Month End Sale 70% Discount Offer - Ends in 0d 00h 00m 00s - Coupon code: save70

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

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Question 1

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

Options:

A.

Objective audit evidence and findings

B.

Maintenance and improvement of competence

C.

Schedule of audits

Buy Now
Question 2

What type of audit evidence are policies and guidelines?

Options:

A.

Confirmative evidence.

B.

Technical evidence.

C.

Documentary evidence.

Question 3

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

Options:

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

Question 4

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.

Options:

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.

Question 5

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.

During the audit, a team member finds that a number of print jobs have been rejected by several clients over a number of months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract. The auditor raises a nonconformance against clause 10.2.1.b of ISO 9001.

Which one of the evidence statements would support this finding?

Options:

A.

There was no record that the organisation evaluated the effectiveness of the training given to new employees.

B.

There was no evidence that a check of spelling took place before the release of printing to the client.

C.

The actions taken to deal with customer complaints did not prevent recurrence of the problem.

D.

The organisation did not provide the correct resources to prevent nonconformity.

Question 6

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?

Options:

A.

Evidence-based decision making

B.

Relationship management

C.

Leadership

Question 7

An audit team leader arrives at a printing company 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. The Quality Manager wants the ISO 9001 certificate to cover the new contract.

During the audit, a team member found that some print jobs had been rejected by several clients over some months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract.

The auditor finds that the responsibility for checking spelling errors is placed on the printer that sets up the print run.

In line with the policy of the certification body, the audit team raise improvement opportunities in the audit report. Which

three of the following options would represent acceptable opportunities for improvement in the report?

Options:

A.

Operational planning activities may benefit from a clearer risk-based approach.

B.

The organisation needs to delay its certification to gain more experience of the QMS.

C.

The responsibility for checking printing needs to be independent of the operators.

D.

A business consultant can be recommended for advice on improving operations.

E.

A plan to determine why the errors occur and to prevent them.

F.

An intensive training plan that involves all production personnel.

G.

The recruitment process to include spelling tests to filter out unsuitable candidates.

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.

You are interviewing the Manufacturing Manager (MM).

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

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

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

Options:

Question 9

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

Options:

A.

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

B.

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

C.

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

Question 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).

Options:

Question 11

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

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

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

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

Based on the scenario above, answer the following question:

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

Options:

A.

To verify whether the audit objectives have been met

B.

To encourage the implementation of corrective actions as soon as possible

C.

To identify the persons responsible for the nonconformities

Question 12

Select the words that best complete the sentence:

Options:

Question 13

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

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

requires that a cleaning plan is produced.

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

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

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

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

in the contract?"

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

hospital requests it."

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

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

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

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

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

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

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

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

Options:

A.

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

B.

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

C.

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

D.

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

E.

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

Question 14

You are conducting 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 have gathered audit evidence as outlined below. Match the ISO 9001 Clause 8 extract to the audit evidence.

Options:

Question 15

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'.

Options:

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.

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.

You are interviewing the Manufacturing Manager (MM).

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

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

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

You decide to raise a non-conformity.

Options:

Question 17

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.

Options:

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.

Question 18

A small deaning services organisation is about to start work on a hospital dleaning contract for the local Health Trust. You, as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract requires that a cleaning plan is produced. You: "How was the cleaning plan for the contract developed?" Service Manager: "We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer." You: "How does the plan deal with locations like the intensive care wards and the operating theatres, which are included in the contract?" Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it." You: "Are you aware of the regulatory requirements for cleaning standards in hospitals?" Service Manager: "No. We depend on the hospital to look after that side of things in the contract." You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001. You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was substituted to that specified in the contract. At the follow- up audit, the corrective action proposed was to "obtain a concession from the Health Trust for use of the new chemical." Which one of the following options is the reason why you did not accept this action taken?

Options:

A.

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

B.

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

C.

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

D.

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

E.

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

Question 19

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

Options:

A.

Number of sites to be audited

B.

Risk to achieving audit objectives

C.

Expectations of the organisation's management

D.

Scope of the audit

Question 20

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?

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.

Question 21

You have been nominated audit team leader of a third-party audit. Which of the following could be the two most relevant objectives of this audit?

Options:

A.

Evaluate the satisfaction interested parties

B.

Evaluate the effectiveness of the management system

C.

Identify the need of resources

D.

Evaluate the capability of the management system to establish and achieve objectives

E.

