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This document provides information about an ISO 9001:2015 internal auditor training course. The course will cover the requirements auditors need to know to comply with certification requirements, including theories, methodologies, and tools. It will also discuss how internal audits can help organizations demonstrate sound management and meet customer challenges. Appropriately trained auditors can add value to organizations and help drive innovation. The training will use an activity-based approach to enhance learning.

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100% found this document useful (1 vote)

88 views72 pages

02 Slides (Same) - QMS03001ENGX - v5 (AD03) - Feb2020

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ISO 9001:2015 Internal Auditor Training Course

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Please note that this course is aimed at personnel who already have knowledge of the
requirements of ISO 9001:2015; as the requirements of this Standard are not specifically

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taught on this internal auditor’s course.

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The BSI Training Academy, on this course, will also cover the areas your Certification Body
(CB) will be generally looking for to comply with generic internal auditing requirements in
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Management System Standards. This will include the meanings and intention of certification
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criteria and associated theories, methodologies, techniques or tools.

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Your tutor will cover the above, along with a handout, at a suitable point in this course.
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ISO 9001:2015 Internal Auditor Training Course

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Appropriately trained auditors will bring added value to the internal audit process.
Organizations today do not just sell/offer a product or service to a customer/user around the

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corner. In the rapid evolution of a global market-place, having a set of common auditing

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guidelines is critical to facilitating organizational performance.
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At the same time, these rules have to be flexible enough to be as applicable to an organization
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in Hokkaido, Japan or Salvador, Brazil, as they are for one in San Francisco, USA or Reykjavik,
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Iceland.
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Increasingly in this single world market, an organization needs to be able to demonstrate

sound management that is orientated towards the customer. There is growing evidence that
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this results in advantages in customer retention, increased staff morale and motivation,
compliance with regulations, and other areas of operations. A Quality Management System
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(QMS) audit provides a solid framework for meeting customer challenges and realizing the
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above benefits. The International Standard ISO 9001 is used as a model for implementing a
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QMS by more than 1,000,000 organizations in over 112 countries.

A QMS enables an organization to have confidence in the products and services it provides to
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its customers. This in turn benefits many other interested parties which makes for an
improved society. This is achieved by an organization taking a risk-based approach to how it
operates through its QMS, and other processes, to the benefit of all concerned.

When all members in an organization are challenged to think differently, it leads to the
creation of innovative products and services. An effective internal audit will help to achieve
this.

Your learning will be through an activity-based, delegate centred approach. This will help you
share experiences and knowledge with other attendees; bringing alive the information
presented and resulting in enhanced retention and application to your own workplace. You
have the full support and training from a world-class BSI tutor also at your disposal! We hope
you very much enjoy the course and take back valuable knowledge and skills to your
workplace.

QMS03001ENGX v5.0(AD03) Feb 2020 Copyright © 2020 BSI. All rights reserved. 2
ISO 9001:2015 Internal Auditor Training Course

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For your personal safety, please be aware of the emergency exits from your classroom and
the building.

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The tutor will inform you of the nearest restrooms. Au
Please do not leave valuable items unattended in the classroom. Keep them with you, or make
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other arrangements for their safekeeping.

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Please be considerate of other delegates and avoid distractions from the beeping of your
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mobile telephone or other devices. In other words, please turn them off.
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Please do not use recording devices since they may restrict free discussion.
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The tutor will inform you of the lunch and break schedule. Please return to class on time.
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If there are any special needs (dietary etc.) please inform the tutor now.
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ISO 9001:2015 Internal Auditor Training Course

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Your tutor(s) will introduce themselves.

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Your turn!

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• Delegate name?
• Organization and product, or service?
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• Job position or role?

• Experience of any Management System auditing, and knowledge of ISO 9001?

• Any specific questions/problems to be answered/expectation from the course?

• Something interesting about YOU?

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ISO 9001:2015 Internal Auditor Training Course

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The course is broken down into a combination of knowledge and skills. We will increase your
knowledge of the guidelines for auditing management systems and how a Quality

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Management System (QMS) can be audited for conformity.

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ISO 9001:2015 Internal Auditor Training Course

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Learning objectives describe in outline what you will know and be able to do by the end of
the course.

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On completion, delegates will gain the displayed knowledge and skills.
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Delegates will have the knowledge to:
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• Explain the guidelines of auditing management systems according to ISO 19011:2018

• Describe the application of these guidelines to auditing ISO 9001:2015

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Delegated will have the skills to:

• Initiate the audit
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• Prepare audit activities

• Conduct audit activities
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• Prepare and distribute the audit report

• Complete the audit

• Audit follow-up
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ISO 9001:2015 Internal Auditor Training Course

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This course includes a detailed delegate workbook, practical activities and classroom
discussions.

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The contents of the delegate workbook includes an agenda, slides and associated notes (like
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these), activities, references and case study materials.
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Model answers (in References section) are included in the folder for reference only after
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completing the activity, not for copying from during the activities. The activities are designed
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for creating knowledge of the key learning points; for the delegate to look at the answers
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prior to the activity will cause the effect to be lost.

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Delegates are encouraged to participate, experiment, and question in a stress-free

environment.
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ISO 9001:2015 Internal Auditor Training Course

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ISO 9001:2015 Internal Auditor Training Course

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As an auditor, it is very important that you are aware of the intended outcome(s)/result(s)
of the particular management system you are auditing against. For ISO 9001:2015 the

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intended outcome(s)/result(s) of a quality management system provide confidence to the

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customer, the organization and its interested parties.
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Consistent with the organization’s quality policy, the intended outcome(s)/result(s) of a
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quality management system include:

• Meeting customers’ requirements

• Conforming to customer and applicable statutory/regulatory requirements

• Enhancing customer satisfaction

• Improvement.
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These are contained in the ‘1 Scope’ section; namely:

• An organization needs to demonstrate its ability to consistently provide products and

services that meet customer and applicable statutory and regulatory requirements
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• An organization should aim to enhance customer satisfaction though the effective

application to the system, including processes for improvement of the system and the
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assurance of conformity to customer and applicable statutory and regulatory

requirements.

