Assessment name: QMS-1

1. Below are four of the seven principles on which ISO 9000 series are based. Match each a related potential
benefit to each of quality management principles (QMP).

Quality management principles:

• Customer focus : ________________________________________

• Engagement of people : ________________________________________
• Improvement : _________________________________________
• Evidence-based decision-making : _________________________________________

To complete the table, 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, you may drag and drop each of the following potential benefits
to a QMP.

Option:

• Better communication between levels and functions of the organisation

• Increased revenue and market share
• Common understanding of objectives and values among interested parties
• Improved operational effectiveness and efficiency
• Enhanced trust and collaboration throughout the organisation
• Enhance drive for innovation Increased ability to demonstrate effectiveness of past actions

2. ISO 9001 is based on quality management principles. Match each of the following quality management
principle to the related activity.

Related activities:

• Communicate client needs and expectations throughout the organisation: ________________

• Encourage an organisation-wide commitment to quality: ___________________________
• Empower staff to determine constraints to performance and to take initiatives without fear: _____________
• Establish authority, responsibility, and accountability for managing processes: _______________________
• Continuously educate and train people at all levels on how to apply basic tools and methodologies to achieve
objectives: ________________________
• Determine, measure, and monitor key indicators to demonstrate the organisation's performance: _________
• Determine relevant interested parties (such as providers, partners, customers, investors, employees, or
society as a whole) and their connection with the organisation: _____________________________

To complete the table, 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, you may drag and drop each of the following quality
management

Options:

• Customer focus
• Leadership
• Engagement of people Process approach
• Improvement
• Evidence-based decision making
• Relationship management
 3. Which one of the following options is the definition of the context of an organisation?
o Complexity of internal and external issues that can take an effect on an organisation's approach to
developing and achieving its purpose.
o Consideration of internal and external issues that can have a positive or negative effect on an
organisation's success.
o Combination of internal and external issues can have an effect on an organisation's approach to
developing and achieving its objectives.
o Control of internal and external issues that can have an effect on an organisation's desire to achieve its
objectives.

4. Read the following role descriptions. Select four that accurately describe the role of a person directly involved
in the audit process.
o A guide - a person who is appointed by the auditee to assist the audit team during the audit.
o An auditor-in-training - a person who accompanies the audit team leader or team members during the audit.
o A technical expert - a person who provides specific knowledge or expertise to the audit team but is not
normally an auditor.
o An interpreter – a person who witnesses the audit to assist the auditors with language issues.
o An audit team leader - a person responsible for managing an audit until the audit is completed.
o An observer - a person who sees the performance of the audit team leader, audit team members and/or
auditee.

5. Which three of the following aspects of a quality management system must the organisation continually
improve?
o Adequacy
o Efficiency
o Suitability
o Effectiveness
o Applicability
o Responsiveness

6. You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as internal
auditor. The Quality Manager asks you to lead the next internal audit to Production and includes two other
internal auditors.

To complete the sentences, 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, you may drag and drop section.

*if practicable

• You should not: _________________________

• You need not: ___________________________
• You must: ___________________________
• You must not: __________________________
• You should: __________________________

Options:

• audit production
 • carry out a formal opening meeting
• raise audit findings if necessary
• change the audit team
• send the audit report to the Quality Manager

7. According to ISO 19011, what four activities take place during the audit follow-up?
o Contact client to agree requirements for personal protection equipment (PPE)
o Report on status of the corrective actions to the person managing the audit programme
o Update the audit programme, if required
o Lead the opening meeting
o Prepare the audit plan
o Prepare and distribute the audit report
o Prepare audit work documents
o Assign roles and responsibilities of observers
o Determine feasibility of the audit
o Verify effectiveness of actions taken to fix the reported nonconformities
o Verify effectiveness of the implemented corrective actions

8. In the context of a third-party certification audit, match the roles with the following responsibilities:

To complete the table click on the blank section you want to complete so it is highlighted in red and then click on the
applicable text from the option responsibility.

Responsibilities:

• Conduct the audit to the assigned area.

• Assist the auditors in identifying personnel to participate in the audit.
• Assign each team member's responsibility for the audit.
• Respond to questions and provide evidence to the auditor.

Options:

• Auditors
• Guide
• Audit team leader
• Auditee

9. To complete the sentence, the with best word(s), click on the blank section you want to complete so it is
highlighted in red and then click on the applicable text from the option(s) below. Alternatively, you may drag and
drop the option(s) to the appropriate blank section.

