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In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.
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?
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?
XYZ Corporation is an organisation that employs 100 people. As audit team leader, you are conducting a
certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you
find that quality objectives have been set for every employee in the organisation except top management.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive
is asking questions about how much it will cost. He asks for your opinion on whether this is the correct
method of setting objectives.
Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit
Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality
objectives for all employees and replaced them with a single objective for himself. This states that "The
Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates
that this gives him the authority to issue instructions to department managers when quality improvement is
needed. He says that this approach has the full backing of senior management. He shows you the latest
Quality Improvement Request that was included in the last management review.
After further auditing, the issues below were found. Select three statements that apply to the term 'audit trail'
A 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?
Which two of the following are included in the objectives of the 'Stage 1 initial certification audit'?
For a third-party, match the Activity with the Responsibility for conducting it.
TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important
customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit
team discussed and agreed both nonconformities with TIX's quality manager. The Closing meeting was planned for 6pm with the general manager,
quality manager and service manager at the meeting room.
At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the
warehouse supervisor. Neither have participated in the audit.
The dialogue among them is as follows:
Audit team leader: "Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?"
Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and
the other two managers have had to leave urgently to attend the emergency."
Warehouse supervisor: "They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message
from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed."
Which one of the following options would be your preferred response to the final comment made by the warehouse manager?
You are conducting a third-party audit to ISO 9001 and the next item on your audit plan is 'internal auditing'.
When reviewing a sample of audit records up to 5 years previously, you find that many contain non-conformance reports and no actions have been taken. You interview the Quality Manager.
You: "I have noted that many of the older files contain non-conformances that have not had any corrective action taken."
Quality Manager: "Because the business is always changing, the departmental managers tell me that the non-conformances are no longer applicable. I made a decision that any non-conformance over 3 years old is automatically closed"
You: "Do you obtain any confirmation beforehand from the appropriate departments that the non-conformances are no longer applicable."
Quality Manager: " No, because they are so old I consider that they are no longer appropriate. Please remember that we take a risk-based approach which means we audit where and when it is considered important to do so.
Select one course of action you would now take from the options.
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?
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?
At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only
two people are present and waiting for them: the Health and Safety supervisor and the Administrative Officer.
Neither has participated in the audit. However, the team had previously agreed with the auditee Quality
Manager on two nonconformities identified during the audit (NC1 and NC2).
They said:
Health and Safety Supervisor: "Good evening. We are sorry to inform you that the general manager was
involved in a serious car accident, and the other two managers have had to leave urgently to attend to the
emergency."
The Administration Officer: "Concerning 'nonconformity 2', the General Manager left a message asking us
to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in
which he explains why."
Which one of the following would be your preferred answer (as team leader) to the General
Manager's request?
Among others, what does Clause 4.4 (Quality Management System and Its Processes) of ISO 9001 require from organizations?
Which of the following subjects should an auditor discuss when communicating with the auditee’s top management?
One of the conflict resolution techniques is toning down. How is the conflict managed in that case?
'XYZ' has already sent to you a list with all documented procedures and work instructions related to the services provided to 'ABC' (a quality manual is not included in the list).
To complete the audit planning which additional information would you ask to XYZ to submit? Select four.
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?
You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The company
processes waste plastics into raw material for plastic bottle manufacturers. You reach the manual
picking line where operators are removing contaminant materials from incoming products, such as
plastic bags, plastic film and badly contaminated items that would compromise the recycling process.
You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also
compromise our quality standards. We need to protect our reputation for good quality output
materials."
You: "What happens to the rejected items?"
Auditee: "Some get melted down in another process later on and some are disposed of as waste
products that cannot be recycled."
You: "What happens to the waste products?"
Auditee: "I'm not sure. I suppose they go to landfill."
After further auditing, you have gathered additional evidence.
During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.
Which corrective action is the best one?
XYZ Corporation employs 100 people, and during a Stage 1 certification audit, certain issues are identified with the Quality Management System (QMS). Which two options describe the circumstances in which you could raise a nonconformity against Clause 6.2 of ISO 9001:2015?
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.
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?
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 decides to review the training course design process in more depth.
Select three options that provide a meaningful audit trail for this process.
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.
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?
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.
Which stages of the audit were performed?
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:
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.
Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit?
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.
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?
The Closing meeting of a second-party audit was planned for 6 pm with the general manager and the quality manager.
