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1. © Operational Excellence Consulting
ISO 22000:2018
Food Safety Management Systems
© Operational Excellence Consulting. All rights reserved.

2. © Operational Excellence Consulting
LEARNING OBJECTIVES
2
Provide background
knowledge on ISO
22000
Describe the audit
approach and learn
useful tips for
handling an audit
session
Gain an overview of
the ISO 22000:2018
structure
Define the ISO
22000:2018
certification process
NOTE: This is a PARTIAL PREVIEW.
To download the complete presentation, please
visit: https://www.oeconsulting.com.sg

3. © Operational Excellence Consulting
CONTENTS
3
OVERVIEW OF
ISO 22000
ISO 22000:2018
STRUCTURE
ISO 22000:2018
CERTIFICATION
PROCESS
AUDIT APPROACH
01 04
03
02
HANDLING AN
AUDIT SESSION
05

4. © Operational Excellence Consulting
ISO STANDARDS CONTRIBUTE DIRECTLY TO THE U.N. SUSTAINABLE
DEVELOPMENT GOALS (SDGs)
4
ISO 14001:2015
Environmental
Management Systems
ISO/IEC
27001:2022
Information Security
Management Systems
ISO 22000:2018
Food Safety
Management Systems
ISO 26000:2010
Social Responsibility
ISO 9001:2015
Quality Management
Systems
ISO 50001:2018
Energy Management
Systems
ISO 37001:2016
Anti-Bribery
Management Systems
ISO 45001:2018
Occupational Health &
Safety Management
Systems
Some examples of popular ISO standards that are adopted
by various companies and organizations:

5. © Operational Excellence Consulting
600 M
Or almost 1 in 10 people around the world fall ill after eating contaminated food,
leading to over 420,000 deaths every year.
5
Source: World Health Organization (WHO), 2022

6. © Operational Excellence Consulting 6
MORE THAN 200 DISEASES ARE SPREAD THROUGH FOOD
Unsafe food can have severe health
consequences, so it's crucial for organizations
in the food supply chain to take steps to
ensure their processes and products are safe.

7. © Operational Excellence Consulting
● ISO 22000 is a food safety standard for
businesses in the global food chain
● Specifies requirements for a Food
Safety Management System (FSMS)
● Combines and supplements the core
elements of ISO 9001 and HACCP to
provide an effective framework for food
safety management
● Covers organizations across the whole
food chain, from the farm to the table
WHAT IS ISO 22000?
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8. © Operational Excellence Consulting
KEY FEATURES OF ISO 22000:2018
8
Harmonizes the
voluntary
international
standards
Global food safety
standard
Enables a common
understanding of
what a food safety
management system
is
Employs proven
management system
principles
Integrates existing
good practice
Requires legal
compliance
checking
Internal and external
monitoring

9. © Operational Excellence Consulting
PRIMARY ELEMENTS OF AN FSMS
9
Interactive
communication across
the organization
System management
that includes
documentation
Prerequisite programs,
which ensure a clean,
sanitary environment
HACCP principles,
which help identify,
prevent and remove
food safety hazards

10. © Operational Excellence Consulting
BENEFITS TO AN ORGANIZATION FOR IMPLEMENTING AN FSMS
10
Increase credibility and
reputation
Increase in profitability of
the company
Improves transparency
Conformance to legal and
regulatory requirements
Improves customer
satisfaction
Improves health and safety

11. © Operational Excellence Consulting
ADVANTAGES OF CERTIFICATION
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● Certification to ISO 22000 is
voluntary
● Independent check of conformity by a
third party
● Indicates an effective FSMS
● National/International recognition
● Provides competitive advantage
● Improves company image
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12. © Operational Excellence Consulting
● Identifying potential risks, likelihood
and consequences
● Documenting assumptions and criteria
● Identifying activities by risk
classification in order of priority
● Allocating necessary resources to risk
management plan
● Documenting results and develop a
Risk Management Action plan
RISK-BASED THINKING
12
Risk
Evaluation
Risk
Analysis
Risk
Identification
Risk Assessment
Risk Treatment
Scope, Context, Criteria
COMMUNICATION
&
CONSULTATION
MONITORING
&
REVIEW
RECORDING & REPORTING

13. © Operational Excellence Consulting
ANNEX L IS A FRAMEWORK FOR A GENERIC MANAGEMENT SYSTEM
13
Annex L
High-level structure Identical core text Common definition
However, it requires the addition of discipline-specific
requirements to make a fully functional standard.

