ISO 22000:2018

ISO 22000:2018
Food Safety Management System (FSMS)

Comprehensive Guide to Food Safety Management System

Implementation and Compliance
ISO 22000:2018

ISO (INTERNATIONAL ORGANIZATION FOR

STANDARDIZATION)
ISO (Interna�onal Organiza�on for Standardiza�on), is a global
organiza�on that develops and publishes interna�onal standards for
various industries. ISO standards are designed to ensure quality, safety,
efficiency, and consistency across products, services, and systems,
benefi�ng both consumers and companies.
Common ISO standards include:
1. ISO 9001 (Quality Management Systems)
2. ISO 22000 (Food Safety Management)
3. ISO 14001 (Environmental Management Systems)
4. ISO 45001 (Occupa�onal Health and Safety)
5. ISO 26000 (Social Responsibility)
These standards provide a framework for achieving specific goals and can lead to cer�fica�ons,
which enhance an organiza�on's credibility and trust with stakeholders. Let me know if you’d like
more details about a specific standard or its applica�on in the food industry!

Introduction to ISO 22000:2018

ISO 22000:2018 is an interna�onal standard for Food Safety Management Systems (FSMS),
designed to ensure food safety throughout the en�re food chain, from produc�on to
consump�on. The adop�on of this standard is a strategic decision for organiza�ons, offering
benefits such as consistent delivery of safe food, risk management, and compliance with statutory
and regulatory requirements.
The standard integrates risk-based thinking and follows the principles of the Hazard Analysis and
Cri�cal Control Points (HACCP) system, combining Prerequisite Programs (PRPs), opera�onal
controls, and a structured management system to prevent food safety hazards.
Scope: Applicable to all types of organiza�ons in the food chain.
Focus: Prevents, eliminates, or reduces food safety hazards to safe levels.
Framework: Encourages con�nual improvement, stakeholder communica�on, and compliance
with global food safety regula�ons.
ISO 22000:2018

History and Development:

ISO 22000 was first introduced in 2005 to establish a global
standard for food safety management systems (FSMS). Its goal
was to harmonize food safety prac�ces across the supply chain.
The standard was updated in 2018 to align with the ISO high-
level structure (Annex SL), making it easier to integrate with
other ISO management systems like ISO 9001. The 2018 version
emphasizes risk-based thinking, clearer requirements, and
con�nuous improvement through the PDCA cycle (Plan-Do-
Check-Act).

This standard employs a Process Approach

ISO 22000:2018 is an interna�onally recognized standard for food safety management systems
(FSMS). This standard employs a Process Approach to ensure that organiza�ons effec�vely control
and improve their processes.
1. Process Approach
The Process Approach emphasizes understanding and managing interconnected processes to
achieve safe food produc�on consistently.
 Focus on Processes: View all ac�vi�es in the food chain as interrelated processes rather
than isolated tasks. Each process contributes to the overall goal of food safety.
 Interdependence: Processes are interdependent; the output of one process (e.g.,
ingredient prepara�on) o�en serves as the input for another (e.g., final product assembly).
Managing this interrela�onship ensures the effec�veness of the FSMS.
2. Con�nuous Improvement
Con�nuous improvement is integral to ISO 22000:2018. It enables organiza�ons to iden�fy areas
for enhancing food safety, efficiency, and effec�veness.
3. Risk-Based Thinking
Risk-based thinking addresses risks and opportuni�es at two levels:
 Organiza�onal level: Focus on strategic risks, including resource planning and regulatory
compliance.
 Opera�onal level: Emphasis on hazard analysis and control through the HACCP principles,
ensuring safe food produc�on.
4. Integra�on with the Plan-Do-Check-Act (PDCA) Cycle
ISO 22000:2018 incorporates the PDCA cycle at two levels:
ISO 22000:2018

 Organiza�onal Level: Covers overall FSMS planning, implementa�on, monitoring, and

con�nual improvement.
 Opera�onal Level: Focuses on planning and controlling food safety processes using
HACCP principles.

PDCA Cycle Breakdown:

1. Plan

 Set food safety objec�ves and goals.

 Iden�fy food safety hazards and necessary controls (HACCP).

 Develop ac�on plans and allocate resources.

2. Do

 Implement the food safety plan and prerequisite programs (PRPs).

 Execute processes as per defined controls and collect relevant data.
3. Check

 Monitor and measure results against food safety objec�ves.