In the context of third-party audit, the amount of detail provided in the audit plan should reflect the ____________
and ____________ of the audit, as well as the risk of not achieving the audit objectives.

Options:

• requirements
• time
• scope
• management's expectation
• complexity
10. Which four of the following statements related to Stage 1 of an initial certification audit against ISO
9001:2015 are true?

During the Stage 1 audit, the audit team:

o Reviews the client's management system documented information

o Reviews the allocation of resources for Stage 2 audit
o Verifies the compliance with legal requirements
o Verifies the degrees of customer satisfaction
o Reviews the processes with high level of risk Reviews
o Evaluates the results of the last management review
o Verifies the planning of internal audits
o Evaluates the conditions of all sites
o Reviews the understanding of the requirements of ISO 9001 by the production manager
o Audits top management

11. Which three of the following may be changed once a Stage 2 certification audit has commenced?
o Audit plan
o Audit checklists
o Members of the audit team
o Audit scope

12. 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?

o ISO management system standards

o Commitment to follow principles issued by an NGO
o Environmental aspects register
o Claims made on the organisation's website
o Commercial advertisements
o Health and safety notices
o Organisation's documented information
o Verbal statements by the general manager
o Verbal agreements with interested parties
o Written agreements with interested parties

13. 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?

o Advise the Quality Manager that the audit scope has been set and the audit will proceed as planned.
o Suggest that the Quality Manager cancels the audit contract and reapplies for the new situation.
o Determine whether the Quality Management System covers the new work area and, if so, proceed with the
audit.
o Suggest that she will advise the programme manager that the audit scope should be revised to include the
new work area.
 o Advise the Quality Manager that, within the existing scope, the new work area can be included without any
problem.
o Advise the Quality Manager that an extension of the scope is possible but will have to go through established
procedures.

14. A customer decides to carry out a second-party audit of an external provider.

The scope of the audit is defined by the ___________, the ___________is defined by the _______________, and the
audit team is nominated by the customer.

To complete the sentence, the with best word(s), click on the blank section you want to complete so it is highlighted in
red and then click on the applicable text from the option(s) below. Alternatively, you may drag and drop the
appropriate blank section.

Options:

• external provider
• individual(s) managing the audit programme
• audit programme
• certification body
• customer
• audit plan
• audit team leader

15. You are a member of the audit team of a second party audit to an organisation with n (= 625) employees. The
audit procedure recommends using as sampling criteria √n (= 25) when auditing personnel competence
documented information. The audit team leader developed an audit plan allocating one hour to audit the
Human Resources department (from 11.30am to 12.30pm). She told you that she could not allocate any
additional time.

What would you do?

o Extend the audit until 1.00pm and ask for a quick lunch later.
o Plan to review as many as possible until 12.30pm and then review the rest during the lunch break.
o Plan to review less than 25 examples.
o Plan to review as many as possible and see if you can stay later during the first day of the audit to review the
rest.

16. Which of the following two documents does an auditor need to prepare and complete prior to the on-site
audit?
o Checklist/Prompts
o Procedures
o Audit Plan
o Audit Report
o Findings
o Risk Matrices
17. Which three of the following work documents are not required for audit planning by an auditor conducting a
certification audit?
o An organisation's financial statement
o A sample plan
o A checklist
o A career history of the quality manager
o An audit plan
o A list of external providers

18. 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."

You decide to raise a nonconformity.

To complete the nonconformity report, click on the blank section you want to complete so it is highlighted in red and
then click applicable text from the options below. Alternatively, you may drag and drop the options to the appropriate
blank section.

Nonconformity Report

ISO 9001 Clause Number: ____________________

Nature of problem: _______________________

ISO 9001 requirement that has not been fulfilled: _______________________________

Options:

Clause: 1) 7.1.6 2) 7.1.2 3) 7.2

Problems:

1) The organisation has not ensured that persons doing work under the organisation's control are aware of
relevant quality objectives.
2) The business has not maintained its organisational knowledge.
3) The organisation has not determined the necessary competence of the Regulatory Experts with respect to
relevant regulatory requirements.
Requirement:

1) ISO 9001 - "The organization shall determine and provide the persons necessary for the effective implementation
of its quality management system."

2) ISO 9001 - "The organization shall determine the knowledge necessary for the operation of its processes and to
achieve conformity products and services."

