ISO 9001 Internal Auditor Course Notes MF
ISO 9001 Internal Auditor Course Notes MF
ISO 9001:2015
INTERNAL AUDITOR TRAINING
COURSE
QUALITY
MANAGEMENT
SYSTEM
a. Management systems
INTRODUCTION
• The Plan, Do, Check, Act (PDCA) cycle
THE COMPANY • The core elements of a management
system and the interrelationship
TUV SUD Philippines designed this between top management
Quality Management Systems (QMS) responsibility, policy, objectives,
Internal Auditor training course to; planning, implementation,
measurement, review and continuous
• provide attendees with the knowledge improvement.
and skills required to perform first,
second and third-party audits of Quality
b. Quality management
management systems against ISO 9001,
in accordance with ISO 19011, as • The fundamental concepts and the
applicable, seven quality management principles
(see ISO 9000).
All references to ISO standards in this • The relationship between quality
document are to the current versions, management and customer satisfaction.
unless stated otherwise.
c. ISO 9001
Course Notes;
An understanding of the requirements of
ISO 9001 and the commonly used quality
• is designed for the purpose of detailing management terms and definitions, as
the presentation of the course TUV SUD given in ISO 9000, which may be gained by
PHILS as an ISO 9001 Internal Auditor completing a CQI and IRCA Certified ISO
training course. 9001:2015 Foundation (QMS)Training
• details the minimum requirements course or equivalent
presented fully in accordance with the
company confidential nature of training
methods and materials used for this
course.
• is established and developed to ensure
that the learning objective is effectively
attained and meet the requirement, the
company’s training policy and TUV SUD
Phil’s satisfaction.
TUV SUD ME.QIT072 Rev. No.: 00 Rev. Date: 17 MAY. 2020 Page 1 of 40 FROF
Learning objectives COURSE OUTLINE
Learning objectives describe what attendees The Quality Management System Internal
shall be able to do by the end of the course. Auditor Training Course is a 2-day course
Attendees will need to demonstrate acceptable combining tutorials, group exercises and role
performance in all of these areas in order to play activities in relation to the simulated
complete the course successfully. assessment of the case study company. It will
provide with both theory and practical
By the end of the course attendees should be application in a safe learning environment.
able to attain:
COURSE FORMAT
Knowledge
This is applied for the whole duration of 2 days.
1.1.1 With reference to the PDCA cycle,
explain the process-based quality
management system model for ISO The course is formatted as follows;
9001 and the role of an internal audit
in the maintenance and improvement • The first day starts with introduction of
of quality management systems (see participants and tutor/s.
2.1). • Course outlined to view the program for
the 2-day training schedules.
1.1.2 Explain the role and responsibilities of • Training by formal tutorials, individual
an auditor to plan, conduct, report and task, group exercises and role play
follow-up an internal quality involving assessment of a fictitious
management system audit, in company.
accordance with ISO 19011. Discussion and feedbacks after the
exercises.
• The training days begin with review of
Skills the previous day topics and end in
consolidation of the learning objectives
1.1.3 Plan, conduct, report and follow-up an for the day.
internal audit of part of a quality • Breaks’ timing in between lessons.
management system based on ISO
9001, and in accordance with ISO The format and structure of the course is subject
19011. for continuing improvement by providing
allowance for adjustment or changes thus giving
both theory and practical applications in a safe
learning environment.
TUV SUD ME.QIT072 Rev. No.: 00 Rev. Date: 17 MAY. 2020 Page 2 of 40 FROF
Classroom-based training
COURSE PROGRAM
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COURSE NOTES
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DAY 1
Day 1 - Understanding of Quality Management System Internal Audit and related issues
REQUIREMENT NOTES
• Registration
• Distribution of
training materials
• Participants/Tutor • Name
introduction • Organization
• Attendance
• Responsibility
• Training rules and
regulations • Understanding of ISO 9001 (rate 1- 10)
• Introduction • Expectation in this course
Learning objectives All participants of this course are expected to have the following prior
Prior Knowledge knowledge: Please check if you have the knowledge, if not read the note
below.
a. Management systems
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b. Quality management
c. ISO 9001
REQUIREMENT NOTES
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Quality The adoption of a quality management system is a strategic decision for an
Management organization that can help to improve its overall performance and provide a sound
System basis for sustainable development initiatives.
