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Free and Premium PECB ISO-9001-Lead-Auditor Dumps Questions Answers

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Question 1

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?

Options:

A.

Systematic sampling

B.

Stratified sampling

C.

Block selection sampling

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Question 2

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 3

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

Options:

Question 4

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 5

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

Options:

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

Question 6

Who maintains ownership of the audit report?

Options:

A.

The audit team leader

B.

The auditee

C.

The certification body

Question 7

During a Stage 1 audit, the Quality Manager asks that the audit includes coverage of a new work area they have expanded into since the application was made.

Which of the following two actions should the auditor take?

Options:

A.

Advise the Quality Manager that an extension of the scope is possible but will have to go through established procedures.

B.

Advise the Quality Manager that the audit scope has been set and the audit will proceed as planned.

C.

Advise the Quality Manager that, within the existing scope, the new work area can be included without any problem.

D.

Determine whether the Quality Management System covers the new work area and, if so, proceed with the audit.

E.

Suggest that she will advise the programme manager that the audit scope should be revised to include the new work area.

F.

Suggest that the Quality Manager cancels the audit contract and reapplies for the new situation.

Question 8

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."

The Administration Officer: "Concerning 'nonconformity 2', the General Manager left a message asking us

to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in

which he explains why."

Which one of the following would be your preferred answer (as team leader) to the General

Manager's request?

Options:

A.

OK. I will get in contact with my company tomorrow to ask for instructions on what to do with

this non-conformity.

B.

OK. Please, let me review the message. I will try to see if I can change the text of the

nonconformity if necessary. Let's take a 10-minute break, as I would like to discuss this issue with

the audit team.

C.

Please tell him that I will phone him in two days and will discuss the issue. Could you please give

me his mobile phone number?

D.

Please tell him that this nonconformity has been previously accepted by the quality manager

during the audit and will stand. I will include it in the report, along with the concern of the

General Manager about it.

Question 9

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.

Options:

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.

Question 10

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?

Options:

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

Question 11

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 12

Which one of the following options is the definition of the context of an organisation?

Options:

A.

Combination of internal and external issues that can have an effect on an organisation's approach to developing and achieving its objectives.

B.

Comparison of internal and external issues that can have an effect on an organisation's desire to achieve its objectives.

C.

Complexity of internal and external issues that can have an effect on an organisation's approach to developing and achieving its purpose.

D.

Coordination of internal and external issues that can have a positive or negative effect on an organisation's success.

Question 13

Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).

Options:

Question 14

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 15

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."

Options:

Question 16

What is a horizontal audit?

Options:

A.

In-depth investigation of one process across various departments in the organization

B.

In-depth investigation of all the processes in a specific department or organizational unit

C.

In-depth investigation of all the processes in major functional areas of the organization

Question 17

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

Options:

A.

To define the audit schedule

B.

To supervise all audit functions and activities

C.

To establish an internal audit program

Question 18

A small cleaning services organisation is about to start work on a hospital cleaning contract for the local Health Trust. You,

as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract

requires that a cleaning plan is produced.

You: "How was the cleaning plan for the contract developed?"

Service Manager: "We have a basic template that covers the materials, labour requirements and cleaning methods to be

employed. Some of that is specified by the customer."

You: "How does the plan deal with locations like the intensive care wards and the operating theatres, which are included

in the contract?"

Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if the

hospital requests it."

You: "Are you aware of the regulatory requirements for cleaning standards in hospitals?"

Service Manager: "No. We depend on the hospital to look after that side of things in the contract."

You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001.

You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the

cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was

substituted to that specified in the contract. At the follow-up audit, the corrective action proposed was to

"obtain a concession from the Health Trust for use of the new chemical."

Which one of the following options is the reason why you did not accept this action taken?

Options:

A.

Staff have not been trained in the use of the new chemical.

B.

The action assumes that the Health Trust will agree to the change.

C.

The process for making changes to the contract has not been addressed.

D.

The substitute chemical has not been used before in the Health Trust.

E.

The substitute chemical may not be as effective as the original.

Question 19

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers regulatory consultancy services to manufacturers of cosmetics. The business operates from ten regional offices.

You are nearing the end of the audit and need to decide if sufficient evidence of top management leadership and commitment with respect to the quality management system has been gathered.