QMS03001ENGX v5.0(AD03) Feb 2020 Copyright © 2020 BSI. All rights reserved. 9
ISO 9001:2015 Internal Auditor Training Course

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PDCA cycle controls all activities.

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Plan

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Establish the objectives and processes necessary to deliver results in accordance with customer
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requirements and the organization’s policies.
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Do
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Implement the processes.

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Check
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Monitor and measure processes and product against policies, objectives and requirements for
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the product and report the results.

Act
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Take actions to improve process performance.

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Permission to reproduce extracts from ISO 9001:2015 is granted by BSI. British Standards can be obtained in PDF
or hard copy formats from the BSI online shop: www.bsigroup.com/Shop or by contacting BSI Customer Services
for hardcopies only: Tel: +44 (0)20 8996 9001, Email: [email protected].

QMS03001ENGX v5.0(AD03) Feb 2020 Copyright © 2020 BSI. All rights reserved. 10
ISO 9001:2015 Internal Auditor Training Course

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This high level structure (above) of the Standard is a very useful way of finding your way
around its requirements. It also gives a flow to how the Standard operates.

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The structure can be a very useful tool when planning and conducting audits.
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Also the standard advocates, in Clause 4.4, that the QMS should be described using processes
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needed and their interactions.

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Please look overleaf for a summary list of its sub clauses (as a refresh).
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ISO 9001:2015 Internal Auditor Training Course

4 Context of the organization 8 Operation

4.1 Understanding the organization and its 8.1 Operation planning and control
context

4.2 Expectations of interested parties 8.2 Requirements for products and services

4.3 Scope of management system 8.3 Design and development of products and
services
4.4 Quality Management System and its 8.4 Control of externally provided processes,
processes products and services

5 Leadership 8.5 Production and service provision

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5.1 Leadership and commitment 8.6 Release of products and services

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5.2 Policy 8.7 Control of nonconforming outputs

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5.3 Roles, responsibilities and authorities 9 Performance evaluation
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9.1 Monitoring, measurement, analysis and
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6 Planning
evaluation
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6.1 Actions to address risk and opportunities 9.2 Internal audit

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6.2 Quality objectives and planning to

9.3 Management review

achieve them
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6.3 Planning of changes 10 Improvement

7 Support 10.1 General

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7.1 Resources 10.2 Nonconformity and corrective action

10.3 Continual improvement

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented information

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ISO 9001:2015 Internal Auditor Training Course

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Within ISO 9001, Clause 9.2.1 states that the organization shall conduct internal audits at
planned intervals to provide information on whether the quality management system:

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a) conforms to: Au
• the organization’s own requirements for its Quality Management System
• the requirements of this International Standard
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b) is effectively implemented and maintained

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The keyword here is shall. It means it is a requirement and not a guideline or a suggestion.
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It doesn’t dictate the period of time between internal audits, but states that the audit
programme (basically a schedule of audits over a time period) shall take into consideration
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the importance of the processes concerned, changes affecting the organization and the
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results of previous audits.

(An audit programme will be formally defined in the next Activity)

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ISO 9001:2015 Internal Auditor Training Course

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ISO 9001:2015 Internal Auditor Training Course

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This International Standard provides guidance on auditing management systems, including
the principles of auditing, managing an audit programme and conducting management

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system audits; as well as guidance on the evaluation of competence of individuals involved

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in the audit process, including the person managing the audit programme, auditors and
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audit teams.
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It is applicable to all organizations that need to conduct internal, or external audits of

management systems, or manage an audit programme.

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The application of this International Standard to other types of audits is possible, provided
that special consideration is given to the specific competence needed.
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Your tutor will provide you with a loan copy later.

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ISO 9001:2015 Internal Auditor Training Course

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Activity 1: Terms and definitions (auditing)

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Purpose:

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To familiarize delegates with the common audit terms in ISO 19011:2018.
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Duration:
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10 minutes individual work

10 minutes class discussion

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Directions:
Working individually, review the auditing terms and definitions on the next page, and note
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which definitions belong to which term. (Simply note the correct letter of the definition next
to the appropriate term, compare with your colleague and note any differences)
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Once completed, the tutor will discuss the correct answers with the class.
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QMS03001ENGX v5.0(AD03) Feb 2020 Copyright © 2020 BSI. All rights reserved. 16
ISO 9001:2015 Internal Auditor Training Course

TERM DEFINITION (letter)

1 Audit Criteria

2 Audit Evidence

3 Audit Findings

4 Auditee

5 Auditor

6 Nonconformity

7 Audit Team

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8 Audit Programme

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9 Audit Plan

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10 Audit Scope

11 Technical Expert
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12 Audit
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Definitions:
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A. Person who provides specific knowledge or expertise to the audit team

B. Description of the activities and arrangements for an audit

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C. Sets of requirements used as a reference against which objective evidence is compared

D. Organization as a whole or parts thereof being audited

E. Systematic, independent and documented process for obtaining objective evidence and
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evaluating it objectively to determine the extent to which the audit criteria are fulfilled

F. Arrangements for a set of one or more audits planned for a specific time frame and
directed towards a specific purpose

G. Records, statements of fact or other information, which are relevant to the audit criteria
and verifiable

H. Person who conducts an audit

I. Extent and boundaries of an audit

J. One or more persons conducting an audit, supported if needed by technical experts

K. Results of the evaluation of the collected audit evidence against audit criteria

L. Non-fulfillment of a requirement

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ISO 9001:2015 Internal Auditor Training Course

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What is an audit?

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Systematic, independent and documented process for obtaining objective evidence and

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evaluating it objectively to determine the extent to which the audit criteria are fulfilled.
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(Clause 3.1, ISO 19011:2018)
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We are now going to explore each area underlined.