Purpose:
The potential benefits to an organization of implementing a quality management
system based on this International Standard are:
• the ability to consistently provide products and services that meet customer and
applicable statutory and regulatory requirements;
• facilitating opportunities to enhance customer satisfaction;
• addressing risks and opportunities associated with its context and objectives;
• the ability to demonstrate conformity to specified quality management system
requirements.
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hilippines nternal ditor raining o rse ss ed . .
REQUIREMENT NOTES
Structure and ISO 9001 Standard promotes the adoption of a process approach when developing,
content of ISO implementing and improving the effectiveness of a quality management system, to
9001 based on enhance customer satisfaction by meeting customer requirements.
PDCA cycle
The process approach involves the systematic definition and management of
Process-based processes, the interrelationships and interdependencies among the processes of the
ISO 9001 system, to achieve the intended results by using the PDCA cycle with an overall focus
on risk-based thinking aimed at taking advantage of opportunities and preventing
undesirable results.
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REQUIREMENT NOTES
Quality
Management
Systems
Processes
QUALITY
MANAGEMENT
SYSTEM
OBJECTIVES
QUALITY
MANAGEMENT
SYSTEM
PROCESS
Relationship between Quality Management System purpose, processes and its significance of
these for QMS auditor.
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WORKSHOP 1 – ISO 9001:2015 Requirements Interrelationship
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ISO 19011:2018 Guidelines for auditing management systems and its terminologies
REQUIREMENT NOTES
Seven INTEGRITY:
principles of the foundation of professionalism
auditing
FAIR PRESENTATION:
the obligation to report truthfully and accurately
CONFIDENTIALITY:
security of information
INDEPENDENCE:
the basis for the impartiality of the audit and objectivity of the audit
conclusions
EVIDENCE-BASED APPROACH:
the rational method for reaching reliable and reproducible audit
conclusions in a systematic audit process
RISK-BASED APPROACH:
audits are focused on matters that are significant for the audit client, and
for achieving the audit program objectives.
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TERMS AND Referring to ISO 9000 review the definition of the terms in the table.
DEFINITION These terms and definitions are the terminology used in this international
USE IN standard and is commonly used in auditing.
AUDITING
ACCORDING Audit program
TO ISO Requirement
19011:2018 Audit Evidence
Audit
Audit Objective
Effectiveness
Audit Plan
Process
Audit Findings
Audit Conclusion
Audit Criteria
Audit Scope
Internal Audit
INTERNAL REQUIREMENTS
AUDIT
The organization shall:
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INTERNAL • verify the quality management system of an organization:
AUDIT • determine and meet conformance and capability;
OBJECTIVES • evaluate effectiveness and identification of potential improvement;
suggest how these different types of audit can contribute to the
maintenance and improvement of quality management systems
EXERCISE 2
REQUIREMENT NOTES
Types of Audit The table shows the different types of audits and its typical audit objective with
its contribution to the organization.
The illustration gives internal auditors confidence that each type of audit needs
their contribution for an effective implementation of the management system.
Auditing firm hired to audit a manufacturing industry for its ability to comply
with the requirements of a Trading company who hires the firm.
Auditing firm hired to audit the stores of the Trading company who hires the
firm and report the result to the Trading company.
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Trading company outsourced their internal audit, send HR to see qualified
auditing firm to verify if it meets their requirements.
REQUIREMENT NOTES
Audit Process The outline of audit process that typically define the sequence of
Flow conducting the audit.
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Auditing activities are step-by-step methods for;
• preparing,
• performing,
• reporting, and
• follow-up audit.
5. Managing
audit program
The individual(s) managing the audit program should have the necessary
competence to manage the program and its associated risks and
opportunities,
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In order to understand the context of the auditee, the audit program
sho ld take into acco nt the a ditee’s
• organizational objectives;
• relevant external and internal issues;
• the needs and expectations of relevant interested parties;
• information security and confidentiality requirements.
The planning of internal audit programs and, in some cases programs for
auditing external providers, can be arranged to contribute to other
objectives of the organization.
