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We at Crack4sure are committed to giving students who are preparing for the PECB ISO-9001-Lead-Auditor Exam the most current and reliable questions . To help people study, we've made some of our QMS ISO 9001:2015 Lead Auditor Exam exam materials available for free to everyone. You can take the Free ISO-9001-Lead-Auditor Practice Test as many times as you want. The answers to the practice questions are given, and each answer is explained.
The certification body has not been able to verify the implementation of corrective actions for any identified major nonconformity within six months after the last day of the Stage 2 audit. What must the certification body do in this case?
(Select one option which defines the purpose of a second-party audit to ISO 9001.)
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?
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.
(When raising a non-conformity during an audit, which two of the following items should you include in the non-conformity statement?)
(As the audit team leader, you are planning an audit at an organisation that is seeking certification to ISO 9001. You have confirmed and agreed on the audit scope and audit date with the auditee. The audit team comprises of you and one other auditor. The auditee has two sites and one of these sites is the Head Office where the top management team are based.
The other site is referred to as Site 1, which is located in another country. Apart from that, each site is essentially similar in terms of customer service provision. The other auditor has been selected to audit Site 1 as she lives nearby.
Select four issues you need to finalise before documenting the audit plan.)
An organisation wants to certify their ISO 9001:2015-based QMS for the first time. Arrange the activities in the correct sequence from 2 to 5.
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.
What competence, among others, should each audit team member have?
Select the word that best completes the sentence:
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?
During an internal audit, a manufacturer of polystyrene packaging products for the electronics industry found that six per cent of finished products being ejected from the moulding machines fell onto the factory floor instead of into collection baskets. The factory floor was wet and dirty in places, so a lot of products were rejected at inspection. Auditors raised a non-conformity to the Maintenance Manager.
Select three options for the corrective action to be taken by the Maintenance Manager that could be needed to prevent rejects from recurring.
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.
ISO 9001 addresses changes through several requirements, two examples of which are Clause 6.3 (Planning of Changes) and Clause 8.5.6 (Control of Changes). How do the requirements of Clause 8.5.6 differ from those of Clause 6.3?
Select the words that best complete the sentence:
What type of audit evidence are policies and guidelines?
Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting
The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Ten employees of POLKA were part of the audit team that conducted the internal audit. Is this acceptable?
Read the following role descriptions. Select two roles that are not directly involved in the audit process.
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?
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?
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top-notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS. They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS. AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
The CEO of AL-TAX hired an experienced consultant to help with the implementation of the QMS. Is this required from ISO 9001?
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.
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?
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?
Match the process descriptions below to the process names:
Which two of the following aspects of a quality management system must the organisation continually improve?
Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.
During a second-party audit of a dairy farm (by a potential customer) complying with ISO 9001:2015, the auditor verifies that there is large variability in the daily production of the milking yard. The current agreement with their only customer is to provide 2,000 litres per day. However, in the last two years, they have noticed an increasing variability in daily production.
If they produce less than 2,000 litres, they are penalised with a fine of 1.5 pesos for every litre that they do not provide. If they produce more than 2,000 litres, they use the extra milk to feed the pigs.
This process has been in operation for decades. The dairy farm was founded by the grandfather of the current owners, who did not want to alter the established practices.
The auditor raises a nonconformity on the basis that the process is not under control (Clause 8.1).
If you had been the auditor, which one of the following actions would you have accepted?
Whistlekleen is a national dry cleaning and laundry organization 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 those are the oldest shops in the organization. The cleaning equipment needs replacing, but the organization cannot afford it now. Complaining customers are offered a financial incentive to close the complaint.
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.
Select the one option which correctly describes the non-conformity to be raised against ISO 9001.
Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
Scenario 6 indicates that although the top management did not agree with the audit findings, the audit team began preparing the audit report. Is this acceptable?
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?
Which action indicates that an organization is meeting the requirements of ISO 9001 regarding nonconforming outputs?
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?
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
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?
Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
"The scope of the QMS includes all activities related to food processing."
Leslie established a quality policy and presented it to the team for review before top management approval. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
In scenario 2, the team determined the QMS scope by taking into account only the requirements of top management. Is this compliant with ISO 9001?
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.
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at
a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance
expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?"
GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal
requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon,
shortage of chemicals for the analysis. It was quite a good experience."
You: "Did you document these issues?"