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ISO 9001:2015 Internal Auditor Training Course

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Systematic
An audit is based around the acronym P.E.R.C. – Plan, Execute, Report, Close-out.

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Each of these areas will be covered in this order; it acts like a process – one leads into the
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next.
This also links to PDCA – continual improvement. The audit is not complete or effective unless
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these four stages have been completed.

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Another acronym that can be used is P.E.T.E.C. – Plan, Establish, Test, Evaluate and
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Conclude (see your References section). Your tutor will explain these terms.
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The course will however focus on P.E.R.C.

Independent
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Auditors should be independent of the activity being audited wherever practical, and should in
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all cases act in a manner that is free from bias and conflict of interest. For internal audits,
auditors should be independent from the operating managers of the function being audited.
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Auditors should maintain objectivity throughout the audit process to ensure that the audit
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findings and conclusions are based only on the audit evidence.

For small organizations it may not be possible for internal auditors to be fully independent of
the activity being audited, but every effort should be made to remove bias and encourage
objectivity.

Documented
Information required to be controlled and maintained by an organization and the medium on
which it is contained. Documented information can be in any format, any media and from any
source. The audit will need documenting.

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ISO 9001:2015 Internal Auditor Training Course

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A Process is a set of interrelated or interacting activities that use inputs to deliver an
intended result. The below process contains a set of activities that are interrelated (showing

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links from/to), interacting (showing inputs/outputs), and the transformation of process

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inputs into process outputs. A good way of remembering this is through the acronym MARIO
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(Managed, Activity, Resources, Input, Output).
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OTHER PROCESSES
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XYZ Process
DETERMINED INPUTS (a-c)
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a b c
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(Activity?) 1
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(interacting – inputs/outputs)
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e (interrelated - links)
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2 3 Set of activities
k g f (1 – 7)
h 4
5 6
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n o p
DETERMINED OUTPUTS (n – p)

OTHER PROCESSES

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ISO 9001:2015 Internal Auditor Training Course

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In generic terms, applicable to all audits against whatever criteria, the auditor gathers
objective evidence which is verifiable, and evaluates it against the Audit Criteria. The auditor

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then makes a decision based on the evaluation, to derive the output (audit findings). The

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output then feeds into the audit report, which we will come to later.
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ISO 9001:2015 Internal Auditor Training Course

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ISO 19011:2018

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‘Set of requirements used as a reference against which objective evidence is compared’

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If the audit criteria are legal (including statutory or regulatory) requirements, the terms
“compliant” or “noncompliant” are often used in an audit finding.
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How are we going to obtain Objective Evidence?

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There are three methods:

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1. We can visually see a process being carried out.
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2. We can be told a “Statement of Fact” from an interview with a responsible individual
from the area that we are auditing. Beware though: Any verbal evidence must be
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admissible, in other words the truth. You may have to ask more people or somebody in
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authority to verify what you have been told.

3. We can inspect relevant documented information.

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The preceding slides hopefully makes the definition of an audit clearer now.
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For any audit carried out it is crucial that the 3 parameters (Audit Scope, Criteria and
Objectives) are clearly stated.

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There is one other very important parameter that goes with the scope and that is the duration
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of the audit. How much time do you have to carry out the audit? If you think that the duration
is too short you must say so (you will never be given too much time!)
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Activity 2: Principles of auditing

to
Purpose:

di
To introduce the principles of auditing, as documented in ISO 19011:2018 – Guidelines for
Au
auditing management systems.
al

Duration:
rn

10 minutes in groups
te

5 minutes classroom discussion

Directions:
5
01

The tutor will hand out laminated cards of two colors. Put the cards into pairs, one principle
to one expansion.
:2
01

Be prepared to brief the rest of the delegates on your answers.

……………………………………………………………………………………………………………………………………
O
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Your tutor will now direct the class to ISO 19011:2018 Clause 6 (Conducting an audit), and
provide an overview of the above sub-clauses with you.

to
di
‘6.1 General Au
This clause contains guidance on preparing and conducting a specific audit as part of an audit
programme….. The extent to which the provisions of this clause are applicable depends on the
al

objectives and scope of the specific audit.’

rn
te

Therefore, please note, all these activities may not be required for an internal audit.
In

These activities will be explored further (as applicable to an internal audit), in the forthcoming
5
01

slides, but first an introduction into what an audit programme is.

:2
01

………………………………………………………………………………………………………………………………………
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The definition of an audit programme is:

to
‘Arrangements for a set of one or more audits planned for a specific time frame and

di
directed towards a specific purpose’ Au
(As defined in ISO 19011:2018, clause 3.4)
al
rn

Auditing a management system is auditing an organization’s processes and their interactions

in relation to one or more management system standard(s).

Within your organization, there should be an individual(s) managing your audit programme.
5
01

This person will identify the resources needed (including the auditor assigned – possibly
you!) for each audit. They will inform you of the specific objective, scope and criteria for the
:2

audit, and provide the resources necessary to accomplish the objective.

01
90

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Arrive on time:
Ensure that the auditee knows when the audit will commence, who needs to be involved.

to
Arrive prepared and consider the auditee’s needs (they are busy people; being too early is

di
as bad as being too late). Au
Maintain confidentiality:
al

Information shared regarding the organization may be confidential and must remain so;
rn

although you work for the same organization, it is important that any audit findings are not
te

discussed or shared outside of the audit. Sharing audit information with others will
In

undermine the credibility of auditors and the audit process.

Be objective and ethical:

Collect audit evidence; records, statements of fact or other information which are relevant to
:2

the audit criteria and verifiable.

NOTE: Audit evidence can be qualitative or quantitative.

Support the audit team leader (if there is one):

When working as part of a team, take on the tasks allocated by the team leader. Do not
IS

undermine the team leader’s authority. If you need to bring things to the attention of the
team leader, do so at the appropriate time and place.

Plan the audit and prepare work documents:

Ensure the plan is completed and communicated. Prepare appropriate checklists for the
relevant audit activities. Share the plan and the checklists with the auditee.