14. © Operational Excellence Consulting
ISO 22000:2018 IS BASED ON THE ISO HIGH-LEVEL STRUCTURE FOR
MANAGEMENT SYSTEM STANDARDS
14
1. Scope
2. Normative References
3. Terms & Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement

15. © Operational Excellence Consulting
HLS – THE SAME CORE ELEMENTS
15
Environment
ISO 14001
Food Safety
ISO 22000
Quality Management
ISO 9001
Occupational
Health & Safety
ISO 45001
THE SAME
CORE
ELEMENTS

16. © Operational Excellence Consulting
ISO 22000:2018 IS BASED ON THE PDCA MODEL
16
Source: Adapted from ISO
SCOPE OF THE FOOD SAFETY MANAGEMENT SYSTEM (4.3/4.4)
IMPLEMENT
& OPERATE
THE FSMS
ESTABLISH
FSMS
MAINTAIN &
IMPROVE
THE FSMS
MONITOR
& REVIEW
THE FSMS
Plan Do
Check
Act
INTERNAL &
EXTERNAL
ISSUES (4.1)
NEEDS &
EXPECTATIONS
OF INTERESTED
PARTIES (4.2)
INTENDED
OUTCOMES OF
THE FOOD
SAFETY
MANAGEMENT
SYSTEM

17. © Operational Excellence Consulting
ISO 22000 – THE PDCA CYCLE AT THE TWO LEVELS
17
DO (FSMS)
8. Operation
PLAN (FSMS)
4. Context of the
organization
5. Leadership
6. Planning
7. Support (including
control of externally
provided processes,
products or services)
CHECK (FSMS)
9. Performance
evaluation
ACT (FSMS)
10. Improvement
Organizational planning and control
ACT (food safety)
Updating of preliminary information
and documents specifying the
PRPs and the hazard control plan
PLAN (food safety)
PRPs
Traceability System
Emergency preparedness & response
Hazard
analysis
Validation
of control
measures
Validation
planning
Hazard control plan
(HACCP/OPRP plan)
Operational planning and control
CHECK (food safety)
Verification activities
Analysis of results of verification
activities
DO (food safety)
Implementation of the
PLAN (food safety)
Control of monitoring
and measuring
Control of product and
process nonconformities
Source: Adapted from ISO

18. © Operational Excellence Consulting
ISO 22000:2018 KEY CLAUSE STRUCTURE (4-10)
PLAN DO CHECK ACT
4. Context of the
organization
5. Leadership 6. Planning 7. Support 8. Operation 9. Performance
evaluation
10. Improvement
4.1 Understanding the
organization and its context
5.1 Leadership and
commitment
6.1 Actions to address risks
and opportunities
7.1 Resources 8.1 Operational planning and
control
9.1 Monitoring, measurement,
analysis and evaluation
10.1 Nonconformity and
corrective action
4.2 Understanding the needs
and expectations of interested
parties
5.2 Policy 6.2 Objectives of the FSMS
and planning to achieve them
7.2 Competence 8.2 Prerequisite programmes
(PRPs)
9.2 Internal audit 10.2 Continual improvement
4.3 Determining the scope of
the FSMS
5.3 Organizational roles,
responsibilities and authorities
6.3 Planning of changes 7.3 Awareness 8.3 Traceability system 9.3 Management review 10.3 Update of the FSMS
4.4 FSMS 7.4 Communication 8.4 Emergency preparedness
and response
7.5 Documented information 8.5 Hazard control
8.6 Updating the information
specifying the PRPs and the
hazard control plan
8.7 Control of monitoring and
measuring
8.8 Verification related to PRPs
and the hazard control plan
8.9 Control of product and
process nonconformities