GM: "No. Jack said that ISO 9001 does not require us to document these issues."
You: "How did you determine the risks associated with the issues and did you plan actions to address them?"
GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence."
Select two options for how you would respond to the General Manager's suggestion:
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?"
TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry."
You: "How is their regulatory competence maintained?"
TD: "They are dedicated individuals with lots of contacts in the sector."
You: "How does the business enable them to maintain their understanding of current regulatory requirements?"
TD: "We leave that up to them."
What is a horizontal audit?
Which one of the following is not an ISO 9000:2015 quality management principle?
For each of the following scenarios, select four that are corrective actions.
What are the criteria for reviewing documented information?
Select the two statements that are true.
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'.
What is reliability in the context of service quality?
Select the two activities which pertain to Third-Party Audit.
What is a list of actions that should be performed during the audit with their respective timeline?
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).
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?
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?
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'
You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.
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.
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:
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top-notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS. They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS. AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
As stated in scenario 1, AL-TAX tested the effectiveness of the intended actions as part of the QMS improvement through the PDCA cycle. Which stage did it perform in this case?
An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
"The reject rate of the finished product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%."
As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective action, the Quality Manager conducted an investigation into the reject rates. He reported that the collection baskets for products ejecting from the moulding machines were not large enough. About 6% of products fell onto the wet and dirty factory floor. Management stated that replacing the baskets was too costly and ordered the Maintenance Manager to ensure that the floor was kept clean and dry to prevent rejects. The auditor later checked the factory floor, which was wet and dirty in places.
From the following nonconformities, select three that the auditor could raise to ISO 9001.
In the context of a second-party audit, match the activity with the party responsible for conducting it.
Which statement regarding the drafting of the audit conclusions is correct?
The following actions need to be carried out during a third-party audit planning stage. Which two actions correspond to the individual(s) managing the audit program before the involvement of the audit team leader’
When monitoring customer perceptions, which analysis is helpful to use?
An organisation decides to purchase products and services only from ISO 9001 certified suppliers.
Match the four organisational functions to a potential benefit.
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."
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies
specialist laboratory equipment and furniture.
You: "I'd like to look at how you manage change in the organisation. What changes have you made as a
business, say, over the last 12 months?"
Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our
own products in house."
You: "That sounds like quite a significant change. What has been the impact of that?"
Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced
manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members
of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging
time."
You: "I'm sure. What were the reasons for making the change?"
Auditee: "Our manufacturing section was a small operation, and we struggled to cope with fluctuations in
demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with
little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices
that made our product uncompetitive."
You: "How did you go about the change?"
In relation to the auditor's question about how the change was managed, the auditee mentions the steps
listed below. Match the ISO 9001 clauses to the steps.
To complete the table, click on the blank section you want to complete so it is highlighted in red and then
click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which step the
requirement applies to.
You are conducting an ISO 9001 audit of a Materials Recycling Facility. 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."
After further auditing, you have gathered additional evidence. Match the following
statements to the correct ISO 9001 standard clause shown.
To complete the table, click on the blank section you want to complete so that it is
highlighted in red, and then click on the applicable text from the options below.
Alternatively, drag and drop each option to the appropriate blank section.
You are an auditor and are in dialogue with the quality manager and the managing director of a small business that supplies specific IT
hardware and software for manufacturers of medical equipment.
You: "I would like to look at how you manage the design and development of your products.
Auditee: "We have made some strategic changes, the main one being that since last month we no longer produce the software of our
products in-house."
You: "What has been the impact of that?"
Auditee: "We now subcontract the provision of the software needed for our hardware. This allowed us to concentrate our efforts on
the hardware and let specialised organisations develop the software. For the time being, we have subcontracted our software
requirements to three different organisations.
You: "What were the reasons for making the change?"
Auditee: "Our IT software section was a small operation, and we struggled to cope with new technologies. 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."
You: "How did you go about the change?"
In relation to the auditor's question about how the change was managed, the auditee mentions the actions listed
below. Match the ISO 9001 clauses to show which action the requirement applies to.
To complete the table, click on the blank section you want to complete so it is highlighted in red and then click on the
ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which clause the action applies to.
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.
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:
You are an auditor from a construction company 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.”
Select the two checkpoints you should investigate further in the situation.
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TESTED 24 Feb 2026
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