 Verify the effec�veness of controls and analyze devia�ons.
 Gather feedback to improve food safety processes.
4. Act

 Take correc�ve and preven�ve ac�ons based on analysis.

 Update processes and documenta�on for consistent food safety improvement.
 Prepare for the next PDCA cycle for con�nuous enhancement.

Principles of iso 22000:2018

The management principles outlined in ISO 22000:2018, which align with the broader principles
common to ISO management system standards, include:
ISO 22000:2018

1. Customer Focus:
Priori�zing the needs and expecta�ons of customers to ensure that products and services
meet their requirements and deliver sa�sfac�on.

2. Leadership:
Strong leadership is essen�al for establishing a clear vision and direc�on, guiding the
organiza�on towards achieving its food safety objec�ves, and fostering a culture of
commitment to food safety.

3. Engagement of People:
Involving all individuals within the organiza�on, ensuring that they are aware of their roles
in maintaining food safety, and encouraging their par�cipa�on in decision-making and
con�nuous improvement.

 Employee Training and Awareness: All employees must be trained and aware of
their roles in ensuring food safety.
 Collabora�on: Encouraging collabora�on and communica�on across all
departments ensures that everyone contributes to maintaining safe food
produc�on prac�ces.

4. Process Approach:
Viewing the organiza�on’s ac�vi�es as interconnected processes, where managing these
processes effec�vely ensures consistent outcomes and supports the overall goal of food
safety.

5. Improvement:
Emphasizing con�nuous enhancement of processes and prac�ces to adapt to changing
food safety challenges, regulatory requirements, and consumer needs.

 Consistent Evalua�on: Organiza�ons should con�nually assess their food safety

system, iden�fying areas of improvement.
 Adapta�on to Change: The food safety system should adapt to new technologies,
processes, and evolving safety standards.

6. Evidence-Based Decision Making:

Making decisions based on data, facts, and analysis to ensure that food safety
management prac�ces are effec�ve, efficient, and aligned with organiza�onal goals.

7. Rela�onship Management:
ISO 22000:2018

Building and maintaining strong, mutually beneficial rela�onships with stakeholders,

including suppliers, customers, and regulators, to ensure a collabora�ve approach to food
safety across the en�re food supply chain.

Key Components of ISO 22000:2018:

1. Interac�ve Communica�on

Defini�on: This refers to the exchange of informa�on between all stakeholders (e.g., suppliers,
employees, customers, regulatory bodies) involved in the food safety management system.

 Internal Communica�on: It involves sharing relevant food safety informa�on within

the organiza�on.
 External Communica�on: Communica�ng with external stakeholders such as
suppliers, regulatory bodies, and consumers to ensure that food safety requirements
are met at every stage.
ISO 22000:2018

Purpose: It ensures that relevant food safety informa�on is shared effec�vely, leading to be�er
decision-making, improved food safety prac�ces, and �mely responses to food safety issues.

2. Prerequisite Programs (PRPs)

These are basic condi�ons and ac�vi�es that need to be in place before HACCP principles can be
applied effec�vely. PRPs help prevent food safety hazards and create a suitable environment for
food produc�on. Examples include cleanliness programs, equipment maintenance, pest control,
and staff training.
The principles of System Management and HACCP are fundamental to the
implementa�on and opera�on of the FSMS and are thoroughly explained in the
relevant clauses of the standard.

Clauses of ISO 22000:2018

1. Scope
The scope in ISO 22000:2018 defines which parts of your organiza�on the Food Safety
Management System (FSMS) will cover. It sets the boundaries for where and how the FSMS
applies within your organiza�on, ensuring that all necessary processes, ac�vi�es, and areas that
impact food safety are included.
For example, if your company is involved in both food manufacturing and packaging, but you want
to apply ISO 22000 specifically to the food manufacturing process, you would specify that in the
scope. This helps everyone understand that the FSMS will focus on ensuring food safety within
the manufacturing process, while other processes may not be included.
When se�ng the scope for ISO 22000:2018, consider the following:
1. What food products or services are covered by the FSMS: Define which specific food
products or services are included in the system.
2. Which parts of the organiza�on are involved: Iden�fy the departments or processes,
such as produc�on, storage, distribu�on, or food handling, that are part of the FSMS.
3. Any exclusions: Specify any areas or ac�vi�es that are excluded from the FSMS, such as if
certain ISO requirements don't apply to a par�cular part of your business or processes.
The scope essen�ally answers the ques�on: "What exactly will our FSMS focus on within our
organiza�on to ensure food safety?"

