Over a million organizations in 170 countries have adopted ISO 9001:2015 as their quality management standard. Many more are pursuing this certification. Why? Because ISO 9001 helps your company assure quality, save money and customers expect it. ISO 9001 applies to all types of organizations. This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 9001:2015 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors. ​It covers the what and why of ISO 9001, the QMS clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 9001. LEARNING OBJECTIVES  1. Provide background knowledge on ISO 9001 2. Gain an overview of ISO 9001 structure and the certification process 3. Understand the audit approach 4. Gather useful tips on handling an audit session ​ CONTENTS 1. Overview of ISO 9001 2. ISO 9001 Structure 3. ISO 9001 Certification Process 4. Audit Approach 5. Handling an Audit Session To download this complete presentation, please go to: https://www.oeconsulting.com.sg

1. © Operational Excellence Consulting
ISO 9001:2015
Quality Management Systems
© Operational Excellence Consulting. All rights reserved.

2. © Operational Excellence Consulting
LEARNING OBJECTIVES
2
Provide background
knowledge on ISO
9001
Describe the audit
approach and learn
useful tips on
handling an audit
session
Gain an overview of
the ISO 9001:2015
structure
Define the ISO
9001:2015
certification process
NOTE: This is a PARTIAL PREVIEW.
To download the complete presentation, please
visit: https://www.oeconsulting.com.sg

3. © Operational Excellence Consulting
CONTENTS
3
OVERVIEW OF
ISO 9001
ISO 9001:2015
STRUCTURE
ISO 9001:2015
CERTIFICATION
PROCESS
AUDIT APPROACH
01 04
03
02
HANDLING AN
AUDIT SESSION
05

4. © Operational Excellence Consulting
“
It is not enough to do your
best; you must know what
to do, then do your best.”
W. EDWARDS DEMING
4

5. © Operational Excellence Consulting
● Non-governmental organization
(NGO) established in 1947, based
in Geneva, Switzerland
● Has a membership of over 160
national standards institutes from
countries in all regions of the world
● The world’s largest developer of
voluntary International Standards,
based on global and market
relevance
ABOUT ISO
● Developed more than 20,000
standards for all dimensions of
sustainable development
● Technical Committee ISO/TC
176/SC 2 was responsible for the
development of ISO 9001:2015
● The ISO 9001:2015 standard was
last reviewed and confirmed
in 2021. Therefore this version
remains current.
5

6. © Operational Excellence Consulting
● ISO 9001 is the world’s most
popular and most commonly used
standard for Quality Management
Systems (QMS)
● International consensus on good
management practice
WHAT IS ISO 9001?
● Focuses on meeting customer
requirements and other interested
parties
● Distilled into standard
requirements
● Covers any organization –
whatever the size, industry or
culture
6

7. © Operational Excellence Consulting
WHY IS A QUALITY MANAGEMENT SYSTEM IMPORTANT?
7
Improve customer
satisfaction and loyalty
Create a continual
improvement culture
Increase efficiency,
fewer mistakes and less
wasted time
Enhance process flow
and integration
Increase sales and
profits
Reduce overall risks
Improve engagement
of employees
Create sustainable
competitive advantage

8. © Operational Excellence Consulting
ADVANTAGES OF CERTIFICATION
© Operational Excellence Consulting
● Certification to ISO 9001 is voluntary
● Independent check of conformity by a
third party
● Indicates an effective Quality
Management System
● National/International recognition
● Provides competitive advantage
● Improves company image
8
8

9. © Operational Excellence Consulting 9
QUALITY MANAGEMENT PRINCIPLES
1.
Customer
Focus
2.
Leadership
3.
Engagement of
People
4.
Process
Approach
5.
Improvement
7.
Relationship
Management
QUALITY
MANAGEMENT
PRINCIPLES
6.
Evidence-based
Decision Making

10. © Operational Excellence Consulting
BENEFITS OF THE NEW ISO 9001:2015
10
Puts greater
emphasis on
leadership
engagement
Helps address
organizational
risks and
opportunities in a
structured manner
Uses simplified
language and a
common structure
and terms
Addresses supply
chain management
more effectively
Is more user-friendly
for service and
knowledge-based
organizations

11. © Operational Excellence Consulting
ISO 9001:2015 IS BASED ON THE ISO HIGH-LEVEL STRUCTURE FOR
MANAGEMENT SYSTEM STANDARDS
11
1. Scope
2. Normative References
3. Terms & Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement

12. © Operational Excellence Consulting
THE PLAN-DO-CHECK-ACT (PDCA) PROCESS MODEL
12
ACT
CHECK
DO
PLAN
THE
DEMING
CYCLE
1. PLAN
Establish objectives,
programs and processes
necessary to deliver results
in accordance with the
organization’s QMS policy.
2. DO
Implement the processes of
the QMS.
4. ACT
Take actions to continually
improve the QMS
performance to achieve the
intended outcomes.
3. CHECK
Monitor and measure
activities and processes
with regard to the QMS
policy and objectives, and
report the results.
The Deming Cycle

13. © Operational Excellence Consulting
ISO 9001 APPROACH IS BASED ON THE PDCA CYCLE
13
Organization and
its context (4)
Customer
Requirements
Customer
Satisfaction
Products
and services
Results of
the QMS
Needs and expectations
of relevant interested
parties (4)
Leadership
(5)
Performance
evaluation
(9)
Support &
Operation
(7,8)
Planning
(6)
Improvement
(10)
Plan Do
Check
Act
Source: Based on ISO

