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

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Total 217 questions

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Question 1

Which statement below indicates that an organization has developed its communication strategy by taking into account the principle of appropriateness?

Options:

A.

The organization provides relevant information to interested parties using formats, language, and media that meet their interests and needs, enabling them to fully participate.

B.

The organization responds to the queries and concerns of interested parties in a full and timely manner.

C.

The organization communicates the processes, procedures, methods, data sources, and assumptions used to all interested parties, taking into account the confidentiality of information.

D.

The organization ensures that all external communications are only handled by the top management team.

Question 2

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.

Which statement below represents the level of responsibility demonstrated by the audit team in scenario 3?

Options:

A.

No negligence, the audit team has demonstrated diligence during the audit and followed the best practices.

B.

Ordinary negligence, the audit team has demonstrated lack of diligence.

C.

Gross negligence, the audit team has demonstrated a total lack of diligence.

D.

Willful misconduct, the audit team intentionally disregarded audit procedures.

Question 3

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.

Based on scenario 4, conducting which of the activities below is NOT the responsibility of Anne?

Options:

A.

Establishing audit criteria and objectives.

B.

Determining the audit feasibility.

C.

Assigning responsibilities for the audit team members.

D.

Signing the certification agreement.

Question 4

Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.

Options:

A.

Audit use of certification marks on marketing materials.

B.

Review changes to the QMS since last visit.

C.

Confirm effectiveness of internal audit and management review.

D.

Complete a full document review of the quality management system.

E.

Failing to meet financial responsibilities.

F.

Review the status of previously raised findings and audit effectiveness of any outstanding findings.

G.

Review the calibration status of the instrumentation.

Question 5

What does the application of the process approach in a QMS enable?

Options:

A.

The improvement of processes based on the needs and expectations of interested parties

B.

The consideration of processes in terms of financial value

C.

The achievement of effective process performance

D.

The reduction of resource consumption

Question 6

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.

In scenario 3, the audit team required access to see the organizational chart and job descriptions to verify the employees’ competence. Based on audit best practices, is this acceptable?

Options:

A.

Yes, because that would be sufficient evidence to verify competence.

B.

No, because the audit evidence would not be relevant.

C.

Yes, because auditors should see the organizational chart and job descriptions to verify competence.

D.

No, because competence should only be verified through direct observation.

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 question:

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

Options:

A.

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

B.

No, only the audit team leader must make the certification decision

C.

No, auditors that take part in the audit should never take part in the certification decision

Question 8

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 question:

The CEO of AL-TAX hired an experienced consultant to help with the implementation of the QMS. Is this required from ISO 9001?

Options:

A.

Yes, especially for companies that do not have competent personnel.

B.

No, contracting external consultants is not required.

C.

Yes, external advice is necessary for an effective implementation.

Question 9

During a third-party surveillance audit, the auditor finds that the management review meeting minutes record that the improvement actions set by the previous review have not been completed for a second year running. It states that a new Quality Manager has been brought in at the middle management level to rectify the situation. You learn that top management is not involved in the QMS other than being copied into the minutes of the management review meeting.

The audit reveals that the new Quality Manager was given responsibility by top management to:

a) take accountability for the effectiveness of the QMS,

b) select, approve, and monitor improvement actions without involving and reporting to top management,

c) promote the improvement of the QMS, and

d) make efficient use of the limited financial and personnel resources allocated for the QMS by top management.

The auditor considers whether there is a nonconformity against clause 5.1.1 of ISO 9001:2015.

Select two options of the evidence required for such a nonconformity:

Options:

A.

Top management is not accountable for the effectiveness of the QMS.

B.

The Quality Manager avoids giving improvement actions to the Chief Executive.

C.

The Chief Executive never attends the management review meetings in person.

D.

The Quality Manager is on target to complete only half of the improvement actions.

E.

The Quality Manager only reports to one designated senior manager.

F.

The Quality Manager does not have access to the resources needed for the QMS.

Question 10

You are conducting a third-party audit to ISO 9001 and the next item on your audit plan is 'internal auditing'.

When reviewing a sample of audit records up to 5 years previously, you find that many contain non-conformance reports and no actions have been taken. You interview the Quality Manager.

