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© Operational Excellence Consulting
ISO 45001:2018
Occupational Health & Safety (OH&S)
Management Systems
© Operational Excellence Consulting. All rights reserved.
© Operational Excellence Consulting
LEARNING OBJECTIVES
2
Provide background
knowledge on ISO
45001
Describe the audit
approach and learn
useful tips for
handling an audit
session
Gain an overview of
the ISO 45001:2018
structure
Define the ISO
45001:2018
certification process
NOTE: This is a PARTIAL PREVIEW.
To download the complete presentation, please
visit: https://www.oeconsulting.com.sg
© Operational Excellence Consulting
CONTENTS
3
OVERVIEW OF
ISO 45001
ISO 45001:2018
STRUCTURE
ISO 45001:2018
CERTIFICATION
PROCESS
AUDIT APPROACH
01 04
03
02
HANDLING AN
AUDIT SESSION
05
© 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 283
was responsible for the
development of ISO 45001
Occupational Health & Safety
Management Systems
4
© Operational Excellence Consulting
ISO STANDARDS CONTRIBUTE DIRECTLY TO THE U.N. SUSTAINABLE
DEVELOPMENT GOALS (SDGS)
5
ISO 14001:2015
Environmental
Management Systems
ISO/IEC
27001:2022
Information Security
Management Systems
ISO 22000:2018
Food Safety
Management Systems
ISO 26000:2010
Social Responsibility
ISO 9001:2015
Quality Management
Systems
ISO 50001:2018
Energy Management
Systems
ISO 37001:2016
Anti-Bribery
Management Systems
ISO 45001:2018
Occupational Health &
Safety Management
Systems
Some examples of popular ISO standards that are adopted
by various companies and organizations:
© Operational Excellence Consulting
WHAT IS A MANAGEMENT SYSTEM?
6
A management system is the way in which an
organization manages the interrelated parts of its
business in order to achieve its objectives.
Source: Adapted from ISO
© Operational Excellence Consulting
2.8 M
people worldwide die annually due to work-related injuries.
7
Source: International Labour Organization (ILO)
© Operational Excellence Consulting
Source: International Labor Organization (ILO)
WORKPLACE INJURY STATISTICS
8
● 2.78 million fatal accidents occur
at work yearly
● 7,700 persons die of work-related
diseases or injuries daily
● 374 million non-fatal work-related
injuries and illnesses each year
● 180 million people with
occupational disease
● 4% of world GDP = work accidents
and diseases
© Operational Excellence Consulting
● ISO 45001 is a global standard for
occupational health and safety
management systems (OH&S MS)
● Specifies requirements for an OH&S
MS
● Applies to all types and sizes of
organizations
WHAT IS ISO 45001?
© Operational Excellence Consulting 9
© Operational Excellence Consulting
DEVELOPMENT OF ISO 45001
10
OHSAS 18001:2007 (2nd issue)
ISO 45001:2018 (1st issue)
1999
2000
2018
OHSAS 18001:1999 (1st issue)
OH&S Management System
© Operational Excellence Consulting
● Growing demand for a management
system based standard for OH&S
● Need for health and safety
management system that could be
audited and certified
● Rising health and safety costs
● Increased regulation
© Operational Excellence Consulting
WHY WAS ISO 45001 DEVELOPED?
11
© Operational Excellence Consulting 12
OBJECTIVES OF ISO 45001
Help organizations
minimize the risk of harm
to all those working under
their control (defined as
“workers” within the
standard)
Provide a platform for
continual improvement in
OH&S performance
Integrate OH&S within an
organization’s overall
business management
system
© Operational Excellence Consulting
KEY FOCUS OF ISO 45001
13
Top management is
accountable for OH&S
management and need
to demonstrate
leadership
Worker participation in
identification of
hazards and risks, and
development and
operation of the OH&S
management system
The need to prevent ill-
health (including
mental illness), as well
as injuries
The need to recognize
the causes of ill-health
and injuries
© Operational Excellence Consulting
BENEFITS TO AN ORGANIZATION FOR IMPLEMENTING AN OH&S
MANAGEMENT SYSTEM
14
Improve public
image
Reduced costs
Better access to
capital
Reduced liability
Fewer accidents
Improved OH&S
performance
© Operational Excellence Consulting
ADVANTAGES OF CERTIFICATION
© Operational Excellence Consulting
● Certification to ISO 45001 is
voluntary
● Independent check of conformity by a
third party
● Indicates an effective OH&S
Management System
● National/International recognition
● Provides competitive advantage
● Improves company image
15
15
© Operational Excellence Consulting
THE PLAN-DO-CHECK-ACT (PDCA) PROCESS MODEL
16
ACT
CHECK
DO
PLAN
THE
DEMING
CYCLE
1. PLAN
Establish objectives,
programs and processes
necessary to deliver results
in accordance with the
organization’s OH&S policy.
