ISO 9001:2015

LEAD AUDITOR
COURSE EXERCISE
WORKBOOK
 TABLE OF CONTENTS

Exercise No. 1 Mapping out Management Principles...............2

Exercise No. 2 Determining PDCA...........................................3
Exercise No. 3 Auditing the Process........................................4
Exercise No. 4 Auditing the Risk and Opportunity Management 5
Exercise No. 5 QMS Terms & Definition...................................6
Exercise No. 6 Auditing Terms & Definition.............................6
Exercise No. 7 Different Types of Audits.................................8
Exercise No. 8 Audit Process...................................................9
Exercise No. 9 Roles and Responsibilities of Audit Team......10
Exercise No. 10 Audit principle & Auditor attributes.............11
Exercise No. 11 Performing Document Review – Context of the
Organization..........................................................................12
Exercise No. 12 Performing Document Review – Leadership and
Commitment..........................................................................13
Exercise No. 13 Performing Document Review – Planning....14
Exercise No. 14 Performing Document Review – Support.....15
Exercise No. 15 Performing Document Review – Operations 16
Exercise No. 16 Performing Document Review –Performance evaluation
..............................................................................................17
Exercise No. 17 Performing Document Review –Improvement18
Exercise No. 18 Preparing Audit Plan....................................19
Exercise No. 19 Audit Checklist Preparation..........................22
Exercise No. 20 Opening Meeting.........................................23
Exercise No. 21 Performing Stage 2 Audit – Case study Analysis 24
Exercise No. 22 Performing Stage 2 Audit – Interview Roleplay28
Exercise No. 23 Writing Non-Conformity Report...................29
DISS/QMS/LA/Exercise book V1.0 Page 1 of 38
Exercise No. 24 Closing Meeting...........................................33
Exercise No 25 Writing Audit Report.....................................34
Exercise No 26 Evaluating Corrective action.........................37

For Classroom Course - Students are recommended to

work in the Flip Chart Provided in the class, later they
can complete their answers individually in this exercise
book for and submit it to the Tutor for continuous
assessment purpose.
For Virtual Course - Students are recommended to
work in the editable file of this workbook during the
Team exercises and present as a Team, later they can
complete their answers individually in the LMS Portal
(learndiss.com) and submit for continuous
assessment purpose.

DISS/QMS/LA/Exercise book V1.0 Page 2 of 38

Exercise No. 1 Mapping out Management
Principles
Instructions: Discuss within the group to match the possible
actions that can be taken by the organization with the
relevant Quality Management principle.
1. Customer Focus 2. Leadership 3. Engagement of people 4.
Process Approach
5. Improvement 6. Evidence Based Decision Making 7.
Relationship Management

S. Possible Actions Management

No Principle
1 Define objectives of the system and PROCESS
processes necessary to achieve them APPROACH
2 Communicate with people to promote ENGAGEMENT
understanding of the importance of their OF PEOPLE
individual contribution;
3 Empower people to determine constraints ENGAGEMENT
to performance and to take initiatives OF PEOPLE
without fear
4 Manage processes and their interrelations PROCESS
as a system to achieve the organization’s
quality objectives effectively and efficiently; APPROACH
5 Link the organization’s objectives to CUSTOMER
customer needs and expectations. FOCUS
6 Encourage an organization-wide LEADERSHIP
commitment to quality;
7 Track, review and audit the planning, IMPROVEMENT
implementation, completion and results of
improvement projects
8 Integrate improvement consideration into IMPROVEMENT
development of new or modified products
and services and processes
9 Determine, measure and monitor key EVIDENCE-
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 indicators to demonstrate the organization’s BASED
performance DECISION
MAKING
10 Measure performance and provide RELATIONSHIP
performance feedback to interested parties, MANAGEMENT
as appropriate, to enhance improvement
initiatives
11 CUSTOMER
Communicate customer needs and FOCUS
expectations throughout the organization
12 Determine relevant interested parties (such RELATIONSHIP
as providers, partners, customers, MANAGEMENT
investors, employees or society as a whole)
and their relationship with the
organization
13 EVIDENCE
Analyse and evaluate data and information
DECISION BASE
using suitable methods
MAKING
14 Ensure the necessary information is PROCESS
available to operate and improve the APPROACH
processes and to monitor, analyse and
evaluate the performance of the overall
system
15 Communicate the organization’s mission, LEADERSHIP
vision, strategy, policies and processes
throughout the organization

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Exercise No. 2 Determining PDCA
Instructions: Discuss within the group the given phrases to
identify the ISO 9001:2015 standard Clause requirements and
find out the activities fall within which stage of plan, do,
check, and act.