You: "I have noted that many of the older files contain non-conformances that have not had any corrective action taken."

Quality Manager: "Because the business is always changing, the departmental managers tell me that the non-conformances are no longer applicable. I made a decision that any non-conformance over 3 years old is automatically closed"

You: "Do you obtain any confirmation beforehand from the appropriate departments that the non-conformances are no longer applicable."

Quality Manager: " No, because they are so old I consider that they are no longer appropriate. Please remember that we take a risk-based approach which means we audit where and when it is considered important to do so.

Select one course of action you would now take from the options.

Options:

A.

Interview Top management to determine whether they were aware of and agreed the actions of the Quality Manager

B.

Review all non-conformances reports related to clause 9.2 of ISO 9001

C.

Interview relevant Departmental managers to assess whether the older non-conformances are still valid.

D.

Raise a non-conformance report against clause 9.2.2.e of ISO 9001

Question 11

During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.

Which corrective action is the best one?

Options:

A.

We will select one sample, which we will send to an external laboratory and will use it as our internal standard.

B.

We will look for a local company to provide this service.

C.

We will have the results on one out of ten of our routine production samples double-checked by an external local laboratory.

D.

We will add this to our external issue register, assess its associated risk, and plan action to address that risk.

Question 12

A person who provides specific knowledge or expertise to the audit team during the audit is known as a/an:

Options:

A.

Observer.

B.

Technical expert.

C.

Guide.

Question 13

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.

Based on the last paragraph of scenario 3, which audit principle did the audit team follow?

Options:

A.

Fair presentation.

B.

Integrity.

C.

Confidentiality.

D.

Objectivity.

Question 14

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.

Options:

A.

No, the quality policy must be established and approved by top management.

B.

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

C.

No, the quality policy must be established and approved only by the quality manager.

D.

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

Question 15

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.

During the audit, a team member finds that a number of print jobs have been rejected by several clients over a number of months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract. The auditor raises a nonconformance against clause 10.2.1.b of ISO 9001.

Which one of the evidence statements would support this finding?

Options:

A.

There was no record that the organisation evaluated the effectiveness of the training given to new employees.

B.

There was no evidence that a check of spelling took place before the release of printing to the client.

C.

The actions taken to deal with customer complaints did not prevent recurrence of the problem.

D.

The organisation did not provide the correct resources to prevent nonconformity.

Question 16

Which two of the following may be changed once a Stage 2 certification audit has commenced?

Options:

A.

Agreed language of the audit

B.

Audit scope

C.

Audit plan

D.

Agreed standard for the audit criteria

E.

Audit checklist

F.

Increase of audit duration

Question 17

In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.

Options:

A.

Number of sites to be audited

B.

Risk to achieving audit objectives

C.

Expectations of the organisation's management

D.

Scope of the audit

Question 18

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 question:

According to Scenario 6, the audit team required DC’s top management to submit corrective action plans within two weeks. Is this action acceptable?

Options:

A.

No, because the deadline for the client to present a corrective action plan is at least within 7 days

B.

No, because the decision for the deadline should have been suggested by the top management

C.

Yes, because a deadline from 10 to 60 days is a best practice for the submission of action plans

Question 19

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?

Options:

A.

Sorry, 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.

B.

We 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.

C.

We 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.

D.

We 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.

Question 20

Scenario 5: Mechanical-Electro (ME) Audit Stages

Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.

Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.

In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.

A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.

Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.

Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.

To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.

The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.

Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.

Which stages of the audit were performed?

Options:

A.

Audit follow-up and stage 1 audit.

B.

Stage 1 and stage 2 audit.

C.

Stage 2 audit and surveillance audit.

Question 21

ABC is a service organisation that cleans and irons bed and table linen for four large hospitals in the city centre. It claims to meet ISO 9001:2015 requirements. During an internal audit, an auditor observes that

machine No. 4 is being operated with the three variables outside the limits established in the applicable documented procedure SP-701. The auditor has decided to raise a nonconformity.

Which six elements should be included in the nonconformity report?

Options:

A.

Condition of the table linens upon receipt from the hospital

B.

Applicable procedure: SP-701

C.

Competence record of the machine operator

D.

Identification number of the washing machine

E.

Manufacturer of the washing machine

F.

Name of the Quality Manager

G.