14. © Operational Excellence Consulting
ISO 9001:2015 KEY CLAUSE STRUCTURE (4-10)
PLAN DO CHECK ACT
4. Context of the
organization
5. Leadership 6. Planning 7. Support 8. Operation 9. Performance
evaluation
10. Improvement
4.1 Understanding the
organization and its
context
5.1 Leadership and
commitment
6.1 Actions to address
risks and opportunities
7.1 Resources 8.1 Operational planning
and control
9.1 Monitoring,
measurement, analysis
and evaluation
10.1 General
4.2 Understanding the
needs and expectations
of interested parties
5.2 Policy 6.2 Quality objectives
and planning to achieve
them
7.2 Competence 8.2 Requirements for
products and services
9.2 Internal audit 10.2 Nonconformity and
corrective action
4.3 Determining the
scope of the QMS
5.3 Organizational roles,
responsibilities and
authorities
6.3 Planning of changes 7.3 Awareness 8.3 Design and
development of products
and services
9.3 Management review 10.3 Continual
improvement
4.4 QMS and its
processes
7.4 Communication 8.4 Control of externally
provided processes,
products and services
7.5 Documented
information
8.5 Production and
service provision
8.6 Release of products
and services
8.7 Control of
nonconforming outputs 14

15. © Operational Excellence Consulting
● The certification body examines the
QMS for conformity to the ISO 9001
standard
● The QMS audit is a compliance
audit
● Certification means the organization
has a documented QMS that is fully
implemented and meets ISO 9001
requirements
BECOMING ISO 9001 CERTIFIED
© Operational Excellence Consulting 15
15

16. © Operational Excellence Consulting
TRANSITIONING TO THE LATEST ISO 9001:2015 STANDARD
16
Familiarize with the new document
1 Provide appropriate training and
awareness
4
Identify gaps to meet the new
requirements
2 Update the existing QMS to meet
the revised requirements
5
Develop an implementation plan
3 Liaise with your certification body
for transition
6

17. © Operational Excellence Consulting 17
ISO 9001:2015 CERTIFICATION PROCESS
3 5 7
1 4 6
2
Implementation of QMS Selection of a
Certification Body
Stage 2 Audit Continual Improvement
and Surveillance Audits
Conduct Internal Audit
and Review Result by
Top Management Stage 1 Audit
Confirmation of
Registration

18. © Operational Excellence Consulting
WHAT ARE AUDITS USED FOR?
18
Auditing conformity
Auditing effectiveness
Looking at the overall process
Approving external service providers
Investigating problems
Way of improving
Assessing for certification
Highlight examples of good practice

19. © Operational Excellence Consulting 19
AUDIT FOCUS
Effectiveness of the QMS in achieving the
organization’s objectives and in providing
products and services that conform to
requirements of interested parties.

20. © Operational Excellence Consulting
● Focuses on employees’
understanding of the organization’s
processes and verifies that these
processes are:
o complied with
o under control
o achieving the desired results
● Provide evidence, e.g. records,
meeting minutes, reports, data and
emails
AUDIT APPROACH
© Operational Excellence Consulting 20
20

21. © Operational Excellence Consulting
AUDIT FINDINGS
21
MAJOR NON-CONFORMITY
§ A major non-conformity
relates to the absence or
total breakdown of a required
process or a number of
minor non-conformities listed
against similar areas
§ A major non-conformity at
the Registration Audit would
defer recommendation for
registration until that major
has been closed
MINOR NON-CONFORMITY OBSERVATION
§ A minor non-conformity is an
observed lapse in your
systems ability to meet the
requirements of the standard
or your internal systems,
while the overall process
remains intact
§ An observation or
opportunity for improvement
relates to a matter about
which the Auditor is
concerned but which cannot
be clearly stated as a non-
conformity
§ Observations also indicate
trends which may result in a
future non-conformity

22. © Operational Excellence Consulting
HOW TO HANDLE AN AUDIT SESSION?
22
Ask and clarify
Admit obvious non-conformities
Do not panic
Take note of improvement areas highlighted
by the auditor
Show internal audit report, when necessary
Offer evidence and explain patiently

23. © Operational Excellence Consulting
● Polite
● Professional
● Positive / Receptive
● Sincere
● Commitment
● Formal but not overly serious
AUDITEE’S CONDUCT
© Operational Excellence Consulting 23
23

24. © Operational Excellence Consulting
● Be honest and open
● Recognize they may be experts
● Realize they may not be subject
matter experts
● Understand the purpose of the
meeting and review related
records prior to interviews
INTERACTING WITH AUDITORS – DO’S
● Turn mobile phones to silent mode
● Get the right person in to answer
the question
● Listen carefully and understand
each question before answering –
Be sure responses are complete
and accurate
24

25. © Operational Excellence Consulting
Operational Excellence Consulting is a management training
and consulting firm that assists organizations in improving
business performance and effectiveness. Based in Singapore,
the firm’s mission is to create business value for organizations
through innovative design and operational excellence
management training and consulting solutions. For more
information, please visit www.oeconsulting.com.sg
ABOUT OPERATIONAL EXCELLENCE CONSULTING