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

Question 1

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 2

Which of the following three options could be considered potential threats to impartiality in an audit context?

ACompetence

BExperience

CFamiliarity

DIntimidation

ESelf-audit

Answer : C, D, E

Questions no: 1 Verified Answer: = C, D, E Comprehensive But Short = Potential threats

Question 3

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.

AAs a member of the management team, the Deputy Catering Manager is not sufficiently aware of the QMS.

BThe Deputy Catering Manager is not competent to manage the QMS.

CThe effectiveness of the QMS depends on the Catering Manager being present on site.

DThe Quality Policy only exists as a document in the Catering Manager's office.

Answer : A

Question 4

TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important

customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit

team discussed and agreed both nonconformities with TIX's quality manager. The Closing meeting was planned for 6pm with the general manager,

quality manager and service manager at the meeting room.

At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the

warehouse supervisor. Neither have participated in the audit.

The dialogue among them is as follows:

Audit team leader: "Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?"

Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and

the other two managers have had to leave urgently to attend the emergency."

Warehouse supervisor: "They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message

from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed."

Which one of the following options would be your preferred response to the final comment made by the warehouse manager?

ASorry, but we cannot proceed with the Closing meeting. So, we are leaving now, and please tell the quality manager that I will phone him tomorrow early in the morning.

BWe will hear what you were asked to tell us and will ask you to sign the nonconformity reports as evidence that you have accepted them. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to complete the Closing meeting.

CWe will hear what you were asked to tell us and will leave copies of the nonconformity reports that have been agreed with the quality manager. Please tell the managers that we will consider this as the Closing meeting and that the individual(s) managing the audit programme will send the full report in five days.

DWe will hear what you were asked to tell us and will then leave. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to carry out the Closing meeting.

Answer : D

Question 5

You have been just hired as the Internal Lead Auditor of a large organisation, responsible for internal audits. Your first job is to analyse the answers to nonconformities included in the report of a recent internal audit to Top Management.

The report contained one nonconformity as follows:

There is no evidence of Top Management ensuring the availability of resources to operate the QMS, the establishment of objectives, the promotion of continual improvement, and the promoting of the process approach.

Which four of the following Top Management actions can be considered 'corrections to the nonconformity'?

ATop Management appoints a senior manager to oversee the quality manangement system

BTop Management completed a course on ISO 9001

CAll these actions will be reviewed during the Top Management meetings

DImprovement action has been promoted

EObjectives have been established

FProcess approach has been communicated to the personnel

GResources have been provided

HTop Management review will be carried out every six months instead of annually

Answer : E, F, G, H

Question 6

You work as an external quality consultant for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', to ISO 9001 which provides packaging materials to your organisation. It is 4 pm and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled at 5 pm.

You, as Audit Team Leader, audited top management. You explain to the audit team that you identified two nonconformities:

a. There is no documented information on Top Management Reviews, as required in clause 9.3 of ISO 9001:2015.

b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO 9001:2015. (e.g., not ensuring the availability of resources

to operate the QMS, not ensuring the establishment of objectives, no promotion of improvement, no promotion of the process approach).

All agreed to present these two nonconformities. They went to meet the Top Management of 'B' and noticed that the General Manager and three other managers (Production, Human Resources, and Sales) were present in the meeting room.

Considering the seriousness of the two nonconformities to Top Management, as audit team leader, from the following select the best option:

APresent the nonconformities to the whole group and inform that you will recommend your company to remove them from the approved suppliers list.

BPresent the nonconformities to the managers, inform them that the report will be sent within 10 days, close the meeting and leave the site.

CAsk the General Manager to have a private conversation in which you present the nonconformities only to him because of their sensitive nature.

DPresent the nonconformities to the whole group and analyse with them how to overcome this situation.

Answer : D

According to the guidance on conducting the audit closing meeting1, the audit team leader should provide a summary of the audit findings and conclusions, invite discussions, and agree on timelines for any corrective actions. The audit team leader should also be respectful, constructive, and objective when presenting the nonconformities, and avoid any personal or emotional comments. The audit team leader should also consider the impact of the disruptive event (such as the Covid-19 pandemic) on the auditee's context, interested parties, and risks2, and acknowledge any good practices or improvements observed during the audit. Therefore, option D is the best option, as it follows the best practices for the closing meeting and allows the auditee to understand the nonconformities and their implications, and to participate in the analysis and resolution of the issues. Option A is not correct, as it is not respectful, constructive, or objective, and it does not invite any discussion or feedback from the auditee. It also assumes that the audit team leader has the authority to recommend the removal of the supplier from the approved list, which may not be the case. Option B is not correct, as it does not provide enough information or explanation to the auditee, and it does not allow any discussion or feedback from the auditee. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, acknowledging any good practices, and agreeing on timelines for corrective actions. Option C is not correct, as it does not involve the other managers who are responsible for the functions or processes that were audited, and who may have valuable input or information to share. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, inviting discussions, and agreeing on timelines for corrective actions. Reference: 1: Conducting the Audit Closing Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive Event.

Question 7

You work for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other

auditors) to audit a supplier, 'B', which provides packaging materials to your organisation. It is 4 p.m. and the audit is close to an end; you are having

an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled

for 5 p.m.

You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.

Auditor 1 audited the two manufacturing lines and dispatch areas.

You to Auditor 1: "What findings would you report?"

Auditor 1: "When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same

batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at 11.30 am. Procedure P-02 Rev.3 says

that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device."

You: "OK, what do you think?"

Auditor 2: "I think that this is a nonconformity."

You: "OK. How would you describe the evidence on which the nonconformity will be based"?

Identify which one of the following statements best describes the identified nonconformity.

ADispatch personnel are not fully aware of the need to conform to written procedures.

BDispatch personnel do not always carry out its activities in conformance with Procedure P-02 rev 3.

CThe batch 33555 was delivered split in two different trucks (011 and 025).

DA product delivered to the client was not identified as required in P-02 Rev 3.

Answer : C

According to the definition in ISO 9000, a nonconformity is ''non-fulfillment of a requirement''. There are three parts to a well-documented nonconformity: the audit evidence to support auditor findings; a record of the requirement against which the nonconformity is detected; and the statement of nonconformity1. In this case, the audit evidence is the dispatch records that show the same batch number of the product being delivered by two different trucks at different times. The requirement is the procedure P-02 Rev.3 that says that trucks should carry a complete batch. The statement of nonconformity is that the batch 33555 was delivered split in two different trucks (011 and 025), which does not conform to the procedure. Therefore, option C best describes the identified nonconformity, as it includes all three parts of a well-documented nonconformity. Option A is not correct, as it does not state the audit evidence or the requirement. Option B is not correct, as it does not specify the audit evidence or the statement of nonconformity. Option D is not correct, as it does not match the audit evidence or the requirement. Reference: 1: ISO 9001 Auditing Practices Group Guidance on Nonconformity - Documenting.

PECB QMS ISO 9001:2015 Lead Auditor Exam Practice Test