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

Questions 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.

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.

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Questions 5

Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?

Options:

A.

During the Stage 1 audit, the audit team:

B.

Verifies the degrees of customer satisfaction

C.

Evaluates the conditions of all sites

D.

Reviews the client's management system documented information

E.

Evaluates the results of the last management review

F.

Verifies the compliance with legal requirements

G.

Reviews the processes with high level of risk

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Questions 6

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

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Questions 7

Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.

A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.

In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.

Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.

Based on the scenario above, answer the following question:

Scenario 6 indicates that although the top management did not agree with the audit findings, the audit team began preparing the audit report. Is this acceptable?

Options:

A.

No, the audit report should have been prepared before the audit findings were presented in the closing meeting

B.

No, during the closing meeting, the audit team had to inform the auditee about the complaint and appeal handling process

C.

Yes, the audit team had to begin preparing the audit report although the top management did not agree with the audit findings

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Questions 8

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

Options:

A.

Adhere to the CQI Professional Code of Conduct.

B.

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

C.

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

D.

Remove audit evidence without the permission of the auditee.

E.

Share audit conclusions with competitor organisations.

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Questions 9

The Closing meeting of a second-party audit was planned for 6 pm with the general manager and the quality manager.

At 6 pm, when the audit team enters the meeting room, only the Quality Manager is present and walting for them.

The dialogue among them is as follows:

Auditor team leader: "Good evening, could you please inform the general manager that we are ready to start with the closing meeting?"

Quality manager: "Good evening. I am sorry to inform you that the general manager will not be able to attend the meeting. He will try to

participate virtually to make some closing remarks."

Auditor team leader: "OK. We identified seven nonconformities - these are the reports. Could you please review them and sign them?"

Quality manager: "OK. As you know, I reviewed them after yesterday's meeting and accept of all them, where shall I sign?"

General manager (from speakers in the room and addressing the quality manager): "Hold on! Do not sign the two nonconformities related to ABC

Bank! I have just checked, and we did not provide any services to ABC Bank during September! You can sign the remaining five nonconformities."

How would you proceed with the audit? Select one.

Options:

A.

I will discuss this issue with our corporate quality manager and will let you know what we will do

B.

I will include the seven nonconformities in the report, considering that we identified objective evidence on which all these nonconformities are based

C.

I will review this issue at length with the audit team tonight and will phone you tomorrow to let you know our decision

D.

I withdraw the two nonconformities related to service to ABC and will present the report with the remaining five nonconformities

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Questions 10

What is reliability in the context of service quality?

Options:

A.

Ability to offer safe services

B.

Readiness and goodwill in providing services

C.

Providing the promised services correctly and dependably

D.

Ensuring service costs remain low

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Questions 11

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.

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Questions 12

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."

This scenario presents a number of audit trails to different ISO 9001 requirements.

Which three of the following requirements would be relevant audit trails for this scenario?

Options:

A.

Organisational knowledge

B.

Control of externally provided processes, products, and services

C.

Design and development of products and services

D.

Documented information

E.

Measurement traceability

F.

Organisation roles and responsibilities

G.

Preservation of product

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Questions 13

When should the certification body accept the audit?

Options:

A.

After considering the integrity and reputation of the auditee.

B.

After considering the nature of the operations of the auditee.

C.

Both A and B.

D.

Only if the auditee has no previous major nonconformities.

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Questions 14

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:

ISO-9001-Lead-Auditor Question 14

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."

ISO-9001-Lead-Auditor Question 14

Options:

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Questions 15

Scenario 5: Mechanical-Electro (ME) Audit Stages

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

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

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

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

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

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

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

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

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

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

Options:

A.

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

B.

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

C.

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

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Questions 16

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:

Based on Scenario 7, the team worked together to draft the final audit report. Is this acceptable?

Options:

A.

Yes, audit team members should contribute to drafting one general report for the findings and conclusions

B.

No, audit team members should draft separate reports for their findings and conclusions

C.

No, it is the responsibility of the audit team leader to draft the audit report

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Questions 17

According to ISO 9000, what is quality?

Options:

A.

The ability of an object to realize an output that will fulfill the requirements for that output

B.

The degree to which a set of inherent characteristics of an object fulfills requirements

C.

A set of conditions under which work is performed

D.

The efficiency with which resources are utilized in achieving objectives

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Questions 18

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.

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Questions 19

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

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Questions 20

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

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Questions 21

Which two of the following aspects of a quality management system must the organisation continually improve?

Options:

A.

Suitability

B.

Adaptability

C.

Effectiveness

D.

Responsiveness

E.

Efficiency

F.

Applicability

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Questions 22

Even though past audits have highlighted a consistently large number of nonconformities within an organisation's design team, the organisation has not varied the frequency or duration of audits on its audit plan.

The decision for whether this situation is acceptable or not should be governed by which of the following?

Options:

A.

A risk-based approach to the audit programme

B.

The authority of the audit team leader

C.

The availability of competent internal auditors

D.

The organisation's reasoning behind the lack of change to the audit plan

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Questions 23

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?