S. ISO 9001
No Standard requirements Clause Stage
Number
1 Determining the internal issues and 4.1 P
external issues
2 Evaluating the effectiveness of the 7.2a C
Training conducted
3 Communicating the Raw material 8.4.3a DO
specification to the supplier
4 Top management reviewing the 5.1.1 or ACT/
effectiveness of the risk control
measures 5.1.2 CHECK
5 Monitor customers’ perceptions of the 9.1.2 CHECK
degree to which their needs and
expectations have been fulfilled.
6 Organizing the changes in a way that 6.3b P
it will not affect the integrity of the
QMS.
7 Verifying the performance of the 8.4.1
subcontractor
8 Performing Internal audits to find out 9.2.1a DO
the conformities against requirements
9 5.2.1b PLAN
Developing policy and setting
framework for objectives
10 Enhancing the product quality to meet 10.1a ACT
customer’s future needs.
11 8.6b DO
Authorized person releasing the
product after final inspection
1 Storing the product appropriately to 8.5.4 DO
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 2 ensure no impact on its quality
1 8.3.2j DO
Documenting the design and
3
development outputs
1 10.1b ACT
Correcting the defective parts to meet
4
the customer requirements
1 Investigating the root cause to 10.2.1b ACT
5 determine the cause of the non-
conformity

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Exercise No. 3 Auditing the Process
Instructions: Discuss within the group to determine the Input,
Activities, Output, for assigned Process to be considered while
auditing the process.

Source Inputs Proces Outputs Custom

s/ s er/
Supplie Receive
rs rs

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Exercise No. 4 Auditing the Risk and
Opportunity Management
Instructions: Discuss within the group the objective evidence
can be gathered for risk and opportunity
Management of an organizations to determine the extent of
conformity against ISO 9001:2015 requirements

Clau Clause Title Objective evidence

se
Nu
mbe
r

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Exercise No. 5 QMS Terms & Definition
Instructions: Discuss within the group and match the
following Terms and Definition with reference to
ISO 9000:2015.
S.N Meaning / Definition Term Ans
O wer
1 Set of interrelated or interacting activities Quality
which transforms inputs into outputs
2 Person or group of people that has its own
functions with responsibilities, Policy
authorities, and relationships to achieve
its objectives
3 Action to eliminate the cause(s) of a Objectiv
nonconformity or an incident and to es
prevent recurrence
4 recurring activity to enhance performance Process
5 combination of internal and external Manage
issues that can have an effect on an
organization’s approach to developing and ment
achieving its objectives System
6 Set of interrelated or interacting elements
of an organization to establish Organiza
policies and objectives and processes to tion
achieve those objectives
7 Action to eliminate the cause of a Intereste
potential nonconformity or other potential d Parties
undesirable situation
8 Intentions and direction of an organization Context
as formally expressed by its top of the
management Organiza
tion
9 person or organization that can affect, be Risk
affected by, or perceive itself to be
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 affected by a decision or activity
10 Degree to which a set of inherent
Compete
characteristics of an object fulfils nce
requirements.
11
Effect of Uncertainty Validatio
n
12 confirmation, through the provision of Monitori
objective evidence that the
requirements for a specific intended use ng
or application have been fulfilled
13 determining the status of a system, a Correctiv
process, a product, a service, e
or an activity Action
14 Ability to apply knowledge and skills to Preventi
achieve intended results ve
action
15 Result to be achieved Continua
l
Improve
ment

Exercise No. 6 Auditing Terms & Definition

Instructions: Discuss within the group and match the Terms
with right definition with reference to ISO

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38
19011:2018.

S. Meaning / Definition Term Answer

No
1 fulfilment of a requirement Audit
2 Results of the evaluation of Audit
the collected audit evidence programm
against audit criteria e.
3 Outcome of an audit, after Audit
consideration of the audit plan
objectives and all audit
4 data supporting the existence Audit
or verity of something Objectives
5
Results to be achieved by Audit
performing the Audit Scope
6 Arrangements for a set of one
or more audits planned for a Audit
specific time frame and Criteria
directed towards a specific
purpose
7 Records, statements of fact or Requirem
other information which are ent
relevant to the audit criteria
and verifiable
8 set of requirements such as
standard, Policies, procedures Objective
used as a reference against Evidence
which objective
evidence is compared
9 Description of the activities Audit
and arrangements for an evidence.
audit
10 extent and boundaries of an Conformi
audit ty

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38
11
Measurable Result Nonconfor
mity
12 extent to which planned Audit
activities are realized and findings
planned results achieved
13
Non-fulfilment of a Audit
requirement conclusion
14 need or expectation that is
Performa
stated, generally implied or nce
obligatory
15 systematic, independent and
documented process for Effectiven
obtaining objective evidence ess
and evaluating it objectively
to determine the extent to
which the audit
criteria are fulfilled

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38
Exercise No. 7 Different Types of Audits
Instructions: Discuss within the team and identify the type
of audits and match with the given description

