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ISO-9001-Lead-Auditor QMS ISO 9001:2015 Lead Auditor Exam Question and Answers

Question # 4

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."

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Question # 5

XYZ Corporation is an organisation that employs 100 people. As audit team leader, you are conducting a

certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you

find that quality objectives have been set for every employee in the organisation except top management.

The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive

is asking questions about how much it will cost. He asks for your opinion on whether this is the correct

method of setting objectives.

Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit

Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality

objectives for all employees and replaced them with a single objective for himself. This states that "The

Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates

that this gives him the authority to issue instructions to department managers when quality improvement is

needed. He says that this approach has the full backing of senior management. He shows you the latest

Quality Improvement Request that was included in the last management review.

After further auditing, the issues below were found. Select three statements that apply to the term 'audit trail'

A.

Decisions on improvement action timescales not involving departmental managers.

B.

Evaluation of the results of the improvement action not always documented by the Quality Manager.

C.

Limited knowledge of the content of Quality Improvement Requests by departmental staff.

D.

Quality improvements not aligning with the quality policy.

E.

The single quality objective set for the organisation by the Quality Manager.

F.

Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.

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Question # 6

What does an auditor evaluate during an audit follow-up?

A.

The effectiveness of all corrections and corrective actions taken

B.

If internal audits and management reviews are being planned and performed

C.

The auditee’s site-specific conditions

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Question # 7

Who maintains ownership of the audit report?

A.

The audit team leader

B.

The auditee

C.

The certification body

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Question # 8

How much time is usually spent on the Stage 1 audit?

A.

20% of the total audit time

B.

30% of the total audit time

C.

40% of the total audit time

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Question # 9

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

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.

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Question # 10

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?

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

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Question # 11

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.

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.

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Question # 12

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?

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.

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Question # 13

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:

Scenario 7 states that Sean planned audit activities on his own. Is this acceptable?

A.

No, audit activities should be planned by top management

B.

Yes, it is the responsibility of the audit team leader to plan audit activities

C.

No, the audit team leader should always cooperate with the other members of the team to plan audit activities

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Question # 14

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?

A.

Control risk.

B.

Inherent risk.

C.

Detection risk.

D.

Operational risk.

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Question # 15

According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?

A.

Communicating the quality objectives needed for the Quality Management System.

B.

Ensuring customer requirements are consistently met.

C.

Establishing the Quality Management System quality policy.

D.

Planning actions to address risks and opportunities.

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Question # 16

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. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements. The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.

You are interviewing the Training Manager (TM).

You: "What quality objectives apply to the training process?"

TM: "One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses."

You: "How do you measure this objective?"

The Training Manager shows you a record on her computer and you see the following:

Which two of the following statements are true?

A.

You would check the training of personnel.

B.

You would determine how the exam pass rate figures were analysed.

C.

You would determine the relative difficulty of each training course by reviewing them.

D.

You would determine what corrective action was being taken to address the low pass rates.

E.

You would raise a nonconformity as a requirement in clause 10.2 has not been fulfilled.

F.

You would raise a nonconformity as a requirement in clause 8.7 has not been fulfilled.

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Question # 17

How can an organization ensure the objectivity and impartiality of the internal audit function?

A.

By having a representative of top management involved during the internal audit process

B.

By assigning internal auditors that do not have operational roles related to the QMS

C.

By always outsourcing the internal audit function to a third party

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Question # 18

You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM)

You: "Would you tell me about your management review process?"

QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained."

You: "May I see the records from the last two management reviews?"

Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.

The Quality Manager then gives you the previous management review record, which took place one year before the latest review.

You: "Are there any other review reports in the last two years?

QM: "No, these are the only ones."

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Question # 19

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.

A.

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

B.

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

C.

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

D.

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

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Question # 20

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.

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Question # 21

What competence, among others, should each audit team member have?

A.

Knowledge of the industry in which the auditee operates.

B.

Knowledge of the risk-based approach to auditing.

C.

Expertise in each domain to be audited.

D.

A formal degree in quality management.

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Question # 22

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.

Li Na chose a sampling method that sufficiently represents customer complaints from both areas of ME’s operations. Which sampling method fits that description?

A.

Systematic sampling

B.

Stratified sampling

C.

Block selection sampling

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Question # 23

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?

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

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Question # 24

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.

What type of evidence has been collected by the ACB’s audit team, as presented in scenario 3?

A.

Documentary, confirmative, verbal.

B.

Verbal, documentary, physical.

C.

Physical, verbal, analytical.

D.

Observational, secondary, qualitative.

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Question # 25

The following are stages of an audit, put them in the order they would be conducted.

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Question # 26

Which two of the following should be included in an audit plan?

A.

List of findings from the last audit

B.

Name of the auditee general manager

C.

Signature of Certification Body Technical Reviewer

D.

Sequence and timings of audit activities

E.

Date of next audit

F.

Name of auditees and auditors

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Question # 27

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?