REQUIREMENT NOTES
6. Conducting 6.1 General
the Audit
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This clause contains guidance on preparing and conducting a specific audit
as part of an audit program.
6.1 Typical
Figure 2 provides an overview of the activities performed in a typical audit.
Audit
The extent to which the provisions of this clause are applicable depends on
Activities
the objectives and scope of the specific audit.
Figure 2
6.2 initiating
6.2.1 The responsibility for conducting the audit should remain with the
the audit
assigned audit team leader until the audit is completed.
The audit team leader should ensure that contact is made with the auditee to:
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a confirm comm nication channels with the a ditee’s representatives;
b) confirm the authority to conduct the audit;
c) provide relevant information on the audit objectives, scope, criteria,
methods and audit team composition, including any technical experts;
d) request access to relevant information for planning purposes including
information on the risks and opportunities the organization has identified
and how they are addressed;
e) determine applicable statutory and regulatory requirements and other
requirements relevant to the activities, processes, products and services
of the auditee;
f) confirm the agreement with the auditee regarding the extent of the
disclosure and the treatment of confidential information;
g) make arrangements for the audit including the schedule;
h) determine any location-specific arrangements for access, health and
safety, security, confidentiality or other;
i) agree on the attendance of observers and the need for guides or
interpreters for the audit team;
j) determine any areas of interest, concern or risks to the auditee in relation
to the specific audit;
k) resolve issues regarding composition of the audit team with the auditee or
audit client.
Where the audit is not feasible, an alternative should be proposed to the audit
client, in agreement with the auditee.
REQUIREMENT NOTES
6.3.1 The relevant management system documented information of the auditee
Performing should be reviewed in order to:
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review of
documented ▪ gather information to nderstand the a ditee’s operations and to
information prepare audit activities and applicable audit work documents (see
6.3.4), e.g. on processes, functions;
▪ establish an overview of the extent of the documented information to
determine possible conformity to the audit criteria and detect possible
areas of concern, such as deficiencies, omissions or conflicts.
• the context of the a ditee’s organization, incl ding its size, nat re
and complexity,
• its related risks and opportunities.
• the audit scope, criteria and objectives.
Audit planning should consider the risks of the audit activities on the
a ditee’s processes and provide the basis for the agreement among the
audit client, audit team and the auditee regarding the conduct of the audit.
The amount of detail provided in the audit plan should reflect the scope
and complexity of the audit, as well as the risk of not achieving the audit
objectives. In planning the audit, the audit team leader should consider the
following:
Risks to the auditee can result from the presence of the audit team
members adversely infl encing the a ditee’s arrangements for health and
safety, environment and quality, and its products, services,
personnel or infrastructure (e.g. contamination in clean room facilities).
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6.3.2.2 Audit planning details
The scale and content of the audit planning can differ, for example,
between initial and subsequent audits, as well as between internal and
external audits. Audit planning should be sufficiently flexible to permit
changes which can become necessary as the audit activities progress.
The audit team leader, in consultation with the audit team, should assign to
6.3.3 Assigning each team member responsibility for auditing specific processes, activities,
work to audit functions or locations and, as appropriate,
team authority for decision-making.
Such assignments should take into account the impartiality and objectivity
and competence of auditors and the effective use of resources, as well as
different roles and responsibilities of auditors, auditors-in-training and
technical experts.
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Audit team meetings should be held, as appropriate, by the audit team
leader in order to allocate work assignments and decide possible changes.
Changes to the work assignments can be made as the audit progresses in
order to ensure the achievement of the audit objectives.
6.3.4 Preparing
Documented
Information for
Audit
The audit team members should collect and review the information
relevant to their audit assignments and prepare documented information
for the audit, using any appropriate media. The documented
information for the audit can include but is not limited to:
The use of these media should not restrict the extent of audit activities,
which can change as a result of information collected during the audit.
Documented information prepared for, and resulting from, the audit should
be retained at least until audit completion, or as specified in the audit
program.
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hilippines nternal ditor o rse ss ed . .
REQUIREMENT NOTES
6.4.1 General Audit activities are normally conducted in a defined sequence as
indicated in Figure 1.