2. Norma�ve References
The second clause in ISO 22000:2018 is about Norma�ve References. In simple terms, this sec�on
refers to other documents or standards that are men�oned in ISO 22000:2018 and that
ISO 22000:2018

organiza�ons must follow to properly implement the food safety management system (FSMS).
These references provide addi�onal guidance or specific details that support the main standard.
For example, ISO 22000:2018 might reference the HACCP (Hazard Analysis and Cri�cal Control
Points) standard, or other related food safety guidelines, that help organiza�ons ensure they are
handling food safely. These documents are essen�al to make sure the FSMS is correctly
implemented and aligned with global food safety requirements.

Key Points Explained

1)Dated References: If a reference is dated (e.g., it specifies a par�cular version or edi�on of a
document), only that specific edi�on is applicable. This means that if the referenced document
has been revised or updated, those changes do not apply unless explicitly stated.
2)Undated References: If a reference is not dated, the latest version of that document (along with
any amendments) applies. This ensures that organiza�ons using ISO 9001:2015 are working with
the most current standards and prac�ces.
In short, this clause tells you where to find the suppor�ng materials that help you apply ISO
22000:2018 effec�vely.

3. Terms and Defini�ons

The Terms and Defini�ons sec�on provides clear defini�ons for key concepts and terminology
used throughout the standard. This sec�on is important because it ensures that all par�es
involved have a common understanding of the terms, which helps in effec�ve communica�on
and implementa�on of the quality management system. In ISO 22000:2018 Terms and Defini�ons
are just explana�ons of important words and concepts used in the standard, so everyone using it
understands them the same way.

For example:
 Acceptable Level.
The acceptable level is the maximum allowed level of a food safety hazard in the final
product. If the hazard exceeds this level, the product is considered unsafe.
 Prerequisite Programme (PRP)
A prerequisite programme (PRP) includes the basic condi�ons and ac�vi�es required
within the organiza�on and across the food chain to ensure food safety.
It sets up a founda�on for your Food safety management system (FSMS) by helping you look at
your company’s overall situa�on and how it affects quality. This clause has four main parts:

4. Context of the organiza�on

ISO 22000:2018

4.1 Understanding the Organiza�on and Its Context

What It Means: The organiza�on needs to figure out what outside and inside factors might
impact its ability to deliver safe food products or services.
 External Factors:
 Market trends: Increasing demand for organic or eco-friendly food products.
 Laws and Regula�ons: New food safety laws or stricter regula�ons.
 Compe��on: Other companies offering cheaper or more diverse food op�ons.
 Economic condi�ons: Economic downturns affec�ng customer spending habits.
 Internal Factors:
 Company culture: Employees’ awareness and commitment to food safety.
 Exis�ng skills: The knowledge and exper�se of employees in food safety prac�ces.
 Opera�onal performance: The ability to consistently meet food safety standards
and regula�ons.
This step helps the organiza�on align its food safety management system (FSMS) with both
external market demands and internal strengths and weaknesses. Regularly reviewing these
factors allows the organiza�on to stay adaptable to changes and address challenges in food safety.

4.2 Understanding the Needs and Expecta�ons of Interested Par�es

What It Means:
The organiza�on must iden�fy stakeholders who are affected by or have an interest in the FSMS
and understand what their expecta�ons are in terms of food safety.
Examples:
 Interested Par�es:
 Customers: Expect safe and high-quality food products that meet their dietary or
safety requirements.
 Employees: Want to work in a safe environment with proper food safety training.
 Suppliers: Expect clear requirements for the quality and safety of ingredients or
materials.
 Regulators: Require compliance with food safety laws and regula�ons.
By understanding what each interested party expects, the organiza�on can ensure that the FSMS
addresses all relevant requirements, ensuring compliance and customer sa�sfac�on.

4.3 Determining the Scope of the Food Safety Management System (FSMS)
What It Means:
The organiza�on must define the boundaries of its FSMS, specifying the areas, processes,
products, and services it will cover, based on internal and external factors and the needs of
interested par�es.
ISO 22000:2018

Examples:
 A company producing both packaged food and fresh produce may limit the FSMS to
packaged food, excluding fresh produce.
 A food service company may focus the FSMS on food prepara�on, storage, and delivery,
excluding packaging.