Number of the production order

Question 22

What is a list of actions that should be performed during the audit with their respective timeline?

Options:

A.

The audit objectives.

B.

The audit criteria.

C.

The audit schedule.

D.

The audit offer.

Question 23

Which quality management principle does an organization fulfill when it assesses risks, consequences, and impacts before taking action?

Options:

A.

Process approach

B.

Leadership

C.

Improvement

D.

Relationship management

Question 24

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?

Options:

A.

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

B.

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

C.

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

D.

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

Question 25

You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The organisation processes

waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.

You: "Why are these plastic items being rejected at this stage?"

Auditee: "They do not meet our processing standards."

You: "What is the reason for that?"

Auditee: "These items are likely to damage the machinery down the line. They can also compromise our

quality standards. We need to protect our reputation for good quality output materials."

You: "What happens to the rejected items?"

Auditee: "Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled."

You: "What happens to the waste products?"

Auditee: "I'm not sure. I suppose they go to landfill."

Which two. of the following actions would you take to investigate further?

Options:

A.

Check the process for handling nonconforming items.

B.

Ask to review the percentage of waste materials.

C.

Find out if operators have regular hearing tests.

D.

Determine what happens to the waste products.

E.

Ask about operator PPE (Personal Protective Equipment).

F.

Determine whether there are quality objectives for reducing rejected material.

Question 26

One of the conflict resolution techniques is toning down. How is the conflict managed in that case?

Options:

A.

Following negotiations, each party makes concessions in order to reach a common agreement.

B.

The audit team leader uses their authority to solve the conflict.

C.

The points of agreement are emphasized and the points of disagreement are put into perspective.

Question 27

Audit criteria are a set of requirements used as a reference against which objective evidence is compared.

Which two of the following are not potential audit criteria?

Options:

A.

ISO management system standards

B.

Verbal statements by the general manager

C.

Verbal agreements with interested parties

D.

Health and safety notices

E.

Written agreements with interested parties

F.

Commercial advertisements

G.

Organisation's documented information

Question 28

'XYZ' has already sent to you a list with all documented procedures and work instructions related to the services provided to 'ABC' (a quality manual is not included in the list).

To complete the audit planning which additional information would you ask to XYZ to submit? Select four.

Options:

A.

XYZ's organisational structure

B.

The quality manual

C.

A description of responsibilities and authorities of the key roles of XYZ

D.

The number of personnel involved in activities related to the quality management system

E.

Information to understand XYZ's operations

F.

The results of XYZ's last internal audit

G.

The results of the last two management reviews

Question 29

You are preparing for interviews with two members of top management. Based on the information that you gathered about the organization, you conclude that it is the top management who takes all the important decisions and closely supervises and controls employees. Based on this, which management style is practiced in the organization?

Options:

A.

Autocratic

B.

Laissez-faire

C.

Centralized

Question 30

Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. 80% of complaints originate from five shops in the same region. Most of these complaints

relate to customer laundry not being cleaned as customers require. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it now. You learn that the shop managers were

told to dismiss most of the complaints because of the poor quality of the laundered materials.

On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

You raised a nonconformity against clause 8.5.1 of ISO 9001.

Based on the scenario, select the three options which best describe the evidence for raising such a nonconformity.

Options:

A.

Customer complaints are not taken seriously by the organisation.

B.

Shop managers were told to make excuses to customers with complaints.

C.

Some equipment used was not suitable for the laundry process.

D.

The management failed in planning to replace obsolete equipment.

E.

The operators did not check the condition of the customer's product upon receipt.

F.

The operators did not check the laundry before release to the customer.

G.

The organisation failed to control the laundry operations in 5 shops adequately.

Question 31

What must the auditor consider in order to mitigate audit risks and obtain reasonable assurance?

Options:

A.

The processes deemed material to the auditee.

B.

The needs and expectations of internal interested parties.

C.

The previous audit results.

D.

The financial risks associated with QMS implementation.

Question 32

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 cannot be completed.

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

Options:

A.

The audit team leader

B.

The audit team member

C.

The auditee organisation

D.

The certification body

Question 33

Who maintains ownership of the audit report?

Options:

A.

The audit team leader

B.

The auditee

C.