2. DO
Implement the processes of
the OH&S.
4. ACT
Take actions to continually
improve the OH&S
performance to achieve the
intended outcomes.
3. CHECK
Monitor and measure
activities and processes
with regard to the OH&S
policy and objectives, and
report the results.
The Deming Cycle
© Operational Excellence Consulting
● HLS is a set of 10 clauses that all
ISO management system standards
are required to use in the future
● This is so that all management
system standards (MSS) will have
the same look and feel, and will
enable greater integration between
systems of different disciplines
HIGH-LEVEL STRUCTURE (HLS)
17
© Operational Excellence Consulting 17
© Operational Excellence Consulting
ISO 45001:2018 IS BASED ON THE ISO HIGH-LEVEL STRUCTURE FOR
MANAGEMENT SYSTEM STANDARDS
18
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
© Operational Excellence Consulting
ISO 45001:2018 KEY CLAUSE STRUCTURE (4-10)
PLAN DO CHECK ACT
4. Context of the
organization
5. Leadership &
worker participation
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 workers and
interested parties
5.2 OH&S policy 6.2 OH&S objectives and
planning to achieve them
7.2 Competence 8.2 Emergency
preparedness and
response
9.2 Internal audit 10.2 Incident,
nonconformity and
corrective action
4.3 Determining the
scope of the OH&S
management system
5.3 Organizational roles,
responsibilities and
authorities
7.3 Awareness 9.3 Management review 10.3 Continual
improvement
4.4 OH&S management
system
5.4 Consultation and
participation of workers
7.4 Communication
7.5 Documented
information
© Operational Excellence Consulting
ISO 45001: HIERARCHY OF CONTROLS FOR REDUCING OH&S RISKS
20
Elimination
Substitution
Engineering Controls
Administrative
Controls
PPE
Most
effective
Least
effective
Protect the worker with Personal
Protective Equipment
Change the way people work
Isolate people from the hazard
Replace the hazard
Physically remove the hazard
© Operational Excellence Consulting
● The certification body examines the
OH&S for conformity to the ISO
45001:2018 standard
● The OH&S audit is a compliance
audit
● Certification means the organization
has a documented OH&S that is
fully implemented and meets ISO
45001:2018 requirements
BECOMING ISO 45001:2018
CERTIFIED
© Operational Excellence Consulting 21
21
© Operational Excellence Consulting 22
ISO 45001:2018 CERTIFICATION PROCESS
3 5 7
1 4 6
2
Implementation of OH&S 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
© Operational Excellence Consulting 23
WHAT IS AN ISO AUDIT?
An ISO audit is an audit of your organization’s
compliance with one of the standards set forth by
the International Organization for Standardization
(ISO). An audit measures your company’s systems
against any ISO standard (e.g. ISO 45001:2018).
© Operational Excellence Consulting
WHAT ARE AUDITS USED FOR?
24
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
© 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 25
25
© Operational Excellence Consulting
AUDIT FINDINGS
26
MAJOR NONCONFORMITY
§ A major nonconformity
relates to the absence or
total breakdown of a required
process or a number of
minor nonconformities listed
against similar areas
§ A major nonconformity at the
Registration Audit would
defer recommendation for
registration until that major
has been closed
MINOR NONCONFORMITY OBSERVATION
§ A minor nonconformity 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 nonconformity
© Operational Excellence Consulting
HOW TO HANDLE AN AUDIT SESSION?