4.4 Food Safety Management System and Its Processes

What It Means:
The organiza�on must establish, implement, maintain, and con�nually improve the FSMS. This
includes iden�fying, managing, and improving the processes involved in food safety.
1. Establishing the FSMS:
The organiza�on must set up, implement, maintain, and con�nuously improve its FSMS,
including the processes it needs.
2. Iden�fying Processes:
 Inputs: What resources, informa�on, or materials are needed for each food safety
process (e.g., safe ingredients, training materials).
 Outputs: What food products or services result from each process (e.g., safe meals,
packaged food products).
 Process Interac�on: How each process works with other processes (e.g., supplier
quality checks, produc�on standards).
 Effec�veness Measurement: How to assess if each process is ensuring food safety
(e.g., audits, inspec�ons, tes�ng).
 Resources and Responsibility: The necessary resources and who is responsible for
ensuring food safety in each process.
 Risks and Opportuni�es: Iden�fying poten�al issues that could affect food safety and
areas for improvement.
 Con�nuous Improvement: Reviewing and improving processes to ensure ongoing
food safety.
4. Documen�ng Processes:
The organiza�on should maintain records that demonstrate that processes are being
carried out according to the FSMS plan, suppor�ng traceability and compliance.
Clause 4 helps organiza�ons iden�fy factors that impact food safety, define the scope of their
FSMS, and establish processes to ensure food safety and con�nuous improvement. This is crucial
ISO 22000:2018

for mee�ng customer expecta�ons, regulatory requirements, and maintaining food safety across
the food supply chain.

5. Leadership
5.1 Leadership and Commitment
What It Means:
Top management must show strong leadership and commitment to the FSMS by ensuring its
integra�on into the organiza�on’s overall strategy, securing necessary resources, and promo�ng
its effec�veness. They should also support con�nual improvement and guide employees in
mee�ng food safety requirements.
Examples:
 Management establishes food safety policies and aligns them with the company’s
strategic goals.
 Ensuring necessary resources like staff and technology are available for effec�ve FSMS
implementa�on.
 Communica�ng the importance of food safety to all employees and ensuring compliance
with relevant laws and customer requirements.

5.2 Policy
5.2.1 Establishing the Food Safety Policy
What It Means:
Top management must create, implement, and maintain a food safety policy that outlines the
organiza�on's commitment to food safety, including compliance with legal requirements,
customer needs, and con�nual improvement.
Examples:
 A company establishes a food safety policy that ensures products meet regulatory and
customer safety standards.
 The policy guides se�ng objec�ves for food safety and supports ongoing improvement
efforts.
5.2.2 Communica�ng the Food Safety Policy
What It Means:
The food safety policy must be accessible, understood, and applied at all levels of the
organiza�on.
Examples:
ISO 22000:2018

 The policy is shared across the organiza�on and explained to all employees during
training.
 Relevant par�es, such as suppliers, are made aware of the policy as needed.

5.3 Organiza�onal Roles, Responsibili�es, and Authori�es

What It Means: Top management should clarify and communicate who is responsible for various
roles within the FSMS.
Example:
In a food manufacturing company, management assigns a Food Safety Manager to ensure
compliance with food safety regula�ons, overseeing food safety prac�ces, and repor�ng on
system performance to the execu�ve team.

Clause 5 highlights the vital role of leadership in ensuring the success of the FSMS. It requires
management to take ownership of food safety, set policies aligned with organiza�onal goals,
ensure customer focus, and clearly define roles and responsibili�es within the system. By ac�vely
engaging, top management fosters a culture of food safety, quality, and con�nuous improvement
across the organiza�on.
POLICY
A policy is a formal guideline that directs decision-making and ac�ons within
an organiza�on. It outlines the framework for how things should be done.
Key Characteris�cs of a Policy:
Purpose: Defines the organiza�on’s goals and decision-making framework.
Consistency: Ensures all members follow the same rules and guidelines.
Guidance: Provides clear direc�ons for handling specific situa�ons.
Example:
A quality policy could state: “We are commi�ed to providing high-quality
products that meet customer expecta�ons.” This ensures all employees focus
on quality to meet this goal.

6. Planning
The Planning clause for FSMS ensures that risks and opportuni�es are addressed to achieve food
safety goals, enhance posi�ve outcomes, and support con�nuous improvement. It involves
se�ng clear, measurable food safety objec�ves aligned with the policy, planning ac�ons,
resources, and responsibili�es to achieve them, and managing changes carefully to maintain
system integrity and resource availability.
ISO 22000:2018

6.1 Ac�ons to Address Risks and Opportuni�es

What It Means:
When planning for the FSMS, the organiza�on must assess risks and opportuni�es that could
impact its ability to achieve food safety goals. These risks must be addressed to ensure effec�ve
performance, prevent undesired effects, and encourage con�nual improvement.
Examples:
 A company may iden�fy the risk of contamina�on during food handling and take ac�on
to implement stricter hygiene prac�ces.
 An opportunity may arise to enhance food safety through new technology, which can be
integrated into FSMS processes.