The certification body

Question 34

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to

customers.

You are interviewing the Quality Systems Manager (QSM).

You: "What risks and opportunities have the business identified?"

QSM: "I'1l show you. This was discussed with the Managing Director at the latest management review."

Narrative: The QSM shows you the latest management review record and points to the following table:

Question # 34

You: "How is the business planning to address these risks and opportunities?"

QSM: "The MD said that they already knew about them so it was not necessary."

Question # 34

Options:

Question 35

Which two of the following are included in the objectives of the 'Stage 1 initial certification audit'?

Options:

A.

To evaluate the performance of monitoring and reviewing activities.

B.

To evaluate the preparedness of the organisation for a Stage 2 audit.

C.

To evaluate the internal audit and management review processes.

D.

To review the quality manual.

E.

To make a decision on certification to ISO 9001:2015.

F.

To evaluate the operational processes of the organisation.

Question 36

What is a combined audit?

Options:

A.

Two or more management systems audited together at a single auditee.

B.

Two or more auditing organizations cooperating to audit a single auditee.

C.

Two or more management systems audited simultaneously at several auditees.

Question 37

An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oll and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged

steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality

Manager explains that the Managing Director authorised release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.

Which of the following options for the best description of the nonconformity?

Options:

A.

A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager.

B.

Release of the product without acceptable test results has been accepted by the customer for Project DK.

C.

Products for Project DK have been released before product approval through the quality control process.

D.

The untested product was not recalled until the galvanic efficiency of the anodes was verified.

Question 38

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The

organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product

packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.

You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:

Question # 38

You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is

responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).

You: "Good afternoon."

OD: "Good afternoon."

You: "What responsibility do you have concerning the SWIFT database?"

OD: "I maintain it. If anyone wishes to propose an update to the database, they send me an email with

details of their proposal. I then either process the database update myself, or I send the request to the

consultant who designed the database 20 years ago. The necessary software changes are made, and the

amended software is immediately released to users."

You: "Would you explain how the software amendments are controlled?"

OD: "Of course. I personally update every computer myself."

You: "Do you inform the database users of the changes?"

OD: "No I don't. They find out for themselves by using the software, or they come to see me if they have

any questions."

You: "How do you ensure that the database users use the latest version?"

OD: "That's easy, I update every computer myself."

You: "During the audit, I noted there were several versions of SWIFT in use (you refer to your audit

notes)."

OD: "I know. That's because some versions work better than others, and depending on user needs and

experiences, we allow users to revert to using an earlier version if they find it works better for them."

Based on the scenario, which two of the following statements are true? There is evidence of

nonconformity with a requirement defined in ...

Options:

A.

clause 7.1.3 Infrastructure

B.

... clause 7.1.4 Environment for the operation of processes

C.

clause 7.5.1 Documented information - General

D.

... clause 7.5.2 Documented information - Creating and updating

E.

... clause 7.5.3 Control of documented information

Question 39

Whistiekleen is a national dry cleaning and laundry organisation with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the organisation. The deaning equipment needs replacing but the organisation cannot afford it now. You learn that the shop managers were told to dismiss most of the claims based on the poor quality of the laundered materials.

On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

Match the ISO 9001 Clauses to the statements.

Question # 39

Options:

Question 40

Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.

Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.

The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.

Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting

The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.

Based on the scenario above, answer the following question:

Ten employees of POLKA were part of the audit team that conducted the internal audit. Is this acceptable?

Options:

A.

Yes, members of the company can join the internal audit team

B.

No, ISO 9001 requires hiring a professional team of auditors who are not part of the company to conduct the internal audit

C.

Yes, it is a requirement of ISO 9001 to include employees of the company in the internal audit

Question 41

Select the word that best completes the sentence:

Question # 41

Options:

Question 42

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?

Options:

A.

No, the QMS scope must be determined by considering the needs and expectations of relevant interested parties.

B.

No, the QMS scope must take into account only those directly involved in QMS implementation.

C.

Yes, ISO 9001 does not specify whether any interested party should be considered when determining QMS scope.

D.

Yes, as long as the top management defines the scope, it meets ISO 9001 requirements.

Question 43

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.

Options:

A.

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

B.

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

C.

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

D.