Identify opportunities for improvement

F.

Evaluate the benefits obtained since the implementation of the management system

Question 22

Scenario 4:

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

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

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

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

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

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

Options:

A.

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

B.

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

C.

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

D.

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

Question 23

A Health Trust has contracted with Servitup, a catering services company that has been certified to ISO

9001 for one year. It provides services to 10 small rural hospitals in remote locations involving the

purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for

ward service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with

the Deputy Catering Manager (DCM).

DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really

short of staff."

You: "I see. It really shouldn't affect the QMS so the audit can progress as normal."

DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is."

You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?"

DCM: Give me a minute. I need to look at the Quality Policy on the noticeboard in his office.

You find that two internal audits have been carried out in the first year by the Catering Manager. One of

them indicates that complaints from patients are increasing in number, mainly due to food being served

too cold. The DCM comments that the trolley thermometer is often unreliable.

Which two of the following actions would be "correction" in dealing with the complaints?

Options:

A.

Calibrate thermometers more frequently to ensure accuracy of readings for food temperature on

the trolleys.

B.

Keep a spare thermometer in case of a thermometer malfunction.

C.

Monitor and record the temperature of food on the trolleys against defined standards before

release to the wards.

D.

Plug trolleys into ward electricity sockets to heat food to the correct temperature after a patient

complains.

E.

Purchase a new thermometer to replace the unreliable one used for the ward trolleys.

F.

Request ward staff to test the temperature of the food on the plates before serving to patients.

Question 24

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

Options:

A.

Competence

B.

Experience

C.

Familiarity

D.

Intimidation

E.

Self-audit

Question 25

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

Options:

A.

Requirements of ISO 9001

B.

ISO 19011 Audit principles

C.

Organisation's market sector

D.

Organisation's invoicing and profits of the last 5 years

E.

Organisation's processes

F.

Requirements of auditee's interested parties other than customers

Question 26

According to ISO 9000, what is quality?

Options:

A.

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

B.

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

C.

A set of conditions under which work is performed

D.

The efficiency with which resources are utilized in achieving objectives

Question 27

Scenario 2:

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

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

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

The team defined the QMS scope as:

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

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

The quality policy was established by Leslie and approved by top management. Is this acceptable? Please refer to scenario 2.

Options:

A.

No, the quality policy must be established and approved by top management.

B.

Yes, the quality policy can be established by the QMS implementation team and be approved by top management.

C.

No, the quality policy must be established and approved only by the quality manager.

D.

Yes, as long as top management is informed, the policy can be established by any responsible employee.

Question 28

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

waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.

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

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

You: "What is the reason for that?"

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

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

You: "What happens to the rejected items?"

Auditee: "Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled."

You: "What happens to the waste products?"

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

Which two. of the following actions would you take to investigate further?

Options:

A.

Check the process for handling nonconforming items.

B.

Ask to review the percentage of waste materials.

C.

Find out if operators have regular hearing tests.

D.

Determine what happens to the waste products.

E.

Ask about operator PPE (Personal Protective Equipment).

F.

Determine whether there are quality objectives for reducing rejected material.

Question 29

The procedures of an organisation require that all purchase orders have to be signed by the Purchasing Manager, or, in her absence, by the Production Manager. During an audit carried out in November 2020, an auditor determined that during three weeks in February 2020, the purchase orders were not signed. You raise a nonconformance under Clause 8.4.3 of ISO 9001:2015.

Which one of the following answers would you accept as a 'correction' from the Purchasing Manager?

Options:

A.

All products related to those purchase orders have already been successfully used during the first quarter of 2020, therefore there is no need for correction. We will only take corrective action.

B.

During those weeks, as I was on holiday, the production manager should have signed those purchase orders. As a correction to this particular nonconformity, I will ask him to sign them.

C.

I do not accept the nonconformity. Anything I may ask my employees to do will be seen as another piece of evidence that complying with ISO 9001 requirements is a bureaucratic valueless burden.

D.

I will sign all the purchase orders now. It will take some time to print them since they are on a backup disk, but I will get them done before the end of the audit.

Question 30

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

Options:

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.

Question 31

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

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

Options:

A.

A risk-based approach to the audit programme

B.

The authority of the audit team leader

C.

The availability of competent internal auditors

D.

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

Question 32

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

Options:

A.

The social and economic environments

B.