6.2 Objec�ves of the Food Safety Management System and Planning to Achieve
Them
What It Means:
The organiza�on must establish clear, measurable food safety objec�ves aligned with its policy.
These objec�ves should be monitored and updated regularly to ensure the FSMS meets customer,
regulatory, and food safety requirements.
Examples:

 A food manufacturer may set an objec�ve to reduce contamina�on rates by 20% within a
year.
 Another objec�ve might focus on achieving full compliance with regulatory standards
during an upcoming audit.
Se�ng clear and measurable objec�ves helps the organiza�on stay focused on food safety
priori�es, track progress, and ensure con�nual improvement.

6.3 Planning of Changes

What It Means:
When changes to the FSMS are necessary, such as staff or process changes, the organiza�on must
plan and manage these changes carefully to maintain food safety and system integrity.
Examples:
 A company may plan changes when adop�ng new food safety technology or making
staffing adjustments, ensuring all personnel are trained and resources are allocated.

7. Support
ISO 22000:2018

In ISO 22000:2018, support refers to providing the necessary resources, knowledge, tools, and
structure to ensure the effec�ve opera�on of a Food Safety Management System (FSMS). Support
involves ensuring everything required to maintain food safety—from personnel skills to
documenta�on and communica�on—is in place and well-managed.

7.1 Resources
Organiza�ons must provide all necessary resources to operate the FSMS effec�vely. This includes:
➢ People: Ensure there are enough skilled personnel.
➢ Infrastructure: Maintain facili�es, equipment, and essen�al u�li�es.
➢ Work Environment: Provide suitable work environments to maintain food safety.
➢ Monitoring and Measuring Resources: Use accurate measurement tools and ensure they are
calibrated.
➢ Organiza�onal Knowledge: Capture, maintain, and share knowledge relevant to food safety.

7.2 Competence
Ensure all personnel performing work that affects food safety are competent.
This includes:
 Determining Required Skills: Iden�fy the skills and qualifica�ons necessary for food
safety.
 Providing Training: Provide training programs to develop necessary competencies.
 Evalua�ng Training Effec�veness: Regularly evaluate the effec�veness of training to
ensure staff meets food safety requirements.

7.3 Awareness
Employees should understand the FSMS, including:
 The Food Safety Policy and Objec�ves: Understand the organiza�on’s food safety goals
and objec�ves.
 Individual Contribu�on: Know how they contribute to food safety and the FSMS.
 Consequences of Non-Conformity: Understand the poten�al consequences of failing to
meet FSMS requirements.

7.4 Communica�on
Establish internal and external communica�on channels to ensure:
 Effec�ve Informa�on Sharing: Ensure relevant food safety informa�on is shared
effec�vely across all levels of the organiza�on.
 Clear Communica�on Protocols: Define what, when, and with whom food safety-related
informa�on should be communicated.
ISO 22000:2018

7.5 Documented Informa�on

Maintain necessary documents to ensure FSMS effec�veness, including:

 Crea�ng and Upda�ng: Ensure documents are reviewed, approved, and kept up to date.
 Control of Documents: Protect documents from loss, ensure they are easily accessible,
and properly manage obsolete documents.
Clause 7 ensures that organiza�ons have the support, resources, skills, and documented
informa�on necessary to implement, maintain, and improve the Food Safety Management
System (FSMS) effec�vely, ensuring the safety of food products from farm to table.

8. Opera�on
8.1 Opera�onal Planning and Control
The organiza�on must plan, implement, control, maintain, and update processes to meet the
requirements for safe product realiza�on and to implement ac�ons determined in Clause 6.1.
These ac�ons must include:
 Establishing criteria for the processes.
 Implemen�ng control of processes according to these criteria.
 Maintaining documented informa�on as necessary to demonstrate that the processes
have been conducted as planned.
The organiza�on is responsible for controlling planned changes and reviewing unintended
changes to mi�gate any adverse effects.

