GRS Lead Auditor Training Master Presentation - OHSMS LA Slides

Lead Auditor Training
OH&S ISO
45001:2018
Welcome to Lead Auditor Training

course on ISO 45001:2018
(Occupational Health & Safety
ISO/TC 176/SC 2/ N1267
Management System)
OH&S ISO
45001:2018
About Us
Global Registrar of Systems (GRS) is one of the fastest
growing certification bodies operating across Australia
and New Zealand (ANZ) and has engaged industry
leading professionals in pioneering the system
certification and training services.
GRS provides system certifications for ISO 9001: 2015,

ISO 14001:2015, ISO 45001:2018, OHSAS 18001: 2007
ISO/TC 176/SC 2/ N1267
and AS/NZS 4801:2001, certification across Australia,

New Zealand, and Bangladesh.
OH&S ISO
45001:2018
Welcome to Lead Auditor Training

course on ISO 45001:2018
(Occupational Health & Safety

Management System)
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
About ISO
• Non-governmental organization (NGO) established in 1947,

based in Geneva, Switzerland
• Has a membership of over 169 national standards institutes

ISO/TC 176/SC 2/ N1267
from countries in all regions of the world
• The world’s largest developer of voluntary International

Standards, based on global and market relevance
OH&S ISO
45001:2018
About ISO
• Developed more than 22,000 standards for all dimensions
of sustainable development: economic, environmental and
societal
• Examples of well-known management standards:

• ISO 9001 – Quality Management Systems (QMS)
• ISO 14001 – Environmental Management Systems (EMS)

ISO/TC 176/SC 2/ N1267
• ISO 45001 – Occupational Health & Safety Management Systems

(ISMS)
• ISO’s Technical Committee ISO/TC 283 was responsible for

the development of ISO 45001 Occupational Health &
Safety Management Systems
OH&S ISO
45001:2018
ABOUT THE COURSE

Course Title Lead Auditor Training course on ISO 45001:2018
Level Professional
Course short The aim of this course is to provide delegates with the
Description: knowledge and skills required to perform first, second
and third party audits of Occupational Health & Safety
management systems against ISO 45001 standard in
accordance with ISO 19011 and ISO /IEC 17021, as
applicable.
Assessment: Continuous assessment and 2 hours examination.
ISO/TC 176/SC 2/ N1267
Recommended prior The Plan, Do, Check, Act (PDCA) cycle, Core elements
knowledge: of a management system and the interrelationship.
Fundamental concepts of Occupational Health & Safety
management and the requirements of ISO 45001 :2018
Standard and terms and definitions.
OH&S ISO
45001:2018
Course Timing
Day 1 0900 to 1900
Day 2 0900 to 1800
Day 3 0900 to 1800
Day 4 0900 to 1700
Day 5 0900 to 1700
Lunch breaks: 1300 to 1400

Coffee breaks: mid morning & mid afternoon
OH&S ISO
45001:2018
House rules
• Facilities
• Safety rules & evacuation routes
• Courtesy (mobile phones)
• Local arrangements
SAFETY/SECURITY
Please familiarize with any safety notices and

ISO/TC 176/SC 2/ N1267
the actions to be taken in case of fire or any

other emergency, including the position of
fire/emergency exits in the lecture room and
other parts in the building whilst at the course
venue.
OH&S ISO
45001:2018
Course Structure
• Learning Methods • Evaluation Methods

• Tutorials • Continuous Assessment
• Discussions • Formal Examination
• Exercises and Workshops • Two hours
• Case study • Open book (Only the
• Direct Tutor- Delegate standard)
interaction
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
Delegate assessment
Element Result
Continuous
Pass Pass Fail Fail
assessment
Written Exam Pass Fail Pass Fail
Result Pass Fail ** Fail ** Fail **
Retake Re-sit Re-sit

exam the the
Action None
within whole whole
12 months * course course
• * A delegate can only retake an examination once. After second non-successful

completion, the delegate needs to re-sit the whole course
• ** All delegate have the right to make a complaint or an appeal
OH&S ISO
45001:2018
LEARNING OBJECTIVES
By the end of the course the participants shall be able to:
• Describe the purpose of a quality management system and
explain the seven principles of quality management.
• Explain the purpose, content and interrelationship of ISO
45001 and ISO 19011
• Interpret the requirement of ISO 45001 in the context of audit
• Explain the roles and responsibilities of an auditor and lead
auditor to plan, conduct, report and follow-up a quality
management system audit and audit in accordance with ISO
ISO/TC 176/SC 2/ N1267
19011, and ISO/IEC 17021, as applicable.

• Plan, Conduct, report and follow-up an audit of a quality
management system to establish conformity/ non -conformity
with ISO 45001 and in accordance with ISO 19011 and
ISO/IEC 17021, as applicable.
OH&S ISO
45001:2018
TYPE OF AUDITS
A. FIRST PARTY AUDIT
Audits carried out by a company on its own systems.
B. SECOND PARTY AUDIT
Audits carried out by one organization on another prior to or

after contract placement.
ISO/TC 176/SC 2/ N1267
C. THIRD PARTY AUDIT

Audits carried out by independent accredited organizations.
OH&S ISO
45001:2018
EXERCISE-1
DELEGATE INTRODUCTION
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
FUNDAMENTAL CONCEPTS
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
What is Health and Safety?
► The dictionary defines the words health and safety as

follows:
 Health - the condition of body or mind

 Safety - not being exposed to danger or risks
► In industry, Health and Safety means preventing
accidents and work related ill health.
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
What is Safety?
For the purpose of risk management SAFETY needs to

be defined as:
“not being exposed to an unacceptable risk”
Occupational Health and Safety means preventing as
far as possible accidents and work related ill health.
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
Incidents
• Incidents are any work-related events in which an

injury or ill health or fatality occurred or could
have occurred
• Incidents in which injury, ill health or fatality
occurred are commonly called ACCIDENTS
• Where no injury or loss happens, the ‘incident‘ is
considered a "NEAR MISS“ (close call, dangerous
occurrence, etc.)
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
H. W. Heinrich’s Ratio
1
H. W. Heinrich : Industrial Accident Major Injury
Prevention (first Published in 1931
Based on study of 75,000 accidents)
29
Minor Injuries
300
No- Injury Incidents
ISO/TC 176/SC 2/ N1267
Unsafe Acts or Conditions ???

OH&S ISO
45001:2018
Work Related Ill Health

•Work related ill health is:
‘Identifiable, adverse physical or mental condition

arising from and/or made worse by a work activity
and/or work related situation’
•Work related ill health may be temporary or

permanent
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
Global Toll
• 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
ISO/TC 176/SC 2/ N1267
• 4% of world GDP = work accidents and

diseases
Source: International Labor Organization

(ILO)
OH&S ISO
45001:2018
What is an OH&S Management System?
• An Occupational Health and Safety Management System

(OH&S MS) is a coordinated and systematic approach to
managing health and safety risks
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
What is an OH&S Management System?
• Helps organisations to
continually improve their safety
performance and compliance to
health and safety legislation and
standards
• Establishes safer working

environments that protect
ISO/TC 176/SC 2/ N1267
people at work by eliminating, or

better managing, health and
safety hazards
OH&S ISO
45001:2018
What is ISO 45001?
• 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

ISO/TC 176/SC 2/ N1267
of organizations
OH&S ISO
45001:2018
What ISO 45001 IS NOT
• Does not state specific criteria for OH&S performance
• Does not prescribe the design of an OH&S

management system
• Does not specifically address issues such as product

safety, property damage or environmental impacts, and
an organization is not required to take account of these
issues unless they present a risk to its workers
ISO/TC 176/SC 2/ N1267
• Not intended to be a legally binding document, it is a

management tool for voluntary use by organizations
whose aim is to eliminate or minimize the risk of harm
OH&S ISO
45001:2018
Development of ISO 45001
OH&S Management System
1999 BS OHSAS 18001:1999 (1st issue)
2007 BS OHSAS 18001:2007 (2nd issue)
ISO 45001:2018 (1st issue)

2018
2018-2021
Recertification audits
to the new standard
OH&S ISO
45001:2018
Why Was ISO 45001 Developed?
• 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
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
Who Is This Standard For?
• Any organization, regardless of its size, type and activities
that wants to:
1. Establish, implement and maintain an OH&S
management system to improve occupational health
and safety, eliminate or minimize OH&S risks (including
system deficiencies), take advantage of OH&S
opportunities, and address OH&S management system
nonconformities associated with its activities
2. Continually improve its OH&S performance and the
achievement of its OH&S objectives
ISO/TC 176/SC 2/ N1267
3. Assure itself of conformity with its OH&S policy

4. Demonstrate conformity with the requirements of the
standard
OH&S ISO
45001:2018
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
ISO/TC 176/SC 2/ N1267
management system
OH&S ISO
45001:2018
What’s Changed Since the Last Update?
• ISO 45001:2018 replaces BS OHSAS 18001:2007, an OH&S
management system standard developed by a smaller group of
international experts outside of ISO
• This new standard adopts the High Level Structure used in the
other key management systems standards. In addition it
increases the emphasis on:
• Leadership and the need for those at the top to lead by

example and be held accountable for OH&S performance
ISO/TC 176/SC 2/ N1267
• Consultation with and involvement of workers in making sure

the OH&S management system covers all necessary areas and
communicates effectively with everyone involved
• Designing an OH&S management system to suit the needs of

each organization individually according to its own context
OH&S ISO
45001:2018
Key Focus of ISO 45001
• Top management:
• being accountable for OH&S management
• needing to demonstrate leadership
• Worker participation in:

• the identification of hazards and risks
• the development and operation of the OH&S management
system, and indicates these are essential for success
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
Key Focus of ISO 45001
• The need to prevent ill-health (including mental ill-health),
as well as injuries
• The need to recognize that the causes of ill-health and

injuries can be through
• immediate impacts (e.g. accidents or epidemics)
• longer term impacts (such as repeated exposure to

radiation or carcinogenic chemicals, or to a constantly
ISO/TC 176/SC 2/ N1267
stressful working environment)

OH&S ISO
45001:2018
Based on Plan-Do-Check-Act (PDCA) Process Model
Act Plan
Take actions to Establish objectives,
continually improve the programs and
OH&S performance to processes necessary to
achieve the intended
outcomes
deliver results in
accordance with the
organization’s OH&S
policy
ISO/TC 176/SC 2/ N1267
Check Do
Monitor and measure
Implement the processes
activities and processes of the OH&S
with regard to the OH&S management system
policy and objectives,
and report the results
OH&S ISO
45001:2018
Benefits to an Organization for Implementing
an OH&S Management System
• Improved OH&S performance
• Prevent health and safety hazard
• Reduced liability
• Reduced accidents
• Reduced costs
• Prevent ill health in the first place than to medication
ISO/TC 176/SC 2/ N1267
• Improved public image

• Enhanced customer trust
• Competitive advantage
• Better access to capital
OH&S ISO
45001:2018
Advantages of Certification
• Certification to ISO 45001 is
voluntary
• Independent check of
conformity by a third party
• Indicates an effective OH&S
Management system
• National/International
recognition
ISO/TC 176/SC 2/ N1267
• Provides competitive
advantage
• Improves company image
OH&S ISO
45001:2018
EXERCISE-2
Fundamental
Concepts
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
ISO 45001:2018 Standard Overview

0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of organization
5 Leadership
6 Planning
ISO/TC 176/SC 2/ N1267
7 Support
8 Operation
9 Performance evaluation
10 Improvement
OH&S ISO
45001:2018
Aim of an OH&S management system

The purpose of an OH&S management system is to provide a
framework for managing the prevention of death, work-related
injury and ill health. An OH&S management system can enable an
organization to improve its OH&S performance by:
a) developing and implementing an OH&S policy and OH&S
objectives;
b) ensuring top management demonstrate leadership and
commitment with respect to the OH&S management system;
c) establishing systematic processes which consider its context
ISO/TC 176/SC 2/ N1267
(see A.4.1) and which take into account its risks and its
opportunities;
d) determining the hazards and OH&S risks associated with its
activities; seeking to eliminate them, or
putting in controls to minimize their potential effects;
OH&S ISO
45001:2018
Aim of an OH&S management system
e) establishing operational controls to eliminate or minimize its