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

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Question # 28

ISO 9001 addresses changes through several requirements, two examples of which are Clause 6.3 (Planning of Changes) and Clause 8.5.6 (Control of Changes). How do the requirements of Clause 8.5.6 differ from those of Clause 6.3?

A.

Clause 8.5.6 refers to changes during the production and service provision.

B.

Clause 8.5.6 refers to changes during the design and development of products and services.

C.

Clause 8.5.6 refers to changes to legal and regulatory requirements.

D.

Clause 8.5.6 refers to leadership and management system responsibilities.

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Question # 29

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:

A.

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

B.

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

C.

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

D.

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

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Question # 30

During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at

a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance

expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.

You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?"

GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal

requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon,

shortage of chemicals for the analysis. It was quite a good experience."

You: "Did you document these issues?"

GM: "No. Jack said that ISO 9001 does not require us to document these issues."

You: "How did you determine the risks associated with the issues and did you plan actions to address them?"

GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence."

Select two options for how you would respond to the General Manager's suggestion:

A.

I would not accept the legal compliance expert answering the question.

B.

I would ask to audit the Technical Manager by phone.

C.

I would delay the audit until the return of the technical manager

D.

I would look for evidence that the actions resulting from the risk assessment had been taken.

E.

I would ask for a different guide instead of the legal compliance expert.

F.

I would ask the consultant to leave the meeting since he is not an employee of the organisation.

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Question # 31

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?

A.

Audit follow-up and stage 1 audit.

B.

Stage 1 and stage 2 audit.

C.

Stage 2 audit and surveillance audit.

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Question # 32

Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

A.

Consistently provide products that meet customers' requirements

B.

Decreased number of management system nonconformities

C.

Decreased number of warranty claims

D.

Decreased number of nonconforming products in all stages of the manufacturing cycle

E.

Enhanced customer satisfaction

F.

Increased profits

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Question # 33

You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.

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Question # 34

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 raises a nonconformity against ISO 9001. Which one of the following options is the basis for the nonconformity?

A.

8.3.5 - The improvements made to course designs are not documented. Feedback from customers is not always actioned.

B.

8.3.2.c - Design planning does not include design validation. Design verification is part of the planning process.

C.

8.3.4.d - Design validation is not always conducted. It is omitted about half of the time.

D.

8.6 - Course materials are released without proper approval. A course for 247 Insurance was released on an urgent basis.

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Question # 35

Takitup is a small fabrication organisation that manufactures steel fencing, stairs and platforms for the construction sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit plan during a surveillance audit covers the organisation's improvement actions and the auditor asks to see the most recent management review meeting minutes.

The auditor finds that the management review report records that none of the improvement actions set by the previous review has been realised for a second time. A new Quality Manager has been brought in at the middle management level to rectify the situation as the organisation is concerned that it might lose its certification.

Select three options that would provide evidence of conformance with clause 10.3 of ISO 9001.

A.

Outsource more processes to external providers

B.

Removing expensive external providers from the database.

C.

An increase in the number of quality staff.

D.

A quality objective to achieve lower reject rates by quality control.

E.

Considering results from the analysis of the effectiveness of corrective actions to determine improvement opportunities.

F.

The certification body auditor reporting fewer nonconformities.

G.

An enhanced customer satisfaction survey score than in the previous year.

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Question # 36

Which two of the following auditors would not participate in a first-party audit?

A.

An auditor employed by an external consultancy organisation

B.

An auditor from an interested party

C.

An auditor trained in-house

D.

An auditor trained in the IRCA scheme

E.

An auditor certified by IRCA

F.

An auditor from a customer

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Question # 37

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?

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

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Question # 38

Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.

A.

Requirements of ISO 9001

B.

ISO 19011 Audit principles

C.

Organisation's market sector

D.

Organisation's invoicing and profits of the last 5 years

E.

Organisation's processes

F.

Requirements of auditee's interested parties other than customers

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Question # 39

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

A.

Verify the effectiveness of the implemented corrective actions

B.

Verify corrections taken to fix the reported non-conformities

C.

Verify legal compliance

D.

Plan the next audit

E.

Determine feasibility of the audit

F.

Assign roles and responsibilities of observers

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Question # 40

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

A.

Objective audit evidence and findings

B.

Maintenance and improvement of competence

C.

Schedule of audits

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Question # 41

Put the following steps of a third-party audit into the correct sequence in which they happen.

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Question # 42

Who assigns a guide to assist the audit team?

A.

The certification body

B.

The auditee

C.

The audit team leader

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Question # 43

For a third-party, match the Activity with the Responsibility for conducting it.

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Question # 44

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 situation presented in scenario 2 is NOT compliant with ISO 9001?

A.

The QMS implementation team comprised five middle managers.

B.

The QMS implementation team did not include a representative from top management.

C.

The responsibilities and authorities for QMS roles were assigned by Leslie, the quality manager.

D.

The quality policy was reviewed by the implementation team before top management approval.

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Question # 45

During a second-party audit, the auditor examines the records that are available for the external provider, ABC Forgings, to whom manufacturing has recently been outsourced.

