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Question # 4

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

A.

Autocratic

B.

Laissez-faire

C.

Centralized

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Question # 5

You are a member of the audit team of a second-party audit of an organisation with 625 employees. The audit procedure recommends using sampling criteria which requires the review of the documented competence for 25 personnel. The audit team leader developed an audit plan allocating one hour to audit the Human Resources department (from 11:30 am to 12:30 pm). She told you that she could not allocate any additional time.

What would you do?

A.

Extend the audit until 1.00pm and ask for a quick lunch later.

B.

Plan to review less than 25 cases.

C.

Plan to review as many as possible and see if you can extend the audit duration by one day.

D.

Plan to miss lunch and review as many as possible.

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Question # 6

"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:

A.

Management system

B.

Standard

C.

Organization scope

D.

Quality manual

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Question # 7

Select which one of the following statements is true.

A.

The team leader shall be an auditor that is qualified in the scheme.

B.

An audit team can include non-qualified auditors.

C.

A technical expert can replace a qualified auditor on an audit team.

D.

Audits leading to auditor qualification are undertaken annually.

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Question # 8

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.

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Question # 9

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

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

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

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

You raised a nonconformity against clause 8.5.1 of ISO 9001.

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

A.

Customer complaints are not taken seriously by the organisation.

B.

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

C.

Some equipment used was not suitable for the laundry process.

D.

The management failed in planning to replace obsolete equipment.

E.

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

F.

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

G.

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

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Question # 10

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).

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Question # 11

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

A.

Individual(s) managing the audit programme

B.

Auditee

C.

Guide

D.

Consultant

E.

Observer

F.

Technical expert

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Question # 12

Select the word that best completes the sentence:

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Question # 13

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

A.

Knowledge of the industry in which the auditee operates.

B.

Knowledge of the risk-based approach to auditing.

C.

Expertise in each domain to be audited.

D.

A formal degree in quality management.

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Question # 14

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

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

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

A.

Outsource more processes to external providers

B.

Removing expensive external providers from the database.

C.

An increase in the number of quality staff.

D.

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

E.

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

F.

The certification body auditor reporting fewer nonconformities.

G.

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

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Question # 15

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

A.

The quality policy

B.

Internal audit

C.

Both A and B

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Question # 16

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

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

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

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

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

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

You: "Good afternoon."

OD: "Good afternoon."

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

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

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

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

amended software is immediately released to users."

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

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

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

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

any questions."

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

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

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

notes)."

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

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

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

nonconformity with a requirement defined in ...

A.

clause 7.1.3 Infrastructure

B.

... clause 7.1.4 Environment for the operation of processes

C.

clause 7.5.1 Documented information - General

D.

... clause 7.5.2 Documented information - Creating and updating

E.

... clause 7.5.3 Control of documented information

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Question # 17

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

A.

20% of the total audit time

B.

30% of the total audit time

C.

40% of the total audit time

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Question # 18

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

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.

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Question # 19

Scenario 4:

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

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

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

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

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

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

A.

Establishing audit criteria and objectives.

B.

Determining the audit feasibility.

C.

Assigning responsibilities for the audit team members.

D.

Signing the certification agreement.

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Question # 20

You will lead a third-party audit next Monday on ABC, an organisation that provides services for cleaning windows from the outside of tall buildings. They work on demand, and usually have 4-5 orders per week. All documented information on these activities is kept at the central office.

On Friday evening, before the audit, you are informed by mail that customers cancelled all orders for the next week; therefore, the auditors will not have the chance to see them working at the customer's premises, but the field supervisors will be available at the ABC offices.

You have prepared the audit plan and the checklist. Choose the best action you would take:

A.

Start the audit on Monday at ABC's as planned, interviewing the functions that regularly work at the central office, and plan visits to ABC customers wherever they may be working during the following week.

B.

Ask the Certification Body you work for how to proceed with the audit.

C.

Start the audit on Monday as planned, interviewing the functions that regularly work at the central office, and visit another customer's premises they cleaned the week before.

D.

Complete the audit but ask the quality manager to clean some windows at the ABC's office, simulating the process they carry out at customers' premises.

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Question # 21

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.

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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Question # 22

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?

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.

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Question # 23

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

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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Question # 24

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?

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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Question # 25

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?

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?

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Question # 26

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

A.

The effectiveness of all corrections and corrective actions taken

B.

If internal audits and management reviews are being planned and performed

C.

The auditee’s site-specific conditions

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Question # 27

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

A.

Suitability

B.

Adaptability

C.

Effectiveness

D.

Responsiveness

E.

Efficiency

F.

Applicability

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Question # 28

Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.

A.

Manages the performance

B.

Monitors the performance

C.

Dictates the performance

D.

Improves the performance

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Question # 29

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:

As stated in scenario 1, AL-TAX tested the effectiveness of the intended actions as part of the QMS improvement through the PDCA cycle. Which stage did it perform in this case?

A.

Do

B.

Check

C.

Act

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Question # 30

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).

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Question # 31

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

A.

Evidence-based decision-making

B.

Leadership

C.

Process approach

D.