S. Description Type of
No Audit
1 Purchase department audited by Quality
Manager
2 XYZ Corporation audited by its Client
Manager for evaluating the XYZ’s
capability in delivering product as per their
requirements.
3 XYZ corporation is audited by the
independent organization for purpose of
certification or Registration.
4 ABC certification body auditor performed
the audit activities at the
organization’s locations.
5 Auditors review the document thru Online
discussion and observes the work activities
thru surveillance camera from auditor’s
office.
6 ABC certification body auditors performed
the audit on XYZ corporation against their
Quality management system and
Information security management system
together.
7 XYZ corporation is audited by their
customers along with the ABC certification
body.
8 Qatar State Audit Bureau auditing XYZ
Corporation for Verifying the compliance
with applicable laws and regulations.
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9 XYZ corporation assigned ABC certification
body to audit their suppliers for annual
evaluation.
10 XYZ corporation’s Top management
assigned ABC certification body to audit
their different sites for benchmarking their
system.
11 ABC Company implemented QMS and
decided to qualify their external provider,
so they audited them
12 XYZ company audited by local regulatory
body for its capability to comply with
relevant legislation in relation to the
building extension.
13 ABC outsourced the internal auditing to the
external agency and sent their quality
manager to evaluate the auditing firm to
verify if it will meet their requirements.
14 ABC Firm hired the auditing firm to audit a
warehouse facility that will supply the
storage service to the ABC.
15 Auditing firm hired for auditing the
organization’s different site
Exercise No. 8 Audit Process
Instructions: Discuss within the team for the
sequence of activities to be performed during
the Certification body audit by aligning the given
set of activities in a sequential
manner and present it to the forum

Audit Activities Seque

nce
Reviewing the evidence and closing out the
non-conformities
Establish Audit Program objectives
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Conducting the audit activities including
assigning responsibilities to observer
and guide
Evaluating the effectiveness of the corrective
action
Conducting Opening Meeting
Establish and Implement Audit program
Conducting onsite Audit activities including
Interview, Observation, Reviewing
Documents and Records, Analyze the Data
Determining the Audit Objectives, Audit
Scope, Audit criteria for individual audit
Collecting and reviewing information
Select and Determine Audit Methods
Generate audit findings
Selecting the Audit Team and Assigning
Responsibilities
Determine Audit conclusion
Initiating and Preparing the Audit activities
Conducting Closing Meeting
Contacting the auditee and determine
Feasibility
Preparing and distributing audit Reports
Performing document review
Reviewing and approving the corrective
action
Developing the Audit Plan & Assigning work
to the audit team
Preparing documented information for the
audit
Determining and evaluating Audit Programme
Risk and Opportunities

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Exercise No. 9 Roles and
Responsibilities of Audit Team
Instructions: Discuss and assign the listed
Responsibilities to the correct Audit team
members (Lead Auditor, Auditor & Auditee,
Guide, Trainee Auditor, Observer and
Technical Expert)

S. Responsibilities Role
No
1 Select the audit team
2 Communicating audit requirements to
the auditee
3 Auditing in accordance with the
relevant checklists
4 Where time permits, examining
discovered areas of concern
5 Documenting observations
6 Recording evidence
7 support the audit team to complete the
audit in a timely manner
8 Verifying the effectiveness of the
Management System
9 Reporting audit results to the Lead
Auditor
10 Co-operating with and assisting the
Lead Auditor
11 Direct the audit team members
Escorting the auditor team and do not
12 influence or interfere in the audit
process or outcome of the audit.
13 Planning the audit & make effective
use of resources
providing relevant access to the data,
14 activities, process, procedure
and records.
15 Represent and managing the audit
team
16 Follow up of an audit finding with an
agreed timeframe.
17 The preparation of the report
18 Lead the audit team to reach audit
conclusions
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19 Control of the opening and closing
meetings
20 Submission of the report & Audit
records
21 Supports an auditor and provide
feedback on their experience
Provide individual account of an audit
22 to the audit team but does not
participate in the audit
23 Review of the audit team ‘s work
24 Prevent & resolve conflicts
support the audit team on technical
requirements where a team or team
25
member does not have technical
knowledge on specific industry
Process and products.
26 Establish contacts and interview
timings
27 Arrange visits to the areas to be
audited
28 Ensure that safety rules are followed by
the audit team
29 Witness the audit on behalf of the
auditee
30 Providing the clarification or assisting
in collecting information.

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Exercise No. 10 Audit principle & Auditor
attributes
Instructions: Discuss as a Team to analyze the following
scenario about the auditor’s Behavior to determine Good
or Bad and identify the relevant Auditing Principle or the
Auditor Attribute.

S. Go Auditing
N Scenario od Principle
o / /Auditor
Bad Attribute
1 Auditor locking his laptop while leaving to
the washroom and make sure his Audit
records were made available only to the
relevant personnel after the
audit.
2 The auditor audits the QMS of the ABC
company while also serving as the
consultant for developing QMS for ABC
Company.
3 During the interview with the Quality Team
Leader, the QMS certification auditor asked
about the necessary competence
requirements of the QC officers and any
training provided. The Quality Team Leader
informs that the competence requirements
are defined, and the team members were
trained already years ago. Records are
available in the HR department, of course.
The certification auditor accepts the
answer without further.
verification in the HR department. It is the
Quality Team Leader why she should
tell a lie.
4 The auditor diplomatically avoids a
discussion related to the Sports event and
political condition of the state to prevent
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 embarrassment or conflict at a later
stage.
5 ABC Company is unhappy with the
conclusion of the audit report and
threatens to switch the CB next year. Since
the ABC Company is the biggest client of
the
CB, The Auditor modify the audit report to
favor to recommend the certificate.
6 Auditor politely deny accepting the gift
from the Top management as they
provided a laptop as a token of
appreciation for the audit.
7 Auditors do not embellish findings beyond what
objective evidence indicates. He
doesn’t make a situation sound more dire than
it is in an effort to embarrass the auditee into
action. Nor he does minimize findings out of
fear of alienating the auditee feel better. His
reports are truthful, objective, unbiased, and
devoid of condescension. Also, He exercise
discretion, refraining from idle gossip and
disclosure of confidential
information.
8 When an Auditors observes the entire QMS
documentation were kept in electronic
medium, He insists the site to produce
Paper copy to issue the
conformity
9 During the site tour of QMS audit, at the
Lab, while interviewing the QC Inspector,
the Auditor assessing the work
environment, adherence to clothing and
safety protocols, the flow of activities,
placement of product, Lab
equipment’s, its calibration status and
requisite material identification practices,
etc.
10 When an Auditee disagrees and argue
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 against a non-conformity, The Auditor not
taking the arguments in to personal and
explains how the gathered
evidence indicating the non-conformity
against the requirements.