OH&S risks;
f) increasing awareness of its OH&S hazards and risks, and
associated operational controls, through
information, communication and training;
g) evaluating its OH&S performance and seeking to improve it;
h) establishing and developing the necessary competencies;
i) developing and supporting an occupational health and safety
ISO/TC 176/SC 2/ N1267
culture in the organization;

j) ensuring that workers, and where they exist, workers’
representatives, are informed, consulted and participate.
OH&S ISO
45001:2018
Success factors
The success of the OH&S management system depends on:
a) top management leadership and commitment;
b) top management developing, leading and promoting a culture
in the organization that supports the
OH&S management system;
c) participation of workers, and where they exist, workers’
representatives;
d) processes for communication and consultation;
e) allocation of the necessary resources for its sustainability;
ISO/TC 176/SC 2/ N1267
f) clear OH&S policies, which are compatible with the overall

strategic objectives and direction of the
organization;
OH&S ISO
45001:2018
Success factors
g) the integration of the OH&S management system into the
organization's business processes;
h) the continual evaluation and monitoring of the OH&S
management system to improve OH&S performance;
i) OH&S objectives that align with the OH&S policies and reflect
the organization's OH&S hazards and risks;
j) awareness of its applicable legal requirements and other
requirements;
ISO/TC 176/SC 2/ N1267
k) effective processes for identification of OH&S hazards, control

of the OH&S risks and taking advantage of OH&S opportunities.
OH&S ISO
45001:2018
Plan-Do-Check-Act cycle
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
Contents of this International Standard

• Clauses 4 to 10 contain requirements that can be used to assess
conformity.
• Annex A provides informative explanations to assist in the
interpretation of those requirements.
• In this International Standard, the following verbal forms are
used:
• “shall” indicates a requirement;
• “should” indicates a recommendation;
• “may” indicates a permission;
ISO/TC 176/SC 2/ N1267
• “can” indicates a possibility or a capability.

• Information marked as "NOTE" is for guidance in understanding
or clarifying the associated requirement.
• “Notes to entry” used in Clause 3 provide additional information
that supplements the terminological data and can contain
provisions relating to the use of a term.
OH&S ISO
45001:2018
1 Scope
• applicable to any organization regardless of its size, type and
activities and applies to the OH&S risks under the
organization’s control
• does not state specific criteria for OH&S performance, nor is it
prescriptive about the design of an OH&S management system
• enables an organization, through its OH&S management
system, to integrate other aspects of health and safety, such as
worker wellness/ wellbeing.
• does not address issues such as product safety, property
ISO/TC 176/SC 2/ N1267
damage or environmental impacts, beyond the risks they

provide to workers and other relevant interested parties
• This International Standard can be used in whole or in part to
systematically improve OH&S management.
OH&S ISO
45001:2018
2 Normative references
• There are no normative references.
3 Terms and definitions
For the purposes of this document, 37 terms and definitions

given in this standard which are related to OH&SMS.
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
EXERCISE-03
Terms and Definitions

ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
ISO 45001 Clause Structure (4-10)
PLAN DO CHECK ACT
4. Context of the 5. Leadership & 6. Planning 7. Support 8. Operation 9. Performance 10. Improvement
organization worker participation evaluation
4.1 Understanding 5.1 Leadership and 6.1 Actions to 7.1 Resources 8.1 Operational 9.1 Monitoring, 10.1 General
the organization and commitment address risks and planning and measurement,
its context opportunities control analysis and
evaluation
4.2 Understanding 5.2 OH&S policy 6.2 OH&S 7.2 Competence 8.2 Emergency 9.2 Internal audit 10.2 Incident,
the needs and objectives and preparedness and nonconformity and
expectations of planning to achieve response corrective action
workers and them
interested parties
4.3 Determining the 5.3 Organizational 7.3 Awareness 9.3 Management 10.3 Continual
scope of the OH&S roles, responsibilities review improvement
ISO/TC 176/SC 2/ N1267
management system and authorities
4.4 OH&S 5.4 Consultation and 7.4 Communication

management system participation of
workers
7.5 Documented
information
OH&S ISO
45001:2018
Context of the organization

ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
4. Context of the organization
1. Understanding the organisation and its

context
2. Understanding the needs and expectations
of workers and other interested parties
3. Determining the scope of the OH&S
management system
4. Occupational Health & Safety
ISO/TC 176/SC 2/ N1267
Management system
OH&S ISO
45001:2018
4.1 Understanding the organization and its context
“The organization shall determine

external and internal issues that are
relevant to its purpose and that affect
its ability to achieve the intended
outcome(s) of its OH&S management
system”.
ISO/TC 176/SC 2/ N1267
(ISO 45001, 4.1)

OH&S ISO
45001:2018 Organization
Culture
Relationship
with internal Governance
Internal
stake holders
Issues
Decision
Organizationa
making
l Structure
process
Internal
Issues
Process Current Roles

maturity & Resp.
ISO/TC 176/SC 2/ N1267
Current
system and Strategy
tools
Resource
levels
OH&S ISO
45001:2018
Relationship Culture External

with external Social Issues
stakeholders
Organizational Political
trends
Key External
organizational Issues Regulatory
drivers
ISO/TC 176/SC 2/ N1267
Competitive
environmen
t Financial
Technologica
l aspects Economic
OH&S ISO
45001:2018
4.2 Understanding the needs and expectations of
workers and other interested parties
The organization shall determine:

• a) the other interested parties, in addition to its workers, that
are relevant to the OH&S management system;
• b) the relevant needs and expectations (i.e. requirements) of
workers and these other interested parties;
• c) which of these needs and expectations become applicable
legal requirements and other requirements.
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
4.3 Determining the scope of the OH&S management
system
The organization shall determine the boundaries and applicability
of the OH&S management system to establish its scope.
When determining this scope, the organization shall :
a) consider the external and internal issues referred to in 4.1;
b) take into account the requirements referred to in 4.2;
c) take into account the work related activities performed.
ISO/TC 176/SC 2/ N1267
Once the scope is defined, the OH&S management system shall

include activities, products and services within the organization’s
control or influence that can impact the organization’s OH&S
performance.
The scope shall be available as documented information.
OH&S ISO
45001:2018
4.4 OH&S management system
The organization shall establish, implement, maintain and

continually improve an OH&S management system, including the
processes needed and their interactions, in accordance with the
requirements of this International Standard.
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
5.0 Leadership and worker participation
5.1 Leadership and commitment
5.2 OH&S Policy
5.3 Organizational roles, responsibilities,

accountabilities and authorities
ISO/TC 176/SC 2/ N1267
5.4 Participation and consultation

OH&S ISO
45001:2018

Top management shall demonstrate leadership and
commitment with respect to the OH&S management
system by:
a) taking overall responsibility and accountability for the
protection of workers’ work-related health and safety;
b) ensuring that the OH&S policy and related OH&S
objectives are established and are compatible with
the strategic direction of the organization;
c) ensuring the integration of the OH&S management
ISO/TC 176/SC 2/ N1267
system processes and requirements into the

organization’s business processes;
d) ensuring that the resources needed to establish,
implement, maintain and improve the OH&S
management system are available;
OH&S ISO
45001:2018

f) communicating the importance of effective OH&S management
and of conforming to the OH&S management system
requirements;
g) ensuring that the OH&S management system achieves its
intended outcome(s);
h) directing and supporting persons to contribute to the
effectiveness of the OH&S management system
i) ensuring and promoting continual improvement of the OH&S
management system to improve OH&S performance by
systematically identifying and taking actions to address
ISO/TC 176/SC 2/ N1267
nonconformities, opportunities, and work related hazards and

risks, including system deficiencies ;
j) supporting other relevant management roles to demonstrate
their leadership as it applies to their areas of responsibility;
k) developing, leading and promoting a culture in the organization
that supports the OH&S management system.
OH&S ISO
45001:2018
5.2 OH&S policy
Top management shall establish, implement and maintain an
OH&S policy in consultation with workers
at all levels of the organization (see 5.3 and 5.4) that:
a) includes a commitment to provide safe and healthy working
conditions for the prevention of work related injury and ill health
and is appropriate to the purpose, the size and context of the
organization and to the specific nature of its OH&S risks and
OH&S opportunities;
b) provides a framework for setting the OH&S objectives;
c) includes a commitment to satisfy applicable legal
ISO/TC 176/SC 2/ N1267
requirements and other requirements;

d) includes a commitment to the control of OH&S risks using
the hierarchy of controls (see 8.1.2);
e) includes a commitment to continual improvement of the
OH&S management system (see 10.2) to enhance the
organization’s OH&S performance;
OH&S ISO
45001:2018
5.2 OH&S policy
f) includes a commitment to participation, i.e. the
involvement of workers’, and where they exist,
workers’ representatives, in the decision-making
processes in the OH&S management system .
The OH&S policy shall:

— be available as documented information;
— be communicated to workers within the
organization;
ISO/TC 176/SC 2/ N1267
— be available to interested parties, as appropriate;

— be reviewed periodically to ensure that it remains
relevant and appropriate.
OH&S ISO
45001:2018
5.3 Organizational roles, responsibilities,
accountabilities and authorities
Top management shall ensure that the responsibilities,
accountabilities and authorities for relevant roles within the OH&S
management system are assigned and communicated at all levels
within the organization and maintained as documented
information. Workers at each level of the organization shall
assume responsibility for those aspects of OH&S management
system over which they have control.
Top management shall assign the responsibility and authority for:

ISO/TC 176/SC 2/ N1267
a) ensuring that the OH&S management system conforms to the

requirements of this International Standard;
b) reporting on the performance of the OH&S management
system to top management.
OH&S ISO
45001:2018
5.4 Participation and consultation (1/3)
The organization shall, establish, implement and maintain
process(es) for participation (including consultation) in
the development, planning, implementation, evaluation
and actions for improvement of the OH&S management
system by workers at all applicable levels and functions,
and where they exist, workers’ representatives.
The organization shall:
a) provide mechanisms, time, training and resources
necessary for participation;
b) provide timely access to clear, understandable and
ISO/TC 176/SC 2/ N1267
relevant information about the OH&S management

system;
c) identify and remove obstacles or barriers to
participation and minimize those that cannot be removed;
OH&S ISO
45001:2018
d) give additional emphasis to the participation of non-
managerial workers in the following:
1) determining the mechanisms for their participation and
consultation;
2) hazard identification and assessment of risk (see 6.1,
6.1.1, and 6.1.2);
3) actions to control hazards and risks (see 6.1.4);
4) identification of needs of competence, training and
evaluation of training (see 7.2);
5) determining the information that needs to be
ISO/TC 176/SC 2/ N1267
communicated and how this should be done (see 7.4);

6) determining control measures and their effective use (see
8.1, 8.2, and 8.6);
7) investigating incidents and nonconformities and
determining corrective actions (see 10.1);
OH&S ISO
45001:2018
e) give additional emphasis to the inclusion of non-managerial
workers in consultation related to the following:
1) determining the needs and expectations of interested parties (see
4.2);
2) establishing the policy (see 5.2);
3) assigning organizational roles, responsibilities, accountabilities
and authorities as applicable (see 5.3);
4) determining how to apply legal requirements and other
requirements (see 6.1.3);
5) establishing OH&S objectives (see 6.2.1);
6) determining applicable controls for outsourcing, procurement
ISO/TC 176/SC 2/ N1267
and contractors (see 8.3, 8.4, and 8.5);

7) determining what needs to be monitored, measured and
evaluated (see 9.1.1);
8) planning, establishing, implementing and maintaining an audit
programme(s) (see 9.2.2);
9) establishing a continual improvement process (see 10.2.2).
OH&S ISO
45001:2018
EXERCISE-04

CLAUSE IDENTIFICATION
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018

EXERCISE-05

REVIEW OF OH&S POLICY
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
6.0 Planning
6.1 Actions to address risks and

opportunities
6.2 OH&S objectives and planning
to achieve them
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
6.0 Planning
 6.1 Actions to address risks and opportunities

