Month End Sale - Special 70% Discount Offer - Ends in 0d 00h 00m 00s - Coupon code: 70dumps

ISO-9001-Lead-Auditor Questions and Answers

Question # 6

A Health Trust has contracted with Servitup, a catering services organisation which has been certified to ISO 9001 for 1 year. It provides services to ten, small rural

hospitals in remote locations involving purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital

staff. An auditor is conducting the first sole surveillance audit at one site with the Deputy Catering Manager (DCM).

At the closing meeting attended solely by the DCM, the auditor informs him that he has found numerous gaps in the QMS processes which lead him to consider

recommending suspension of the organisation's certification. He is particularly concerned with the evidence that patient health is being adversely affected by produce

stored beyond its safe consumption date, poor kitchen hygiene and undercooked meals. The DCM says that he cannot make any decisions about these issues in the

absence of the Catering Manager due to illness but will write everything down and report to the Catering Manager.

Which two actions should you take in the context of the audit?

A.

Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit.

B.

Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body.

C.

Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course.

D.

Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work.

E.

Recommend that all personnel should be given urgent in-depth training in the QMS.

F.

Thank the DCM for his time and express an expectation that improvements will be made in the QMS.

Full Access
Question # 7

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.

Full Access
Question # 8

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.

Full Access
Question # 9

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

A.

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

B.

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

C.

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

D.

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

E.

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

F.

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

Full Access
Question # 10

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

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

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

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

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

method of setting objectives.

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

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

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

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

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

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

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

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

A.

Decisions on improvement action timescales not involving departmental managers.

B.

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

C.

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

D.

Quality improvements not aligning with the quality policy.

E.

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

F.

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

Full Access
Question # 11

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

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.

Full Access
Question # 12

Which statement regarding the drafting of the audit conclusions is correct?

A.

The audit conclusions must be drafted based on observation

B.

The audit conclusions must be based on evidence that is examined and evaluated in terms of quantity and quality

C.

The audit conclusions must not include the revisions that resulted from the closing meeting

Full Access
Question # 13

You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing

structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the

adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.

You: "How do you tell when the billet is ready for the rolling stage?"

Operator: "I've done this job for 20 years. I can tell by the bright red colour."

You: "What happens if the colour is wrong?"

Operator: "The billet goes back into the furnace."

You: "Is the pyrometer ever used?"

Operator: "Only in borderline cases."

You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the borderline cases.

Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.

A.

Periodic analysis of the results of temperature checks.

B.

Certification of conformance to national standards from the manufacture of the pyrometer.

C.

An increase in the use of the pyrometer by operators.

D.

Maintenance plan for the furnace.

E.

A procedure that provides instruction in taking billet temperature.

F.

Planning for monitoring and measuring the billet temperature.

G.

A quality objective to achieve lower recycle rates for billets.

Full Access
Question # 14

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

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

Match the ISO 9001 Clauses to the statements.

Full Access
Question # 15

You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below;

Head Office and Site 1 - Day 1

Site 2 (150 Km from HQ) - Days 2 and 3

During Day 1 of the audit, the dient informs you that the laboratory at Site 2 has been dosed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.

As the audit team leader, what would you do?

Choose the best acceptable action you could take:

® Ask the audit Programme Manager for direction.

Complete the audit on day 3 and report back to the certification body for a certification decision.

Continue the audit on days 2 and 3 and return later to audit the Site 2 laboratory.

Immediately cancel the audit since the audit plan cannot be completed.

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

A.

The audit team leader

B.

The audit team member

C.

The auditee organisation

D.

The certification body

Full Access
Question # 16

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."

Full Access
Question # 17

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.

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

Full Access
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.

Full Access
Question # 19

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.

Full Access
Question # 20

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

Which two of the following are not potential audit criteria?

A.

ISO management system standards

B.

Verbal statements by the general manager

C.

Verbal agreements with interested parties

D.

Health and safety notices

E.

Written agreements with interested parties

F.

Commercial advertisements

G.

Organisation's documented information

Full Access
Question # 21

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).

Full Access
Question # 22

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.

Full Access
Question # 23

Who maintains ownership of the audit report?

A.

The audit team leader

B.

The auditee

C.

The certification body

Full Access
Question # 24

Who assigns a guide to assist the audit team?