3) ISO 9001 - "The organization shall ensure that persons are competent on the basis of appropriate education,
training, or experience.

19. 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.

Date Batches of product made Production line to be Number of cleaning Cleaned by records
cleaned

10/XX 10 Line 1 DS 6

14 Line 2 HM 8

11/XX 12 Line 1 WR 7

12 Line 2 DD 9

12/XX 15 Line 1 DS 10

To complete the nonconformity report, 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, you may drag and drop the options to the
appropriate blank section.

Nonconformity report

ISO 9001 Clause Number: ________________

Nature of problem: ___________________________

ISO 9001 requirement that has not been fulfilled: ________________________________

Evidence: 40 cleaning records available for 63 batches.

Options:

Clause: 1) 6.2.1 2) 8.5.4 3) 8.7

Problem:

1) Cleaning and sanitising not always completed.

2) Cleaning and sanitising not always completed by trained staff.
3)

Requirement:

1) ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the
product requirements have been met."
2) ISO 9001-"The organization shall implement production provision under controlled conditions."

20. 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 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 below. 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 clause 8.3 extracts listed below. Alternatively, you
drag and drop each clause to the audit evidence that applies.

Audit evidence:

• Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got
enough people in his team to cope with the demand for new products.
• The NPD Manager explains many changes are made to cosmetic formulations during product development
owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on
SWIFT.
• The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by
email. These emails are kept on SWIFT.
• The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior
to full-scale launch.
• The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trails
on some formulations during product development.

Options:

“8.3.2e) …internal… resource needs for the design and development of products..."

"8.3.6... retain documented information..."

"8.3.5... retain documented information...”

“8.3.4d) conducted to ensure that the design and development outputs meet...”

"8.3.2e) ... external... resource needs for the design and development of products...”
21. 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."

highlighted in red and then click on the applicable text from the options below. Alternatively, you may drag and drop
the options to the appropriate blank section.

Nonconformity report

ISO 9001 Clause Number: _________________________

Nature of problem: _____________________________

ISO 9001 requirement that has not been fulfilled: _______________________

Options:

Clause: 1) 9.3.3 2)9.3.1 3)9.3.2

Problem:

1) Management review records are not being retained.

2) Issues raised at management review are not being actioned.
3) Management review has not been conducted at the defined frequency.

Requirement:

1) ISO 9001-"Top management shall review the organization's quality management system."
2) ISO 9001-"The organization shall retain documented information as evidence of the results of management
review."
3) ISO 9001-"Top management shall review the organization's quality management system at planned
intervals."

22. 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 have been realised for a second time. A new Quality Manager has been brought in at 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.

o A quality objective to achieve lower reject rates by quality control.

o An increase in the programme of internal audits.
o The certification body auditor reporting fewer nonconformities.
o An enhanced customer satisfaction survey score than in the previous year.
o Removing underperforming external providers from the database.
o Considering results from the analysis of the effectiveness of corrective actions to determine improvement
opportunities.

23. 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.

Quality Improvement Request QI/12/20/HR-3

To: HR Manager QMS awareness training is to be included as part of the Date: 12/12/20XX
induction training for new employees.
Action by: 31/03/20XX

Update by: 01/20XX Update by: 02/20XX Update by: 03/20XX Signed: (QM)

Notes: Use of external resources for this action must be approved by senior Action Completed:
management.
(Signature)

Date:

After further auditing, the issues below were found. Select three statements that apply to the term 'nonconformity.

o Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the
Quality Manager.
o Quality improvements not aligning with the quality policy.
o Limited knowledge of the content of Quality Improvement Requests by departmental staff.
o The single quality objective set for the organisation by the Quality Manager.
 o Decisions on improvement action timescales not involving departmental managers.
o Evaluation of the results of the improvement action not always documented by the Quality Manager.

24. 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 six options that provide a meaningful audit trail for this process.

o What risks and opportunities have been identified as significant?

o What input does a customer have in the course design process?
o What training does a tutor have in the completed course?
o How is design documentation controlled and managed?
o How are students advised about prior learning requirements?
o What are the qualifications of the development staff?
o How is technical content of courses verified as correct?
o How is the cost of the course calculated?
o How is customer feedback integrated into the course?