 6.1.1 General
 6.1.2 Hazard identification and assessment of
OH&S risks
 6.1.3 Determination of applicable legal
ISO/TC 176/SC 2/ N1267
requirements and other requirements

 6.1.4 Planning to take action
OH&S ISO
45001:2018
6.1 Actions to address risks and opportunities (1/3)
6.1.1 General
• shall consider the issues referred to in 4.1
(context), the requirements referred to in 4.2
(interested parties) and 4.3 (the scope of its
OH&S management system)
• determine the risks and opportunities that
need to be addressed to:
 a) give assurance that the OH&S
management system can achieve its
ISO/TC 176/SC 2/ N1267
intended outcome(s);
 b) prevent, or reduce, undesired effects;
 c) achieve continual improvement.
OH&S ISO
45001:2018

• consider the effective participation of
workers (see 5.4) and other interested
parties.
• Take into account:
 a) OH&S hazards and their associated
OH&S risks (see 6.1.2.3) and OH&S
opportunities (see 6.1.2.4);
 b) applicable legal requirements and other
requirements (see 6.1.3);
ISO/TC 176/SC 2/ N1267
 c) risks (see 6.1.2.3) and opportunities

(see 6.1.2.4) related to the operation of
the OH&S management system that can
affect the achievement of the intended
outcomes.
OH&S ISO
45001:2018

• Assess the risks and identify the opportunities
• Risks associated with changes in the
organization, its processes, or the OH&S
management system.
• In the case of planned changes, permanent or
temporary, this assessment shall be undertaken
before the change is implemented (see 8.2).
• The organization shall maintain documented
information of its:
 OH&S risks and OH&S opportunities that need
ISO/TC 176/SC 2/ N1267
to be addressed;
 processes needed to address risks and
opportunities (see 6.1.1 to 6.1.4) to the extent
necessary to have confidence they are carried
out as planned.
OH&S ISO
45001:2018
6.1.2 Hazard identification and assessment of OH&S risks

6.1.2.1 Hazard identification
• The organization shall establish, implement and
maintain a process for the identification of hazards
arising.
• The process shall take into account but not be limited
to:
• a) routine and non-routine activities and situations,
including consideration of:
 1) infrastructure, equipment, materials, substances and
the physical conditions of the workplace;
ISO/TC 176/SC 2/ N1267
 2) hazards that arise as a result of product design

including during research, development, testing,
production, assembly, construction, service delivery,
maintenance or disposal;
 3) human factors;
 4) how the work is actually done;
OH&S ISO
45001:2018
• b) emergency situations;
• c) people, including consideration of:
 1) those with access to the workplace and
their activities, including workers,
contractors, visitors
 and other persons;
 2) those in the vicinity of the workplace
who can be affected by the activities of the
ISO/TC 176/SC 2/ N1267
organization;
 3) workers at a location not under the
direct control of the organization;
OH&S ISO
45001:2018
• d) other issues, including consideration of:

• 1) the design of work areas, processes,
installations, machinery/equipment, operating
procedures and work organization, including
their adaptation to human capabilities;
• 2) situations occurring in the vicinity of the
workplace caused by work-related activities
under the control of the organization;
• 3) situations not controlled by the organization
ISO/TC 176/SC 2/ N1267
and occurring in the vicinity of the workplace

that can cause work-related injury and ill health
to persons in the workplace;
OH&S ISO
45001:2018
e) actual or proposed changes in the

organization, its operations, processes,
activities and OH&S management system
(see 8.2);
f) changes in knowledge of, and
information about, hazards;
g) past incidents, internal or external to
the organization, including emergencies,
and their causes;
ISO/TC 176/SC 2/ N1267
h) how work is organized and social

factors, including workload, work hours,
leadership and the culture in the
organization.
OH&S ISO
45001:2018
OCCUPATIONAL
HEALTH HAZARDS
OH&S ISO
45001:2018
PHYSICAL
HAZARD
ERGONOMIC CHEMICAL
HAZARD HAZARD
ISO/TC 176/SC 2/ N1267
BIOLOGICAL
HAZARD
OH&S ISO
45001:2018
HAZARD AND RISK

 HAZARD
 occupational health and
 source or situation safety risk (OH&S risk)
with a potential to  combination of the
cause injury and ill likelihood of occurrence
health of a work-related
hazardous event or
exposure(s) and the
ISO/TC 176/SC 2/ N1267
severity of injury and ill

health (3.18) that can be
caused by the event or
exposures
OH&S ISO
45001:2018
CHEMICAL HAZARDS
OH&S ISO
45001:2018
Chemical Hazards
Routes of entry into the body
Inhalation Skin Contact
ISO/TC 176/SC 2/ N1267
Ingestion
OH&S ISO
45001:2018
Chemical Hazards
Routes of excretion
ISO/TC 176/SC 2/ N1267
Gastro-intestinal Renal (urine) Respiratory Skin (sweat, hair, nails)

(feces) (exhalation)
OH&S ISO
45001:2018
Chemical Hazards
Measures of concentration of toxic substances
• Threshold Limit Value (TLV)- average concentration of

an airborne substance to which most workers could be
safely exposed over an eight-hour working day or forty-
hour working week throughout a working lifetime
ISO/TC 176/SC 2/ N1267
• Maximal Allowable Concentration (MAC)- peak or

maximum concentration of an airborne to which most
workers could be safely exposed.
OH&S ISO
45001:2018
Chemical Hazards
Health Effects
 Renal Diseases
 Respiratory Diseases
 Skin Diseases
 Hematologic Diseases
 Cardiovascular
Diseases
ISO/TC 176/SC 2/ N1267
 Neurologic Diseases
 Carcinogenic
 Teratogenic
OH&S ISO
45001:2018
Chemical Hazards
Effects Chemical Agent Industry/Process
Renal Diseases: Battery, chemical

acute/chronic renal Mercury, cadmium, industries,
failure chloroform pesticide
Respiratory Diseases:
Irritation, inflammation Solvents, ammonia Chemical industries
Pneumoconiosis Inorganic dust Mining, construction,

sandblasting, coal
Cancer Chromium Plating, metal refining

OH&S ISO
45001:2018
Chemical Hazards
Blood Diseases:
Anemia Lead Battery mfg., lead
smelting
Aplastic anemia Benzene Solvent & soap mfg.
Skin Diseases:
Allergic/contact Plastic epoxides Plastic, varnish
dermatitis
Acne Cutting oils, grease Machine-tool

operators
Skin Cancer Arsenic, tar Petroleum refinery
OH&S ISO
45001:2018
Chemical Hazards
Liver Disease:
Acute liver toxicity Carbon Cleaning fluids, dry
tetrachloride cleaners
Liver cancer Vinyl chloride Plastics & vinyl
chloride mfg.
Cardiovascular Disease:
Hypertension Lead, Cadmium Battery mfg. &
recycling
Atherosclerosis Carbon disulfide Degreasing, dry
cleaning
Arrythmias Fluorocarbon, Refrigeration, solvent
trichloroethylene workers
OH&S ISO
45001:2018
PHYSICAL HAZARDS
OH&S ISO
45001:2018
Physical Hazards
• Noise
• Vibration
• Extreme Temperature
ISO/TC 176/SC 2/ N1267
• Illumination
• Radiation
OH&S ISO
45001:2018
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
NOISE
Early Signs of Hearing Loss

• Difficulty in understanding spoken words in a noisy
environment
• Need to be near or look at the person speaking to
help understand words
• Familiar sounds are muffled
• Complaints that people do not speak clearly
ISO/TC 176/SC 2/ N1267
• Ringing noises in the ears (tinnitus)

OH&S ISO
45001:2018
Other Harmful Effects of Noise
• Hypertension
• Hyperacidity
• Palpitations
• Disturbs relaxation and sleep
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
VIBRATION
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
VIBRATION
• Physical factor which affects man by transmission of
mechanical energy from oscillating sources
• Types
• Segmental vibration
• Whole body vibration
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
Segmental Vibration:
• Health Effects:
—Hand Arm Vibration Syndrome (HAVS)
—tingling, numbness, blanching of fingers
—pain
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
Whole Body Vibration:

• Health effects:
• Fatigue
• Irritability
• Headache
• Disorders of the spine
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
EXTREME TEMPERATURE
• Sources of heat stress:
• Natural Conditions
• Hot work processes related to furnaces, kilns,
boilers and smelting
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
Health Effects of Heat Stress

Disorders Clinical features
Prickly Heat (Miliaria rubra) Pruritic rash
Heat cramps Cramps in the body,

usually legs
Heat exhaustion Dizziness, fainting attack,

blurring of vision, cold,
ISO/TC 176/SC 2/ N1267
clammy and sweaty skin

Heat stroke Cyanosis, muscle
twitchings, disorientation,
delirium, convulsions
OH&S ISO
45001:2018
EXTREME TEMPERATURE
• Sources of Cold Environment:
• Ice plants and freezers in the food industry

ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
Inadequate Illumination
Health Effects
• Visual Fatigue
• Double Vision
• Headaches
• Painful irritation
• Lacrimation
• Conjunctivitis
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
RADIATION
Types Sources Health Effects
Ionizing X-rays Cancer, congenital
Gamma rays defects, death
Non-ionizing Ultraviolet skin redness, premature

skin ageing, and skin
cancer
Infrared corneal and conjunctival
burns, retinal injury,
cataract
Laser
Skin and eye problem
OH&S ISO
45001:2018
BIOLOGICAL HAZARDS
OH&S ISO
45001:2018
BIOLOGICAL HAZARDS
VIRUSES FUNGI
ISO/TC 176/SC 2/ N1267
BACTERIA PARASITES
1
OH&S ISO
45001:2018
Selected Infectious Diseases and
Occupations
Agent / Disease Occupation
Colds, influenza, scarlet fever, May be contacted anywhere
diphtheria, smallpox, Corona
Virus
Tuberculosis Silica workers, people exposed
to heat and organic dusts, and
medical personnel
ISO/TC 176/SC 2/ N1267
Anthrax Animal handlers and handlers

of carcasses, skins, or hair of
infected animals, including wool
carpet processors and
handlers.
1
OH&S ISO
45001:2018
ERGONOMIC HAZARDS
OH&S ISO
45001:2018
ERGONOMICS
Human Biological Science
+
Engineering Science
____________________________________
MAXIMUM SATISFACTION AND

INCREASE PRODUCTIVITY
ISO/TC 176/SC 2/ N1267
“ fitting the job to the worker”
1
OH&S ISO
45001:2018
ERGONOMICS
the task
(job content &
context)
the the
organization tool
ISO/TC 176/SC 2/ N1267
the the
environment workstation
1
OH&S ISO
45001:2018
ERGONOMICS
• Goal
• to reduce work-related musculoskeletal
disorders (MSDs) developed by workers
• MSDs are injuries and illnesses that affect

muscles, nerves, tendons, ligaments, joints or
ISO/TC 176/SC 2/ N1267
spinal discs.
1
OH&S ISO
45001:2018
ERGONOMICS
Common Symptoms of MSDs
• Painful joints
• Pain, tingling, numbness in hands, wrists, forearms,
shoulders, knees and feet
• Shooting or stubbing pains
• Swelling or inflammation
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
ERGONOMICS
Common Symptoms of MSDs
• Fingers or toes turning white
• Back or neck pain
• Stiffness
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
Risk Factor: ERGONOMICS
Static
posture
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
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ISO/TC 176/SC 2/ N1267
Forceful exertion
1
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ISO/TC 176/SC 2/ N1267
Repetitive movement
1
OH&S ISO
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ISO/TC 176/SC 2/ N1267
Extreme range of motion
1
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Awkward posture
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
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ERGONOMICS
OH&S ISO
45001:2018
STRESS
OH&S ISO
45001:2018
STRESS
The harmful physical and emotional responses that

occurs when the requirements of the job do not
match the capabilities, resources or needs of the
worker.
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
STRESS: Effects
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
STRESS
Manifestations of Stress BEHAVIORAL
PSYCHOLOGICAL
 Drug use
PHYSIOLOGICAL
 Fatigue
 Alcohol intake
 Heart rate  Heavy smoking
 Anxiety  Blood pressure  Impulsive emotional
 Tension
 Indigestion
 Irritability behavior
 Depression
ISO/TC 176/SC 2/ N1267
 Boredom
 Inability to  Poor work &
concentrate family
 Low esteem relationship
 Social isolation
 Family 1
OH&S ISO
45001:2018
6.1.2.2 Assessment of OH&S risks and other risks to the
OH&S management system
• The organization shall establish, implement and
maintain a processes to:
• a) assess OH&S risks from the identified hazards:
• applicable legal requirements
• other requirements
• effectiveness of existing controls;
• b) identify and assess the risks related to the issues
identified in 4.1 and the needs and expectations
identified in 4.2.
ISO/TC 176/SC 2/ N1267
• The organization’s methodology(ies) and criteria for

assessment of OH&S risks shall be defined.
• These methodologies and criteria shall be maintained
and retained as documented information.
OH&S ISO
45001:2018
Risk Level
•R = L x C
•Risk= Likelihood X Consequence
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
Risk analysis – Risk Matrix Example
CONSEQUENCES:
How severely it hurts someone (if it happens)?
LIKELIHOOD
Catastrophic
Insignifi`can
How likely is it
Moderat
to happen?
Minor
Major
e
t
Almost certain
- - - - -
Likely
Possible
- - - - -
- - - - -
ISO/TC 176/SC 2/ N1267
Unlikely - - - - -
Rare - - - - -
RISK/ OPPORTUNITY ANALYSIS SHEET