A.

The certification body

B.

The auditee

C.

The audit team leader

Full Access
Question # 25

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

processes waste plastics into raw material for plastic bottle manufacturers. You reach the manual

picking line where operators are removing contaminant materials from incoming products, such as

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

You interview the line supervisor.

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

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

You: "What is the reason for that?"

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

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

materials."

You: "What happens to the rejected items?"

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

products that cannot be recycled."

You: "What happens to the waste products?"

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

After further auditing, you have gathered additional evidence.

Full Access
Question # 26

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

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

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

during the audit (NC1 and NC2).

They said:

Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a

serious car accident, and the other two managers have had to leave urgently to attend to the emergency."

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

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

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

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

A.

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

B.

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

C.

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

D.

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

Full Access
Question # 27

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements. The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.

You are interviewing the Training Manager (TM).

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

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

You: "How do you measure this objective?"

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

Which two of the following statements are true?

A.

You would check the training of personnel.

B.

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

C.

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

D.

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

E.

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

F.

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

Full Access
Question # 28

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.

Full Access
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:

Scenario 1 indicates that AL-TAX did not ensure clear and open communication channels with interested parties. Which quality management principle did the organization not follow in this case?

A.

Evidence-based decision making

B.

Relationship management

C.

Leadership

Full Access
Question # 30

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

A.

A career history of the quality manager

B.

A checklist

C.

A list of interested parties

D.

An audit plan

E.

An evidence sampling strategy

F.

An organisation's financial statement

Full Access
Question # 31

Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit

of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.

The auditor samples the design records for a recently completed course for the 247 Insurance organisation. Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage

was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.

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

A.

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

B.

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

C.

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

D.

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

Full Access
Question # 32

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.

Full Access
Question # 33

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

A.

An auditor employed by an external consultancy organisation

B.

An auditor from an interested party

C.

An auditor trained in-house

D.

An auditor trained in the IRCA scheme

E.

An auditor certified by IRCA

F.

An auditor from a customer

Full Access
Question # 34

Which one of the following documents addresses audit time calculation for third-party certification audits?

A.

ISO 17021-1

B.

ISO 19011

C.

ISO 9000

D.

ISO 9001

Full Access
Question # 35

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

A.

The social and economic environments

B.

The competitive environment

C.

Knowledge

D.

The expectations of suppliers

Full Access
Question # 36

TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important

customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit

team discussed and agreed both nonconformities with TIX's quality manager. The Closing meeting was planned for 6pm with the general manager,

quality manager and service manager at the meeting room.

At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the

warehouse supervisor. Neither have participated in the audit.

The dialogue among them is as follows:

Audit team leader: "Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?"

Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and

the other two managers have had to leave urgently to attend the emergency."

Warehouse supervisor: "They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message

from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed."

Which one of the following options would be your preferred response to the final comment made by the warehouse manager?

A.

Sorry, but we cannot proceed with the Closing meeting. So, we are leaving now, and please tell the quality manager that I will phone him tomorrow early in the morning.

B.

We will hear what you were asked to tell us and will ask you to sign the nonconformity reports as evidence that you have accepted them. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to complete the Closing meeting.

C.

We will hear what you were asked to tell us and will leave copies of the nonconformity reports that have been agreed with the quality manager. Please tell the managers that we will consider this as the Closing meeting and that the individual(s) managing the audit programme will send the full report in five days.

D.

We will hear what you were asked to tell us and will then leave. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to carry out the Closing meeting.

Full Access
Question # 37

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.

Full Access
Question # 38

When should the certification body accept the audit?

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.

Full Access
Question # 39

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

Full Access
Question # 40

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

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

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

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

Based on the scenario above, answer the following question:

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

A.

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

B.

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

C.

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

Full Access
Question # 41

State the correct sequence of events in the certification process for an organisation to obtain third-party accredited certification to ISO 9001.

Full Access
Question # 42

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

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

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

A.

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

B.

Verify if Teak Ltd are certified to ISO 9001

C.

Verify the controls concerning customer property implemented by Teak Ltd

D.

Verify how ABC Ltd evaluates the performance of Teak Ltd

E.

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

F.

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

Full Access
Question # 43

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?

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.

