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.
Which type of audit risk is the risk that a significant defect may occur in the QMS, although the organization has internal control mechanisms in place?
What are the criteria for reviewing documented information?
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?
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?
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?
During a Stage 1 audit, the Quality Manager asks that the audit includes coverage of a new work area they have expanded into since the application was made.
Which of the following two actions should the auditor take?
"A set of interrelated or interlacing elements of an organization to establish policies and objectives, and processes to achieve those objectives" is the definition of a/an:
Which action indicates that an organization is meeting the requirements of ISO 9001 regarding nonconforming outputs?
In the context of a management system audit, identify the sequence of a typical process for collecting and verifying information. The first one has been done for you.
To complete the sequence click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.
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:
The audit team delayed audit activities until DC’s top management submitted their action plans. Is this acceptable?
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."
Audit criteria are a set of requirements used as a reference against which objective evidence is compared.
Which two of the following are not potential audit criteria?
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.
Which of the following is correct with regard to the internal 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.
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."
In the context of a third-party audit, match the activity with the party responsible in relation to the audit process.
An organisation decides to purchase products and services only from ISO 9001 certified suppliers.
Match the four organisational functions to a potential benefit.
An audit team leader arrives at a printing company to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. The Quality Manager wants the ISO 9001 certificate to cover the new contract.
During the audit, a team member found that some print jobs had been rejected by several clients over some months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract.
The auditor finds that the responsibility for checking spelling errors is placed on the printer that sets up the print run.
In line with the policy of the certification body, the audit team raise improvement opportunities in the audit report. Which
three of the following options would represent acceptable opportunities for improvement in the report?
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.
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.
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?
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD’s top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
Based on scenario 4, conducting which of the activities below is NOT the responsibility of Anne?
In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.
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:
Which of the following misconceptions about ISO 9001 was present in scenario 1?
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 'finished' product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%."
Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells
the audit team leader that a member of the audit team was seen taking photographs of the factory on his phone during the day and
wants him suspended from the Closing meeting with any nonconformities raised by him rescinded. The issue of photographs was not
discussed during the opening meeting.
Select the three options for how the audit team leader might deal with this situation.
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.
Scenario 4 mentions that Anne received a document that contained the audit scope, criteria, duration, and the limits to the audit engagement. What did Anne receive in this case?
What is an advantage of group interviews?
In the context of a third-party certification audit, it is very important to have effective communication. Which is not the responsibility of the audit team leader?
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.
You are preparing for interviews with two members of top management. Based on the information that you gathered about the organization, you conclude that it is the top management who takes all the important decisions and closely supervises and controls employees. Based on this, which management style is practiced in the organization?
ABC is a fast food shop that receives orders by phone or the internet. The normal menu includes 15 different types of hamburgers; however, in the
last two days, due to a shortage of a special type of meat, they can only prepare six of the 15 varieties.
You are performing a third-party audit of ABC; you observed that the menu offering food on the website is still the normal one, with 15 different
hamburgers. During a 30-minute period, you observed several customers reluctantly accepting other than the hamburger they preferred. You decided
to raise the following nonconformity as follows:
"There is evidence that ABC has not reviewed the ability to provide customers the offered products".
The restaurant manager does not accept the nonconformity. She says that ABC had an extensive training programme for all personnel, which you have already seen when auditing Human Resources. This shortage of some hamburgers cannot be considered a management system failure.
Which one would be your answer from the following options?
Match each of the following statements into the table below to show whether they apply to first-party audits, second-party audits or third-party audits:
You are conducting a third-party Stage 1 audit at ABC Ltd, a single-site organisation that manufactures wooden furniture. You interview the Technical Director to learn more about the organisation. The Technical Director explains that they have had a successful year and that obtaining ISO 9001 certification will support the further growth of the business. You ask for an overview of the organisation's structure and its interrelationships with external interested parties.
The Technical Director shows you a document detailing all business processes and interrelationships. You notice in this document that another organisation called Teak Ltd manufactures wooden furniture on behalf of ABC Ltd. The Technical Director confirms this capability has been accounted for in the scope of the quality management system. You learn that the furniture manufactured by Teak Ltd has accounted for 40% of the sales revenue over the previous 12 months.
Which two of the following options best describe how you would plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd?
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?
Who maintains ownership of the audit report?
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:
Scenario 7 states that Sean planned audit activities on his own. Is this acceptable?
You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM)
You: "Would you tell me about your management review process?"
QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained."
You: "May I see the records from the last two management reviews?"
Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."
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?
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be Imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
At the Closing meeting, the audit team leader presents the findings of the audit and comes to the above
nonconformity. The Quality Manager produces the test report for Project DK, which shows an acceptable galvanic efficiency, and presents an email from the customer confirming acceptance of the anodes. He asks that the nonconformity be withdrawn.
Which two of the following responses by the audit team leader would be acceptable?
You are auditing a manufacturer of specialty tea products during a Stage 2 certification audit. In the quality laboratory, you interview one of three operatives conducting sensory testing of a batch from the production line.
Select three options of evidence which could demonstrate conformance with clause 9.1.1 of ISO 9001:2015.
According to ISO 19011, what two activities take place during the conduct of a audit follow-up?
Which two of the following are included in the objectives of the 'Stage 1 initial certification audit'?
What is a combined audit?
Which statement regarding the drafting of the audit conclusions is correct?
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?
Which two of the following may be changed once a Stage 2 certification audit has commenced?
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 conducting an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements. The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You have gathered audit evidence as outlined below. Match the ISO 9001 Clause 8 extract to the audit evidence.
Which one of the following documents addresses audit time calculation for third-party certification audits?
Which of the following subjects should an auditor discuss when communicating with the auditee’s top management?
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.
When should the certification body accept the audit?
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."
This scenario presents a number of audit trails to different ISO 9001 requirements.
Which three of the following requirements would be relevant audit trails for this scenario?
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?
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?
What does an auditor evaluate during an audit follow-up?
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?
Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit?
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:
Sean requested unrestricted access to the employees, executives, and documented information of POLKA. Is this in accordance with audit best practices?
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?
What type of audit evidence are policies and guidelines?
During the opening meeting of a third-party audit of a pharmaceutical organisation (CD9000) with seven COVID-19 testing laboratories in various terminals at a major international airport, you are asked if you could
visit all laboratories. As audit team leader you say that, based on sampling criteria, you had planned to audit only three of them as CD9000 is a multisite organisation.
They tell you that they have worked so hard to get ready for the audit that the supervisors of those laboratories that would not be visited would be quite disappointed.
The following are possible responses to the request, select the two best responses:
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.