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Exercise No. 11 Performing Document
Review – Context of the Organization
Instructions:
1. Tutor shall assign the teams for performing
Documented information review of the Lion
Polymers arrangements against clause Number
4 of ISO 9001:2015
2. Team shall nominate Lead Auditor and the lead
auditor shall assign the responsibilities within the
team.

Claus Comments Confor Evidence /

e mity Remarks
No. (Yes/
No/NA)
4.1

4.2

4.3

4.4

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Exercise No. 12 Performing Document
Review – Leadership and Commitment
Instructions:
1. Tutor shall assign the teams for performing
Documented information review of the Lion
Polymers arrangements against clause Number
5 of ISO 9001:2015
2. Team shall nominate Lead Auditor and the lead
auditor shall assign the responsibilities within the
team.

Claus Confor
e Comments mity Evidence /
No. (Yes/ Remarks
No/NA)
5.1.1

5.1.2

5.2

5.3

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Exercise No. 13 Performing Document
Review – Planning
Instructions:
1. Tutor shall assign the teams for performing
Documented information review of the Lion
Polymers arrangements against clause Number
6 of ISO 9001:2015
2. Team shall nominate Lead Auditor and the lead
auditor shall assign the responsibilities within the
team.

Claus Confor
e Comments mity Evidence /
No. (Yes/ Remarks
No/NA)
6.1

6.2

6.3

DISS/QMS/LA/Exercise book V1.0 Page 23 of 38

Exercise No. 14 Performing Document
Review – Support
Instructions:
1. Tutor shall assign the teams for performing
Documented information review of the Lion
Polymers arrangements against clause Number
7 of ISO 9001:2015
2. Team shall nominate Lead Auditor and the lead
auditor shall assign the responsibilities within the
team.

Claus Confor
e Comments mity Evidence /
No. (Yes/ Remarks
No/NA)
7.1

7.2

7.3

7.4

7.5

DISS/QMS/LA/Exercise book V1.0 Page 24 of 38

Exercise No. 15 Performing Document
Review – Operations
Instructions:
1. Tutor shall assign the teams for performing
Documented information review of the Lion
Polymers arrangements against clause Number
8 of ISO 9001:2015
2. Team shall nominate Lead Auditor and the lead
auditor shall assign the responsibilities within the
team.

Claus Confor
e Comments mity Evidence /
No. (Yes/ Remarks
No/NA)
8.1

8.2

8.3

8.4

8.5

8.6

8.7

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Exercise No. 16 Performing Document
Review –Performance evaluation
Instructions:
1. Tutor shall assign the teams for performing
Documented information review of the Lion
Polymers arrangements against clause Number
9 of ISO 9001:2015
2. Team shall nominate Lead Auditor and the lead
auditor shall assign the responsibilities within the
team.

Claus Confor
e Comments mity Evidence /
No. (Yes/ Remarks
No/NA)
9.1

9.2

9.3

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Exercise No. 17 Performing Document
Review –Improvement
Instructions:
1. Tutor shall assign the teams for performing
Documented information review of the Lion
Polymers arrangements against clause Number
10 of ISO 9001:2015
2. Team shall nominate Lead Auditor and the lead
auditor shall assign the responsibilities within the
team.

Claus Confor
e Comments mity Evidence /
No. (Yes/ Remarks
No/NA)
10.1

10.2

10.3

DISS/QMS/LA/Exercise book V1.0 Page 27 of 38

Exercise No. 18 Preparing Audit Plan
Instructions: Discuss within the Team and prepare an audit
plan using Flipchart for Performing the audit on Lion
Polymer’s QMS.
Team can refer Lion Polymer QMS Documented Information
provided to them for necessary details and use the IAF
Guideline for planning the number of man days.