6.4.2 Assigning Guides and observers may accompany the audit team with approvals
roles and from the audit team leader, audit client and/or auditee, if required. They
responsibilities should not influence or interfere with the conduct of the audit.
of guides and If this cannot be assured, the audit team leader should have the right to
observers deny observers from being present during certain audit activities.
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Guides, appointed by the auditee, should assist the audit team and act
on the request of the audit team leader or the auditor to which they have
been assigned. Their responsibilities should include the following:
For other audit situations, the meeting may be formal and records of
attendance should be retained.
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DAY 2
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REQUIREMENT NOTES
Review of day 1 6. CONDUCTING THE AUDIT
6.4.4 During the audit, it may be necessary to make formal arrangements for
Communicating communication within the audit team, as well as with the auditee, the audit
during client and potentially with external interested parties (e.g. regulators),
Audit especially where statutory and regulatory requirements require mandatory
reporting of nonconformities.
During the audit, the audit team leader should periodically communicate
the progress, any significant findings and any concerns to the auditee and
audit client, as appropriate. Evidence collected during the audit that
suggests an immediate and significant risk should be reported without
delay to the auditee and, as appropriate, to the audit client. Any concern
about an issue outside the audit scope should be noted and reported to the
audit team leader, for possible communication to the audit client and
auditee.
Where the available audit evidence indicates that the audit objectives are
unattainable, the audit team leader should report the reasons to the audit
client and the auditee to determine appropriate action.
Such action may include changes to audit planning, the audit objectives or
audit scope, or termination of the audit.
Any need for changes to the audit plan which may become apparent as
auditing activities progress should be reviewed and accepted, as
appropriate, by both the individual(s) managing the audit program and the
audit client, and presented to the auditee.
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6.4.5 Audit The audit methods chosen for an audit depend on the defined audit
information objectives, scope and criteria, as well as duration and location. The
availability and location is where the information needed for the specific audit activity is
access available to the audit team. This may include physical and virtual locations.
Where, when and how to access audit information is crucial to the audit.
REQUIREMENT NOTES
6.4.6 he a ditee’s relevant doc mented information sho ld be
REVIEWING reviewed to:
DOCUMENTED
INFORMATION • determine the conformity of the system, as far as
WHILE documented, with audit criteria;
CONDUCTING • gather information to support the audit activities.
AUDIT
The review may be combined with the other audit activities and
may continue throughout the audit, providing this is not
detrimental to the effectiveness of the conduct of the audit.
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should inform both the individual(s) managing the audit program
and the auditee. Depending on the audit objectives and scope, a
decision should be made as to whether the audit should be
continued or suspended until documented information concerns
are resolved.
eference
REQUIREMENT NOTES
6.4.7 Collecting The figure above provides an overview of a typical process, from
and verifying collecting information to reaching audit conclusions
information
During the audit, information relevant to the audit objectives, scope and
criteria, including information relating to interfaces between functions,
activities and processes should be collected by means of
appropriate sampling and should be verified, as far as practicable.
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b) correct (the content conforms to other reliable sources such as
standards and regulations);
c) consistent (the documented information is consistent in itself and
with related documents);
d) current (the content is up to date).
Selecting The sources of information selected may vary according to the scope
sources of and complexity of the audit and may include the following:
information
a) interviews with employees and other individuals;
b) observations of activities and the surrounding work environment and
conditions;
c) documented information, such as policies, objectives, plans,
procedures, standards, instructions, licenses and permits,
specifications, drawings, contracts and orders;
d) records, such as inspection records, minutes of meetings, audit
reports, records of monitoring program and the results of
measurements;
e) data summaries, analyses and performance indicators;
f) information on the a ditee’s sampling plans and on any proced res
for the control of sampling and measurement processes;
g) reports from other sources, e.g. customer feedback, external surveys
and measurements, other relevant information from external parties
and external provider ratings;
h) databases and websites;
i) simulation and modelling.