OH&S ISO
45001:2018
6.1.2.3 Identification of OH&S opportunities and other
opportunities
The organization shall establish, implement and
maintain processes to identify:
 a) opportunities to enhance OH&S performance
taking into account:
 1) planned changes to the organization, its
processes or its activities;
 2) opportunities to eliminate or reduce OH&S risks;
 3) opportunities to adapt work, work organization
ISO/TC 176/SC 2/ N1267
and work environment to workers;

 b) opportunities for improving the OH&S
management system
OH&S ISO
45001:2018
EXERCISE-6
Hazard Identification & Risk Control

ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
6.1.3 Determination of applicable legal requirements and
other requirements.
The organization shall establish, implement and
maintain a process to:
a) determine and have access to up-to-date legal
b) determine how these requirements apply to the
organization and what needs to be communicated
ISO/TC 176/SC 2/ N1267
c) take these requirements into account for

continually improving its OH&S management
system.
The organization shall maintain and retain up-to-date
documented information
OH&S ISO
45001:2018
6.1.4 Planning to take action

The organization shall plan:
a) actions to:
1) address these risks and opportunities
2) address applicable legal requirements and other
requirements;
3) prepare for, and respond to, emergency situations;
b) how to
1) integrate and implement the actions into its OH&S
ISO/TC 176/SC 2/ N1267
management system processes or other business

processes;
2) evaluate the effectiveness of these actions.
Shall take into account the hierarchy of controls and
outputs from the OH&S management system
OH&S ISO
45001:2018
6.2 OH&S objectives and planning to achieve them

6.2.1 OH&S objectives
The OH&S objectives shall:
a) be consistent with the OH&S policy;
b) take into account applicable legal requirements and
other requirements;
c) take into account the results of the assessment of
OH&S risks and OH&S opportunities and other risks and
opportunities;
d) take into account the outputs of consultation with
workers, and where they exist, workers’
ISO/TC 176/SC 2/ N1267
representatives;
e) be measurable (if practicable) or capable of
evaluation;
f) be monitored;
g) be clearly communicated (see 7.4);
h) be updated as appropriate.
OH&S ISO
45001:2018
Objectives
S.M.A.R.T. is a useful ‘system’ to use when setting and testing
objectives.
Specific
Measurable
Achievable
Realistic
Time-bound
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
6.2.2 Planning to achieve OH&S objectives

When planning how to achieve its OH&S objectives, the
organization shall determine:
a) what will be done;
b) b) what resources will be required;
c) c) who will be responsible;
d) d) when it will be completed;
e) e) how it will be measured through indicators (if
practicable) and monitored, including frequency;
f) f) how the results will be evaluated;
g) g) how the actions to achieve OH&S objectives will be
ISO/TC 176/SC 2/ N1267
integrated into the organization´s business

h) processes.
Shall maintain and retain documented information

OH&S ISO
45001:2018
OH&S Objective
The organization shall maintain and retain
documented information on the OH&S objectives
and plans to achieve them:
Additionally:
▪ How will results be evaluated?
When will it
be completed? ▪ How the results will be evaluated,
Who is
responsible?
including indicators for
monitoring progress toward
What are the achievement of its measurable
ISO/TC 176/SC 2/ N1267
resources
needed? OH&S objectives?
▪ How the actions to achieve OH&S
What will objectives will be integrated into
be done?
the organization´s business
processes?
1
OH&S ISO
45001:2018
EXERCISE-7
Objectives and Targets

ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
7.0 Support
7.0 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Information and Communication
ISO/TC 176/SC 2/ N1267
7.5 Documented information

OH&S ISO
45001:2018
Clause 7.1 Resources
 Determine and provide the resources

needed for:
 Establishment,
 Implementation,
 Maintenance
ISO/TC 176/SC 2/ N1267
 Continual improvement
OH&S ISO
45001:2018
Clause 7.2 Competence
 a) determine the necessary competence of
workers that affect or can affect its OH&S
performance;
 b) ensure that workers are competent on the
basis of appropriate education, induction,
training, or experience;
 c) where applicable, take actions to acquire the
ISO/TC 176/SC 2/ N1267
necessary competence, and evaluate the

effectiveness of the actions taken;
 d) retain appropriate documented information
as evidence of competence.
OH&S ISO
45001:2018
Clause 7.3 Awareness
 Workers shall be made aware of:
 a) the OH&S policy;
 b) their contribution to the effectiveness of the
OH&S management system, including the benefits
of improved OH&S performance;
 c) the implications of not conforming with the
OH&S management system requirements,
including the consequences, actual or potential,
ISO/TC 176/SC 2/ N1267
of their work activities;

 d) information and outcome of the investigation of
relevant incidents;
 e) OH&S hazards and risks that are relevant for
them.
OH&S ISO
45001:2018
Clause 7.4 Information and Communication
The organization shall determine the need for internal and
external information and communications relevant to the OH&S
management system including:
a) on what it will inform about and communicate;
b) when to inform and communicate;
c) who to inform and with whom to communicate:
1) internally among the various levels and functions of the
organization;
2) with contractors and visitors to the workplace;
ISO/TC 176/SC 2/ N1267
3) with other external or interested parties;

d) how to inform and communicate;
e) how it will receive, maintain documented information on, and
respond to relevant communications.
OH&S ISO
45001:2018
Clause 7.4 Information and Communication
• shall define the objectives to be achieved by
informing and communicating, and shall evaluate
whether those objectives have been met.
• shall take into account diversity aspects (for
example language, culture, literacy, disability),
• shall ensure that, when appropriate, the views of
relevant external interested parties about matters
ISO/TC 176/SC 2/ N1267
pertinent to the OH&S management system are

considered.
OH&S ISO
45001:2018
Clause 7.5 Documented Information
7.5.1 General
The organization’s OH&S management system shall include:
a) documented information required by this International

Standard;
b) documented information determined by the organization as

being necessary for the effectiveness of the OH&S
management system.
ISO/TC 176/SC 2/ N1267
― the size of organization and its type of activities, processes,

products and services;
― the complexity of processes and their interactions;
― the competence of persons.

OH&S ISO
45001:2018
7.5.2 Creating and updating
When creating and updating documented

information the organization shall ensure
appropriate:
a) identification and description (e.g. a title, date,
author, or reference number);
b) format (e.g. language, software version,
ISO/TC 176/SC 2/ N1267
graphics) and media (e.g. paper, electronic);

c) review and approval for suitability and adequacy.
OH&S ISO
45001:2018
7.5.3 Control of documented Information
Documented information required by the OH&S management
system and by this International Standard shall be controlled to
ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality,
improper use, or loss of integrity).
For the control of documented information, the organization shall
address the following activities, as applicable:
— distribution, access, retrieval and use;
ISO/TC 176/SC 2/ N1267
— storage and preservation, including preservation of legibility;

— control of changes (e.g. version control);
— retention and disposition;
— access by workers, and where they exist, workers’ representatives, to
relevant documented information.
Documented information of external origin shall be controlled.
OH&S ISO
45001:2018
EXERCISE-8

DOCUMENTED INFORMATION
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
8.0 Operation
8.1 Operational planning and control
8.1.1 General
8.1.2 Hierarchy of controls
8.2 Management of change
8.3 Outsourcing
ISO/TC 176/SC 2/ N1267
8.4 Procurement
8.5 Contractors
8.6 Emergency preparedness and response
OH&S ISO
45001:2018
Clause 8.1 Operational Planning and Control
 8.1.2 Hierarchy of controls
 The organization shall establish a process and determine controls
for achieving reduction in OH&S risks using the following hierarchy:
 a) eliminate the hazard;
 b) substitute with less hazardous materials,

processes, operations or equipment;
 c) use engineering controls;
Eliminate
 d) use administrative controls;
Substitute
 e) provide and ensure use of adequate
ISO/TC 176/SC 2/ N1267
personal protective equipment. Engineering Controls

Administrative Controls
PPE
OH&S ISO
45001:2018
8.2 Management of change
 process for the implementation and control of planned changes
that impact OH&S performance such as:
 a) new products, processes or services;
 b) changes to work processes, procedures, equipment, or
organizational structure;
 c) changes to applicable legal requirements and other
requirements;
 d) changes in knowledge or information about hazards and
related OH&S risks;
 e) developments in knowledge and technology.
ISO/TC 176/SC 2/ N1267
 shall control temporary and permanent changes to promote

OH&S opportunities and to ensure they do not have an adverse
impact on OH&S performance.
 shall review the consequences of unintended changes, taking
action to mitigate any adverse effects, as necessary, including
addressing potential opportunities (see Clause 6).
OH&S ISO
45001:2018
8.3 Outsourcing
 The organization shall ensure that outsourced

processes affecting its OH&S management system
are controlled.
 The type and degree of control to be applied to
these processes shall be defined within the OH&S
management system.
ISO/TC 176/SC 2/ N1267
 NOTE The type and degree of control of an

outsourced process are part of the OH&S
management system, wherever the process is
carried out at the workplace.
OH&S ISO
45001:2018
8.4 Procurement
The organization shall establish controls

to ensure that the procurement of goods
and services conform to its OH&S
management system requirements.
 products,
 hazardous materials
 substances,
ISO/TC 176/SC 2/ N1267
 raw materials,
 equipment
OH&S ISO
45001:2018
8.5 Contractors
The organization shall establish processes to identify and
communicate the hazards and to evaluate and control the OH&S
risks, arising from the:
 a) contractors’ activities and operations to the
organization’s workers;
 b) organization’s activities and operations to the
contractors' workers;
 c) contractors’ activities and operations to other interested
parties in the workplace ;
 d) contractors’ activities and operations to contractors’
ISO/TC 176/SC 2/ N1267
workers.
 The organization shall establish and maintain processes to
ensure that the requirements of the organization's OH&S
management system are met by contractors and their workers.
 These processes shall include the OH&S criteria for selection of
contractors.
OH&S ISO
45001:2018
 The organization shall identify potential emergency situations;
assess OH&S risks associated with these emergency situations
(see 6.1.2) and maintain a process to prevent or minimize OH&S
risks from potential emergencies, including:
 a) the establishment of a planned response to emergency
situations and including first aid;
 b) the periodic testing and exercise of emergency response
capability;
 c) the evaluation and, as necessary, revision of emergency
preparedness processes and procedures including after testing
ISO/TC 176/SC 2/ N1267
and in particular after the occurrence of emergency situations;

 d) the communication and provision of relevant information to
all workers and at all levels of the organization on their duties
and responsibilities;
OH&S ISO
45001:2018
 e) the provision of training for emergency prevention, first
aid, preparedness and response;
 f) the communication of relevant information to
contractors, visitors, emergency response services,
government authorities, and, as appropriate, the local
community.
 In all stages of the process the organization shall take into
account the needs and capabilities of all relevant
interested parties and ensure their involvement.
ISO/TC 176/SC 2/ N1267
 The organization shall maintain and retain documented

information on the process and on the plans for
responding to potential emergency situations.
OH&S ISO
45001:2018
EXERCISE-9