Guideline for Calculating Number of Man-day require for

planning QMS audit

DISS/QMS/LA/Exercise book V1.0 Page 28 of 38

 AUDIT PLAN
AUDIT PLAN
Name of Lions Polymer LLP Audit Ref.
Organizati
on No.
Contact Mr. David John Contact 12345678
Person Number
Head Building No. 3, Street 444 Doha Qatar
Office
Site (s) LLP, E4 Sites Ras Laffan
Audit Very conformity with ISO 9001and other Legal Requirements
criteria
Audit Assess compliance with all applicable requirements of the ISO
Objective standard (9001) and regulatory requirements
Scope of Organization’s processes related to the executing turnkey projects
Audit in the field of design, construction of Residential buildings,
commercial buildings and sports complex including the Head
Office in LLP E4 Project Sites, and Departments including,
Operations, Design & Engineering, QA/QC, HSE, Procurements,
HR and Senior Management and Construction Management.
Exclusions N/A
, if any
Audit 23 to 24 January 2024 Total Man 8 days
Date(s) Days
Audit Role Name Remarks
Team Team Leader Felix
Auditor 1 Ahmed
Auditor 2 Angelito
Technical Yahaya/Abid
Expert
Remarks,
if any:

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 AUDIT SCHEDULE
Time
Date From To Process to Auditor / TE
be audited
23rd January 8:00a.m 8:45am Opening Felix
meeting
operation Ahmed
Design and Angelito
Engineering
9:00am 12:00noon Senior Felix
management
procurement Angelito
Logistics Yahaya
12:00 1:00pm Lunch break Audit team
1:00pm 3:30pm HSE Yahaya
QA/QC Angelito
HR Ahmed
Construction Felix
Management
3:30pm 4:00pm Day briefing Audit
team(Each
member)
24th January 8:00am 12:00pm Site visits to All audit team
LLP E4 Sites members
General Angelito
construction
activities
Stores, Ahmed
access/egress,
welfare
12 noon 1:00pm Lunch Audit team
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 1pm 3pm Auditors will Each auditor
compile audit
findings
3pm 3:30 Audit Felix
conclusion
3:30 4pm Closing meeting Audit team and
the
Auditee(Lion
Polymer)

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Exercise No. 19 Audit Checklist Preparation
Instructions:
1. Team Leader can assign responsibilities within the
team and all individuals shall develop Audit
questions/checkpoints to evaluate the extent of
conformity of the QMS of Lion Polymer against Lion
Polymer’s own requirement, ISO 9001:2015 clause
requirements and any applicable legal requirements.
2. Team can use the output generated from previous
exercise 11 to 17 as well to develop the audit
questions based on the area assigned to him as per
the audit plan developed in the exercise 18 .

Clause Requirements Confo Obje Remar

Number rmity ctive ks
(Y/N/ evid
NA) ence

DISS/QMS/LA/Exercise book V1.0 Page 32 of 38

DISS/QMS/LA/Exercise book V1.0 Page 33 of 38
Exercise No. 20 Opening Meeting
Instructions: Discuss in the team to prepare an
agenda for conducting the Opening Meeting and
nominate a Lead Auditor from your team to chair the
Closing meeting.

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Exercise No. 21 Performing Stage 2 Audit –
Case study Analysis
Instructions:
Analyze the Scenario to determine the relevant ISO
9001:2015 Clause requirements and assess the given facts to
determine conformity/Non-conformity/Requires further
investigation