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

Question 44

At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only two people

are present and waiting for them: the Health and Safety supervisor and the administrative officer. Neither has participated in

the audit. However, the team had previously agreed with the auditee Quality Manager on two nonconformities identified

during the audit (NC1 and NC2).

They said:

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 to the emergency."

Administration officer: "Our quality manager, before leaving, left a written message about 'NC2'. He declares that the

correction and corrective action have been already implemented and has attached some documents to the message as

evidence of these actions. Therefore, he expects that 'NC2' will not be included in the report."

Which one of the following would be your preferred answer to the Quallty Manager's request?

Options:

A.

Let me review the message and documents, and I will give you my answer in a few minutes

B.

OK. I will record in the audit report that 'nonconformity 2' was closed during the Closing meeting

C.

OK. Let's all go to the workshop to see the supervisor. I hope he will be able to explain what they did to correct the nonconformity and prevent its recurrence

D.

The scope of the audit does not allow auditors to review actions taken in response to the nonconformity. There would not be enough time for the full cycle of corrective action to take effect

Question 45

Select one option that must be considered when determining the scope of a QMS to ISO 9001.

Options:

A.

Business improvement

B.

Performance of business processes

C.

External issues of the organisation's context

D.

Competence of top management

Question 46

You are conducting an ISO 9001 audit of a Materials Recycling Facility. The organisation processes

waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line

where operators are removing contaminant materials from incoming products, such as plastic bags,

plastic film and badly contaminated items that would compromise the recycling process. You

interview the line supervisor.

You: "Why are these plastic items being rejected at this stage?"

Auditee: "They do not meet our processing standards."

You: "What is the reason for that?"

Auditee: "These items are likely to damage the machinery down the line. They can also

compromise our quality standards. We need to protect our reputation for good quality output

materials."

You: "What happens to the rejected items?"

Auditee: "Some get melted down in another process later on, and some are disposed of as waste

products that cannot be recycled."

You: "What happens to the waste products?"

Auditee: "I'm not sure. I suppose they go to landfill."

After further auditing, you have gathered additional evidence. Match the following

statements to the correct ISO 9001 standard clause shown.

To complete the table, click on the blank section you want to complete so that it is

highlighted in red, and then click on the applicable text from the options below.

Alternatively, drag and drop each option to the appropriate blank section.

Question # 46

Options:

Question 47

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 question:

The audit team delayed audit activities until DC’s top management submitted their action plans. Is this acceptable?

Options:

A.

No, the audit report should be prepared and submitted to the certification body prior to the submission of action plans by the auditee

B.

Yes, the audit report can be prepared once the auditee submits the action plans in cases of minor nonconformities

C.

Yes, DC’s top management promised the submission of action plans within a short period of time

Question 48

You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.

You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.

You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?"

TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry."

You: "How is their regulatory competence maintained?"

TD: "They are dedicated individuals with lots of contacts in the sector."

You: "How does the business enable them to maintain their understanding of current regulatory requirements?"

TD: "We leave that up to them."

Question # 48

Options:

Question 49

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 statement related to the last paragraph of scenario 2 is correct?

Options:

A.

Customer surveys are the best method for obtaining and monitoring customer perceptions.

B.

Top management demonstrated leadership and commitment with respect to customer satisfaction.

C.

Customer surveys should be conducted every week to have a clear understanding of the needs and expectations of customers.

D.

Customer satisfaction is only measured through complaints, making surveys unnecessary.

Question 50

Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit?

Options:

A.

A career history of the quality manager

B.

A checklist

C.

A list of interested parties

D.

An audit plan

E.

An evidence sampling strategy

F.

An organisation's financial statement

Question 51

ABC is a fast food shop that receives orders by phone or the internet. The normal menu includes 15 different types of hamburgers; however, in the

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

You are performing a third-party audit of ABC; you observed that the menu offering food on the website is still the normal one, with 15 different

hamburgers. During a 30-minute period, you observed several customers reluctantly accepting other than the hamburger they preferred. You decided

to raise the following nonconformity as follows:

"There is evidence that ABC has not reviewed the ability to provide customers the offered products".

The restaurant manager does not accept the nonconformity. She says that ABC had an extensive training programme for all personnel, which you have already seen when auditing Human Resources. This shortage of some hamburgers cannot be considered a management system failure.