Hazard Identification and
Operational Control
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
9.0 Performance Evaluation
9.1 Monitoring, measurement, analysis

and evaluation
9.2 Internal audit
9.3 Management review

ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
The organization shall establish, implement and maintain a
process for monitoring, measurement and evaluation.
The organization shall determine:
a) what needs to be monitored and measured, including:
1) applicable legal requirements and other requirements;
2) its activities and operations related to identified
hazards and OH&S risks; risks, and OH&S opportunities;
ISO/TC 176/SC 2/ N1267
3) operational controls;
4) the organization’s OH&S objectives;
OH&S ISO
45001:2018
9.1 Monitoring, measurement, analysis and evaluation
b) the criteria against which the organization will evaluate its OH&S
performance;
c) the methods for monitoring, measurement, analysis and
evaluation, as applicable, to ensure valid results;
d) when the monitoring and measuring shall be performed;
e) when the results from monitoring and measurement shall be
analyzed , evaluated and communicated.
The organization shall ensure, as applicable, that monitoring and
measurement equipment is calibrated or verified and is used and
maintained as appropriate.
ISO/TC 176/SC 2/ N1267
The organization shall evaluate the OH&S performance, and

determine the effectiveness of the OH&S management system.
The organization shall retain appropriate documented information
as evidence of the monitoring, measurement, analysis and
evaluation results.
OH&S ISO
45001:2018
9.1.2 Evaluation of compliance with legal
 The organization shall plan, establish, implement and
maintain a process for evaluating compliance with
applicable legal requirements and other requirements (see
6.1.3).
 The organization shall:
 a) determine the frequency and method(s) by which
compliance will be evaluated;
 b) evaluate compliance;
ISO/TC 176/SC 2/ N1267
 c) take action if needed in accordance with 10.1;

 d) maintain knowledge and understanding of its status of
compliance with legal requirements and other requirements;
 e) retain documented information of the compliance
evaluation result(s).
OH&S ISO
45001:2018
9.2 Internal audit
 9.2.1 Internal audit objectives
 The organization shall conduct internal audits at planned
intervals to provide information on whether the OH&S
management system:
 a) conforms to:
 1) the organization’s own requirements for its OH&S
management system, including the OH&S policy and
OH&S objectives;
ISO/TC 176/SC 2/ N1267
 2) the requirements of this International Standard;

 b) is effectively implemented and maintained.
OH&S ISO
45001:2018
9.2.2 Internal audit process
 The organization shall:
 a) plan, establish, implement and maintain an audit
programme(s) including the frequency, methods,
responsibilities, consultation, planning requirements and
reporting, which shall take into consideration the
importance of the processes concerned and the results of
previous audits, as well as:
 1) significant changes impacting the organization;
 2) performance evaluation and improvement results
(see Clauses 9 and 10);
ISO/TC 176/SC 2/ N1267
 3) significant OH&S risks, risks and OH&S

opportunities;
 b) define the audit criteria and scope for each audit;
 c) select competent auditors and conduct audits to ensure
objectivity and the impartiality of the audit process;
OH&S ISO
45001:2018
9.2.2 Internal audit process
 d) ensure that the results of the audits are reported to
relevant management;
 e) ensure that relevant audit findings are reported to
relevant workers, and where they exist, workers’
representatives, and relevant interested parties;
 f) take appropriate action to address nonconformities
(see 10.1) and continually improve its OH&S
performance (see 10.2);
 g) retain documented information as evidence of the
ISO/TC 176/SC 2/ N1267
implementation of the audit programme and the audit

results.
 NOTE For more information on auditing, refer to ISO
19011 Guidelines for auditing management systems.
OH&S ISO
45001:2018
9.3 Management review (1/3)
 Top management shall review the organization’s OH&S
management system at planned intervals to ensure its
continuing suitability, adequacy and effectiveness.
 The management review shall include consideration of:
 a) the status of actions from previous management
reviews;
 b) changes in external and internal issues that are
relevant to the OH&S management system including:
 1) applicable legal requirements and other
ISO/TC 176/SC 2/ N1267
requirements;
 2) the organization's OH&S risks, risks and OH&S
opportunities;
 c) the extent to which the OH&S policy and the OH&S
objectives have been met;
OH&S ISO
45001:2018
 d) information on the OH&S performance, including trends
in:
 1) incidents, nonconformities, corrective actions and
continual improvement;
 2) worker participation and the outputs of consultation;
 3) monitoring and measurement results;
 4) audit results;
 5) results of evaluation of compliance;
 6) OH&S risks, risks and OH&S opportunities;
ISO/TC 176/SC 2/ N1267
 e) relevant communication(s) with interested parties;

 f) opportunities for continual improvement;
 g) adequacy of resources for maintaining an effective
OH&S management system.
OH&S ISO
45001:2018
 The outputs of the management review shall include
decisions related to:
 conclusions on the continuing suitability, adequacy
and effectiveness of the OH&S management system;
 continual improvement opportunities;
 any need for changes to the OH&S management
system, including resources needed;
 actions needed, when objectives have not been met.
 The organization shall communicate the relevant outputs
ISO/TC 176/SC 2/ N1267
of the management review to its relevant workers, and

where they exist, workers’ representatives (see 7.4.).
 The organization shall retain documented information as
evidence of the results of management reviews.
OH&S ISO
45001:2018
10.0 Improvement
10.1 Incident, nonconformity and corrective

action
10.2 Continual Improvement

ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
action
 a process to manage incidents and
nonconformities including reporting,
investigating and taking action.
 When an incident or a nonconformity
occurs, the organization shall:
 a) react in a timely manner to the incident
or nonconformity, and, as applicable:
 1) take direct action to control and
ISO/TC 176/SC 2/ N1267
correct it;
 2) deal with the consequences;
OH&S ISO
45001:2018
10.1 Incident, nonconformity and corrective action
 b) evaluate, with the participation of workers (see
5.4) and the involvement of other relevant
interested parties, the need for corrective action
to eliminate the root cause(s) of the incident or
nonconformity, in order that it does not recur or
occur elsewhere, by:
 1) reviewing the incident or nonconformity;
 2) determining causes of the incident or
nonconformity;
ISO/TC 176/SC 2/ N1267
 3) determining if similar incidents,

nonconformities, exist, or could potentially
occur;
OH&S ISO
45001:2018
action
 c) review the assessment of OH&S risks and
risks, as appropriate (see 6.1);
 d) determine and implement any action needed,
including corrective action, in accordance with
the hierarchy of controls (see 8.1.2) and the
management of change (see 8.2);
 e) review the effectiveness of any corrective
action taken;
 f) make changes to the OH&S management
ISO/TC 176/SC 2/ N1267
system, if necessary.
 Corrective actions shall be appropriate to the
effects or potential effects of the incidents or
nonconformities encountered.
OH&S ISO
45001:2018
actiondocumented information as
 The organization shall retain
evidence of:
 — the nature of the incidents or nonconformities and any
subsequent actions taken;
 — the results of any corrective action, including the
effectiveness of the actions taken.
 The organization shall communicate this documented
information to relevant workers, and where they exist,
workers’ representatives, and relevant interested parties.
ISO/TC 176/SC 2/ N1267
 NOTE The reporting and investigation of incidents without

delay can assist in the removal of hazards and in
minimizing associated OH&S risks.
OH&S ISO
45001:2018
10.2 Continual improvement
10.2.1 Continual improvement objectives
 The organization shall continually improve the suitability,
adequacy and effectiveness of the OH&S management
system to:
 a) prevent occurrence of incidents and
nonconformities;
 b) promote a positive occupational health and safety
culture;
 c) enhance OH&S performance.
 The organization shall ensure the participation of workers,
ISO/TC 176/SC 2/ N1267
as appropriate, in the implementation of its continual

improvement objectives.
OH&S ISO
45001:2018
10.2.2 Continual improvement process
 The organization shall plan, establish, implement
and maintain a continual improvement
process(es), which takes into account the outputs
of the activities described in this International
Standard.
 The organization shall communicate the results of
continual improvement to its relevant workers,
and where they exist, workers’ representatives.
 The organization shall retain documented
ISO/TC 176/SC 2/ N1267
information as evidence of the results of continual

improvement.
OH&S ISO
45001:2018
EXERCISE-10
OH&S Quiz
ISO/TC 176/SC 2/ N1267
OH&S ISO
45001:2018
AUDIT
Audit Programme
OH&S ISO
45001:2018
AUDIT PROGRAMME
Set of one or more audits planned for as specific
a time frame and directed towards specific
purpose
This includes:
• Planning
• Organizing
• Conduct of the audit
ISO/TC 176/SC 2/ N1267
• Objectives of the programme

• Extent of the programme (Scope)
• Audit Criteria
1
OH&S ISO
45001:2018
PLAYERS IN THE AUDIT

• Client
• Audit Team
• Auditee
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
MANAGING AUDIT PROGRAMME

Task of the Audit Management:
• Authority and responsibility
• Objectives and extent of the programme
• Resources
• Procedures
• Implementation
• Records
ISO/TC 176/SC 2/ N1267
• Monitoring and review
1
OH&S ISO
45001:2018
AUDIT ACTIVITIES
Task of the Audit Team
• Initiating the audit
• Conducting Document Review
• Preparing for on-site audit activities
• Conducting the audit
• Preparing, approving and distributing the audit
report
ISO/TC 176/SC 2/ N1267
• Completing the audit

• Audit follow up
1
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45001:2018
AUDIT OBJECTIVES
ISO 19011:2018
 To evaluate capability of management system to
ensure compliance with statutory, regulatory and
contractual requirements
 To determine the effectiveness of the
implemented management system in meeting
specified objectives
 To determine the conformity or non conformity of
ISO/TC 176/SC 2/ N1267
the management system elements with specified

requirements
 To identify areas for potential improvement of the
management system
1
OH&S ISO
45001:2018
AUDIT OBJECTIVES
Audit Programme Objectives : based on consideration
of;
• Management priorities
• Commercial intentions
• Management system requirements
• Statutory, regulatory & contractual requirements
• Need for supplier evaluation
ISO/TC 176/SC 2/ N1267
• Customer and other interested parties needs and

requirements
• Risks to the organization
1
OH&S ISO
45001:2018
EXERCISE-11
SEQUENCING AUDIT ACTIVITIES

(PICK UP THE RIGHT CARD)
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
QUALITY AUDIT TYPES

1st Party-WE are auditing our own system
(Internal)
2nd Party- WE are auditing another
organization:
normally our supplier
(External)
ISO/TC 176/SC 2/ N1267
3rd Party-WE are being audited by a

certification/registration body
(External)
1
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REASON FOR 1ST PARTY AUDIT

 Requirement of ISO 9001.2015
 Monitors health of the system
 Source of information for use by
management
 Powerful tool for continual improvement
through
ISO/TC 176/SC 2/ N1267
Employee involvement
Communication
Employee awareness, etc
1
OH&S ISO
45001:2018
REASON FOR 2nd PARTY AUDIT
• Aids selection and grading of suppliers

• Helps improve suppliers‘ quality systems
• Foundation for supplier partnerships
• Aids deployment of JIT, TQM etc.
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
REASON FOR 3rd PARTY AUDIT

 May reduce need for 2nd party audits
 Recognition of conformity to an
international standard
 Contributes to reduction in avoidable
costs to suppliers
 Aids market competitiveness
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
AUDIT PROCESS
INITIAL CERTIFICATION AUDIT IS CONDUCTED INTWO
STAGES
ASSESS DOCUMENTED SYSTEM AND