Risk-based approach

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Question # 32

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

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

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

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

to raise the following nonconformity as follows:

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

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

Which one would be your answer from the following options?

A.

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

B.

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

C.

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

D.

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

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Question # 33

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:

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.

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Question # 34

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Pro’s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company’s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

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

A.

Documentary, confirmative, verbal.

B.

Verbal, documentary, physical.

C.

Physical, verbal, analytical.

D.

Observational, secondary, qualitative.

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Question # 35

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

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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Question # 36

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Pro’s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company’s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

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

A.

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

B.

No, because the audit evidence would not be relevant.

C.

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

D.

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

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Question # 37

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

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Question # 38

What are the objectives of the Stage 2 audit?

A.

To evaluate whether the QMS is effectively implemented

B.

To review the auditee's management system documented information

C.

To gather information regarding the scope of the QMS

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Question # 39

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

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

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

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

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

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

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

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

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Question # 40

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

A.

PEST analysis

B.

Market-share analysis

C.

Gap analysis

D.

Competitive benchmarking

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Question # 41

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?

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.

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Question # 42

What is reliability in the context of service quality?

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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Question # 43

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

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Question # 44

Consultancy ABC, which is a subsidiary of a certification body called ABC-CERT, provided consultancy services regarding the implementation of a QMS based on ISO 9001 to an organization. Considering this, can ABC-CERT provide certification services to the organization which obtained consultancy services from Consultancy ABC?

A.

Yes, after a minimum period of two years has passed.

B.

Yes, if both parties sign an agreement which states that previous services by Consultancy ABC will not impact the judgment of auditors.

C.

No, ABC-CERT is not allowed to provide certification services to that organization ever, as this would be a conflict of interest.

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Question # 45

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 two statements that apply to the term

`nonconformity'.

A.

No quality objectives planned for the top management team

B.

Decisions on improvement action timescales not involving departmental managers.

C.

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

D.

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

E.

Quality improvements not aligning with the quality policy.

F.

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

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Question # 46

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?

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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Question # 47

Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?

A.

Audit Report

B.

Audit Plan

C.

Procedures

D.

Checklist / Prompts

E.

Risk Matrices

F.

Findings

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Question # 48

Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

A.

Concession

B.

Correction

C.

Corrective action

D.

Preventive action

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Question # 49

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

A.

The audit objectives.

B.

The audit criteria.

C.

The audit schedule.

D.

The audit offer.

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Question # 50

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

A.

Communicating the quality objectives needed for the Quality Management System.

B.

Ensuring customer requirements are consistently met.

C.

Establishing the Quality Management System quality policy.

D.

Planning actions to address risks and opportunities.

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Question # 51

Who maintains ownership of the audit report?

A.

The audit team leader

B.

The auditee

C.

The certification body

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Question # 52

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

A.

Maintaining logistics

B.

Filling any potential gaps in the auditor's knowledge

C.

Witnessing the audit process on behalf of the certification body

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Question # 53

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.

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Question # 54

You work for organisation A. You are asked to lead an internal audit of A's quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.

Which of the following actions would you consider appropriate when planning the internal audit of A's quality management system?

A.

Visit Plant A2 to interview personnel of company B

B.

Visit Plant A2 to interview B's quality manager

C.

Visit Plant A2 to interview A's security personnel and B's maintenance department

D.

Interview the A2 plant manager, now working in Plant A1

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Question # 55

What should the auditor document during the Stage 1 audit?

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

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Question # 56

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.

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Question # 57

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Pro’s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company’s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

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

A.

Fair presentation.

B.

Integrity.

C.

Confidentiality.

D.

Objectivity.

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Question # 58

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?

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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Question # 59

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.

When reviewing the customer complaint file, you find that the organisation is facing a legal dispute with a customer over damage to an expensive cashmere coat.

Select the best option for how this should be handled by the Quality Management System.

A.

Settle the court case by negotiation with the customer.

B.

Report the situation to the customer with suggested remedial action.

C.

Make an offer to replace the coat with a new one.

D.

Give an explanation to the customer of what went wrong.

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Question # 60

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

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

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

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

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

Based on the scenario above, answer the following question:

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

A.

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

B.

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

C.

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

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Question # 61

During the opening meeting of a third-party audit of a pharmaceutical organisation (CD9000) with seven COVID-19 testing laboratories in various terminals at a major international airport, you are asked if you could

visit all laboratories. As audit team leader you say that, based on sampling criteria, you had planned to audit only three of them as CD9000 is a multisite organisation.

They tell you that they have worked so hard to get ready for the audit that the supervisors of those laboratories that would not be visited would be quite disappointed.

The following are possible responses to the request, select the two best responses:

A.

I could audit the other laboratories virtually at the end of this audit.

B.

I could decide to extend the audit for an extra day.

C.

I could try to revise the audit programme to see if I can audit all laboratories.

D.

Sorry, this is the plan, we cannot change it. However, they could attend the audit as observers.

E.

The programme manager has selected the sample and we must follow it.

F.

We could stay every day for one hour longer to see those supervisors and their laboratories.

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