27
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
© Operational Excellence Consulting
● Polite
● Professional
● Positive / Receptive
● Sincere
● Commitment
● Formal but not overly serious
AUDITEE’S CONDUCT
© Operational Excellence Consulting 28
28
© 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
29
© 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

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ISO 45001:2018 (Occupational Health & Safety Management Systems) Awareness Training

  • 1. © Operational Excellence Consulting ISO 45001:2018 Occupational Health & Safety (OH&S) Management Systems © Operational Excellence Consulting. All rights reserved.
  • 2. © Operational Excellence Consulting LEARNING OBJECTIVES 2 Provide background knowledge on ISO 45001 Describe the audit approach and learn useful tips for handling an audit session Gain an overview of the ISO 45001:2018 structure Define the ISO 45001:2018 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 45001 ISO 45001:2018 STRUCTURE ISO 45001:2018 CERTIFICATION PROCESS AUDIT APPROACH 01 04 03 02 HANDLING AN AUDIT SESSION 05
  • 4. © 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 283 was responsible for the development of ISO 45001 Occupational Health & Safety Management Systems 4
  • 5. © Operational Excellence Consulting ISO STANDARDS CONTRIBUTE DIRECTLY TO THE U.N. SUSTAINABLE DEVELOPMENT GOALS (SDGS) 5 ISO 14001:2015 Environmental Management Systems ISO/IEC 27001:2022 Information Security Management Systems ISO 22000:2018 Food Safety Management Systems ISO 26000:2010 Social Responsibility ISO 9001:2015 Quality Management Systems ISO 50001:2018 Energy Management Systems ISO 37001:2016 Anti-Bribery Management Systems ISO 45001:2018 Occupational Health & Safety Management Systems Some examples of popular ISO standards that are adopted by various companies and organizations:
  • 6. © Operational Excellence Consulting WHAT IS A MANAGEMENT SYSTEM? 6 A management system is the way in which an organization manages the interrelated parts of its business in order to achieve its objectives. Source: Adapted from ISO
  • 7. © Operational Excellence Consulting 2.8 M people worldwide die annually due to work-related injuries. 7 Source: International Labour Organization (ILO)
  • 8. © Operational Excellence Consulting Source: International Labor Organization (ILO) WORKPLACE INJURY STATISTICS 8 ● 2.78 million fatal accidents occur at work yearly ● 7,700 persons die of work-related diseases or injuries daily ● 374 million non-fatal work-related injuries and illnesses each year ● 180 million people with occupational disease ● 4% of world GDP = work accidents and diseases
  • 9. © Operational Excellence Consulting ● ISO 45001 is a global standard for occupational health and safety management systems (OH&S MS) ● Specifies requirements for an OH&S MS ● Applies to all types and sizes of organizations WHAT IS ISO 45001? © Operational Excellence Consulting 9
  • 10. © Operational Excellence Consulting DEVELOPMENT OF ISO 45001 10 OHSAS 18001:2007 (2nd issue) ISO 45001:2018 (1st issue) 1999 2000 2018 OHSAS 18001:1999 (1st issue) OH&S Management System
  • 11. © Operational Excellence Consulting ● Growing demand for a management system based standard for OH&S ● Need for health and safety management system that could be audited and certified ● Rising health and safety costs ● Increased regulation © Operational Excellence Consulting WHY WAS ISO 45001 DEVELOPED? 11
  • 12. © Operational Excellence Consulting 12 OBJECTIVES OF ISO 45001 Help organizations minimize the risk of harm to all those working under their control (defined as “workers” within the standard) Provide a platform for continual improvement in OH&S performance Integrate OH&S within an organization’s overall business management system
  • 13. © Operational Excellence Consulting KEY FOCUS OF ISO 45001 13 Top management is accountable for OH&S management and need to demonstrate leadership Worker participation in identification of hazards and risks, and development and operation of the OH&S management system The need to prevent ill- health (including mental illness), as well as injuries The need to recognize the causes of ill-health and injuries
  • 14. © Operational Excellence Consulting BENEFITS TO AN ORGANIZATION FOR IMPLEMENTING AN OH&S MANAGEMENT SYSTEM 14 Improve public image Reduced costs Better access to capital Reduced liability Fewer accidents Improved OH&S performance