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a) interviews should be held with individuals from appropriate levels
and functions performing activities or tasks within the audit scope;
b) interviews should normally be conducted during normal working
hours and, where practical, at the normal workplace of the individual
being interviewed;
c) attempts should be made to put the individual being interviewed at
ease prior to and during the interview;
d) the reason for the interview and any note taking should be explained;
e) interviews may be initiated by asking individuals to describe their
work;
f) the type of question used should be carefully selected (e.g. open,
closed, leading questions, appreciative inquiry);
g) awareness of limited non-verbal communication in virtual settings;
instead focus should be on the type of questions to use in finding
objective evidence;
h) the results from the interview should be summarized and reviewed
with the interviewed individual;
i) the interviewed individuals should be thanked for their participation
and cooperation
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REQUIREMENT NOTES
6.4.8 Generating Audit evidence should be evaluated against the audit criteria in order
audit findings to determine audit findings. Audit findings can indicate conformity or
nonconformity with audit criteria. When specified by the audit plan,
individual audit findings should include conformity and good
practices along with their supporting evidence, opportunities for
improvement, and any recommendations to the auditee.
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Nonconformities can be graded depending on the context of the
organization and its risks. This grading can be;
The audit team should meet as needed to review the audit findings
at appropriate stages during the audit.
WRITING
NONCONFORMITY
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EXERCISE 4: - Evaluate the scenario and write a nonconformity
report.
REQUIREMENT NOTES
6.4.9 6.4.9.1 Preparation for closing meeting
Determining
audit The audit team should confer prior to the closing meeting in
conclusions order to:
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a) the extent of conformity with the audit criteria and
robustness of the management system, including the
effectiveness of the management system in meeting the
intended outcomes, the identification of risks and
effectiveness of actions taken by the auditee to address
risks;
b) the effective implementation, maintenance and
improvement of the management system;
c) achievement of audit objectives, coverage of audit scope
and fulfilment of audit criteria;
d) similar findings made in different areas that were audited
or from a joint or previous audit for the purpose of
identifying trends.
6.4.10
Conducting A closing meeting should be held to present the audit findings
closing meeting and conclusions.
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d) possible consequences of not adequately addressing the
audit findings;
e) presentation of the audit findings and conclusions in such
a manner that they are understood and acknowledged by
the a ditee’s management;
f) any related post-audit activities (e.g. implementation and
review of corrective actions, addressing audit complaints,
appeal process).
REQUIREMENT NOTES
6.5 Preparing and 6.5.1 Preparing audit report
distributing audit
report The audit team leader should report the audit conclusions in
accordance with the audit program.
a) audit objectives;
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b) audit scope, particularly identification of the organization (the
auditee) and the functions or processes audited;
c) identification of the audit client;
d) identification of a dit team and a ditee’s participants in the a dit;
e) dates and locations where the audit activities were conducted;
f) audit criteria;
g) audit findings and related evidence;
h) audit conclusions;
i) a statement on the degree to which the audit criteria have been
fulfilled;
j) any unresolved diverging opinions between the audit team and the
auditee;
k) audits by nature are a sampling exercise; as such there is a risk
that the audit evidence examined is not representative.
6.6 COMPLETING
THE AUDIT The audit is completed when all planned audit activities have been
carried out, or as otherwise agreed with the audit client (e.g. there
might be an unexpected situation that prevents the audit being
completed according to the audit plan).
Unless required by law, the audit team and the individual(s) managing
the audit program should not disclose any information obtained during
the audit, or the audit report, to any other party without the explicit
approval of the audit client and, where appropriate, the approval of
the auditee. If disclosure of the contents of an audit document is
required, the audit client and auditee should be informed as soon
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as possible.
Lessons learned from the audit can identify risks and opportunities for
the audit program and the auditee.
M
determine if correction is
acceptable,
erify effective
implementation of the
corrective action on set
follow p a dit
lose the a dit if corrective
action to nonconformity is
effectively implemented.
REQUIREMENT NOTES
6.7 Audit follow-up The outcome of the audit can, depending on the audit objectives,
indicate the need for corrections, or for corrective actions, or
opportunities for improvement. Such actions are usually decided
and undertaken by the auditee within an agreed timeframe. As
appropriate, the auditee should keep the individual(s) managing the
audit program and/or the audit team informed of the status of these
actions.
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CORRECTIVE
ACTION PROCESS
• reviews the:
- corrections,
- identified causes and
- corrective actions
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,
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EXAMINATION
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