Which four of the following would demonstrate top management leadership and commitment with respect to the quality management system?

Options:

A.

Approving company car budgets for the fiscal year

B.

Briefing staff on the development of an improvement culture

C.

Chairing management review meetings

D.

Conducting staff disciplinary meetings

E.

Investing time and money in corrective actions arising from nonconformities

F.

Not attending audit closing meeting

G.

Promoting the importance of following procedures

Question 20

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

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

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

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

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

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

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

Options:

A.

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

B.

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

C.

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

D.

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

Question 21

You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies

specialist laboratory equipment and furniture.

You: "I'd like to look at how you manage change in the organisation. What changes have you made as a

business, say, over the last 12 months?"

Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our

own products in house."

You: "That sounds like quite a significant change. What has been the impact of that?"

Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced

manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members

of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging

time."

You: "I'm sure. What were the reasons for making the change?"

Auditee: "Our manufacturing section was a small operation, and we struggled to cope with fluctuations in

demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with

little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices

that made our product uncompetitive."

You: "How did you go about the change?"

In relation to the auditor's question about how the change was managed, the auditee mentions the steps

listed below. Match the ISO 9001 clauses to the steps.

To complete the table, click on the blank section you want to complete so it is highlighted in red and then

click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which step the

requirement applies to.

Options:

Question 22

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 23

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 24

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 25

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

Options:

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.

Question 26

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 27

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 28

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

Options:

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

Question 29

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 30

You are conducting a third-party Stage 1 audit at ABC Ltd, a single-site organisation that manufactures wooden furniture. You interview the Technical Director to learn more about the organisation. The Technical Director explains that they have had a successful year and that obtaining ISO 9001 certification will support the further growth of the business. You ask for an overview of the organisation's structure and its interrelationships with external interested parties.

The Technical Director shows you a document detailing all business processes and interrelationships. You notice in this document that another organisation called Teak Ltd manufactures wooden furniture on behalf of ABC Ltd. The Technical Director confirms this capability has been accounted for in the scope of the quality management system. You learn that the furniture manufactured by Teak Ltd has accounted for 40% of the sales revenue over the previous 12 months.

Which two of the following options best describe how you would plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd?

Options:

A.

Verify Teak Ltd supply arrangements as described in the ABC Ltd quality management system

B.

Verify if Teak Ltd are certified to ISO 9001

C.

Verify the controls concerning customer property implemented by Teak Ltd

D.

Verify how ABC Ltd evaluates the performance of Teak Ltd

E.

Verify the quality management system at Teak Ltd by conducting an audit at their site

F.

Verify whether the design processes of Teak Ltd comply with ISO 9001

Question 31

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 32

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:

According to Scenario 7, one of the auditors requested permission from Sean to audit the department in which he worked on a daily basis. Should Sean grant the auditor permission?

Options:

A.

No, internal auditors should be independent of the processes being audited

B.

Yes, Sean should grant the auditor permission

C.

Yes, but Sean himself must be present in every audit activity

Question 33

XYZ Corporation employs 100 people, and during a Stage 1 certification audit, certain issues are identified with the Quality Management System (QMS). Which two options describe the circumstances in which you could raise a nonconformity against Clause 6.2 of ISO 9001:2015?

Options:

A.

Quality objectives are not being implemented by the organisation's personnel.

B.

The consultant has not interpreted ISO 9001 correctly.

C.

Establishing quality objectives did not include top management.

D.

Quality objectives were not established in alignment with the organisation's quality policy.

E.

The organisation cannot afford to undertake quality objectives all at once.

F.

Quality objectives are not maintained as documented information.

Question 34

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 35

Technical experts must operate under the supervision of:

Options:

A.

The auditee

B.

An auditor

C.

The audit team leader only

Question 36

Match each of the following statements into the table below to show whether they apply to first-party audits, second-party audits or third-party audits:

Options:

Question 37

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 38

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'?

Options:

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

Question 39

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

Options:

A.

20% of the total audit time

B.

30% of the total audit time

C.

40% of the total audit time

Question 40

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 oil 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 the 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.

At the Closing meeting, the audit team leader presents the findings of the audit and comes to the above

nonconformity. The Quality Manager produces the test report for Project DK, which shows an acceptable galvanic efficiency, and presents an email from the customer confirming acceptance of the anodes. He asks that the nonconformity be withdrawn.