At 6 pm, when the audit team enters the meeting room, only the Quality Manager is present and walting for them.
The dialogue among them is as follows:
Auditor team leader: "Good evening, could you please inform the general manager that we are ready to start with the closing meeting?"
Quality manager: "Good evening. I am sorry to inform you that the general manager will not be able to attend the meeting. He will try to
participate virtually to make some closing remarks."
Auditor team leader: "OK. We identified seven nonconformities - these are the reports. Could you please review them and sign them?"
Quality manager: "OK. As you know, I reviewed them after yesterday's meeting and accept of all them, where shall I sign?"
General manager (from speakers in the room and addressing the quality manager): "Hold on! Do not sign the two nonconformities related to ABC
Bank! I have just checked, and we did not provide any services to ABC Bank during September! You can sign the remaining five nonconformities."
How would you proceed with the audit? Select one.
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS)
documentation, you find that quality objectives have been set for every employee in the organisation except top management. The Quality Manager complains that this has created a lot of resistance
to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
How would you respond with the following options? Select three.
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?
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.
Which statement below indicates that an organization has developed its communication strategy by taking into account the principle of appropriateness?
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 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.
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?
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?
You are carrying out an annual audit at an organisation that has been certificated to ISO 9001 for two years. The organisation offers home security
services. The scope of the quality management system covers alarm installation, alarm servicing, alarm monitoring and response. The business
operates from a single office and employs subcontract installers and service technicians across the country.
You have just completed the opening meeting. You are interviewing the Managing Director (MD).
You: "I would like to gain an understanding of how the quality management system has been supporting your business and its strategic direction."
MD: "We are continuing to face difficult times. The market is extremely competitive, and customers typically look for the least expensive option when
choosing home security services. We have not yet seen any business benefit from our quality management system."
You: "Tell me how you determine external and internal issues."
MD: "We use SWOT analysis (Strengths Weaknesses, Opportunities, Threats)."
You: "How have the outputs from your SWOT been used?"
Select two of the following audit trails would you take to explore the extent to which the SWOT analysis and the outputs from this
have been used to enable the business to achieve the intended results(s) of its quality management system according to ISO 9001.
Takitup is a small fabrication organisation that manufactures steel fencing, stairs and platforms for the construction sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit plan during a surveillance audit covers the organisation's improvement actions and the auditor asks to see the most recent management review meeting minutes.
The auditor finds that the management review report records that none of the improvement actions set by the previous review has been realised for a second time. A new Quality Manager has been brought in at the middle management level to rectify the situation as the organisation is concerned that it might lose its certification.
Select three options that would provide evidence of conformance with clause 10.3 of ISO 9001.
Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
According to general principles of sampling procedure, did the audit team select a valid sample for electrical services?
Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
"The scope of the QMS includes all activities related to food processing."
Leslie established a quality policy and presented it to the team for review before top management approval. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
Which of the following indicates that Bell has defined its quality objectives?
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.
You work for organisation A. You are asked to lead an internal audit of A's quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.
Which of the following actions would you consider appropriate when planning the internal audit of A's quality management system?
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?
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.
You are auditing an organisation that has been certificated to ISO 9001 for ten years. The organisation is a privately-owned, multi-site car tyre fitting
organisation. You are auditing one of the sites. You are auditing the car tyre fitting service. You are interviewing the Site Manager (SM).
You: "Would you explain the car tyre fitting service?"
SM: "Of course. Customers typically call us by phone with their requirements. We ask them what they want. We check whether we have the tyres
they need in stock. If we don't have the tyres in stock, we contact our supplier to confirm when they would be able to supply the tyres. We then
determine the cost. We then check what availability we have in our busy schedule to fit the new tyres. We then inform the customer with details of
cost and when we can fit the tyres. If the customer is happy to proceed with the booking, we update our Work Schedule. The same process applies
for customers who walk into our office and for online requests."
You: "What information do you retain should there be a defect reported by a manufacturer of tyres that you have fitted?"
SM: "We maintain records of customer names, addresses and contact phone numbers. We maintain a record of the type of tyre fitted and the tyre
manufacturers batch information. We also maintain a record of the registration numbers of the vehicles we have fitted tyres to. All records are in our
Work Schedule."
Which two of the following options you would take to enable you to gather further audit evidence to validate what the Site Manager
has told you?
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."
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?
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.
TESTED 30 Aug 2025