STAGE 1 ASSESS THE PREPAREDNESS OF THE
CLIENT
(INTENT)
ISO/TC 176/SC 2/ N1267
ASSESS SYSTEM IMPLEMENTATION

STAGE 2 (VERIFY PRACTICE WITH INTENT)
1
OH&S ISO
45001:2018
AUDIT PROCESS
PLANNING & PREPARATION
INITIAL CONTACT
PRE-ASSESSMENTVISIT
DOCUMENT REVIEW
INITIAL PREPARATION
DEVELOPMENT OF ASSESSMENT SCHEDULE
COMMUNICATION
ISO/TC 176/SC 2/ N1267
DETAILED PLANNING
1
OH&S ISO
45001:2018
AUDIT PROCESS
ON-SITE AUDIT
 OPENING MEETING
 AUDIT
 EVALUATE RESULTS
 CLOSING MEETING
FORMAL REPORT
CORRECTIVE ACTION
ISO/TC 176/SC 2/ N1267
FOLLOW-UP AND SURVEILLANCE
1
OH&S ISO
45001:2018
AUDIT PLANNING
AUDIT PLANNING
&
PREPARATION
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
AUDIT PLANNING
 Appoint a team leader
 Understand the business
 Understand the audit objective
 Agree the scope
 Determine the processes
 Determine the interaction of the processes
ISO/TC 176/SC 2/ N1267
 Carry out process analysis and understand how

ISO 9001 requirements apply to each process
1
OH&S ISO
45001:2018
AUDIT PLANNING
 Understand what clauses to check at different
locations
 Calculate the audit duration
 Select the team
 Draw up an audit plan
 Contact the auditee-agree the date(s) and plan
ISO/TC 176/SC 2/ N1267
 Brief the team

 Prepare checklist
1
OH&S ISO
45001:2018
AUDIT PROCESS
There needs to be clear understanding

between the assessing organization
and the organization to be assessed;
WHY it is necessary, and
WHAT WILL HAPPEN
when the result is known
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
AUDIT PROCESS
OBJECTIVES & SCOPES
NEED TO BE CLEARLY UNDERSTOOD BY

ASSESSMENT TEAM
ISO/TC 176/SC 2/ N1267
AND BY ORGANISATION TO BE ASSESSED
1
OH&S ISO
45001:2018
AUDIT SCOPE
Those parts of the organization that

are the focus of the assessment and
will be subject to audit activity
Determined by the objectives

ISO/TC 176/SC 2/ N1267
And “client” needs
1
OH&S ISO
45001:2018
AUDIT PREPARATION
 Auditor gets the audit sample from the team
leader
 Auditor analyses the processes and
understands the
 ISO 9001 clauses applicable for audit
 Auditor prepares detailed checklist for
process audit of each process applicable in
ISO/TC 176/SC 2/ N1267
two parts-
Part 1- What to check
Part 2- How to check
1
OH&S ISO
45001:2018
RESPONSIBILITY OF TEAM LEADER

 Stage-1 Audit & Document Review
 Planning the on-site audit (audit
schedule)
 Interface with 'client'
 Interface with organization being
audited
ISO/TC 176/SC 2/ N1267
 Final report
(ALL STAGES OF THE AUDIT PROCESS)
1
OH&S ISO
45001:2018
EXERCISE - 12
PDCA CYCLE
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
AUDIT – STAGE 1
 Clarify scope and objective of audit
 Gain an understanding of the business
 Define process flow and interaction
 Agree procedures to be used during audit
 Resolve any misunderstandings
 Identify any special needs, skills, protective
ISO/TC 176/SC 2/ N1267
clothing
 Identify layout of company/plant
1
OH&S ISO
45001:2018
AUDIT – STAGE 1 (Contd..)

 Identify logistics & administrative Arrangements
 Understand the culture & attitude
 Better understanding of nature & status of system
(Process interactions, procedures etc.)
 Better rapport with the company
 Establish the adequacy of documentation
ISO/TC 176/SC 2/ N1267
 Assess the organization's readiness for an audit

 Plan the audit (Stage 2)
1
OH&S ISO
45001:2018
DOCUMENTATION REVIEW
 Also called Desk Top Audit / Adequacy Audit

 Can be carried out independently or at the
time of pre audit visit
 To assess whether the intent is in line with
the Standard
ISO/TC 176/SC 2/ N1267
1
OH&S ISO
45001:2018
DOCUMENTATION REVIEW
How Review of documented information i.e.
Quality Manual/ Procedure/ Quality Plan
with criteria (ISO 9001)
Benefits  Determine deficiencies in the documentation
vis-a-vis criteria Determine the status of system
readiness for on-site Audit
 Help sin preparation of checklist
 Familiarization with process, activities and
system elements applicable
 Getting knowledge about procedures
ISO/TC 176/SC 2/ N1267
 Helps to understanding planning needs: Audit

program team selection
 Helps to understand company language
 Helps in deciding if the system is auditable
1
OH&S ISO
45001:2018
EXERCISE - 13
DOCUMENT REVIEW
(CASESTUDY MANUAL)
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT PLAN
Description of the activities and

arrangements for an audit
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT PLAN
 Audit Objective(s), Scope and Criteria
 Timetable
 Roles and responsibilities of audit team
members and accompanying persons
 Allocation of resources
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT PLAN MAY ALSO INCLUDE

 Identification of auditee representatives
 Working and reporting language
 Audit report topics
 Logistic arrangements
 Confidentiality matters
 Any audit follow up actions
ISO/TC 176/SC 2/ N1267
 The plan needs to be agreed amongst the Client,

auditee and audit team before implementation
2
OH&S ISO
45001:2018
SELECTION FACTORS
AUDITOR & DURATION
 Type of business carried out by the organization

 Physical layout of the organization
 Range of products or services
 Complexity of processes being audited
 The level of automation and sophistication in
operations
ISO/TC 176/SC 2/ N1267
 Size of work force employed

 Locations of functional units to be audited
2
OH&S ISO
45001:2018
PROCESS ANALYSIS
ANALYSIS OF PROCESSES
FOR AUDIT
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
PROCESS
 ''Set of interrelated or interacting activities
that use input to deliver an intended
outcome (ISO 9000:2015)
 Outputs from one process are typically
inputs into other processes.
 Overall aim is to add value by planning and
ISO/TC 176/SC 2/ N1267
controlling processes.
2
OH&S ISO
45001:2018
PROCESS
If it is defined – It can be measured
If it is measured – It can be analyzed
If it is analyzed – It can be controlled
If it is controlled – It can be improved
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
PROCESS
 Analyze all processes
 Determine Inputs, Activities, Outputs, Resources
and Controls
 Analyze what clauses can be audited in each
process
 Decide the Must and Should audit clauses for each
process
ISO/TC 176/SC 2/ N1267
 Determine time required for auditing each process

 Determine audit team requirements including
technical experts, if any
2
OH&S ISO
45001:2018
EXERCISE - 14
PLANNING AND AUDIT

ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT
APPROACH TO AUDITING
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT
Systematic, independent and documented

process for obtaining audit evidence and
evaluating it objectively to determine the
extent to which the audit criteria are
fulfilled.
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT EVIDENCE
Records, statements of factor other

information, which are relevant to the audit
criteria, and verifiable
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT CRITERIA
Set of policies, procedures or requirements
These are used as reference against which

audit evidence is compared
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT
Auditing is primarily a feedback mechanism.
It involves a systematic and independent

examination to verify if requirement are being met.
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT
A FORMAL activity to
INDEPENDENTLY examine
OBJECTIVE EVIDENCE and verify
compliance or otherwise with
ISO/TC 176/SC 2/ N1267
SPECIFIED REQUIREMENTS
2
OH&S ISO
45001:2018
OBJECTIVE EVIDENCE
 Data supporting the existence or verity of
something - ISO 9001:2015
 May be obtained through observation,
measurement, test or other means
 May be stated or (preferably) documented
 Can be verified
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
OBJECTIVE EVIDENCE
 Evidence that exists
 Can be stated in concrete terms
 Can be quantitative or qualitative
 Can be verified or based on observation
 A statement by personnel responsible for their
activity
ISO/TC 176/SC 2/ N1267
 Is about a process included in QMS

 Uninfluenced by emotion or prejudice
2
OH&S ISO
45001:2018
OBJECTIVE EVIDENCE
Objective evidence:
• is evidence which exists
• is uninfluenced by emotion or prejudice
• can be stated
• can be documented
• is about quality
• should be quantitative (countable)
ISO/TC 176/SC 2/ N1267
• should be qualitative(measured by degree)

• should be verifiable(i.e. documented/ based on observable
phenomena)
2
OH&S ISO
45001:2018
SPECIFIED REQUIREMENTS
• Customer requirements
• Quality system requirements
o Manuals
o Procedures/work instructions
• QMS standard (ISO 9001:2015)
• Legal requirements-statutory, regulatory or industry
ISO/TC 176/SC 2/ N1267
body
• Regulations of registration body
2
OH&S ISO
45001:2018
QUALITY AUDIT
Three aspects to be evaluated
• INTENT - Extent to which the QMS, as it is
intended to operate, is appropriate to the
organization's activities and such as to ensure
compliance with regulatory and customer
requirements
• IMPLEMENTATION - Extent to which the QMS is
ISO/TC 176/SC 2/ N1267
implemented in practice
• EFFECTIVENESS - Extent to which QMS objectives
are attained
2
OH&S ISO
45001:2018
MANAGEMENT SYSTEM AUDITING

• Guide to Quality Systems Auditing
• Contains 7 clauses out of which main clauses:
o Clause 4 Principles of Auditing
o Clause 5 Managing an Audit Programme
o Clause 6 Audit Activities
ISO/TC 176/SC 2/ N1267
o Clause 7 Competence and Evaluation of

Auditors
2
OH&S ISO
45001:2018
6 Principles Of Auditing
• Integrity
• Fair Presentation
• Due Professional Care
• Confidentiality
• Independence
ISO/TC 176/SC 2/ N1267
• Evidence based approach
2
OH&S ISO
45001:2018
INTEGRITY
Honesty, Diligence, responsibility,

competence, impartial etc.
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
FAIR PRESENTATION
The obligation to report truthfully and accurately
• Audit findings, audit conclusions and audit reports

reflect truthfully and accurately the audit activities.
ISO/TC 176/SC 2/ N1267
• Significant obstacles encountered during the audit

and unresolved diverging opinions between the
audit team and the auditee are reported.
2
OH&S ISO
45001:2018
DUE PROFESSIONAL CARE
 Due professional care: the application of

diligence and judgment in auditing
 Auditors exercise care in accordance with
the importance of the task they perform
and the confidence placed in them by audit
ISO/TC 176/SC 2/ N1267
clients and other interested parties.
2
OH&S ISO
45001:2018
CONFIDENTIALITY
 Security of Information
 Audit information should not be used
inappropriately for personal gain or in a
manner detrimental to the legitimate
interest of the audit team
 Appropriate handling of sensitive and
ISO/TC 176/SC 2/ N1267
confidential information
2
OH&S ISO
45001:2018
INDEPENDENCE
 The basis for the impartiality of the audit and
objectivity of the audit conclusions
 Auditors are independent of the activity being
audited and are free from bias and conflict of
interest.
 Auditors maintain an objective state of mind
through out the audit process to ensure that the
ISO/TC 176/SC 2/ N1267
audit findings and

 Conclusions will be based only on the audit
evidence.
2
OH&S ISO
45001:2018
EVIDENCE BASED APPROACH

 The rational method for reaching reliable and
reproducible audit conclusions in a systematic
audit process
 Audit evidence is verifiable. It is based on samples
of the information available, since an audit is
conducted during a finite period of time and with
finite resources.
ISO/TC 176/SC 2/ N1267
 The appropriate use of sampling is closely related

to the confidence that can be placed in the audit
conclusions.
2
OH&S ISO
45001:2018
AUDITORS
Person who conducts an audit.

ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDITOR COMPETENCY REQUIREMENT
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S
H& a n
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O k
ir c lls
e i l s
Personal Attributes en sk ific skil
G nd ec d
a p
s an
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tr dge
Appropriate education s
ndu wle
I o
ISO/TC 176/SC 2/ N1267
kn
Appropriate work
experience
Appropriate Audit
Experience
Auditor training
2
OH&S ISO
45001:2018
AUDITOR ROLES
Various roles of an auditor
 A catalyst for improvement
 Management instrument
 An interface with
•Suppliers
ISO/TC 176/SC 2/ N1267
•Customers
•Colleagues
 A 'consultant‘ (NOT 3rd Party)
2
OH&S ISO
45001:2018
AUDITOR ATTRIBUTES
 Local Requirements
 Culture
 Practices
 Approach
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDITOR ATTRIBUTES
Auditors must be flexible to
 Changing situations
 Differing management styles
 Differing management/employee levels
 Auditors must be competent in
 Reasoning of nonconformities
ISO/TC 176/SC 2/ N1267
 Evaluating appropriateness of proposed corrective

action
 Evaluating effectiveness of corrective action
2
OH&S ISO
45001:2018
SOME ATTRIBUTES OF A GOOD AUDITOR

• Open-minded
• Diplomatic
• Observant
• Perceptive
• Tenacious
ISO/TC 176/SC 2/ N1267
• Decisive
• Self-reliant
• Ethical
2
OH&S ISO
45001:2018
LEAD AUDITOR RESPONSIBILITIES

• Plan the audit and make effective use of
resources
• Represent the audit team in communications
with the auditee
• Organize and direct audit team members
• Provide direction and guidance to auditors-in-
training
ISO/TC 176/SC 2/ N1267
• Lead the audit team to reach the audit

conclusions
• Prevent and resolve conflicts
• Prepare and complete the audit report
2
OH&S ISO
45001:2018
AUDITOR DUTIES
 Support the team leader  Assist team leader with
 Prepare checklist reports
 Arrive on time  Safeguard all documents
 Participate at opening  Maintain confidentiality
meeting
 Carry out assigned tasks
 Keep to the timetable
ISO/TC 176/SC 2/ N1267
 Document all findings

 Keep auditee informed
2
OH&S ISO
45001:2018
ETHOS OF AUDITING
 Positive approach
 Aim to help improve system
 Don't look for blame
 Aid identification of solutions
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDITEE REACTION
Enlisting help
Continual challenge
Volunteered information
Diversionary or time wasting tactics
Internal conflicts
Authority
ISO/TC 176/SC 2/ N1267
Antagonism
2
OH&S ISO
45001:2018
AUDITOR REQUIREMENT
All Audits
 Understand the business
 Understand the processes
 Understand the interaction of processes
 Team player
External, complete system audits
 Understand the business sector
ISO/TC 176/SC 2/ N1267
 Proficient in auditing top management (lead audit or?)

 Proficient in legal requirements (or ensure the team has
the relevant knowledge)
2
OH&S ISO
45001:2018
AUDIT LIFE STYLE

Audit process also follows P-D-C-A approach. Audit
life cycle is often referred to as P.E.R.C.
• Planning
• Execution
• Recording
ISO/TC 176/SC 2/ N1267
• Close out
2
OH&S ISO
45001:2018
EXERCISE - 15
AUDITORS ROLES AND RESPONSIBILITY

ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT CHECKLIST
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
CHECKLIST
• Planning Tool
• Provides clarity on processes and
performance measures
• Aide-memoire
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
CHECKLIST METHODOLOGY
• Ask for an overview of the process(es)
• How do these processes interrelate with other
processes within the organization?
• How are processes controlled?
• How are processes monitored/measured?
• What evidence of continual improvement is there?
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
CHECKLIST PREPARATION
1. Understand the process
2. Interaction of process
3. Convert clauses of the standard into
questions/topics
4. Using these questions and the quality manual
 Plan what to look at
ISO/TC 176/SC 2/ N1267
 Plan what look for

 Consider sample sizes
5. Prepare checklist
2
OH&S ISO
45001:2018
CHECKLIST
QUESTIONS TO BE ASKED
+AUDIT SAMPLE
All those things that the auditor wishes to

examine, together with how many to examine
ISO/TC 176/SC 2/ N1267
Documents, records, tools, materials etc.
2
OH&S ISO
45001:2018
SAMPLE CHECKLIST (PURCHASING)

 How is the need to purchase identified?
 Who receives the purchased product?
 How are processes measured?
 What objectives have been set for the process?
 What evidence is there of improvement activity
towards achieving the objectives?
 Sample through purchasing documents/interviews for
ISO/TC 176/SC 2/ N1267
Controls
 Clear information
 Evaluation of suppliers
 Training and competence of staff
2
OH&S ISO
45001:2018
CHECKLIST BENEFITS
 Keeps audit objectives clear

 Evidence of audit planning
 Maintains audit pace and continuity
 Reduces auditor bias
 Reduces work load during audit
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
CHECKLIST DRAWBACKS
 Checklists tend to lose value if they are
o Tick lists
o Questionnaires
 Prepare them as a memory aid only
 Auditors are not to be slave to checklist.
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
EXERCISE - 16
PREPARING AUDIT CHECKLIST

ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
REPRESENTATIVE SAMPLE
When planning samples , consider
 The major process of the department
 The other duties it undertakes
 What it does when things go wrong
Samples include People, Documents, Records,
Products, Materials, Equipment, Tools, Test,
ISO/TC 176/SC 2/ N1267
Equipment etc. which the auditor would like to

Verify during audit
2
OH&S ISO
45001:2018
AUDIT
ON SITE AUDIT
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT EXECUTION
 The opening meeting
 The audit process
 Gather information
 Verify (audit evidence)
 Compare evidence against audit criteria
(audit findings)
ISO/TC 176/SC 2/ N1267
 Evaluate findings(audit conclusions)

 The closing meeting
2
OH&S ISO
45001:2018
OPENING MEETING
 Introductions-including  Conditions under which
roles audit may
 Objective, Scope, Criteria be terminated and
 Review audit plan appeal system
 Methods and limitations  Restrictions?
 Guides  Clarifications?
ISO/TC 176/SC 2/ N1267
 Logistics
 Reporting methods
 Confidentiality
2
OH&S ISO
45001:2018
EXERCISE - 17
OPENING MEETING
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
EVIDENCE
COLLECTION OF EVIDENCE
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
CONDUCT OF THE AUDIT

 Enter the area
 Introductions by guide
 Explain what you want to see
 Investigate to the depth necessary
 No problems found, move on
 Don't keep on auditing until problems are found
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
GUIDES
• RESPONSIBILITIES • REMEMBER
 Guide & Introduce  Should Not Answer For Auditee
 Interpreter  Should Not Act As Auditor
 Witness To Facts Found
 Safety Of Auditors
 Company Confidentiality
• COMPETENCE
ISO/TC 176/SC 2/ N1267
 Reasonable Seniority
 Company Auditors
 Understanding Of Audit Process
 And Auditors Needs
2
OH&S ISO
45001:2018
COLLECTION OF EVIDENCE
• Interviews
• Observations of activities and conditions
• Review of Documents
• Examination of other sources of
information
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
INTERVIEW TECHNIQUES
 Arrive on time
 Introductions
 Re-state purpose
 Be well prepared
 Interview the right people
 Let the interviewee relax
ISO/TC 176/SC 2/ N1267
 Adjust style to suit

 Respond to questions
2
OH&S ISO
45001:2018
QUESTIONING TECHNIQUES - OPEN

OPEN QUESTIONS REQUIRE A RESPONSE THAT
PROVIDES THE AUDITOR WITH INFORMATION
• Why
• Who
• What
• When
ISO/TC 176/SC 2/ N1267
• Where
• How
2
OH&S ISO
45001:2018
QUESTIONING TECHNIQUES - OPEN
PLEASE TELL ME
 Who (does it)
 What(is done)
 Where (is it done)
 Why (is it done)
 When (does it get done)
ISO/TC 176/SC 2/ N1267
 How(is it done; often is it done)

PLEASE SHOW ME
2
OH&S ISO
45001:2018
QUESTIONING TECHNIQUES – USE FUL

Don't waste time by asking
 Unrelated questions
 Leading questions
 Loaded questions
 Too many closed questions
Do ask waste time by asking
 Open questions
ISO/TC 176/SC 2/ N1267
 Probing questions
 Close questions only when necessary
2
OH&S ISO
45001:2018
QUESTIONING TECHNIQUES - PROBING
• ABOUT THE SUBJECT /THEME UNDER

EXAMINATION
• SEEK OPINIONS
• REPETITIVE
• HYPOTHETICAL
• CONFIRMATORY
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
QUESTIONING TECHNIQUES - ATTENTION
 Non verbal communication

 Body language
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
POINTS TO REMEMBER
 Talk to the person who does the job.
 Talk the language of the auditee
 Speak clearly.
 Don't confuse-pose one question at a time
 Re-phrase the question if not understood
 Come back if information is not
immediately available.
ISO/TC 176/SC 2/ N1267
 Be polite
 Do not show off or act superior
2
OH&S ISO
45001:2018
EXAMINATION INFORMATIONS
INFORMATION: DOCUMENTATION & OTHER
SOURCES
 Documentation
 Records
 Tools
 Monitoring Devices
ISO/TC 176/SC 2/ N1267
 Materials
 People
 Products
2
OH&S ISO
45001:2018
OBSERVATIONS
 Conditions
 House Keeping
 Activities
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
EVIDENCE VERIFICATION
 Necessary to make evidence Objective
 Confirm statements
 Use different methods
 Sample chosen by the auditor
 Permission sought
 Establish and agree the facts
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
FOLLOW TRAILS
 A number of trails get revealed during the conduct of audit.
Some of these could lead to considerable information. Some
examples:
 Instruments are used by inspectors but are calibrated in the
laboratory
 Personnel work in departments; their training records may be
centrally controlled
If potential audit trails appear,
 Decide to
ISO/TC 176/SC 2/ N1267
 Disregard
 Note for later
 Follow up immediately
 Might affect the sample size
 Might affect the audit programme
2
OH&S ISO
45001:2018
AUDIT ETIQUETTE
 Introductions & Thanks
 Remain pleasant & polite
 Have respect for people & their culture
 Remember that you are a guest in the
auditee's organization
 Remain objective and not Subjective or
ISO/TC 176/SC 2/ N1267
opinionated
 Do not behave like a police force
2
OH&S ISO
45001:2018
EVIDENCE TRIANGLE
Record
(Notes)
ASK Asking the right type of questions

ISO/TC 176/SC 2/ N1267
CHECK Checking that what is being done is carried

out and done consistently
OBJSERVE Observing actual practice against
established process.
RECORD Take notes
2
OH&S ISO
45001:2018
NOTES TAKING
 Recording the objective evidence
 Names of the auditees
 Departments
 Admissible statements
 Document numbers and issue/revision levels
 Other Identifiers
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
NOTES TAKING
Notes could be used as reference for
 Immediate investigation
 Investigation later
 Use by a colleague
 Subsequent audits
Notes must therefore be
ISO/TC 176/SC 2/ N1267
 Legible
 Retrievable
 Sufficiently detailed
2
OH&S ISO
45001:2018
NOTES TAKING
Notes taken during an audit area record of
 The audit sample taken
 What was reported
 What was observed
 What was checked
 Who all were interviewed
ISO/TC 176/SC 2/ N1267
Notes may be referenced by subsequent auditors
2
OH&S ISO
45001:2018
EXERCISE - 18
AUDIT ROLEPLAY (CASE STUDY)

ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
EXERCISE - 19
IDENTIFICATION AND GRADINGOF AUDIT FINDINGS

(CASESTUDY)
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
REVIEW MEETING
Review meetings, normally 15 to 20 minutes in duration, may
be carried out at the end of each auditing day or at the
beginning of next auditing day, with either the management
representative or guides to-
 Review any nonconformities
 Resolve any problems

ISO/TC 176/SC 2/ N1267
Report audit progress

 Clarify any misunderstandings
 Obtain signatures to any nonconformities
2
OH&S ISO
45001:2018
COMMUNICATION AUDITOR AUDITEE