Options:

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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Questions 24

In the context of a third-party audit, match the activity with the party responsible in relation to the audit process.

ISO-9001-Lead-Auditor Question 24

Options:

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Questions 25

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

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Questions 26

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.

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Questions 27

In the context of a third-party certification audit, it is very important to have effective communication. Which is not the responsibility of the audit team leader?

Options:

A.

If audit objectives are unattainable, reporting the reasons to the accreditation body.

B.

Planning formal communication arrangements, so an auditee can communicate with the auditor any time during the audit.

C.

Confirming formal communication channels between the audit team and the auditee during the opening meeting.

D.

Communicating the progress, any significant findings and any concerns to the auditee and audit client, as appropriate.

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Questions 28

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

Options:

A.

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

B.

The consideration of processes in terms of financial value

C.

The achievement of effective process performance

D.

The reduction of resource consumption

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Questions 29

XYZ Corporation is an organisation that employs 100 people. As the 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.

How would you respond with the following options? Select three.

Options:

A.

Suggest asking the certification body for guidance on this matter.

B.

Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organisation's requirements.

C.

Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.

D.

Inform the Quality Manager that you will comment on the subject in your audit report.

E.

Indicate that ISO 9001 requires a minimum of two quality objectives.

F.

Suggest that all employees undertake a training course on ISO 9001.

G.

Advise the Quality Manager that, as an auditor, you cannot provide advice to the organisation on how it should operate its QMS.

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Questions 30

Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer

complaints. 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 company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn

that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.

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

ISO-9001-Lead-Auditor Question 30

Options:

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Questions 31

Among others, what does Clause 4.4 (Quality Management System and Its Processes) of ISO 9001 require from organizations?

Options:

A.

To change the QMS quarterly

B.

To review the QMS annually

C.

To continually improve the QMS

D.

To conduct a QMS gap analysis every two years

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Questions 32

Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top-notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.

In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.

Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS. They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.

During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS. AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.

Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.

Based on the scenario above, answer the following question:

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

Options:

A.

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

B.

No, contracting external consultants is not required.

C.

Yes, external advice is necessary for an effective implementation.

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Questions 33

Select the two statements that are true.

Options:

A.

The audit team leader shall only communicate any concerns to the auditee during the closing meeting.

B.

Inform the general manager if the auditor finds uncontrolled documents.

C.

Where the available audit evidence indicates that the audit objectives are unattainable, the individual(s) managing the audit programme shall be immediately informed.

D.

Changes to the audit scope, which become apparent during the audit, shall be approved with the auditee.

E.

During the audit, the audit team leader shall periodically assess audit progress.

F.

An immediate and significant risk to the audit shall be informed to the auditee and if possible to the certification body.

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Questions 34

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

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Questions 35

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 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.

ISO-9001-Lead-Auditor Question 35

Options:

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Questions 36

What type of audit evidence are policies and guidelines?

Options:

A.

Confirmative evidence.

B.

Technical evidence.

C.

Documentary evidence.

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Questions 37

Scenario 4:

TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.

To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.

After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.

Anne reviewed the document and approved the audit mandate. The certification body and TD’s top management signed the certification agreement.

Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.

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

Options:

A.

The certification agreement.

B.

The audit plan.

C.

The audit offer.

D.

The audit mandate.

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Questions 38

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

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Questions 39

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

Options:

A.

To facilitate auditing for proof of conformity to the standard.

B.

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

C.

To safeguard the integrity of the quality management system.

D.

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

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Questions 40

'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

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Questions 41

In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.

Options:

A.

A recommendation is given in the report.

B.

A finding of good practice is reported.

C.

An opportunity for improvement is raised.

D.

A major non-conformity is raised.

E.

A finding of conformity is reported.

F.

A minor non-conformity is raised.

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Questions 42

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.

ISO-9001-Lead-Auditor Question 42

Options:

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Questions 43

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

Options:

A.

Business improvement

B.

Performance of business processes

C.

External issues of the organisation's context

D.

Competence of top management

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Questions 44

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

Options:

A.

PEST analysis

B.

Market-share analysis

C.

Gap analysis

D.

Competitive benchmarking

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Questions 45

You are auditing an organisation that has been certificated to ISO 9001 for ten years. The organisation is a privately-owned, multi-site car tyre fitting

organisation. You are auditing one of the sites. You are auditing the car tyre fitting service. You are interviewing the Site Manager (SM).

You: "Would you explain the car tyre fitting service?"

SM: "Of course. Customers typically call us by phone with their requirements. We ask them what they want. We check whether we have the tyres

they need in stock. If we don't have the tyres in stock, we contact our supplier to confirm when they would be able to supply the tyres. We then

determine the cost. We then check what availability we have in our busy schedule to fit the new tyres. We then inform the customer with details of

cost and when we can fit the tyres. If the customer is happy to proceed with the booking, we update our Work Schedule. The same process applies

for customers who walk into our office and for online requests."

You: "What information do you retain should there be a defect reported by a manufacturer of tyres that you have fitted?"