Which one would be your answer from the following options?

Options:

A.

I will maintain it open, and I will see what the Certification Body thinks about it.

B.

I will raise it as a major nonconformity and, therefore, cannot recommend certification of the quality management system.

C.

I will raise it as a minor nonconformity; you have the option to appeal to our Certification Body.

D.

You are right, it is not a system failure. I will change the nonconformity to a recommendation, but it will be audited carefully next time.

Question 52

Who assigns a guide to assist the audit team?

Options:

A.

The certification body

B.

The auditee

C.

The audit team leader

Question 53

Scenario 5: Mechanical-Electro (ME) Audit Stages

Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.

Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.

In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.

A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.

Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.

Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.

To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.

The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.

Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.

According to scenario 5, Li Na conducted group interviews with departmental managers and top management by herself. Is this in accordance with audit best practices?

Options:

A.

Yes, only the audit team leader should conduct group interviews.

B.

Yes, the auditee’s top management is always interviewed by the audit team leader only.

C.

No, two auditors should be present in case of group interviews.

Question 54

Which type of audit risk is the risk that a significant defect may occur in the QMS, although the organization has internal control mechanisms in place?

Options:

A.

Control risk.

B.

Inherent risk.

C.

Detection risk.

D.

Operational risk.

Question 55

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

Options:

A.

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

B.

Lack of commitment from the top management

C.

Lack of corrective actions to address recurrent incidents

Question 56

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

Options:

A.

Adhere to the CQI Professional Code of Conduct.

B.

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

C.

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

D.

Remove audit evidence without the permission of the auditee.

E.

Share audit conclusions with competitor organisations.

Question 57

Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.

Options:

A.

To facilitate auditing for proof of conformity to the standard.

B.

To provide confidence in the effectiveness of the quality management system.

C.

To safeguard the integrity of the quality management system.

D.

To support the operation of the processes of the quality management system.

Question 58

Which of the following subjects should an auditor discuss when communicating with the auditee’s top management?

Options:

A.

The quality policy

B.

Internal audit

C.

Both A and B

Question 59

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?

Options:

A.

No, because only one audit team member is required to have knowledge of legal and other regulatory requirements that TD is subject to.

B.

No, because there is no need to have knowledge of the legal and other requirements that TD is subject to.

C.

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.

D.

Yes, but only the lead auditor needs to have knowledge of legal and other regulatory requirements.

Question 60

Which of the following is a responsibility of a guide in an audit?

Options:

A.

Maintaining logistics

B.

Filling any potential gaps in the auditor's knowledge

C.

Witnessing the audit process on behalf of the certification body

Question 61

Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.

The auditor samples the design records for a recently completed course for the 247 Insurance organisation. Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.

The auditor decides to review the training course design process in more depth.

Select three options that provide a meaningful audit trail for this process.

Options:

A.

How are students advised about prior learning requirements?

B.

How is customer feedback integrated into the course?

C.

How is the cost of the course calculated?

D.

What risks and opportunities have been notified to interested parties?

E.

How is design documentation controlled and managed?

F.

How is technical content of courses verified as correct?

G.

How is the tutor trained to deliver the completed course?

Question 62

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 question:

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?

Options:

A.

Evidence-based decision making

B.

Relationship management

C.

Leadership

Question 63

In the context of a management system audit, identify the sequence of a typical process for collecting and verifying information. The first one has been done for you.

To complete the sequence click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

Question # 63

Options:

Question 64

Which action indicates that an organization is meeting the requirements of ISO 9001 regarding nonconforming outputs?

Options:

A.

Retaining documented information only on the actions taken.

B.

Verifying conformity to the applicable requirements prior to correction of the nonconforming outputs.

C.

Taking appropriate action to nonconforming products and services detected after the delivery of products, during or after the provision of services.

D.

Allowing employees to handle nonconformities based on their own judgment without structured procedures.

Question 65

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.

Scenario 4 mentions that Anne received a document that contained the audit scope, criteria, duration, and the limits to the audit engagement. What did Anne receive in this case?

Options:

A.

The certification agreement.

B.

The audit plan.

C.

The audit offer.

D.

The audit mandate.

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Total 217 questions