8.2 Prerequisite Programs (PRPs)

8.2.1 The organiza�on shall establish, implement, maintain, and update PRPs to prevent or reduce
contaminants (including food safety hazards) in products, processing, and the work environment.
8.2.2 The PRPs shall be:
 Appropriate for the organiza�on and its context concerning food safety.
 Suitable to the size and type of opera�on and the nature of the products being
manufactured or handled.
 Implemented across the en�re produc�on system, either as general programs or
specific programs for par�cular products or processes.
 Approved by the food safety team.
8.2.3 When selec�ng and establishing PRPs, the organiza�on must ensure compliance with
statutory, regulatory, and customer requirements. It is important to consider:
 Applicable parts of the ISO/TS 22002 series.
 Relevant standards, codes of prac�ce, and guidelines.
ISO 22000:2018

8.2.4 When establishing PRPs, the organiza�on shall consider factors such as:
 Building construc�on and layout, including u�li�es.
 Workspace design, zoning, and employee facili�es.
 Air, water, energy, and other u�lity supplies.
 Pest control, waste, and sewage disposal.
 Equipment suitability for cleaning and maintenance.
 Supplier approval processes.
 Incoming materials handling, storage, and transporta�on.
 Measures for preven�ng cross-contamina�on.
 Cleaning, disinfec�ng, and personal hygiene procedures.
 Product informa�on and consumer awareness.

8.3 Traceability System

The organiza�on must establish a traceability system to uniquely iden�fy incoming materials and
the first stage of distribu�on of the end product. The following should be considered:
 Tracking lots of materials, ingredients, and intermediate products to final products.
 Reworking of materials and products.
 Distribu�on of end products.
The organiza�on must ensure compliance with applicable statutory, regulatory, and customer
requirements. Documented informa�on to support the traceability system must be retained for
a defined period, at least the shelf life of the product. The system's effec�veness must be verified
and tested, and reconcilia�on of quan��es between ingredients and end products should be
included where appropriate.

8.4 Emergency Preparedness and Response

8.4.1 General
Top management must ensure procedures are in place to respond to poten�al emergency
situa�ons or incidents that may impact food safety, relevant to the organiza�on’s role in the food
chain. Documented informa�on shall be established and maintained to manage such situa�ons
and incidents.
8.4.2 Handling of Emergencies and Incidents
The organiza�on must:
 Respond to actual emergencies by:

 Iden�fying applicable statutory and regulatory requirements.

 Ensuring internal communica�on.

ISO 22000:2018

 Communica�ng externally (e.g., with suppliers, customers, authori�es, and media).

 Take ac�on to minimize the consequences of emergencies, appropriate to their
magnitude and poten�al impact on food safety.
 Periodically test the procedures, where prac�cal.
 Review and update the documented informa�on a�er an incident or test.
Examples of emergencies that may affect food safety and produc�on include natural disasters,
environmental accidents, bioterrorism, workplace accidents, public health emergencies, and
interrup�ons in essen�al services like water, electricity, or refrigera�on.

8.5 Hazard control:

In ISO 22000:2018, Hazard Control refers to the process of iden�fying, evalua�ng, and managing
food safety hazards throughout the food produc�on process to ensure that the food products are
safe for consump�on. Hazard control is essen�al for maintaining food safety and preven�ng any
poten�al risks that could lead to unsafe food. It is a core component of the Food Safety
Management System (FSMS) under Clause 8: Opera�on.
The Hazard Control clause (specifically Clause 8.5) focuses on preven�ng, elimina�ng, or reducing
food safety hazards to acceptable levels at different stages of food produc�on. It ensures that
hazards are controlled effec�vely by implemen�ng preven�ve measures, monitoring procedures,
and correc�ve ac�ons when necessary.
8.5.1 Preliminary (5) Steps to Enable Hazard Analysis
1. Assemble a HACCP Team: Form a team with food safety knowledge to iden�fy and
manage risks, evaluate hazards, and set control measures.
2. Describe the Product: Provide detailed informa�on about ingredients, produc�on
methods, and packaging to iden�fy specific hazards.
3. Iden�fy the Intended Use and Consumers: Understand the product’s use and target
consumers (including vulnerable groups) to assess poten�al handling and safety risks.
4. Create Flow Diagrams: Develop diagrams to map the produc�on process and iden�fy
poten�al hazard points where control measures are needed.
5. Iden�fy Statutory and Regulatory Requirements: Ensure compliance with food safety
regula�ons to guide hazard control and maintain safety standards.
These steps form the basis of a hazard analysis, ensuring all hazards are iden�fied and controlled
throughout the food safety management system.
8.5.2 Hazard Iden�fica�on and Risk Assessment:
 ISO 22000:2018