19. © Operational Excellence Consulting
CONTINUOUS IMPROVEMENT OF THE FSMS
19
Source: ISO 22004
Verification
Monitoring,
Corrective Action
Improvement Implementation
Preliminary
Steps to Enable
Hazard Analysis
Planning,
Realization of
Safe Product(s)
Hazard Analysis
Validation of
Control
Measures
Establishing a
HACCP Plan
Establishing
Operational
PRPs

20. © Operational Excellence Consulting
● The certification body examines the
FSMS for conformity to the ISO
22000:2018 standard
● The FSMS audit is a compliance
audit
● Certification means the organization
has a documented FSMS that is
fully implemented and meets ISO
22000:2018 requirements
BECOMING ISO 22000:2018
CERTIFIED
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21. © Operational Excellence Consulting 21
ISO 22000:2018 CERTIFICATION PROCESS
3 5 7
1 4 6
2
Implementation of FSMS Selection of a
Certification Body
Stage 2 Audit Continual Improvement
and Surveillance Audits
Conduct Internal Audit
and Review Result by
Top Management Stage 1 Audit
Confirmation of
Registration

22. © Operational Excellence Consulting
WHAT DOES CERTIFICATION ASSURE?
22
Regular assessment to
continually monitor and
improve processes
Credibility that the
system can achieve its
intended outcomes
Reduced risk and
uncertainty and
increase market
opportunities
Consistency in the
outputs designed to
meet stakeholder
expectations

23. © Operational Excellence Consulting 23
WHAT IS AN ISO AUDIT?
An ISO audit is an audit of your organization’s
compliance with one of the standards set forth by
the International Organization for Standardization
(ISO). An audit measures your company’s systems
against any ISO standard (e.g. ISO 22000:2018).

24. © Operational Excellence Consulting
● To ensure the whole FSMS
management system is audited to
check:
o The system is being followed
o The system meets ISO
22000:2018 requirements
o The system is effectively
implemented and maintained
INTERNAL AUDIT
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AUDIT FINDINGS
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MAJOR NONCONFORMITY
§ A major nonconformity
relates to the absence or
total breakdown of a required
process or a number of
minor nonconformities listed
against similar areas
§ A major nonconformity at the
Registration Audit would
defer recommendation for
registration until that major
has been closed
MINOR NONCONFORMITY OBSERVATION
§ A minor nonconformity is an
observed lapse in your
systems ability to meet the
requirements of the standard
or your internal systems,
while the overall process
remains intact
§ An observation or
opportunity for improvement
relates to a matter about
which the Auditor is
concerned but which cannot
be clearly stated as a non-
conformity
§ Observations also indicate
trends which may result in a
future nonconformity

26. © Operational Excellence Consulting
HOW TO HANDLE AN AUDIT SESSION?
26
Ask and clarify
Admit obvious non-conformities
Do not panic
Take note of improvement areas
highlighted by the auditor
Show internal audit report, when
necessary
Offer evidence and explain patiently

27. © Operational Excellence Consulting
● Polite
● Professional
● Positive / Receptive
● Sincere
● Commitment
● Formal but not overly serious
AUDITEE’S CONDUCT
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28. © Operational Excellence Consulting
● Be honest and open
● Recognize they may be experts
● Realize they may not be subject
matter experts
● Understand the purpose of the
meeting and review related
records prior to interviews
INTERACTING WITH AUDITORS – DO’S
● Turn mobile phones to silent mode
● Get the right person in to answer
the question
● Listen carefully and understand
each question before answering –
Be sure responses are complete
and accurate
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29. © Operational Excellence Consulting
“From Farm to Plate,
Make Food Safe.”

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