Which two of the following responses by the audit team leader would be acceptable?

Options:

A.

Accept the Quality Manager's request without reviewing the documentation.

B.

Advise management that the information provided will be reviewed at the audit follow-up stage.

C.

Ask the auditor (you) who raised the issue, to state what you think should happen

D.

Indicate that the nonconformity is evidence of a system failure that needs to be rectified.

E.

Refuse to accept the documentation produced and maintain the nonconformity.

F.

Thank the Quality Manager for his contribution but dismiss the information as irrelevant after a quick review.

Question 41

When monitoring customer perceptions, which analysis is helpful to use?

Options:

A.

PEST analysis

B.

Market-share analysis

C.

Gap analysis

D.

Competitive benchmarking

Question 42

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?

Options:

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.

Question 43

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.

Options:

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

Question 44

You are conducting 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

You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.

You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

Options:

Question 45

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.

In scenario 4, the audit team determined the audit feasibility by considering only the resources available for the audit. Is this acceptable?

Options:

A.

No, the audit feasibility should be determined by TD’s top management.

B.

No, because other factors should be considered when determining the audit feasibility, such as information needed to plan the audit, the cooperation of the auditee, duration of the audit, etc.

C.

Yes, considering only the resources available for the audit is sufficient for determining the audit feasibility.

D.

Yes, because the audit team leader has final authority over audit feasibility.

Question 46

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."

Options:

Question 47

"A set of interrelated or interlacing elements of an organization to establish policies and objectives, and processes to achieve those objectives" is the definition of a/an:

Options:

A.

Management system

B.

Standard

C.

Organization scope

D.

Quality manual

Question 48

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 49

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'

Options:

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.

Question 50

In the context of a second-party audit, match the activity with the party responsible for conducting it.

Options:

Question 51

'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 52

The following list gives examples of records that may be evidence of how an organisation has fulfilled the requirements of clause 8.4 of ISO 9001. Match the records to the appropriate requirement of clause 8.4.

Options:

Question 53

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:

Why is it important to discuss the audit findings with DC’s top management prior to the closing meeting and the submission of the final audit report?

Options:

A.

To verify whether the audit objectives have been met

B.

To encourage the implementation of corrective actions as soon as possible

C.

To identify the persons responsible for the nonconformities

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:

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

Options:

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

Question 55

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 56

What should the auditor document during the Stage 1 audit?

Options:

A.

The main processes of the auditee

B.

The interviews with the auditee’s employees

C.

The observations that could result in nonconformities during the on-site audit

Question 57

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

Options:

A.

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

B.

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

C.

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

D.

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

E.

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

F.

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

Question 58

Who would be defined as a witness during a witness audit?

Choose two of the following options:

Options:

A.

Someone with a qualification from the certification body

B.

An auditor

C.

An existing member of the audit team

D.

An assessor for the accreditation body

Question 59

Which two of the following roles do not contribute to the audit outcomes?

Options:

A.

Individual(s) managing the audit programme

B.

Auditee

C.

Guide

D.

Consultant

E.

Observer

F.

Technical expert

Question 60

An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation which manufactures sacrificial anodes for the

oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. As one of

the auditors, you 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 the

release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests rarely fall below the

required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.

During the audit team meeting in preparation for the Closing meeting, the second auditor disagreed with the clause of ISO 9001 selected for the

above nonconformity. He thinks it should be clause 9.1.1.

Choose three options for how the audit team leader should best respond to the situation:

Options:

A.

The audit team leader will refer to the quality manager to determine which clause they agree with.

B.

Advise that he will think about the clause and announce his decision during the Closing meeting.

C.

Immediately agree with the second auditor that clause 9.1.1 would be better.

D.

Immediately overule the objection of the second auditor with no discussion of the clause.

E.

Invite you and the second auditor to fully explain your point of view and then decide which clause to select.

F.

Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best apply.

G.

Suggest that neither clause is accurate and instead propose clause 9.1.3 as the best one for the nonconformity.

Question 61

Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).

Options:

Question 62

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 63

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

Options:

A.

Competence

B.

Experience

C.

Familiarity

D.

Intimidation

E.

Self-audit