-party audit planning stage. Which two actions correspond to the individual(s) managing the audit program before the involvement of the audit team leader'

APrepare the audit plan

BAssign responsibilities within the audit team

CPrepare the checklists

DProvide the resources needed

EReview the reports of previous audits

FSelect the auditteammembers

Answer : D, E

In ISO 9001:2015, the responsibility for managing the audit program lies with those overseeing the entire audit process rather than the Audit Team Leader. During the planning stage, before involving the Audit Team Leader, key actions for managing the audit program include:

1. Providing the Resources Needed: According to clause 7.1 (Resources), the audit program manager must ensure that the necessary resources are in place to conduct the audit effectively. This encompasses logistical support, personnel, and other required resources for the audit to proceed smoothly.

2. Reviewing Reports of Previous Audits: As per clause 9.2.2 (Internal Audit), it is essential to consider the results of previous audits to plan effectively for the upcoming audit. This helps identify areas that require particular attention, ensuring continuity and focusing on recurring issues or improvements since the last audit.

These actions ensure that the audit is thoroughly prepared and that there is continuity and focus on any areas that might need closer inspection. The other options, such as preparing the audit plan, assigning responsibilities, preparing checklists, and selecting the audit team members, generally fall under the duties of the Audit Team Leader once they are appointed and engaged in the planning process.

Question 5

In the context of a third-party management system certification audit, which two of the following statements are correct?

AThe purpose of a Stage 2 audit is to certify an organisation to ISO 9001.

BThe Stage 2 audit must be conducted by auditors who have never worked for the auditee

CThe purpose of a Stage 2 audit is to evaluate the implementation of the auditee's management system.

DA Stage 2 audit evaluates how efficiently the organisation is implementing its management system

EThe Stage 2 audit cannot include remote access to electronic site(s) that contain information relevant to the audit of the management system.

FThe Stage 2 audit should include an opening meeting at the start of the audit and a closing meeting at the conclusion of the audit.

Answer : C, F

Question 6

ABC is a worldwide fast-food organisation. One of the branches, in downtown Cape Town, decided to

implement an ISO 9001 quality management system and you are the audit team leader (with two other

auditors) that will carry out the certification audits, Stage 2.

ABC receive the orders by phone or internet; some of the employees deliver the ordered food to indicated

addresses. The normal menu includes 15 different types of hamburgers; however, in the last two weeks,

due to a shortage of a special type of meat, they can only prepare six of the 15 varieties.

During the internal meeting of the audit team, you ask one of the auditors to describe what she has

observed. She audited the reception of orders from customers (via phone or internet) and the

communication of the orders to the kitchen. She noticed that the menu offering food on the website is still

the normal one, with 15 different hamburgers, and during a 30-minute period, she observed many

customers reluctantly accepting something other than the hamburger they preferred.

You, as audit team leader, inform the Quality Manager of your concern about the major nonconformity,

since you consider this a serious breach of the basic principles of quality that lasted two weeks without

action being taken.

Right at the beginning of the Closing meeting, you discuss the nonconformity with the General Manager.

She got quite upset and said she was going to make a complaint to the certification body and left the

room; the Quality Manager was the only member of ABC left with the audit team. The Quality Manager said the General Manager would not come back to the meeting.

What would you do? Choose the best from the following options:

AAsk the Quality Manager for a break to discuss the issue with the members of the audit team.

BAsk the Quality Manager to listen to the nonconformity the auditor will present and continue with the meeting until its closure.

CInform the Quality Manager that the certification process is put on hold and leave the room.

DInform the Quality Manager that you consider the meeting closed, and that you will report to the Certification Body for instructions.

Answer : B

Question 7

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.

PECB ISO-9001-Lead-Auditor QMS ISO 9001:2015 Lead Auditor Exam Practice Test