 The first step is to iden�fy poten�al biological, chemical, and physical hazards that may
affect food safety.
 A thorough risk assessment is conducted to evaluate the likelihood and severity of these
hazards to priori�ze the control measures.
8.5.3 Cri�cal Control Points (CCPs):
 Once hazards are iden�fied, cri�cal control points (CCPs) or by the OPRP in the produc�on
process are determined. These are points in the process where control is essen�al to
prevent, eliminate, or reduce hazards to an acceptable level.
 For example, a CCP could be a cooking step where the temperature must reach a specific
level to kill harmful pathogens.
8.5.4 Control Measures:
 For each CCP, control measures are implemented to manage the hazard effec�vely. These
could include changes in process condi�ons (e.g., temperature, �me), ingredient
specifica�ons, or packaging procedures.
 Control measures also include monitoring procedures to ensure that hazards remain
under control during produc�on.
8.5.5 Cri�cal Limits:
 Cri�cal limits define the boundaries within which the hazards must be controlled at each
CCP. These limits could be based on factors like �me, temperature, pH, or moisture level.
If the process exceeds or falls short of the cri�cal limit, correc�ve ac�ons are required.
8.5.6 Monitoring Procedures:
 Regular monitoring is necessary to verify that control measures are working and hazards
are being controlled within the defined cri�cal limits.
 Monitoring could involve tes�ng, inspec�ons, or con�nuous data recording (e.g.,
temperature checks).
8.5.7 Correc�ve Ac�ons:
 When monitoring shows that a control measure is not working (e.g., a cri�cal limit is
exceeded), correc�ve ac�ons are taken. These ac�ons are predefined in the system and
could involve adjustments to the process, rejec�ng non-conforming products, or revising
procedures.

8.6 Verifica�on related to PRPs and the hazard control plan

The verifica�on ac�vi�es shall confirm that:
 the PRP(s) are implemented and effec�ve;
 the hazard control plan is implemented and effec�ve;

Ammar Shabbir | Food Technologist

ISO 22000:2018

 hazard levels are within iden�fied acceptable levels;

 input to the hazard analysis is updated;
 other ac�ons determined by the organiza�on are implemented and effec�ve
8.7Control of Nonconforming Products
8.7.1 Monitoring and Evalua�on
 Responsibility: Designated competent persons will evaluate data derived from the
monitoring of OPRPs and CCPs. These individuals have the authority to ini�ate correc�ve
ac�ons when cri�cal limits or ac�on criteria are not met.
 Ac�ons on Nonconforming Products: If cri�cal limits at CCPs or ac�on criteria for OPRPs
are exceeded, affected products will be iden�fied and controlled to prevent unsafe
products from entering the food chain.
8.7.2 Handling Poten�ally Unsafe Products
When products are iden�fied as poten�ally unsafe, the following ac�ons will be taken:
 If food safety hazards are reduced to acceptable levels, the products will be released.
 If not, the product will remain under control un�l the appropriate evalua�on and
disposi�on are determined.
8.7.3 Disposi�on of Nonconforming Products
Products not acceptable for release will be either:
 Reprocessed or further processed to reduce food safety hazards.
 Redirected for other uses if food safety is not affected.
 Destroyed and disposed of as waste if necessary.
 Documented Informa�on: All decisions regarding the disposi�on of nonconforming
products, including approval by authorized personnel, will be documented.

8.8. Withdrawal/Recall Procedure

 Competence and Authority

 A competent person or team with the authority to ini�ate a withdrawal/recall of

poten�ally unsafe products will be appointed.
 Withdrawal/Recall Ac�ons

 The organiza�on will ensure the �mely withdrawal/recall of affected product lots.
 Documented Informa�on:

 No�fica�ons to relevant authori�es, customers, and consumers will be recorded.

ISO 22000:2018

 Ac�ons related to handling withdrawn/recalled products, including products s�ll in

stock, will be documented.
 Effec�veness Verifica�on

 The organiza�on will perform mock withdrawals or prac�ce recalls to verify the
effec�veness of the process.

 Results and effec�veness will be retained as documented informa�on and used in

management reviews.
 Documenta�on Reten�on
 All evalua�ons, correc�ve ac�ons, product disposi�ons, and withdrawal/recall ac�vi�es will
be documented and retained for future reference and audi�ng purposes.
 ISO 22000:2018 mandates organiza�ons to maintain documented informa�on for all hazard
control procedures, including hazard analysis, CCPs, control measures, monitoring ac�vi�es,
and correc�ve ac�ons. This documenta�on serves as proof that hazard control processes
are being effec�vely implemented.