Inform auditees of the audit process:

The audit process is an open one, and will be more effective if the auditee knows what will
happen. Introduce the audit approach at each stage, ensure the auditee understands what is
going to happen. Carry out audit tasks. Complete the tasks required by the plan. Keep to the
timetable. Manage the time against the plan, if required, change the plan. If the plan
changes ensure the auditee is kept informed.

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ISO 9001:2015 Internal Auditor Training Course

Document all findings:

Record accurate records. Make sure the correct sample references are taken. Ensure that any
notes are complete and can be read by others, i.e. legible.

Keep auditees informed throughout the audit:

Advise the auditee what you are going to do. Feed back verbally on the findings. There should
be no surprises for the auditee.

Safeguard all documents:

Ensure that samples/documents are returned to the auditee. Ensure that the audit report is
distributed correctly and not disclosed to others outside of the audit.

Prepare the audit report:

Ensure that you, the auditor understand the report. Ensure that the auditees understand the

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report. Ensure that it is completed on time and that it is balanced, containing both positive
and constructive feedback.

SI
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………………………………………………………………………………………………………………………………………

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di
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Au
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01

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……………………………………………………………………………………………………………………………………

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……………………………………………………………………………………………………………………………………

di
Au
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01

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With the audit objective, scope, criteria, dates and contacts provided, the auditor can start
to initiate the audit.

to
di
This will involve establishing initial contact with the auditee and determining its feasibility.
Au
This is usually quite informal for an internal audit i.e. a quick telephone call, or email
al

confirmation.
rn
te

Please see 6.2.2 and 6.2.3 (ISO 19011:2018).

Assuming the audit is feasible e.g. the auditee is happy with the arrangements, people
5
01

available to be asked questions of, dates, etc. the auditor can start to prepare.
:2
01

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90

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Auditors should be familiar with the relevant parts of the QMS, processes/activities and areas
to be audited.

to
di
Typical areas to consider during the document review will include:
Au
• All relevant sources of information
• Priorities - what is important to management
al

• Problems - process control, nonconforming product or service problems. Details may be

found in records of corrective action, customer complaints, etc.

• Previous audits - to review previous findings and any corrective action follow-up required;
In

not to target areas to hit

• Important to know if any changes to product or services have occurred
5
01

• Preliminary visit - sometimes useful for auditor to familiarize themselves with area and to
deal with any practical concerns e.g. need for protective clothing, arrangements for
:2

access etc.
01
90

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Activity 3: Aligning clauses of ISO 9001 to process activities

to
Purpose:

di
To enable delegates to see which clauses of ISO 9001 apply, and effect the operational
Au
processes of Life Long Learning (LLL).
al

Duration:
rn

35 minutes in groups
te

5 minutes classroom discussion

In
5

Directions:
01

The tutor will allocate to groups various processes from pages 11 to 16 of the case study.
:2

Delegates should look at the processes allocated to them and apply whichever clauses of ISO
01

9001 they think are appropriate. Note that a single activity (within a process) may have a
number of clauses that apply, and some clauses may apply to the whole process.
90

Be prepared to brief the rest of the delegates on your answers.

O
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‘Description of the activities and arrangements for an audit’
(ISO 19011 Clause 6.3.2)

to
di
For an internal audit this is usually quite simple. Au
An audit plan should be prepared, which could include (as appropriate):
al
rn

a) Audit objectives (purpose)

b) Audit scope (boundaries)

c) Audit criteria and any reference documents (what to evaluate against)

d) Locations and activities to be audited, audit duration and the dates of the audit(s)
5
01

e) Audit methods to be used (normally on-site, interactive)

f) Allocation of appropriate resources (people’s time etc.)
:2

g) Audit duration (normally less than 1 day for a simple internal audit)
01
90

No matter how simple or complex an audit is there should be some form of plan.
O

Plans help the auditor manage the audit, but they should also be communicated to the auditee
IS

so that they can prepare and plan themselves for the audit.

The essence of a plan includes: Confirmation of audit scope, criteria and objectives;
coverage of the audit criteria; discussions with the manager and those performing tasks within
the criteria; timescales for each discussion; and time for opening and closing meetings.

Auditing a management system is auditing an organization’s processes and their interactions in

relation to one or more management system standard(s). Audit planning should address or
reference the organization’s processes to be audited.

Please note: The auditor should take a risk-based approach to planning, based on the audit
programme and the documented information provided. The auditor should also consider
opportunities to improve the effectiveness and efficiency of the audit activities, and the risks to
achieving the audit objectives created by ineffective audit planning.

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Your tutor will now explain the concept of “Random Independently Selected Sampling”.

to
This concept forms the foundation of a sound audit report and an audit conducted with

di
integrity. Remember sampling applies to areas/processes, as well as documented
Au
information and interviews.
al

Samples should be chosen:

• By the auditor
te

• Permission sought
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• Establish and agree the facts

• Remain impartial.
5
01

Audit sampling takes place when it is not practical or cost effective to examine all available
:2

information during an audit, e.g. records are too numerous or too dispersed geographically
01

to justify the examination of every item in the population. Audit sampling of a large
90

population is the process of selecting less than 100% of the items within the total available
data set (population) to obtain and evaluate evidence about some characteristic of that
O

population, in order to form a conclusion concerning the population.

The objective of audit sampling is to provide information for the auditor to have confidence
that the audit objectives can or will be achieved.

The risk associated with sampling is that the samples may not be representative of the
population from which they are selected, and thus the auditor’s conclusion may be biased
and be different to that which would be reached if the whole population was examined.
There may be other risks depending on the variability within the population to be sampled
and the method chosen.