Audit criteria – ISO 9001:2015 Clause 4 to 6

S. Scenario ISO Conformi
No
9001: ty/Non-
2015 conformi
Clau ty/RFI
se
Nu
mbe
r
1 Tubbs Products designs and
manufactures products for Automotive
OEM customers. Product design
activities are conducted at the
Corporate Headquarters Tech Center;
manufacturing is conducted at two plant
facilities. Purchasing is centralized at
Corporate as well. For 9001:2015, they
have determined their scope to be
limited to the two manufacturing
facilities; product design conducted at
Headquarters and Corporate Purchasing
activities are not included in the scope.
2 The Quality Policy of AJCC Corporation
has never been changed. Top
Management, who defined it likes the
initially established policy and does not
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 want it to be revised. The policy was
created taking into consideration the
external and internal context, needs
and expectations of ‘interested
parties’ and the strategic direction of
the organization. The policy includes a
commitment to setting quality
objectives, creating continual
improvement and meeting compliance
obligations and other applicable
requirements. The policy is documented
and available to all interested parties.
3 AJCC Company uses a general risk
analysis method with numerical risk
rankings. Risks ranked above a certain
threshold are addressed with actions.
An audit reveals that while there is
evidence of actions taken, most were
actually corrective actions and there is
no specific process for determining the
need for actions to avoid non-
conformances, nor is there
evidence that the actions taken have
been evaluated for effectiveness.
4 AJCC Company’s Senior Management
understands the core business
processes of its organization, and stated
in the QMS documentation that the only
QMS requirements that integrate with
the core business
processes are Management Review and
Internal Audit
5 During an audit of a Training center, you
discover there are multiple employees
considered to be process owners for key
processes. After interviewing many of
DISS/QMS/LA/Exercise book V1.0 Page 36 of 38
 these employees, you determine that
while they understand the processes as
a group, there is not an individual who
understands all elements of any single
process. None of the individuals that
you interview state that they are the
process owner when asked.
When asked who has responsibility for
things like determining Input and
output, determining control
requirements, Resource planning,
tracking customer scorecards, etc., the
Quality Manager states there is no
specific owner for a given process
because there is shared responsibility
for each process, and they want to
“make Sure that each function is
accountable
for their part”.
6 AJCC’s Sales Operation has a process
to monitor and review information
regarding issues such as customer and
market issues that could affect the
organization. Since the Quality
Management system is focused on
Customer Satisfaction, monitoring of
other issues do not
exist.
7 The ABC organization established
Objectives and targets for all the
processes and function except the Top
management, due to financial concerns
few of the departments were not able to
achieve the
objectives.
8 The audit revealed that the XYZ
corporation adopted few latest
DISS/QMS/LA/Exercise book V1.0 Page 37 of 38
 machineries to improve the
productivity to meet the customer
demands, relevant procedures were
developed, and the workers were
trained, however there is no review
and update found in the risk and
opportunity.
9 The process for determining the
interested parties’ requirements
indicates the review of customer
complaints register and periodical
assessment of the regulatory
requirements. No other consideration
were given stated Quality Manager.
10 Fashionable Garments designs and sells
the Kids cloths. They have marketing
and sales processes to sell the
collections which were produced at the
outsourced production site. When the
auditor reviews the scope of QMS, that
indicates “Design, Manufacturing and
commercialization of
fashion clothes collection”.
Audit criteria – ISO 9001:2015 Clause 7 to 8
11 All the Gauges were calibrated as per
the manufacturer’s instruction except
color comparator. The QC manager told
Color comparator cannot be calibrated
as there is no mechanism available and
there is no national
or international standards are available
for the same.
12 The AJCC Organization’s training
process includes general onboarding
and product-specific on- the-job training
to ensure product conformity. All
employees are trained in company
DISS/QMS/LA/Exercise book V1.0 Page 38 of 38
 policies and receive a general overview
on Quality procedures. There were no
other Trainings were planned.
13 AJCC Company has established a
documented procedure for control of
documents and records relevant to
the Quality management system. All
the document and records have
unique identification number, version
number and date to identify and track
the changes, however there is no
master list of documents available to
track how many numbers of
procedure issued and to whom, as a
result, QMS Representative faced
issue of replacing the old procedure
when the procedure got updated
resulted in workers using obsolete
procedures.
14 AJCC Manufacturing communicates its
Quality policy and objectives to
persons doing work under their control
and ensures these personnel are
aware of their contribution to the
effectiveness of the QMS, including the
benefits of improved performance and
the implications of not conforming to
QMS requirements.
15 The drawing of XYZ parts were not
reviewed and updated even after few
concerns were raised by the customer,
also few repeated emails
from customers were indicating a
request of a change in the design.
16 AJCC Corporation communicates their
Quality requirements to existing
contractors and suppliers. According to
the Purchasing Manager, it is the
DISS/QMS/LA/Exercise book V1.0 Page 39 of 38
 responsibility of the contractors to
follow Quality requirements. “We cannot
control them. If we tell them the Quality
requirements during the
supplier selection process, they will
increase the price.”
17 The customer contract reveals that
Customer supplied gauge number A123
shall be used to verify that the
components meet the requirements
given in drawings XB 113 revision 2.
During the audit the gauge numbered
A123 appears in damaged condition.
You ask the Production Operator about
the condition of the gauge.
The operator responds: “I do not know
about how it received from customer, i
was given the gauge in the current
condition, together with a copy of the
customer’s order and their drawings. I
use it in accordance
with the customer’s instructions and the
components are all acceptable
according to the gauge.” Further
enquired with Manager, he surprised to
see the damaged condition.
18 The documented Supplier Quality
Management Process includes activities
for identifying, selecting and qualifying
suppliers. However, there were no
records found for supplier rating.
19 During the audit the Final products
storage area were found in unhygienic
condition with dust and dirt in the rag.
The Product requires to be stored
in a clean and hygienic condition to
ensure its shelf life.
DISS/QMS/LA/Exercise book V1.0 Page 40 of 38
20 Junior inspector performs final
inspections and allow the products to
get dispatched to the customers
however this job is assigned to the
Senior inspector by the top
management
21 The Quality inspector found few
deviations in the welded component
which further need to send to the
Turning process, however he is not
rejecting or recommending for
reprocess as the production manager
requires all the parts for completing the
production targets.
22 During the audit you observed that
the stamping machine was breaking
down for several days, however they
produced parts in the upcoming days
as well and later once the stamping
machine was ready, the production
team punched the serial numbers.
However, the stamped serial numbers
were not the same in the order the
Quality inspected and reported in the
logbook
23 Monitoring of the process control
parameters was not evidenced for
machine washing process as per the
control plan established and thus
resulted in the defective products
24 During the audit of a construction
company, Client contract specifies the
periodical stage review requires to be
performed throughout the design and
development of the building
construction, Manager stated that the
review performed thru regular meeting,
DISS/QMS/LA/Exercise book V1.0 Page 41 of 38
 however there were no records
were evidenced.
Audit criteria – ISO 9001:2015 Clause 9 to 10
25 You are conducting a third party, ISO 9001:2015
audit of a food
processing company’s internal audit process. You
observed Procurement departments NCs were in
increasing trend, Production departments NC’s
were in decreasing trend, QA/QC department
never had any NC in any of the audit, the Sales
department’s overall NC’s are very few, and the
Logistics department’s overall NC’s are very high.
You also observed that the organisation’s internal
audit programme
has been the same for the past four years and all
the departments are
audited once in a year.
26 AJCC Manufacturing schedules monthly
audits of the QMS beginning in January
of each year. It is September and three-
monthly audits have been completed
thus far. During the last audit cycle,
Management Review, Purchasing,
Supplier Control, and Shipping and
Receiving processes were
audited.
27 AJCC Company monitors the QMS
programs for effectiveness. Current risk
and QMS documentation is not reviewed
or revised, as ISO 9001 does not require
any documented procedures. They have
evidence of an employee suggestion
program that has resulted in cost
savings, quality improvement and lost
time reduction for the current and last
year. They had one Customer compliant
DISS/QMS/LA/Exercise book V1.0 Page 42 of 38
 this year for which a corrective action
was
implemented
28 When performing internal audits, you
note there are monthly audits being
performed. The company only maintains
the nonconformities that were written
during the audits, and the corrective
action on file as evidence that
the audits were conducted.
29 When you were auditing Pipe
Manufacturing unit, you found that there
were multiple instances when the Hose
pipe supplied was returned with the
customer note that the size of product
received is not fit for the purpose and
requested for replace. Each instance
replacement sent, customer was happily
accepted and sent a Thank you note.
Also, the returned parts were reworked
to meet the quality requirements and
further dispatched to the customers.
Since the Managing director is happy
with the arrangements, no further
process is required, stated the Quality
Manager.
30 An internal auditor for a small food
company is assigned to audit
management review. In preparation for
their audit, the auditors reviewed the
past two-yearly surveillance audit
reports from the company’s certifying
body and management review reports
conducted February 01, 2021, February
06, 2022, and March 01, 2023. No other
reports were found in the files. The
DISS/QMS/LA/Exercise book V1.0 Page 43 of 38
 objective evidence did not support the
Management Review being conducted
on a quarterly basis as defined in
the QMS Manual.