There are standard external provider checklists for three competitors for the contract and there are inspection records from the trial manufacturing batches produced by ABC Forgings. There is no documented evidence of the criteria used to confirm the appointment of ABC Forgings, and no contract or terms and conditions. Ongoing monitoring indicates that external provider performance is satisfactory, but no documented information has been retained.

Select two options for the evidence which demonstrates a nonconformity with clause 8.4 of ISO 9001.

A.

There was no documentation which provided evidence of any monitoring of the external provider.

B.

The auditee required the outsourced products on an urgent basis before the completion of the paperwork.

C.

The auditee did not retain documentation on the selection and evaluation of the external provider.

D.

The external provider asked for the contract details to be verbal only.

E.

There were no receipt inspection records of the incoming materials.

F.

The auditee trusted the external provider because of a long-standing relationship with them.

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Question # 46

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?

A.

Establishing audit criteria and objectives.

B.

Determining the audit feasibility.

C.

Assigning responsibilities for the audit team members.

D.

Signing the certification agreement.

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Question # 47

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'?

A.

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

B.

Top Management completed a course on ISO 9001

C.

All these actions will be reviewed during the Top Management meetings

D.

Improvement action has been promoted

E.

Objectives have been established

F.

Process approach has been communicated to the personnel

G.

Resources have been provided

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Question # 48

Will the auditee be subject to an audit follow-up if a minor nonconformity has been reported by the audit team leader in the audit conclusions?

A.

No, the auditee will be subject to an audit follow-up only if a major nonconformity is detected

B.

Yes, there should be an audit follow-up regardless of the type of nonconformities that are detected during the audit

C.

No, the audit team should suggest a recommendation only, in which it suggests an adequate corrective action for the nonconformity

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Question # 49

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’

A.

Prepare the audit plan

B.

Assign responsibilities within the audit team

C.

Prepare the checklists

D.

Provide the resources needed

E.

Review the reports of previous audits

F.

Select the audit team members

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Question # 50

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?

A.

Autocratic

B.

Laissez-faire

C.

Centralized

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Question # 51

An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:

"The reject rate of the finished product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%."

As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective action, the Quality Manager conducted an investigation into the reject rates. He reported that the collection baskets for products ejecting from the moulding machines were not large enough. About 6% of products fell onto the wet and dirty factory floor. Management stated that replacing the baskets was too costly and ordered the Maintenance Manager to ensure that the floor was kept clean and dry to prevent rejects. The auditor later checked the factory floor, which was wet and dirty in places.

From the following nonconformities, select three that the auditor could raise to ISO 9001.

A.

10.3 - The organisation did not continuously improve. Reject rates were unchanged.

B.

7.1.4 - The factory environment is not suitably maintained to prevent dirty products.

C.

7.1.1 - The organisation failed to provide the required resources to prevent nonconforming products.

D.

9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3).

E.

8.6 - Dirty products were released to the customer.

F.

7.3 - Staff were not aware that products were falling onto the factory floor.

G.

10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity.

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Question # 52

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?

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.

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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 general principles of sampling procedure, did the audit team select a valid sample for electrical services?

A.

No, the selected sample size is low compared to the population, as for a population from 13 to 52 the minimum sample size should be 5.

B.

No, the selected sample size is high compared to the population, as for a population from 13 to 52 the minimum sample size should be 10.

C.

Yes, the selected sample size is proportionate to the population.

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Question # 54

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?

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

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Question # 55

What are the objectives of the Stage 2 audit?

A.

To evaluate whether the QMS is effectively implemented

B.

To review the auditee's management system documented information

C.

To gather information regarding the scope of the QMS

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Question # 56

Match the process descriptions below to the process names:

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Question # 57

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?

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.

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Question # 58

Which one of the following is not an ISO 9000:2015 quality management principle?

A.

Evidence-based decision-making

B.

Leadership

C.

Process approach

D.

Risk-based approach

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Question # 59

Select one of the options that best describes the purpose of conducting a document review:

A.

To establish nonconformity in the documented system with audit criteria and to gather information to compile the audit report.

B.

To confirm the conformity of the system, where documented, with audit criteria and to gather information to support the audit findings.

C.

To reveal whether the documented system is nonconforming with audit criteria and to gather evidence to support the audit report.

D.

To decide about the conformity of the documented system with audit standards and to gather findings to support the audit process.

E.

To detect any nonconformity of the system, if documented, with audit criteria and to identify information to support the audit plan.

F.

To determine the conformity of the system, as far as documented, with audit criteria and to gather information to support the audit activities.

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Question # 60

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?

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

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Question # 61

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:

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."

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Question # 62

Select the word that best completes the sentence:

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Question # 63

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:

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 ...

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

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Question # 64

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

A.

Observer.

B.

Technical expert.

C.

Guide.

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Question # 65

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.

You are interviewing the Manufacturing Manager (MM).

You: "I would like to begin by looking at the cleaning controls."

MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside."

Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

You decide to raise a non-conformity.

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