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Activity 4: Review case study and proposed audit plan

to
Purpose:

di
Prepare for your audit of the case study organization and review a proposed audit plan.
Au
Duration:
al

30 minutes review case study

15 minutes review audit plan

10 minutes feedback and discussion

Directions:
5
01

Individually, read the case study (Pages 1 to 16 only).Then in your allocated groups, review
a sample audit plan in your References, and comment on its suitability as a means to
:2

achieve:
01
90

Audit Objective:
To assess the implementation of the training processes.
O
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Audit Scope:
Office (LLL) - Cape Town, South Africa, Training Operational Processes OP1-12, Duration
09:00 – 15:00.

Audit Criteria:
OPS02 Version 10, and the relevant clauses from ISO 9001.

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The auditor should prepare work documents for reference and for recording audit evidence.
Such work document may include checklists.

to
di
Checklist (A document that is created during the preparation of audit activities)
Au
It is similar to an aide-memoire, but is more detailed. A checklist is created using the audit
plan, it can essentially be a list of open questions the auditor wishes to ask the auditee, e.g.
al

who, what, where, when, why, how.

rn
te

Its main functions/benefits are to:

• Keep the audit objectives clear

• Provide evidence of audit planning
5
01

• Maintaining the audit pace and continuity

• Reducing workload during the audit
:2

• Reduce risk of auditor bias

01
90

Checklists lose effectiveness when used as purely tick-sheets or questionnaires. They should
not restrict the extent of audit activities, which can change as a result of information
O

collected during the audit.

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As already stated, the ‘checklist’ should not restrict the extent of audit questioning. However
the above checklist structure, if planned effectively before the audit, can be very useful with

to
keeping you to the scope, objectives and criteria of the audit, but it should not be rigidly

di
adhered to. If, from asking a question from the checklist, this leads to other questions
Au
related to the same area that are not on the checklist, but just as relevant, then a decision
has to be made to either ask them now, or make a note of the questions and either ask
al

later, or give them to somebody else to ask.

rn
te

The ‘source’ is the area you are going to look at such as purchasing, HR, management
In

review etc. the ‘evidence’ is the evidence you are looking for to show that something is
conforming (or not). These are often written as open questions to help the auditor further,
5
01

and save trying to decide what to ask in the first instance, although the answer may elicit
further questions.
:2
01

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Other examples of Checklist Questions:
• What is the process? 4.4/8.1

to
• What risks are there in the process? 4.4/6.1/8.5.1

di
• What links are there with other processes? 4.4b Au
• What are the inputs? 4.4a/8.5.1
• What are the planned outputs? 4.1a/8.5.1
al

• What targets/objectives and criteria guide the process? 6.2/8.1

• How is the process controlled? 4.4c/8.5.1

• What documents are used? 7.5

• What level of competence is needed? 7.2

• What equipment is needed? 7.1.3
5
01

• How are they maintained? 7.1.3

• How is the process measured? 9.1
:2

• How are performance problems controlled? 10.2

• How do you ensure planned objectives are achieved? 4.4/6.2.2/9.1

• How is measurement data reviewed? 9.1

• In what ways have improvements been sought? 10.3
O

• What documented information is available as evidence? 7.5

• How are responsibilities and authority described? 5.3

• Etc.

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Activity 5: Work documents (checklists)

to
Purpose:

di
To give the delegate the opportunity to create a checklist for assessing a QMS process.
Au
Duration:
al

30 minutes group work

Feedback and discussion will be provided during your audit later!

te
In

Directions:
5

In your groups, using the case study (Pages 1 – 16 only) and the audit plan from the last
01

activity (taking into account your comments!), start to record some questions (on your
:2

flipchart) you would ask during an interview with the personnel identified, covering the areas in
01

the audit plan. (Your tutor may split the processes up between different groups/individuals, to
make this easier for you)
90

You will find pages 11 to 16 of the case study useful for the audit activity questions.
O
IS

The Audit objective, scope and criteria are the same as provided in Activity 4 (assume the
criteria has now been changed to Version 9 (OPS02), to align with the information provided).
The audit duration however will be much shorter (2 hours).

The tutor will explain which processes delegates are to build their checklists around.

There is no need to read past page 16 of the case study, as these samples will be introduced
tomorrow.

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……………………………………………………………………………………………………………………………………

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di
Au
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01

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90

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IS

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The purpose of the opening meeting is to:
• Provide an overview of what is going to happen

to
• Confirm status of the QMS documentation

di
• Confirm time for the closing meeting Au
• Clarifications
• Confirm the agreement to the audit plan
al

• Ensure that all planned audit activities can be performed

rn
te

An opening meeting should be held with the auditee’s management and where appropriate,
In

those responsible for the functions or processes to be audited. During the meeting an
opportunity to ask questions should be provided.
5
01

The degree of detail should be consistent with the familiarity of the auditee with the audit
:2

process. In many instances for internal audits, the opening meeting may simply consist of
01

communicating that an audit is being conducted and explaining the nature of the audit.
90

(ISO 19011 6.4.3)

O
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General considerations will help ensure a successful interview:

to
Do not:

di
• Argue Au
• Say you understand when you don't
• Ask loaded, leading, trick, vague or close-ended questions
al

• Ask too many questions at once

• Criticize individuals
te

• Take obtrusive notes

Do:
5
01

• Give prior notification

• Ask the right person
:2

• Only ask one question at a time

• Ensure questions are clear and understood

• Give auditee time to answer

• Stay impartial
O

• Keep the auditee informed of your concerns and findings so there are no surprises
IS

Perhaps the biggest challenge for the auditor is the fact that finding out information
depends, amongst other things, on communication skills. Within a very short time of
meeting someone the auditor needs to have developed a degree of rapport with that person
to obtain the facts essential to the investigation, whilst remaining objective. If these facts
are indicative of a lack of management control in the area, then the auditor needs to be
tactful in the way these findings are presented.

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Listening techniques:
Stop talking, concentrate, and look interested.

to
di
Consider non-verbal communication: Au
• Gestures, posture, mannerisms and body language
al

What are you signaling?