25. 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 six of the following requirements would be relevant audit trails for this scenario?

o Control of externally provided processes, products, and services

o Documented information
o Measurement traceability
o Design and development of products and services
o Leadership and commitment
 o Planning of change
o Organisation roles and responsibilities
o Preservation of product
o Property belonging to customers or external providers
o Resources

26. 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?

o Why did you take on this contract knowing that the audit was due to happen?
o Will your organisation pay for the extra half day to cover the audit of the new area?
o How can we audit this area when we do not have an IT specialist in the team?
o Do you realise that this involves an extension to the scope of the audit and will require an application
process?
o Would you mind anting to my programme manager with this request?
o Would you like a separate certificate for the IT packages to show your new client?

27. An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a
meeting with the Quality Manager, she is told that they have won their biggest contract from a computer
manufacturer to print and compile computer documentation packages. They have leased the unit next door for
space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001 certificate
to cover the new contract.
During the audit, a team member finds that a number of print jobs have been rejected by several clients over a
number of months due to spelling errors in the print run. The Print Manager blames the new employees they
had to take on because of a big contract. The auditor raises a non-conformance against clause 10.2.1.b of ISO
9001.

Which of the evidence statements would support this finding?

o There was no record that the organisation evaluated the effectiveness of the training given to new
employees.
o The organisation failed to check the competence in spelling of new employees.
o There was no evidence that a check of spelling took place before the release of printing to the client.
o The actions taken to deal with customer complaints did not prevent recurrence of the problem.
o The organisation did not provide the correct resources to prevent nonconformity.
o The organisation failed to ask the customer to proofread a print sample.

28. Whistlekleen is a national dry cleaning and laundry organisation with 50 shops. You are conducting a
surveillance audit of 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 organisation. The cleaning equipment
needs replacing but the organisation cannot afford it now. You learn that the shop managers were told to
dismiss most of the claims based on 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.

To complete the table, click on the blank section you want to complete so it is highlighted in red and then click on the
applicable clause of ISO 9001 below. Alternatively, you may drag and drop each of the following clause's ISO 9001
shown to the appropriate statement:

• The organisation informing customers of the reason for the damage to their laundry.
• Management allocating sufficient resources to replace outdated equipment.
• Corrective action to deal with customer complaints.
• Top management addressing the risk of damage to customer property.
• Management setting a quality objective for the level of customer complaints.

Options:

• 6.2
• 7.1.3 b
• 10.2.1 b
• 5.1.2 b
• 8.5.3

29. 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 have gathered audit evidence as outlined below. 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 clause 8 extracts listed below. Alternatively, you
may drag and drop each ISO 9001 Clause 8 extract listed with the audit evidence that applies.

Audit evidence:

• Three subcontract trainers who had delivered training were not approved as defined in procedure SA1
Supplier Approval revision 3.
• A training programme for a customer was not documented as required in procedure TD 2 Training revision 2.
• One trainer had not recorded the damage to a customer's training room wall caused by using sticky tape to
hang training aids, as required in procedure TD 2 Training revision 2.
• Five sales orders had no record of having been reviewed to verify the ability to provide these courses.

Options:

• “8.2.3.1 shall conduct a review before committing...”

• “8.4.1…shall apply criteria for ... external providers...”
• “8.3.5…shall retain documented information on design and development outputs."
• "8.5.3...shall retain documented information on what has occurred."

30. 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 external consultant who assisted the implementation of ISO 9001. 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:

o I would not accept the consultant answering the question.

o I would ask the consultant to leave the meeting since he is not an employee of the organisation.
o I would ask to get in contact with the Technical Manager by phone.
o I would look for evidence that the actions resulting from the risk assessment had been taken.

31. 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 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 of the following actions would you take to investigate further? Select three.

o Determine whether there are quality objectives for reducing rejected material.
o Check the waste skip to determine what kind of materials are rejected.
o Check the process for handling nonconforming items.
o Ask about operator PPE (Personal Protective Equipment).
o Find out if operators have regular hearing tests.
o Ask to review operator training records.

32. An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering company which
manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium
products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the
company 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 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.
During the audit team meeting in preparation for the Closing meeting, the second auditor disagrees with the clause
of ISO 9001 selected for the above nonconformity. He thinks it should be clause 9.1.1.

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

o Support you as the auditor raising the nonconformity since you have seen all the evidence.
o Advise that he will think about the clause and announce his decision during the Closing meeting.
o Invite you and the second auditor to fully explain your point of view and then decide which clause to select.
o Try to obtain a consensus between you and the second auditor after a discussion of the different opinions.
o Agree with the second auditor that clause 9.1.1 would be better.
o Suggest that neither clause is accurate and instead propose clause 9.1.3 as the best one for the
nonconformity.
o Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best
apply.