SM: "We maintain records of customer names, addresses and contact phone numbers. We maintain a record of the type of tyre fitted and the tyre

manufacturers batch information. We also maintain a record of the registration numbers of the vehicles we have fitted tyres to. All records are in our

Work Schedule."

Which two of the following options you would take to enable you to gather further audit evidence to validate what the Site Manager

has told you?

Options:

A.

Interview a customer to determine how satisfied they are with the service.

B.

Interview a tyre fitter to determine how long they have worked for the organisation.

C.

Interview a tyre fitter to determine the type and batch of each tyre fitted to a car.

D.

Review the training record of the site manager.

E.

Review the Work Schedule dated three years ago and verify what information has been recorded.

F.

Review the Work Schedule for the past three weeks and verify what information has been recorded.

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Questions 46

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

ISO-9001-Lead-Auditor Question 46

Options:

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Questions 47

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

Options:

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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Questions 48

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

Options:

A.

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

B.

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

C.

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

D.

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

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Questions 49

Who is responsible for the development of surveillance activities?

Options:

A.

A representative of the auditee's top management

B.

The certification body

C.

The audit team leader

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Questions 50

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.

How do you assess the situation presented in the last paragraph of scenario 4?

Options:

A.

Anne cannot withdraw from the audit once the audit mandate is accepted.

B.

TD cannot make any change to the audit scope once it has been defined.

C.

TD should have agreed with the certification body and Anne about any change in the audit scope.

D.

Anne has full authority to reject any scope changes, even if TD and the certification body agree.

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Questions 51

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.

ISO-9001-Lead-Auditor Question 51

ISO-9001-Lead-Auditor Question 51

Options:

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Questions 52

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.

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Questions 53

Which of the following is correct with regard to the internal audit?

Options:

A.

It considers only the effectiveness of the QMS

B.

It has no advisory role within the organization for the improvement of the QMS

C.

It may be conducted on an ongoing basis

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Questions 54

A small deaning services organisation is about to start work on a hospital dleaning 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.

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

B.

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

C.

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

D.

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

E.

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

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Questions 55

Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.

A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.

In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.

Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.

Based on the scenario above, answer the following question:

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

Options:

A.

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

B.

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

C.

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

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Questions 56

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

auditors) to audit an external provider, 'XYZ', which provides packaging materials to your organisation. It is 4 pm, and the audit is dlose 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 pm.

'XYZ' has two manufacturing lines: M1 is a clean room for primary packaging materials (i.e. will be in direct contact with the food), and M2 is for

secondary materials (i.e. will not be in direct contact with food).

Auditor 1 audited the two manufacturing lines.

You: "What findings would you report?"

Auditor 1: "I have one issue. Earlier today in the morning I saw some secondary material stocked in the clean room. I would propose raising a

nonconformity."

You: "How would you write the nonconformity?"

Auditor 1: "In the clean room, there was a pallet with secondary materials."

What additional information would you add to this text to complete the nonconformity report? Select six.

Options:

A.

Batch number of the secondary material

B.

Description of any primary material close to this pallet

C.

Description of the ISO 9001:2015 requirement not being complied with and the clause number

D.

Description of the secondary material

E.

Evidence that the secondary material was approved ready to be used

F.

More information in the place within the clean room where secondary material was found

G.

Name of the forklift driver that was moving the pallet

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Questions 57

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

Options:

A.

Number of sites to be audited

B.

Risk to achieving audit objectives

C.

Expectations of the organisation's management

D.

Scope of the audit

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Questions 58

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

Options:

A.

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

B.

Lack of commitment from the top management

C.

Lack of corrective actions to address recurrent incidents

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Questions 59

Who maintains ownership of the audit report?

Options:

A.

The audit team leader

B.

The auditee

C.

The certification body

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Questions 60

An organization has decided to implement a QMS based on ISO 9001. What should they consider when determining internal issues?

Options:

A.

The social and economic environments

B.

The competitive environment

C.

Knowledge

D.

The expectations of suppliers

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Questions 61

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:

Options:

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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Questions 62

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.

Options:

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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Questions 63

During a second-party audit of a dairy farm (by a potential customer) complying with ISO 9001:2015, the auditor verifies that there is large variability in the daily production of the milking yard. The current agreement with their only customer is to provide 2,000 litres per day. However, in the last two years, they have noticed an increasing variability in daily production.

If they produce less than 2,000 litres, they are penalised with a fine of 1.5 pesos for every litre that they do not provide. If they produce more than 2,000 litres, they use the extra milk to feed the pigs.

This process has been in operation for decades. The dairy farm was founded by the grandfather of the current owners, who did not want to alter the established practices.

The auditor raises a nonconformity on the basis that the process is not under control (Clause 8.1).

If you had been the auditor, which one of the following actions would you have accepted?

Options:

A.

Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a second customer.

B.

Apply the existing process of addressing the risks and opportunities of milk production.

C.

Retain the current contract and try to sell the occasional surplus milk to a second customer.

D.

Analyse the daily dispatch of milk for 7 days to determine its variability.

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Exam Name: QMS ISO 9001:2015 Lead Auditor Exam
Last Update: Mar 31, 2025
Questions: 210

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