• Your appearance?
te

• Your attitude?
In

Things to consider:
5
01

• Eye contact
• Facial expression
:2

• Relative positions
01

• Voice tone
90

DO:
O

• Put the speaker at ease

• Show you want to listen DO NOT:

• Remove distractions • Be judgmental
• Keep calm • Cause interference
• Stop talking • Be close minded (Attitude)
• Give praise when deserved • Have wishful hearing
• Be empathetic • Talk excessively
• Ask open questions:
What, who, when, why, where and how
• You might like to close a question session with a
closed question that should elicit a yes or no answer

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Typical auditor attributes:

• Open-mindedness
• Versatility
• Diplomacy
• Perceptiveness
• Attentiveness
• Decisiveness
• Tenaciousness
• Self-reliance
• Ethical
• Common sense!

Typical auditor competence:

• Knowledge of the Standard
• Understanding of Quality Management relating to the activities/products/services being

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audited

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• Knowledge of Risk-based thinking/Management
• Sufficient knowledge of the activity/process to be audited (possibly technically as well)

r-B
• Related regulatory requirements

to
• Principles of auditing

di
• (Generic knowledge and skills relating to) – understanding the types of risks and
Au
opportunities associated with auditing and the principles of the risk-based approach to
auditing, auditing a process from start to finish, including the interrelations with other
al

processes and different functions, where appropriate

• (Management systems …. knowledge and skills relating to) – relationships and interactions
te

between the management system(s) processes

• (Organization and its context knowledge and skills relating to) – the needs and
expectations of relevant interested parties that impact the MS
5

• (Discipline and sector specific knowledge and skills relating to) – principles, methods and
01

techniques relevant to the discipline and sector, so the auditor can determine and evaluate
:2

opportunities associated with the audit objectives

01
90

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Activity 6: Question types

to
Purpose:

di
To recognize examples of effective communications during an audit.
Au
Duration:
al

15 minutes
rn

15 minutes classroom discussion

te
In

Directions:
In pairs, please consider the question types below that you could ask as an auditor:
5
01

1. Open question
2. Closed question
:2

3. Hypothetical question
01

4. Probing question
90

Please think of one statement to demonstrate the questions above for a real life audit
O

situation. Get ready to present these back to the rest of the class.
IS

How could you funnel these questions to come up with an audit finding? Which ones would
you start with, and end with?

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Only information relevant to the audit objective, scope and criteria should be collected. Also
only information that is verifiable should be accepted as audit evidence. Audit evidence

to
should be recorded.

di
Au
An audit is not a search for nonconformities, but it is to verify conformity with specified
requirements (audit criteria).
al
rn

If there are any doubts regarding conformity, then a nonconformity can be considered. If an
te

issue is not a clear nonconformity, then the auditee should be given the benefit of the
In

doubt, but this should be recorded as an observation for further investigation.

5
01

Reviewing documented information while conducting audit

The auditees relevant documentation should be reviewed to:

• Determine the conformity of the process as far as documented, with the audit criteria
90

• Gather information to support the audit activities.

The review may be combined with other audit activities and may continue throughout the
IS

audit.

Beware of the auditee who just shows you the document and lets you ‘get on with it’. You
are testing their systems, you want to determine if the auditee knows their own systems. So,
ask the auditee to explain what they do and follow this with what is written down - if indeed
it is written down! You may have to rely on verbal evidence, make sure it is admissible.

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Recording the objective evidence

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The auditor’s ‘forms for recording information’ should document the audit and provide the

di
basis for later conclusions. Notes should include: Au
• Visual observations
al

• Names of interviewees (but not in the audit report)

• Information gathered through interviews

• Lists of documented information reviewed
te

• Description and results of tests performed, or comparisons made to evaluate

conformance with quality requirements

5
01

It is important to take complete notes. They provide objective evidence of what happened.
:2

Checklists define samples to be looked at, but notes record samples actually looked at
01

(they may be different).

Some notes may not be included in the formal audit report but are used as records by the
O

audit system. Notes taken now may be useful later e.g. should findings be unclear or their
IS

accuracy challenged.

Information must be clear, retrievable and traceable to origin.

QMS03001ENGX v5.0(AD03) Feb 2020 Copyright © 2020 BSI. All rights reserved. 48
ISO 9001:2015 Internal Auditor Training Course

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r-B
Your tutor will now show you an extract from an internal audit. Please observe and
comment on the auditor’s approach.

to
di
The audit video is intended to be a simple generic audit to cover the audit techniques
Au
involved, and is not specific to any management system standard. You will be asked to
comment on the approach and techniques employed.
al
rn

Please note: Auditors should apply professional judgement during the audit process and
te

avoid concentrating on the specific requirements of each clause of the standard at the
In

expense of achieving the intended outcome of the management system. Some ISO
management system standard clauses do not readily lend themselves to audit in terms of
5
01

comparison between a set of criteria and the content of a procedure or work instruction. In
these situations, auditors should use their professional judgement to determine whether the
:2

intent of the clause has been met.

01
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……………………………………………………………………………………………………………………………………
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QMS03001ENGX v5.0(AD03) Feb 2020 Copyright © 2020 BSI. All rights reserved. 49
ISO 9001:2015 Internal Auditor Training Course

-ID
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Activity 7: True and false quiz

r-B
to
Purpose:

di
To review delegates knowledge of Day 1 content, and refresh knowledge of ISO 9001
Au
requirements.
al

Duration:
rn

20 minutes to complete
10 minutes feedback
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In

Directions:
5

Tutor will facilitate this activity by explaining that:

• Individually delegates should read each statement on the following page and decide if it is
:2

true or false
01

• For the ISO 9001 questions; regardless of whether it is true or false, the delegate should
state which clause best fits the statement
90

• For questions 2, 6, 11, 14 and 19 - clause numbers are not required

O
IS

On completion the tutor will go through all the statements giving the correct answers.

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QMS03001ENGX v5.0(AD03) Feb 2020 Copyright © 2020 BSI. All rights reserved. 50
ISO 9001:2015 Internal Auditor Training Course

ISO 9001 and ISO 19011 requires that: True/False Clause

1. An audit programme is required for every individual

audit?