33. Select six stages you would expect a third-party audit team leader and his audit team to complete in
preparation for a Closing meeting for a four-day initial certification audit.
o Write the audit finding report out when detected and obtain signature of the auditee.
o Final audit team meeting to agree findings and categories including clarification of any uncertainties.
o Re-audit corrective actions taken to correct findings found during the audit.
o Audit team complete final version of their individual findings.
o Audit team review any points raised by the auditee nominated representative.
o Audit team leader sends out invitation for all auditee staff to attend the final meeting.
o Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the
audit for other team members
o Audit team agree final audit outcome recommendation.
o Audit team leader completes final report, including individual findings and certification recommendation.

34. 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?

o Applicable procedure: SP-701

o Number of the production order
o Identification number of the washing machine
o Weight of linen being washed vs the maximum weight required in SP-701
o The planned duration of the process vs the minimum time required in SP-701
o Name of the Quality Manager
o Summary of the competence of the machine operator
o The concentration of the cleaning liquid used vs the concentration fixed in SP-701
o Manufacturer of the washing machine

35. 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%."

As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective
action, the Quality Manager conducted an investigation into the reject rates. He reported that the collection baskets
for products ejecting from the moulding machines were not large enough. About 6% of products fell onto the wet
and dirty factory floor. Management stated that replacing the baskets was too costly and ordered the Maintenance
Manager to ensure that the floor was kept clean and dry to prevent rejects. The auditor later checked the factory
floor, which was wet and dirty in places.

From the following nonconformities, select three that the auditor could raise to ISO 9001.

o 7.1.1 -The organisation failed to provide the required resources to prevent nonconforming products.
o 7.1.4 -The factory environment did not contain the infrastructure for production operations.
o 7.3 -staff were not aware that products were falling onto the factory floor.
o 8.5.1 -production operations were not properly controlled to avoid reject products.
o 8.5.4 -finished products were contaminated by poor handling.
o 9.2.2 -Report 14202 contained a poorly worded nonconformity (NC 3).
o 10.2.1 -Conduct of an investigation is not sufficient to satisfy the requirement for corrective action.
o 10.3-The organisation did not continuously improve. Reject rates were unchanged.

36. 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 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?

o Purchase a new thermometer to replace the unreliable one used for the ward trolleys.
o Keep a spare thermometer in case of a thermometer malfunction.
o Plug trolleys into ward electricity sockets to heat food to the correct temperature during food service as per
procedures.
o Request ward staff to test the temperature of the food on the plates before serving to patients.
o Monitor and record the temperature of food on the trolleys against defined standards before release to the
wards.
o Calibrate thermometers more frequently to ensure accuracy of readings for food temperature on the
trolleys.
37. During a second-party audit to 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 the 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?

o Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and
make an agreement with a second customer.
o Analyse the daily dispatch of milk for 30 days to determine its variability.
o Apply the existing process of addressing the risks and opportunities of milk production.
o Retain the current contract and try to sell the occasional surplus milk to a second customer.

38. 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 is a serious breach to 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:

o Inform the Quality Manager that you consider the meeting closed, and that you will report to the
Certification Body
o Inform the Quality Manager that the certification process is put on hold and leave the room.
o Ask the Quality Manager to listen to the nonconformity the auditor will present and continue with the
meeting until its closed
o Ask the Quality Manager for a break to discuss the issue with the members of the audit team.
39. 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 of the following options would be your preferred response to the final comment made by the warehouse
manager?

o We will hear what you were asked to tell us and will leave copies of the nonconformity reports that have
been agreed with the quality manager. Please tell the managers that we will consider this as the Closing
meeting and that the individual(s) managing the audit programme will send the full report in five days.
o We will hear what you were asked to tell us and will then leave. Please ask the managers to contact us as
soon as the emergency is over to agree on a new date to carry out the Closing meeting.
o We will hear what you were asked to tell us and will ask you to sign the nonconformity reports as evidence
that you have accepted them. Please ask the managers to contact us as soon as the emergency is over to
agree on a new date to complete the Closing meeting.
o Sorry, but we cannot proceed with the Closing meeting. So, we are leaving now, and please tell the quality
manager that I will phone him tomorrow early in the morning.