To ensure that the audit remains helpful,
constructive and professional-
Review audit progress and findings regularly
with the auditee
Beat the grapevine or rumour mill
Generate rapport
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
AUDIT PROCESS
Sources of Information
Collection by appropriate
sampling and verifying
Audit Evidence
Evaluation against audit criteria
Audit Findings
ISO/TC 176/SC 2/ N1267
Review of findings
Audit conclusions
2
OH&S ISO
45001:2018
RESULT EVALUATION
Major
All
Results Minor
OFI
ISO/TC 176/SC 2/ N1267
DO NOT REPORT ONLY TRIVIALS
2
OH&S ISO
45001:2018
AUDIT TEAM MEETINGS

 Item on the audit programme
 Audit team only present
 Controlled by team leader
 Plan for closing meeting
 Team leader prepares audit report
 Finalize over all judgment on system
ISO/TC 176/SC 2/ N1267
 Team completes nonconformity reports

 Team reviews non conformity reports
2
OH&S ISO
45001:2018
JUDGEMENT OF THE AUDIT TEAM

Conclusions to be drawn from all positive and
negative findings-
 Nonconformities
 System intent
 System implementation
 System effectiveness
ISO/TC 176/SC 2/ N1267
 Strengths and weaknesses of departments

 Strengths and weaknesses of the quality system
The auditee must be given the benefit of any doubt
2
OH&S ISO
45001:2018
NONCONFORMITY
INTENT
QMS is not conforming with the quality system standard
IMPLEMENTATION
Practice is not in line with the intent
EFFECTIVENESS
ISO/TC 176/SC 2/ N1267
Practice is not effective
2
OH&S ISO
45001:2018
ESTABLISHING THE FACTS

 Get help from the auditee
 Discuss concerns
 Verify the information
 Record all the evidence
• Exact observation
• Where, what, etc...
ISO/TC 176/SC 2/ N1267
 Establish why a nonconformity or otherwise

 State who (if relevant) - preferably by job title
2
OH&S ISO
45001:2018
WRITING STATEMENT OF NONCONFORMITY

 Use auditee's terminology
 Make it retrievable
 Must be factual
 Make it complete
 Make it concise
 Consider the Seriousness
 What could go wrong if the nonconformity remains
ISO/TC 176/SC 2/ N1267
uncorrected?
 What is the likelihood of such a thing going wrong?
 How likely is it to be detected if it did go wrong?
2
OH&S ISO
45001:2018
WRITING STATEMENT OF NONCONFORMITY
 Area where the nonconformity has been found

 Evidence with source
 Requirement not being met with Reference to the
criteria such as Company manual/ Management
System Standard
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
NONCONFORMITY - 1
While reviewing the Minutes of Management
Reviews with the Managing Director of ABC
Company, it was found that in Minutes dated 20
12-0Y, results of Correction Action were not
mentioned in the minutes.
Quality manual of The company states Corrective

ISO/TC 176/SC 2/ N1267
Actions as one of the inputs for all management

reviews
2
OH&S ISO
45001:2018
NONCONFORMITY - 2
Marketing Manager of XYZ Ltd. could not
provide evidence of the level of customer
satisfaction.
The Quality Manual of the Company dated 21
Nov 2005, Para 8.2.1 states that customer
survey will be carried out every six months
ISO/TC 176/SC 2/ N1267
and customer satisfaction index worked out

from this survey.
2
OH&S ISO
45001:2018
NONCONFORMITY - 3
The objective for rework for the current year has
been promulgated as less than 2% in the Minutes of
Review Meeting dated 23 Feb 200Y.
As per records available with Production Manager,

rework has not reduced below 2.5% during the
ISO/TC 176/SC 2/ N1267
period March OY till date and no corrective action

has been initiated.
2
OH&S ISO
45001:2018
INCIDENT A
During an audit of the design department the auditor

asks the design manager what records are retained
of the design requirements. The manager replies that
the designers deal directly with the customers and
were very experienced and would not forget the
design requirements and had no need to keep
ISO/TC 176/SC 2/ N1267
documented records.
2
OH&S ISO
45001:2018
NONCONFORMITY STATEMENT A
Retention of documented information on design and

Development inputs is not evidenced (Clause 8.3.3)
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
INCIDENT B
During an audit of the personnel department the

auditor asks how the effectiveness of training is
monitored. The personnel manager replies that only
world-class training organizations are used by the
company so monitoring of effectiveness is not
required.
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
NONCONFORMITY STATEMENT B
No evidence of evaluation of effectiveness of training

ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
MAJOR NONCONFORMITY
A SIGNIFICANT NONCONFORMITY WITH A (QUALITY)
MANAGEMENT SYSTEM REQUIREMENT
OR
A FAILURE OF, OR COMPLETE OMISSION OF A (QUALITY)
OR
A SIGNIFICANT NUMBER OF MINOR NONCONFORMITIES
ISO/TC 176/SC 2/ N1267
CONCERNING THE SAME (QUALITY) MANAGEMENT SYSTEM

REQUIREMENT
OR
CUSTOMER IS LIKELY TO GET NONCONFORMING PRODUCT
2
OH&S ISO
45001:2018
MINOR NONCONFORMITY
AN ISOLATED INCIDENT OF
A FAILURE TO COMPLY WITH A PROCEDURE OR
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
OFI
Opportunities for Improvement (OFI)
Areas/processes already at good performance

levels, where performance levels can be
ISO/TC 176/SC 2/ N1267
further enhanced
2
OH&S ISO
45001:2018
EXERCISE - 20
WRITING AN NCR
ISO/TC 176/SC 2/ N1267
2
OH&S ISO
45001:2018
CLOSING MEETING
 Introduction
 Attendees
 Thanks
 Confidentiality
 Objective/scope
 Reporting system
 Limitations
 Summary of finding: Good point
ISO/TC 176/SC 2/ N1267
first
 Agreement on nonconformities
 Recommendation
 Clarifications
2
OH&S ISO
45001:2018
EXERCISE - 21
CLOSING MEETING
ISO/TC 176/SC 2/ N1267
3
OH&S ISO
45001:2018
AUDIT REPORT
REMEMBER WHO IS THE RECIPIENT

REMEMBER WHAT THE RECIPIENT NEEDS
SUMMERISE FINDINGS
PROVIDE THE DETAILS
THINK BEFORE WRITING AND
ISO/TC 176/SC 2/ N1267
WRITE CLEARLY AND CONCISELY

DRAW CONCLUSIONS
3
OH&S ISO
45001:2018
AUDIT REPORT
 Audit reference  Recommendation
 Auditee details  Approval
 Objective, scope,  Circulation
criteria  Ensure confidentiality
 Auditors’ names of report
 Names of auditee's
principals
ISO/TC 176/SC 2/ N1267
 Audit programme
 Summary of findings
(positive & negative)
 Nonconformity reports
3
OH&S ISO
45001:2018
AUDIT RECORDS
 AUDIT IDENTITY
 OBJECTIVES & SCOPE
 AUDITOR DETAILS
 PLANNING DATA
 CHECKLISTS
 AUDITOR'S NOTES
 CONCLUSIONS
 NON-CONFORMITIES
ISO/TC 176/SC 2/ N1267
 CORRECTIVE ACTION PROPOSALS

 CORRECTIVE ACTION VERIFICATION
3
OH&S ISO
45001:2018
EXERCISE - 22
PREPARATION OF AUDIT REPORT

ISO/TC 176/SC 2/ N1267
3
OH&S ISO
45001:2018
AUDIT FOLLOW UP OPTIONS

 Evaluation of submitted corrective actions
 Evaluation by continuing assessment visit
 Partial re-audit
 Full re-audit
ISO/TC 176/SC 2/ N1267
3
OH&S ISO
45001:2018
FOLLOW UP ACTIONS
 Auditee receives nonconformity report
 Auditee determines root cause
 Auditee prepares Corrective action plan and submits
plan (where appropriate) to auditor
 Auditor evaluates response
 Auditee implements plan
 Auditee evaluates effectiveness
 Auditee revises plan if necessary
ISO/TC 176/SC 2/ N1267
 Auditee documents the changes

 Auditor verifies implementation and effectiveness
 Records made of all actions taken (by auditor and
auditee)
3
OH&S ISO
45001:2018
DETERMINATION OF ROOT CAUSE
ASK 'WHY‘ TILL YOU REACH ROOT CAUSE
Question 1: Why did the machine stop?
Answer 1: Because the fuse blew due to an overload.
Question 2: Why was there an overload?
Answer 2: Because the bearing lubrication was inadequate.
Question 3: Why was the lubrication inadequate?
Answer 3: Because the lubrication pump was not functioning
right.
Question 4: Why wasn't the lubricating pump working right?
ISO/TC 176/SC 2/ N1267
Answer 4: Because the pump axle was worn out.

Question 5: Why was it worn out?
Answer 5: Because sludge got in.
Real solution: Attaching a strainer to the lubricating pump.
3
OH&S ISO
45001:2018
DETERMINATION OF ROOT CAUSE

Nonconforming product has been dispatched to the customer
Why?
Final Inspection failed to discover the fault
Why?
Production were unaware of key requirements and made the
product
to conform to standard specifications
Why?
Sales omitted to pass on a key piece of information from the
ISO/TC 176/SC 2/ N1267
customer
Why?
Sales clerk not aware it was his job to do this
Solution: Improve training and communication within departments
3
OH&S ISO
45001:2018
EXERCISE - 23
REVIEW OF CORRECTIVE ACTION

ISO/TC 176/SC 2/ N1267
3
OH&S ISO
45001:2018
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Lead Auditor Training

Welcome to Lead Auditor Training

GRS provides system certifications for ISO 9001: 2015,

and AS/NZS 4801:2001, certification across Australia,

Welcome to Lead Auditor Training

(Occupational Health & Safety

• Non-governmental organization (NGO) established in 1947,

• Has a membership of over 169 national standards institutes

from countries in all regions of the world

• The world’s largest developer of voluntary International

• Examples of well-known management standards:

• ISO 14001 – Environmental Management Systems (EMS)

• ISO 45001 – Occupational Health & Safety Management Systems

• ISO’s Technical Committee ISO/TC 283 was responsible for

ABOUT THE COURSE

Lunch breaks: 1300 to 1400

Please familiarize with any safety notices and

the actions to be taken in case of fire or any

• Learning Methods • Evaluation Methods

Written Exam Pass Fail Pass Fail

Result Pass Fail ** Fail ** Fail **

Retake Re-sit Re-sit

• * A delegate can only retake an examination once. After second non-successful

19011, and ISO/IEC 17021, as applicable.

A. FIRST PARTY AUDIT

Audits carried out by a company on its own systems.

B. SECOND PARTY AUDIT

Audits carried out by one organization on another prior to or

C. THIRD PARTY AUDIT

What is Health and Safety?

► The dictionary defines the words health and safety as

 Health - the condition of body or mind

For the purpose of risk management SAFETY needs to

• Incidents are any work-related events in which an

Unsafe Acts or Conditions ???

Work Related Ill Health

‘Identifiable, adverse physical or mental condition

•Work related ill health may be temporary or

• 4% of world GDP = work accidents and

Source: International Labor Organization

What is an OH&S Management System?

• An Occupational Health and Safety Management System

What is an OH&S Management System?

• Establishes safer working

people at work by eliminating, or

• Specifies requirements for an

• Applies to all types and sizes

• Does not state specific criteria for OH&S performance

• Does not prescribe the design of an OH&S

• Does not specifically address issues such as product

• Not intended to be a legally binding document, it is a

1999 BS OHSAS 18001:1999 (1st issue)

2007 BS OHSAS 18001:2007 (2nd issue)

ISO 45001:2018 (1st issue)

• Growing demand for a management

• Need for health and safety

• Rising health and safety costs

3. Assure itself of conformity with its OH&S policy

Objectives of ISO 45001

• Provide a platform for continual

• Integrate OH&S within an

• Leadership and the need for those at the top to lead by

• Consultation with and involvement of workers in making sure

Result Pass Fail Fail Fail **