ISO 22000:2018

By
Dr.Iman ElBrolos
Food Safety Consultant
By Dr.Iman El Brolos

 Who are ISO ?
 What is ISO 22000?
 An introduction to ISO 22000:2018
 ISO22002 family
 The most important changes
 The newest in the second edition
 PDCA cycle
 ISO 22000 clauses
 Context of the organization
 Leadership
 Planning
 Support
 Operation
 Performance evaluation
 improvement

 The international organization for
standardization (ISO) was established in 1947
and ISO is non-governmental international
organization with a membership of 164
national bodies ISO employs asystem of
technical committees and working group to
develop international standards.

 An international standard that specifies
requirements for food safety management
system.
 ISO 22000 was born in 2005
 This food safety management system is a
triangle of 3 sides
 HACCP,GMP(PRPS)&management system

 In June 2018 ,we were given ISO 22000 new
version.
 In June 2021 whole organization certified
with ISO 22000 should be transferred into ISO
22000:2018

 There are a lot of updates or changes to be
applied and achieve integration with ISO
14001,ISO 45001&ISO 9001through(HLS)high
level structure
 Contain 10 clauses to facilitate integration
between FSMS systems
 The first 3 clauses (scope,normative
references and terms &definitions) are not
auditable

 ISO 22002 TS (PRPS)
 TS 22002-1(FOOD MANUFACTURING)
 TS 22002-2(CATERING)
 TS 22002-3(FARMING)
 TS 22002-4(FOOD PACKAGING)
 TS 22002-5(FOOD STORAGE AND
TRANSPORT)
 TS 22002-6(FEED&ANIMAL PRODUCTION)

 “Shall” indicates a requirement
 “Should” indicates a recommendation
 “May” indicates a permission
 “Can” indicates a possibility or a capability

The most important
changes

 Changes related to integration with (HLS) to
facilitate integration with the most updated
international ISO standrds as ISO 9001:2015

 Differentiate between definition of CCP and
OPRPs

 3.11 (critical control point )CCP:
step in the process (3.36) at which control
measure(s) (3.8) is (are) applied to prevent or
reduce a significant food safety hazard (3.40) to an
acceptable level, and defined critical limit(s) (3.12)
and measurement (3.26) enable the application of
corrections (3.9)
 operational prerequisite programme OPRP
control measure (3.8) or combination of control
measures applied to prevent or reduce a significant
food safety hazard (3.40) to an acceptable level
(3.1), and where action criterion (3.2) and
measurement (3.26) or observation enable effective
control of the process (3.36) and/or product (3.37)

CCP oPRP
STEP IN THE
PROCESS
MEASUREMENT
 CONTROL
MEASURES
 Measurement or
observation

 ISO 22000:2005
 Food safety hazard:biological,chemical or
physical agent in food or condition of food
,with the potential to cause an adverse health
effect.
 ISO 22000:2018
 Food safetyhazard:biological,chemical or
physical agent in food----------with the
potential to cause an adverse health effect.

2018
Significant food safety hazard:
Identified through the hazard assessment ,which needs
to be controlled by control measures.
2005
Control measures:
action or activity that can be used to prevent or
eliminate food safety hazard or reduce it to an
acceptable level.
2018
Control measures:
action or activity that ---is--essential---to prevent --
---a significant food safety hazard or reduce it to an
acceptable level.

 4.1 Understanding the organization and its
context(internal &external issues)

 Understanding the context can be facilitated
by considering external and internal issues,
including, but not limited to, legal,
technological, competitive, market, cultural,
social and economic environments, cyber
security and food fraud, food defence and
intentional contamination, knowledge and
performance of the organization, whether
international, national, regional or local.

 a management process to defend a food
supply chain from the threat of intentional
contamination
 TACCP aligns with HACCP, but has a different
focus that may need input from different
areas of an organization (eg HR, procurement
and security)
 threats are different to vulnerabilities as
they're performed for ideological reasons
rather than economic reasons

 Adulteration
 Substitution
 Dilution
Usually occur in raw material.

 the protection of food products from
contamination or adulteration intended to
cause public health harm or economic
disruption

Raw Material --------production-------
delivery
 Food Fraud -------- Raw material
 Food fraud &food defense---------
Production
 Food defense--------Delivery

Where are we now?
Who are we & what are we doing ?
Who are our interested parties and what are
their expectations?
4.1
Context of the organizaton
Understanding the organization and its context
Understanding the needs and expectations of interested
parties

Food safety management system
Determining the scope of the food safety management
system
What is the scope of the organization?
How can we establish afood safety
management system?