2. Confidential evidence must be safeguarded by the

audit team

3. The QMS policy need only be available to employees?

4. Auditors propose corrective actions?

5. Resources only have to be ‘provided’?

6. Audit scope, objectives and criteria should be

referenced in the audit plan.

-ID
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7. Competence and awareness are the same thing?

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8. Objectives only have to be established at relevant

to
functions and levels?

9. Internal audit programmes should take account of

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Au
changes affecting the organization?
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10. It is necessary to ensure that competence is acquired?

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11. An audit programme and audit plan are the same

thing?
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12. Internal audit nonconformities must be addressed?

01
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13. Internal audits do not consider the effectiveness of the

QMS?
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14. Auditors look for objective evidence?

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15. Top management must ensure the focus on enhancing

customer satisfaction?

16. Risk is a theme that runs through ISO 9001

17. All external and internal issues should be addressed?

18. No justifications are ever required in the QMS scope

19. The feasibility of achieving audit objectives should be

determined

20. The organization has to evaluate the need for action in

respect to the potential occurrence of nonconformities
elsewhere?

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All audit evidence needs to be tied back to the audit criteria provided.

to
If there is any doubt as to whether a nonconformity exists the auditee should

di
get the benefit of the doubt. Au
If in doubt leave it out!
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rn

We will revisit documenting a nonconformity after your audit.

te
In

However, for the time being please ensure you document the audit evidence and the
specific audit criteria you are evaluating it against.
5
01

The tutor will help you with this by asking you to record these on a flip chart for your group.
:2
01

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-ID
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Activity 8: Internal audit

to
Purpose:

di
To give delegates the opportunity to generate audit findings and practice the necessary skills
Au
required for effective internal audit activities.
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Part 1
rn

In your allocated groups, please now review the case study documents (from pages 17
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onwards) and produce new questions and amend your questions previously created (as
In

applicable).
5
01

Normally these documents would be samples you have chosen during your audit. In this case,
:2

the samples have been provided for you: To assist you in your first audit.
01

Duration:
90

40 minutes group work

Part 2
IS

Please now audit the case study organization, one group at a time, using your questions
generated in Part 1.

The tutor will invite other groups to critique your audit approach.

Duration:
2 hours audit
10 minutes overall feedback/reflection to own workplace

-ID
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Structure of nonconformities:

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There is a standard method for recording nonconformities. A nonconformity should consist

di
of three parts: Au
1. Requirement
2. Evidence
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3. Deficiency
rn

Or RED for short!

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In

Requirement:
This is usually against a Standard requirement, or the requirement from an internal process
5
01

etc.
:2

Evidence:
01

You cannot raise a nonconformity without objective evidence to do so. You have to state the
90

exact evidence that led to the nonconformity being raised.

Deficiency:
IS

This is what is wrong. You should state as briefly as possible what the problem is.

Some possible examples of situations where nonconformities may be raised:

• Quality policy not being effectively communicated
• Quality objective not monitored
• Internal audit records did not adequately reference details of nonconformities
• Nonconformities not having their corrective actions closed out
• Staff competencies not being assessed

When writing nonconformities remember ABC:

Accuracy
Brevity
Clarity

-ID
SI
r-B
The Tutor is about to show you various situations to see if you can determine what the N/C is,
and what clause of ISO 9001 it should be raised against.

to
di
Your tutor will now ask you to close your course folder!
Au
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rn

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Details are brief, but the indications are it is a NCR against Clause 8.3.6.d).

to
But this N/C could also be raised against Clause 8.1e).

di
Au
Some N/Cs can be raised against more than one clause; so it is up to the auditor to decide
which clause will have the greatest impact, and which is most appropriate.
al
rn

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In

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to
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Au
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rn

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Details are brief, but the indications are it is a NCR against Clause 9.2.2 a).

to
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……………………………………………………………………………………………………………………………………
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01

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-ID
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Details are brief but the indications are it is a NCR against 7.1.5.2 c)

to
Your tutor will now invite you to re-open your course folder.

di
Au
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-ID
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Activity 9: Documenting nonconformities

to
Purpose:

di
To practice the skills necessary to document concisely a nonconformity.
Au
Duration:
al

30 minutes in groups (from the last activity)

15 minutes class discussion

te
In

Directions:
5

In your groups, please review the findings from your audit (using your completed flipchart).
01

Pick one nonconformity and write on a flipchart a nonconformity statement (using the
template example just covered).
:2
01

Get ready to feedback the nonconformity to the other groups, who will act as the auditee’s
90

management.
O

The tutor will give you further opportunity to practice this important skill (time dependent).
IS

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-ID
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r-B
The auditor should then review all findings (positives and nonconformities) and determine
audit conclusions.

to
di
Audit conclusion can address, for example: Au
• The extent of conformity with the audit criteria
• Effective implementation, maintenance and improvement
al

• Achievement of audit objectives and coverage of scope

• The identification of risks and the effectiveness of actions taken by the auditee to address
te

risks and consider the level of the integration of different management systems and their
In

intended results.
5
01

Auditors should be focused on the intended result of the management system throughout
the audit process. While processes and what they achieve are important, the result of the
:2

management system and its performance are what counts. Content of audit conclusions
01

should address issues such as the identification of risks and effectiveness of actions taken by
90

the auditee to address risks.

Conducting the closing meeting

A closing meeting should then be held to present the audit findings and conclusions.
Participants in the closing meeting should include the management of the auditee and
(where appropriate) those responsible for the functions or processes which have been
audited.

If applicable, the auditor should advise the auditee of situations encountered during the
audit that may decrease the confidence that can be placed in the audit conclusions.

If defined in the management system, or by agreement with the auditee’s management, the
participants should agree on the time frame for:
• Producing an action plan to address any audit findings
• Preparing the documented audit report and confirming who it will be distributed to.