The competitive environment

C.

Knowledge

D.

The expectations of suppliers

Question 33

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

Options:

A.

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

B.

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

C.

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

D.

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

E.

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

F.

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

Question 34

What are the objectives of the Stage 2 audit?

Options:

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

Question 35

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

Options:

A.

Individual(s) managing the audit programme

B.

Auditee

C.

Guide

D.

Consultant

E.

Observer

F.

Technical expert

Question 36

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.

Options:

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.

Question 37

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

Options:

A.

Evidence-based decision-making

B.

Leadership

C.

Process approach

D.

Risk-based approach

Question 38

You have been just hired as the Internal Lead Auditor of a large organisation, responsible for internal audits. Your first job is to analyse the answers to nonconformities included in the report of a recent internal audit to Top Management.

The report contained one nonconformity as follows:

There is no evidence of Top Management ensuring the availability of resources to operate the QMS, the establishment of objectives, the promotion of continual improvement, and the promoting of the process approach.

Which four of the following Top Management actions can be considered 'corrections to the nonconformity'?

Options:

A.

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

B.

Top Management completed a course on ISO 9001

C.

All these actions will be reviewed during the Top Management meetings

D.

Improvement action has been promoted

E.

Objectives have been established

F.

Process approach has been communicated to the personnel

G.

Resources have been provided

Question 39

ABC is a service organisation that cleans and irons bed and table linen for four large hospitals in the city centre. It claims to meet ISO 9001:2015 requirements. During an internal audit, an auditor observes that

machine No. 4 is being operated with the three variables outside the limits established in the applicable documented procedure SP-701. The auditor has decided to raise a nonconformity.

Which six elements should be included in the nonconformity report?

Options:

A.

Condition of the table linens upon receipt from the hospital

B.

Applicable procedure: SP-701

C.

Competence record of the machine operator

D.

Identification number of the washing machine

E.

Manufacturer of the washing machine

F.

Name of the Quality Manager

G.

Number of the production order

Question 40

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

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

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

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

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

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

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

Options:

A.

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

B.

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

C.

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

D.

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

Question 41

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

auditors) to audit a supplier, 'B', which provides packaging materials to your organisation. It is 4 p.m. and the audit is close to an end; you are having

an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled

for 5 p.m.

You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.

Auditor 1 audited the two manufacturing lines and dispatch areas.

You to Auditor 1: "What findings would you report?"

Auditor 1: "When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same

batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at 11.30 am. Procedure P-02 Rev.3 says

that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device."

You: "OK, what do you think?"

Auditor 2: "I think that this is a nonconformity."

You: "OK. How would you describe the evidence on which the nonconformity will be based"?

Identify which one of the following statements best describes the identified nonconformity.

Options:

A.

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

B.

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

C.

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

D.

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

Question 42

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:

Options:

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.

Question 43

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?

Options:

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

Question 44

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

Options:

A.

Observer.

B.

Technical expert.

C.

Guide.

Question 45

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to

customers.

You are interviewing the Quality Systems Manager (QSM).

You: "What risks and opportunities have the business identified?"

QSM: "I'1l show you. This was discussed with the Managing Director at the latest management review."

Narrative: The QSM shows you the latest management review record and points to the following table:

You: "How is the business planning to address these risks and opportunities?"

QSM: "The MD said that they already knew about them so it was not necessary."

Options:

Question 46

Select six tasks you would expect to be completed at the audit team meeting of a third-party audit team leader and his audit team in preparation for a Closing meeting for a four-day initial certification audit.

Options:

A.

Audit team leader informs the individual(s) managing the audit programme that the closing meeting is ready to be held.

B.

Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the audit for other team members.

C.

Final audit team meeting to agree findings and categories including clarification of any uncertainties.

D.

Agree the roles of each audit team member for the closing meeting.

E.

Audit team review any points raised by the auditee nominated representative.

F.

Audit team agree final audit outcome recommendation.

G.

Audit team leader completes final report, including individual findings and certification recommendation.

Question 47

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

Options:

Question 48

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

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

the auditors, you find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the

anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the

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

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

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

above nonconformity. He thinks it should be clause 9.1.1.

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

Options:

A.

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

B.

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

C.

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

D.

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

E.

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

F.

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

G.

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

Question 49

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

Options:

A.

The quality policy

B.

Internal audit

C.

Both A and B

Question 50

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

Options:

A.