DISS/QMS/LA/Exercise book V1.0 Page 44 of 38

Exercise No. 22 Performing Stage 2 Audit –
Interview Roleplay
Instructions:
1. Team leader shall assign responsibilities among
the team and Perform stage 2 audit on LION
POLYMER’S QMS as per the plan developed in
exercise 17 and team member can use the audit
checklist prepared in exercise 18.
1. The tutor shall act as auditee and provide necessary
support to complete the audit.
2. while one team performs the audit. The other team
members shall act as observers.

DISS/QMS/LA/Exercise book V1.0 Page 45 of 38

Exercise No. 23 Writing Non-Conformity
Report
Instructions: write NC reports based on the audit
performed on Lion Polymer’s QMS.

NON-CONFIRMITY REPORT
Audit Reference
Number
NC Reference
Number
Location/Process
audited
Date & Time:
Auditee Name: Category: Major/Minor
Description of the non-conformity

Objective evidence:

DISS/QMS/LA/Exercise book V1.0 Page 46 of 38

ISO 9001:2015 Clause requirement:

DISS/QMS/LA/Exercise book V1.0 Page 47 of 38

 NON-CONFIRMITY REPORT
Audit Ref
Number
NC Reference
Number
Location/
Process
audited
Date & Time:
Auditee Name: Category: Major/Minor
Description of the non-conformity

Objective evidence:

ISO 9001:2015 Clause requirement:

DISS/QMS/LA/Exercise book V1.0 Page 48 of 38

 NON-CONFIRMITY REPORT
Audit Ref
Number
NC Reference
Number
Location/Process
audited
Date & Time:
Auditee Name: Category:
Description of the non-conformity

Objective evidence:

DISS/QMS/LA/Exercise book V1.0 Page 49 of 38

ISO 9001:2015 Clause requirement:

NON-CONFIRMITY REPORT
Audit Ref
Number
NC Reference
Number
Location/Process
audited
Date & Time:
Auditee Name: Category: Major/Minor
Description of the non-conformity

Objective evidence:

DISS/QMS/LA/Exercise book V1.0 Page 50 of 38

ISO 9001:2015 Clause requirement:

DISS/QMS/LA/Exercise book V1.0 Page 51 of 38

Exercise No. 24 Closing Meeting
Instructions: Discuss in the team to prepare an agenda
for conducting the Closing Meeting and
nominate a Lead Auditor from your team to chair the
Closing meeting.

DISS/QMS/LA/Exercise book V1.0 Page 52 of 38

Exercise No 25 Writing Audit Report
Instructions: Discuss within the Team and produce Audit
Reports based on the audit performed on Lion
Polymer’s QMS.