Typical agenda:
1. Attendees
2. Thanks and confidentiality
3. Objective / Scope / Criteria
4. Limitations
5. Summarize findings, nonconformities, and positives encountered
6. Agreement
7. Action plan time frames
8. Audit report time frames and distribution. An explanation of the fact that an audit is
not necessarily fully representative of the overall effectiveness of the auditee’s
processes
9. Clarification and depart

-ID
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SI
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r-B
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rn

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-ID
SI
r-B
Activity 10: Your closing meeting!

to
Purpose:

di
To practice the skills necessary to conduct an effective closing meeting.
Au
Duration:
al

15 minutes preparation, whole class

20 minutes, closing meeting, whole class

10 minutes class discussion

Directions:
5
01

The tutor will select one (or two) delegates to act as the audit team leader. The team
leader(s) are to run the meeting following a typical agenda covered earlier.
:2
01

The closing meeting will relate to the audit you just carried out and the related findings.
90

Management will be in attendance.

Other delegates are to select one nonconformity from their groups findings (please each
IS

select a different one) and write the nonconformity out, as per the last Activity (in your
notebook). These will be individually presented (read out), as directed by the team leader(s)
in the closing meeting.

-ID
SI
r-B
……………………………………………………………………………………………………………………………………

to
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di
Au
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01

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90

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IS

-ID
SI
r-B
Typical audit report contents include:
• Audit reference and date

to
• Auditee(s) and auditor details

di
• Objectives, scope, and criteria Au
• Reference to audit plan e.g. dates, places, and areas audited
• Audit summary; including good areas/activities found
al

• Nonconformity reports and opportunities for improvement

• Uncertainty due to sampling or unresolved issues

• Any areas in audit scope not covered

• Confirmation that audit objectives accomplished

• Distribution list.
5
01

The audit report should provide a complete, accurate, concise and clear record of the audit.
:2

Conclusions should be drawn (both positive and negative).

01
90

Organizations will tend to have their own template for the report. The method of providing a
copy of the report (and to whom) will depend on the policy of your organization.
O
IS

After the audit, the report normally needs to be approved; usually by the management of
the area audited. The audit report is confidential.

Your tutor may ask you now to individually prepare a summary audit report (from your
audit), depending on time and your needs.

Please refer to your Reference section:

Example: Typical audit report

Completing the Audit

The audit is complete when all planned activities have been carried out, documents retained
or destroyed, and lessons learnt entered into the continual improvement process. When
completing the audit, lessons learned from the audit can identify risks and opportunities for
the audit programme and the auditee.

-ID
SI
r-B
……………………………………………………………………………………………………………………………………

to
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di
Au
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IS

-ID
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The conclusions of the audit can, depending on the audit objectives, indicate the need for

to
corrections, or for corrective or improvement actions, or where a risk area may have been

di
raised. Such actions are usually decided and undertaken by the auditee within an agreed
Au
timeframe. As appropriate, the auditee should keep the person managing the audit
programme and the audit team informed of the status of these actions.
al
rn

The completion and effectiveness of these actions should be verified. This verification may
te

be part of a subsequent audit.

Follow up options can include:

• Limited re-audit
01

• Submission and review of amended documentation

• Roll over until the next audit.

01
90

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……………………………………………………………………………………………………………………………………
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-ID
SI
r-B
Activity 11: Audit close-out

to
Purpose:

di
To enhance your ability to review/respond to an auditee’s proposed corrective action.
Au
Duration:
al

30 minutes in pairs
rn

5 minutes summary
te
In

Directions:
In pairs, decide on a particular nonconformity (from your audit) where corrective actions will
5
01

be necessary. On a flip chart, provide a response detailing your proposed corrective action.
:2

Each pair’s proposed corrective action will be presented to another pair (acting as the
01

auditor), where you (the auditor) will decide if this is appropriate.

The tutor may request certain elements of your corrective action to change, or be omitted,
O

to draw out the learning points from each pair.

-ID
SI
r-B
Activity 12: Reflection quiz

to
Purpose:

di
Reflect on learning, check learning objectives met. Au
Duration:
al

15 minutes
rn
te

Directions:
In

In teams or individually as assigned, come up with two/three questions, from the learning
during this course, to which you know the answer!
5
01

As directed, ask your questions of others and provide answers to theirs.

:2
01

The below commentary may also provoke thought and possible questions/answers:
90

ISO 19011:2018 has a theme regarding process audits against risk to achieve
O

intended outcomes, and not ensuring that the details of every clause are
IS

audited. Audit programmes & plans should support process audits and a risk‐
based approach to auditing – so the activities/products/services within a MS
scope should be broken down into the audit programme/plans appropriately to
support process audits. Process audits may cover many clauses for each
activity/area within an MS scope boundary.

Professional judgement and performance results are important. (A.3 & A.4):–

“Auditors should apply professional judgement during the audit process and
avoid concentrating on the specific requirements of each clause of the standard
at the expense of achieving the intended outcome of the management system.
Auditors should be focused on the intended result of the management system
throughout the audit process. While processes and what they achieve are
important, the result of the management system and its performance are what
counts.”

-ID
SI
r-B
• What will you now do differently?
• What have you learnt?

to
• Were you expectations/specific questions/problems answered?

di
Au
Delegates should now have the knowledge to:
• Explain the guidelines of auditing management systems according to ISO 19011:2018
al

• Describe the application of these guidelines to auditing ISO 9001:2015

rn
te

Delegated should now have the skills to:

• Initiate the audit

• Prepare audit activities

• Conduct audit activities

• Prepare and distribute the audit report

• Complete the audit

• Audit follow-up
90
O

……………………………………………………………………………………………………………………………………
IS

-ID
SI
r-B
to
Contact information

di
Au
Address:
al

Telephone:
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Fax:
In

Email:
5
01

<general training email>@bsigroup.com

Links:
01

http://<local web address>

Add local/country contact information

O
IS

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