Question # 4
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organization manufactures cosmetics for major retailers 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.
Question # 5
The following are stages of an audit, put them in the order they would be conducted.
Question # 6
You are a member of the audit team of a second-party audit of an organisation with 625 employees. The audit procedure recommends using sampling criteria which requires the review of the documented competence for 25 personnel. The audit team leader developed an audit plan allocating one hour to audit the Human Resources department (from 11:30 am to 12:30 pm). She told you that she could not allocate any additional time.
What would you do?
Question # 7
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?
Question # 8
Which two of the following aspects of a quality management system must the organisation continually improve?
Question # 9
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?
Question # 10
'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.
Question # 11
You are conducting a Stage 1 audit at an organisation that services refrigeration equipment for a large customer base.
The scope of certification is "Provision of refrigeration equipment maintenance and repair services". You are interviewing
the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives,
and risks and opportunities in ISO 9001 are addressed.
The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time
refrigeration engineers, which helps to optimise overhead costs. The full-time staff employed are essentially a small team
of office staff who process customer enquiries, schedule jobs and process invoices.
The Managing Director adds that the ISO 9001 requirements for competence of personnel extends to both sub-contract
and full-time staff. He also states that the full-time staff are aware of the Quality Policy, objectives and plans to address
risk and opportunities.
You ask if the sub-contract engineers have been informed of the Quality Policy, objectives and plans to address risks and
opportunities, to which the Managing Director replies that this is not applicable as they only use sub-contractors who
operate ISO 9001 certificated quality management systems. The documented information provided to the auditor
confirms this.
Which clause in ISO 9001 is most likely not to have been fulfilled in this instance?
Question # 12
A Health Trust has contracted with Servitup, a catering services company that has been certified to ISO
9001 for one year. It provides services to 10 small rural hospitals in remote locations involving the
purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for
ward service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with
the Deputy Catering Manager (DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really
short of staff."
You: "I see. It really shouldn't affect the QMS so the audit can progress as normal."
DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is."
You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?"
DCM: Give me a minute. I need to look at the Quality Policy on the noticeboard in his office.
You find that two internal audits have been carried out in the first year by the Catering Manager. One of
them indicates that complaints from patients are increasing in number, mainly due to food being served
too cold. The DCM comments that the trolley thermometer is often unreliable.
Which two of the following actions would be "correction" in dealing with the complaints?
Question # 13
Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit?
Question # 14
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.
Question # 15
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?
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Question # 17
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.
Question # 18
During a second-party audit, the auditor examines the records that are available for the external provider, ABC Forgings, to whom manufacturing has recently been outsourced.
There are standard external provider checklists for three competitors for the contract and there are inspection records from the trial manufacturing batches produced by ABC Forgings. There is no documented evidence of the criteria used to confirm the appointment of ABC Forgings, and no contract or terms and conditions. Ongoing monitoring indicates that external provider performance is satisfactory, but no documented information has been retained.
Select two options for the evidence which demonstrates a nonconformity with clause 8.4 of ISO 9001.
Question # 19
In the context of a third-party certification audit, how can the auditor demonstrate confidentiality? Select two.
Question # 20
You work for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other
auditors) to audit a supplier, 'B', which provides packaging materials to your organisation. It is 4 p.m. and the audit is close to an end; you are having
an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled
for 5 p.m.
You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.
Auditor 1 audited the two manufacturing lines and dispatch areas.
You to Auditor 1: "What findings would you report?"
Auditor 1: "When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same
batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at 11.30 am. Procedure P-02 Rev.3 says
that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device."
You: "OK, what do you think?"
Auditor 2: "I think that this is a nonconformity."
You: "OK. How would you describe the evidence on which the nonconformity will be based"?
Identify which one of the following statements best describes the identified nonconformity.
Question # 21
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.
Question # 22
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.
Question # 23
State the correct sequence of events in the certification process for an organisation to obtain third-party accredited certification to ISO 9001.
Question # 24
According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?
Question # 25
An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer
manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001
certificate to cover the new contract.
Which one of the options is the correct response by the auditor?
Question # 26
Which two of the following auditors would not participate in a first-party audit?
Question # 27
In the context of a third-party management system certification audit, which two of the following statements are correct?
Question # 28
You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The organisation processes
waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also compromise our
quality standards. We need to protect our reputation for good quality output materials."
You: "What happens to the rejected items?"
Auditee: "Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled."
You: "What happens to the waste products?"
Auditee: "I'm not sure. I suppose they go to landfill."
Which two. of the following actions would you take to investigate further?
Question # 29
In the context of a second-party audit, match the activity with the party responsible for conducting it.
Question # 30
The following actions need to be carried out during a third-party audit planning stage. Which two actions correspond to the individual(s) managing the audit program before the involvement of the audit team leader’
Question # 31
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'
Question # 32
XYZ Corporation is an organisation that employs 100 people. As audit team leader, you are conducting a
certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you
find that quality objectives have been set for every employee in the organisation except top management.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive
is asking questions about how much it will cost. He asks for your opinion on whether this is the correct
method of setting objectives.
Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit
Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality
objectives for all employees and replaced them with a single objective for himself. This states that "The
Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates
that this gives him the authority to issue instructions to department managers when quality improvement is
needed. He says that this approach has the full backing of senior management. He shows you the latest
Quality Improvement Request that was included in the last management review.
After further auditing, the issues below were found. Select two statements that apply to the term
`nonconformity'.
Question # 33
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?
Question # 34
Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.
Question # 36
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:
Question # 37
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements. The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You are interviewing the Training Manager (TM).
You: "What quality objectives apply to the training process?"
TM: "One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses."
You: "How do you measure this objective?"
The Training Manager shows you a record on her computer and you see the following:
Which two of the following statements are true?
Question # 39
In the context of a third-party audit, match the event with the responsibility for conducting it.