AUDIT REPORT
This report pertains to
Stag Stag Surveill Re- Follow
e1 e2 ance certificatio up
n
Standard: ISO 9001:2015
Audit
Client
Address
Contact
person
Email
Audit
dates
Audit
Location(s)
Audit
objective
Audit
scope
Audit
criteria
DISS/QMS/LA/Exercise book V1.0 Page 53 of 38
 Name of Name of
Lead auditor auditor(s)
Brief
about
client
organiz
ation

This report is confidential, and distribution is limited to

the audit team, client representative and the
CB office.
Areas of good performance

Nonconformity Major
Minor
Observation Observat
ions
OFI

DISS/QMS/LA/Exercise book V1.0 Page 54 of 38

Overall
Comments on
the
compliance
of the system
to the
requirement
of ISO
9001:2015,
Organization’s
policy &
procedure
s and
legal
requireme
nts.

Recommendation:
The Quality Management Systems complies with
the requirements of the reference standard:
Congratulations, on the basis of the above
summary, Lead Auditor is pleased to
put forward a recommendation for issuance of
certificate.
The Quality Management Systems complies with
the requirements of the reference standard with
exception of minor NC: Congratulations, Lead
Auditor is pleased to put forward a
recommendation for registration of Organization
DISS/QMS/LA/Exercise book V1.0 Page 55 of 38
 upon off-site verification of closure of all issues
within 60 days from the date of Stage 2 audit. If
all non-conformances
are not closed within 60 days, a full reassessment
may be required.
Evidence of major nonconformities:
Organization is not recommended for next
assessment at this time. A follow-up
assessment will be scheduled to allow for on-
site verification and closure of all issues within
90 days from the date of Stage 2 audit. If all
non-conformances are not closed within 90
days, a full reassessment may be required.
Not Recommended: Organization is not
recommended for certification, a Stage 2 audit
will be required. To progress your application for
registration, please respond to each non-
conformances, with a plan showing proposed
actions, timescales and responsibilities for
resolution. The organization should consider the
root cause of the non-conformance and the
potential for related issues in other parts of your
system.
Proposed Audit Date for
Surveillance Audit
Sign Off Date: Sign Off Date:
CB Report Submission : Client Acceptance for
Report
Name of Auditor: Signature: Na
me
:
Sig
n:
Designation:
Attachm Audit Plan
ents: Opening and closing
meeting attendance
DISS/QMS/LA/Exercise book V1.0 Page 56 of 38
 record Opening and
closing meeting
attendance record
Assessment checklist
Audit Team Action plan
Report on unresolved issues if any.
Audit Audit
Report client
circula Auditor
tion Team
Certification Manager
Other, please specify

DISS/QMS/LA/Exercise book V1.0 Page 57 of 38

Exercise No 26 Evaluating Corrective action
Instructions: Lion Polymer’s Quality Manager submitted
below correction/corrective action plan. Evaluate the
completeness and effectiveness of correction and
corrective action to close out your audit
findings.
NC 1
The processing plant operators were not aware of the
purpose and importance of the Pressure gauges and
temperature gauges installed in the pasteurizing
equipment and the gauges were found to be overdue for
its calibration.
Correction / Corrective Action proposed by the Auditee.
1. Awareness Training conducted for the Operators
(photographs and Attendance sheet for Training).
2. pressure gauges and temperature gauges were
calibrated. (Calibration certificates attached)
Acceptance of Close out
action Yes/No Justification:
NC 2
The Plastic supplier has not conducted the review before
committing to supply products to a customer, to
incorporate the requirements into the existing Product
as the drawing found not updated with latest
requirements communicated by the customer which
resulted in customer complaints and product return.
Correction/ Corrective Action:
1. Review conducted for the changed
requirements and recorded in the contract review
register (Attached photocopy of the updated
Register)
2. Requirements were updated in the drawing (Attached
Photocopy of updated version drawing)
3. Relevant Procedures were updated, and workers
were communicated about the changes in the
process and product requirements (Attached
DISS/QMS/LA/Exercise book V1.0 Page 58 of 38
updated procedure and Training record)

Acceptance of Close out

action Yes/No Justification:

NC 3
The Final Inspection Records for order number 1234
relating to product XYZ did not contain the
signature of the Chief Inspector, confirming product
conformity with the acceptance criteria, as required
by the product release process.
Correction / Corrective Action:
1. Final inspection records for Order number 1234 was
not signed by Chief inspector as he was on leave on the
Particular day of the delivery.
2. Senior inspector is appointed as alternated person
for product release in the absence of Chief inspector
by the management (Copy of letter of appointment
attached)
3. Senior inspector is Trained for performing Final
inspection against the Client requirements- - Training
records attached -
3.Alternate Persons were identified and appointed
for all key positions affecting the client
requirements and QMS requirements –
Organization chart attached
4. All the appointed person’s RRA matrix updated and
communicated – Records of communication attached
5.Existing Risk and opportunities were reviewed and
updated – Updated R&O register attached.
Acceptance of Close out action Yes/No
Justification:

DISS/QMS/LA/Exercise book V1.0 Page 59 of 38

NC 4
During the audit, Three New employees was found they
have not been undergone for the induction Training as
per the established procedure.
Correction / Corrective Action:
Three employees were sent to attend Induction
Training. -Training attendance sheet, Phot and feedback
from participants were attached.

Acceptance of Close out

action Yes/No Justification:

DISS/QMS/LA/Exercise book V1.0 Page 60 of 38