Performance Evalua�on
Performance Evalua�on in ISO 22000:2018 ensures that organiza�ons monitor, measure, analyze,
and evaluate their Food Safety Management System (FSMS) to assess its effec�veness and
iden�fy areas for improvement.
Here’s a simplified summary:

9.1 Monitoring, Measurement, Analysis, and Evalua�on

 The organiza�on needs to determine what should be monitored, how and when to
measure it, and how to analyze the results.
 The organiza�on must evaluate the effec�veness of the FSMS and retain records of these
results.
 Customer sa�sfac�on should be monitored to evaluate how well customer food safety
requirements are being met, using methods like feedback and surveys.
 Analyzing data helps assess food safety performance, the effec�veness of hazard control,
and areas for improvement.

9.2 Internal Audit

 Regular internal audits are required to verify that the FSMS conforms to both the
organiza�on’s requirements and the ISO 22000:2018 standard.
 The organiza�on should plan and execute an audit program that includes scheduling,
criteria, scope, and responsibili�es.
 Results must be reported to management, with correc�ve ac�ons taken promptly.
 Audit records should be maintained to show compliance and outcomes.
ISO 22000:2018

9.3 Management Review

 Top management should periodically review the FSMS to ensure it remains suitable,
effec�ve, and aligned with the organiza�on’s food safety goals.
 Reviews should consider previous ac�ons, any relevant changes, FSMS performance,
resource adequacy, risk management, and improvement opportuni�es.
 The outcomes of these reviews should result in ac�ons for improvement, necessary
changes to the FSMS, and resource planning.
 Records of management reviews should be retained as evidence.
This clause helps organiza�ons ensure that their FSMS is func�oning effec�vely and con�nuously
improving, with a strong focus on food safety and organiza�onal goals.

10. Improvement in ISO 22000:2018

10.1 Nonconformity and Correc�ve Ac�on
When a nonconformity occurs, the organiza�on must:
 Respond by controlling and fixing it, and addressing the consequences.
 Evaluate if ac�ons are needed to prevent it from happening again by reviewing the causes
and checking if similar problems exist.
 Take necessary correc�ve ac�ons.
 Check if the correc�ve ac�ons were effec�ve.
 Update the FSMS if needed.
10.1.2 Documenta�on
The organiza�on should keep records of:
 The nonconformity and ac�ons taken.
 The results of correc�ve ac�ons.

10.2 Con�nual Improvement

The organiza�on must con�nually improve the FSMS. Top management should ensure
improvement through communica�on, audits, correc�ve ac�ons, and FSMS updates.

10.3 Update of the FSMS

Top management should ensure the FSMS is updated regularly based on feedback, verifica�on
results, and management reviews. All updates should be documented and included in the
management review.
ISO 22000:2018

Benefits of ISO 22000:2018 for Food Businesses and

Consumers
For Food Businesses:
ISO 22000:2018 helps businesses improve food safety management, ensuring compliance with
regula�ons and reducing risks. It enhances reputa�on and brand trust by demonstra�ng a
commitment to food safety, while boos�ng opera�onal efficiency and cu�ng costs. The
cer�fica�on opens doors to global markets, ensuring a compe��ve edge and consumer
confidence.

For Consumers:
Consumers benefit from increased confidence in food safety, knowing that products meet high
standards. ISO 22000 ensures be�er quality, traceability, and transparency, making it easier to
trust the food they consume. It also ensures quicker responses to recalls and protects consumers
from health risks.

Conclusion
ISO 22000:2018 plays a crucial role in enhancing food safety management systems by providing
a structured framework to ensure the safety of food throughout the supply chain. By integra�ng
essen�al prac�ces such as hazard analysis, risk management, and con�nuous monitoring, it helps
businesses improve their opera�onal efficiency, maintain compliance with regula�ons, and build
stronger consumer trust. The cer�fica�on not only fosters the development of safer food
products but also ensures higher standards of quality and transparency. For food businesses, it
leads to reduced risks, cost savings, and expanded market access, while for consumers, it provides
assurance of food safety and quality. Ul�mately, ISO 22000:2018 is essen�al for crea�ng a safer
and more reliable food supply, benefi�ng both producers and consumers alike.