To change the QMS quarterly

B.

To review the QMS annually

C.

To continually improve the QMS

D.

To conduct a QMS gap analysis every two years

Question 51

What is a horizontal audit?

Options:

A.

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

B.

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

C.

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

Question 52

You are conducting a Stage 1 audit at an organisation that services refrigeration equipment for a large customer base.

The scope of certification is "Provision of refrigeration equipment maintenance and repair services". You are interviewing

the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives,

and risks and opportunities in ISO 9001 are addressed.

The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time

refrigeration engineers, which helps to optimise overhead costs. The full-time staff employed are essentially a small team

of office staff who process customer enquiries, schedule jobs and process invoices.

The Managing Director adds that the ISO 9001 requirements for competence of personnel extends to both sub-contract

and full-time staff. He also states that the full-time staff are aware of the Quality Policy, objectives and plans to address

risk and opportunities.

You ask if the sub-contract engineers have been informed of the Quality Policy, objectives and plans to address risks and

opportunities, to which the Managing Director replies that this is not applicable as they only use sub-contractors who

operate ISO 9001 certificated quality management systems. The documented information provided to the auditor

confirms this.

Which clause in ISO 9001 is most likely not to have been fulfilled in this instance?

Options:

A.

7.2 Competence

B.

7.3 Awareness

C.

7.4 Communication

D.

7.5 Documented information

Question 53

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

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

business, say, over the last 12 months?"

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

own products in house."

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

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

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

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

time."

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

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

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

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

that made our product uncompetitive."

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

The auditor asks to speak to the purchasing manager about the selection of the subcontractor to

manufacture the company's own brand products.

You: "How did you choose a supplier to manufacture your products?"

Auditee: "We have had a long-term relationship with a supplier ABC Ltd - we gave them our design

drawings, got them to complete a supplier questionnaire and run a couple of trial batches for us. We were

happy with the result and we have used them ever since."

ISO 9001:2015, clause 8.4.1 outlines situations when controls need to be applied to externally provided processes, products and services. Which one of the following situations is applicable to this scenario?

Options:

A.

Products and services for which the customer(s) supplies materials

B.

A process or part of a process is provided by an external provider as a result of a decision by the organisation.

C.

Products and services are provided directly to the customer(s) by external providers on behalf of the organisation.

D.

Raw materials from external providers are intended for incorporation into the organisation's own products.

Question 54

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

cosmetics for major retailers.

You are interviewing the Manufacturing Manager (MM).

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

MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the

procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records

the time and date alongside."

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

Options:

Question 55

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

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

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

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

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

Based on the scenario above, answer the following question:

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

Options:

A.

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

B.

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

C.

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

Question 56

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?

Options:

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.

Question 57

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

Options:

A.

During the Stage 1 audit, the audit team:

B.

Verifies the degrees of customer satisfaction

C.

Evaluates the conditions of all sites

D.

Reviews the client's management system documented information

E.

Evaluates the results of the last management review

F.

Verifies the compliance with legal requirements

G.

Reviews the processes with high level of risk

Question 58

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

Options:

A.

ISO 17021-1

B.

ISO 19011

C.

ISO 9000

D.

ISO 9001

Question 59

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

Options:

A.

Maintaining logistics

B.

Filling any potential gaps in the auditor's knowledge

C.

Witnessing the audit process on behalf of the certification body

Question 60

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

Options:

A.

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

B.

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

C.

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

D.

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

Question 61

Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.

Options:

A.

Audit use of certification marks on marketing materials.

B.

Review changes to the QMS since last visit.

C.

Confirm effectiveness of internal audit and management review.

D.

Complete a full document review of the quality management system.

E.

Failing to meet financial responsibilities.

F.

Review the status of previously raised findings and audit effectiveness of any outstanding findings.

G.

Review the calibration status of the instrumentation.

Question 62

Which action indicates that an organization is meeting the requirements of ISO 9001 regarding nonconforming outputs?

Options:

A.

Retaining documented information only on the actions taken.

B.

Verifying conformity to the applicable requirements prior to correction of the nonconforming outputs.

C.

Taking appropriate action to nonconforming products and services detected after the delivery of products, during or after the provision of services.

D.

Allowing employees to handle nonconformities based on their own judgment without structured procedures.

Question 63

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

Options:

A.

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

B.

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

C.

By always outsourcing the internal audit function to a third party