Full Access
Question # 44

You are conducting a third-party audit to ISO 9001 and interviewing the Training Manager. She explains that training is more

important than ever because the organisation has had to reduce the number of staff employed. Many of the remaining staff

are now required to be 'multi-skilled'. You ask to see plans for the multi-skilling training and are shown plans that look

comprehensive, and include both 'on the job" training and internal and external training courses.

The records indicate that several staff required parts of their training to be repeated one month after the first training was

provided. You ask why this was needed and are told that an investigation of customer complaints identified that several staff

members did not complete certain tasks in the correct manner. The extra training was therefore recommended as a

corrective action.

Based on this interview, which two of the tollowing audit trails would be the most appropriate to follow?

Select the two most appropriate audit trails from the following.

A.

Ask if customer complaints had ceased since the multi-skilled training finished.

B.

Ask the members of staff whether they found the training received useful.

C.

Assess whether Quality objectives are being met.

D.

Determine whether customers were consulted about the risks associated with the multi-skilling training.

E.

Determine whether management has assessed the impact of staff reduction on the organisation's ability to meet its objectives.

F.

Review records to assess if all planned training has been completed.

Full Access
Question # 45

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?

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

Full Access
Question # 46

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

Full Access
Question # 47

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

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

Full Access
Question # 48

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

Full Access
Question # 49

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.

ACB sent the audit objectives to the audit team after an agreement was reached. Is this acceptable?

A.

Yes, the audit objectives should be known only after an agreement is reached.

B.

No, only the auditee should know the audit objectives.

C.

No, the audit objectives should be part of the audit offer.

D.

Yes, as long as the audit team leader approves.

Full Access
Question # 50

What are the criteria for reviewing documented information?

A.

Content, format, and the procedure for managing documented information

B.

Language of documented information, internal audit reports, client feedback

C.

Archive, volume, and confidentiality of documented information

Full Access
Question # 51

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.

Full Access
Question # 52

ABC is a worldwide fast-food organisation. One of the branches, in downtown Cape Town, decided to

implement an ISO 9001 quality management system and you are the audit team leader (with two other

auditors) that will carry out the certification audits, Stage 2.

ABC receive the orders by phone or internet; some of the employees deliver the ordered food to indicated

addresses. The normal menu includes 15 different types of hamburgers; however, in the last two weeks,

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

During the internal meeting of the audit team, you ask one of the auditors to describe what she has

observed. She audited the reception of orders from customers (via phone or internet) and the

communication of the orders to the kitchen. She noticed that the menu offering food on the website is still

the normal one, with 15 different hamburgers, and during a 30-minute period, she observed many

customers reluctantly accepting something other than the hamburger they preferred.

You, as audit team leader, inform the Quality Manager of your concern about the major nonconformity,

since you consider this a serious breach of the basic principles of quality that lasted two weeks without

action being taken.

Right at the beginning of the Closing meeting, you discuss the nonconformity with the General Manager.

She got quite upset and said she was going to make a complaint to the certification body and left the

room; the Quality Manager was the only member of ABC left with the audit team. The Quality Manager said the General Manager would not come back to the meeting.

What would you do? Choose the best from the following options:

A.

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

B.

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

C.

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

D.

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

Full Access
Question # 53

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.

Full Access
Question # 54

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

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.

Full Access
Question # 55

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

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

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

A.

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

B.

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

C.

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

D.

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

E.

There were no receipt inspection records of the incoming materials.

F.

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

Full Access
Question # 56

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?

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.

Full Access
Question # 57

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

Full Access
Question # 58

Match the process descriptions below to the process names:

Full Access
Question # 59

Scenario 2:

Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.

To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.

Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.

The team defined the QMS scope as:

"The scope of the QMS includes all activities related to food processing."

Leslie established a quality policy and presented it to the team for review before top management approval. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.

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

A.

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

B.

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

C.

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

D.

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

Full Access
Question # 60

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.

Full Access
Question # 61

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

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

Full Access
Question # 62

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.

Full Access
Question # 63

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

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

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

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

Based on the scenario above, answer the following question:

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

A.

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

B.

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

C.

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

Full Access
Question # 64

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

A.

Objective audit evidence and findings

B.

Maintenance and improvement of competence

C.

Schedule of audits

Full Access
Question # 65

In the context of a third-party certification audit, match the roles with the following responsibilities:

Full Access