 Message of organization: the purpose for
which the organization established in certain
environment.
 It is a document of the law or the framework
of the organization that differentiate it from
other organizations

 Description of what the organization want to
be in the future

 Goals of the organization should be smart :
Specific
Measurable
Achievable
Realistic
Time based

 Are person or organization that may have an
impact or affected by decision or activity of
the organization.

 4.1 Understanding the organization and its
context (internal and external issues)
 4.2 Understanding the needs and
expectations of interested parties

 5.1 Leadership and commitment:
Include new requirements for potential
participation and asking for the efficacy of food
safety management system.

 6.1 Actions to address risks and
opportunities :
 It requires from organizations detect risks
and procedures that inhibit risks that my
affect (positive or negative) on the ability of
management system to achieve the best
results
 Focusing on objectives for improvement
(6.2)&(9.1)

 7.4 Communication: become more obligatory
 Determine how, when& what are methods of
communication ?
 The organization shall ensure that the
requirement for effective communication is
understood by all persons whose activities
have an impact on food safety
 To ensure all relevant food safety hazards are
identified and controlled

 Plan(4,5,6,7)
 Do(8)
 Check(9)
 Act(10)
 Whole ISO standards contain only one PDCA
cycle but ISO 22000:2018 contain 2 PDCA
cycles parallel to each other
 One cover management system and another
cover food safety system.
The most important changes

 Animal feed included for food producing
animals and pet food.(SCOPE)
The most important changes

 7.5 Documented information:
 Documented information required by the
FSMS and by this document 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)(7.5.3)

8.2.3 :When selecting and/or establishing
PRP(s), the organization shall ensure that
applicable statutory, regulatory and mutually
agreed customer requirements are identified.
The organization should consider:
 a) the applicable part of the ISO/TS 22002
series;
 b) applicable standards, codes of practice and
guidelines.

ISO 22000:2018ISO 22000:2005
Documented
information
Process
environment
External
provider
improvement
Documents &
records
Work
environment
Supplier
Continuous
improvement

5.2.2 Communicating the food safety
policy:
The food safety policy shall:
a) be available and maintained as
documented information;
b) be communicated, understood and
applied at all levels within the
organization;

 (7.1.6) Control of externally provided processes,
products or services
 The organization shall:
 a) establish and apply criteria for the evaluation,
selection, monitoring of performance and re-
evaluation of external providers of processes,
products and/or services;
 b) ensure adequate communication of requirements
to the external provider(s);
 c) ensure that externally provided processes,
products or services do not adversely affect the
organization's ability to consistently meet the
requirements of the FSMS;
 d) retain documented information

 8.5.2 Hazard analysis
 8.5.2.2 Hazard identification
 Hazards should be considered in sufficient
detail to enable hazard assessment and the
selection of appropriate control measures

2005 2018
Pathogens Pathogenic organisms result from
hand contact:
Fecal viruses
Fecal bacteria
Fecal parasites
Fecal worms
s.Aureus

 8.5.2.3 Hazard assessment
 The organization shall evaluate each food
safety with regard to:
 a) the likelihood of its occurrence in the end
product prior to application of control
measures;
 b) the severity of its adverse health effects in
relation to the intended use

 8.5 Hazard control
 8.5.4 Hazard control plan (HACCP/oPRP)

1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding the organization and its
context
4.2 Understanding the needs and expectations of
interested parties
4.3 Determining the scope of the food safety
management system
4.4 Food safety management system
5 Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and
authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Objectives of the food safety management
system and planning to achieve them
6.3 Planning of changes
7 Support By Dr.Iman El Brolos
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operation
8.1 Operational planning and
control
8.2 Prerequisite programmes
(PRPs)
8.3 Traceability system
8.4 Emergency preparedness
and response
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
9 Performance evaluation
9.1 Monitoring, measurement,
anal
9.1 Monitoring,
measurement, analysis
and evaluation
9.2 Internal audit
9.3 Management
review
10 Improvement
10.1 Nonconformity
and corrective action
10.2 Continual
improvement
10.3 Update of the
food safety man

Thank you
By Dr.Iman ElBrolos
linkedin.com/in/eman-abdullah-
3465a1108
Imanelbrolos@outlook.com

ISO 22000:2018

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