  • 15. © Operational Excellence Consulting ADVANTAGES OF CERTIFICATION © Operational Excellence Consulting ● Certification to ISO 45001 is voluntary ● Independent check of conformity by a third party ● Indicates an effective OH&S Management System ● National/International recognition ● Provides competitive advantage ● Improves company image 15 15
  • 16. © Operational Excellence Consulting THE PLAN-DO-CHECK-ACT (PDCA) PROCESS MODEL 16 ACT CHECK DO PLAN THE DEMING CYCLE 1. PLAN Establish objectives, programs and processes necessary to deliver results in accordance with the organization’s OH&S policy. 2. DO Implement the processes of the OH&S. 4. ACT Take actions to continually improve the OH&S performance to achieve the intended outcomes. 3. CHECK Monitor and measure activities and processes with regard to the OH&S policy and objectives, and report the results. The Deming Cycle
  • 17. © Operational Excellence Consulting ● HLS is a set of 10 clauses that all ISO management system standards are required to use in the future ● This is so that all management system standards (MSS) will have the same look and feel, and will enable greater integration between systems of different disciplines HIGH-LEVEL STRUCTURE (HLS) 17 © Operational Excellence Consulting 17
  • 18. © Operational Excellence Consulting ISO 45001:2018 IS BASED ON THE ISO HIGH-LEVEL STRUCTURE FOR MANAGEMENT SYSTEM STANDARDS 18 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
  • 19. © Operational Excellence Consulting ISO 45001:2018 KEY CLAUSE STRUCTURE (4-10) PLAN DO CHECK ACT 4. Context of the organization 5. Leadership & worker participation 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 workers and interested parties 5.2 OH&S policy 6.2 OH&S objectives and planning to achieve them 7.2 Competence 8.2 Emergency preparedness and response 9.2 Internal audit 10.2 Incident, nonconformity and corrective action 4.3 Determining the scope of the OH&S management system 5.3 Organizational roles, responsibilities and authorities 7.3 Awareness 9.3 Management review 10.3 Continual improvement 4.4 OH&S management system 5.4 Consultation and participation of workers 7.4 Communication 7.5 Documented information
  • 20. © Operational Excellence Consulting ISO 45001: HIERARCHY OF CONTROLS FOR REDUCING OH&S RISKS 20 Elimination Substitution Engineering Controls Administrative Controls PPE Most effective Least effective Protect the worker with Personal Protective Equipment Change the way people work Isolate people from the hazard Replace the hazard Physically remove the hazard
  • 21. © Operational Excellence Consulting ● The certification body examines the OH&S for conformity to the ISO 45001:2018 standard ● The OH&S audit is a compliance audit ● Certification means the organization has a documented OH&S that is fully implemented and meets ISO 45001:2018 requirements BECOMING ISO 45001:2018 CERTIFIED © Operational Excellence Consulting 21 21
  • 22. © Operational Excellence Consulting 22 ISO 45001:2018 CERTIFICATION PROCESS 3 5 7 1 4 6 2 Implementation of OH&S 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
  • 23. © Operational Excellence Consulting 23 WHAT IS AN ISO AUDIT? An ISO audit is an audit of your organization’s compliance with one of the standards set forth by the International Organization for Standardization (ISO). An audit measures your company’s systems against any ISO standard (e.g. ISO 45001:2018).
  • 24. © Operational Excellence Consulting WHAT ARE AUDITS USED FOR? 24 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
  • 25. © 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 25 25
  • 26. © Operational Excellence Consulting AUDIT FINDINGS 26 MAJOR NONCONFORMITY § A major nonconformity relates to the absence or total breakdown of a required process or a number of minor nonconformities listed against similar areas § A major nonconformity at the Registration Audit would defer recommendation for registration until that major has been closed MINOR NONCONFORMITY OBSERVATION § A minor nonconformity 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 nonconformity
  • 27. © Operational Excellence Consulting HOW TO HANDLE AN AUDIT SESSION? 27 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
  • 28. © Operational Excellence Consulting ● Polite ● Professional ● Positive / Receptive ● Sincere ● Commitment ● Formal but not overly serious AUDITEE’S CONDUCT © Operational Excellence Consulting 28 28
  • 29. © 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 29
  • 30. © 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