International Organization for Standardization 22000, ISO 22000:2005 and ISO 22000:2018 with their difference, ISO structure, Food Safety Quality Systems.

1. ISO 22000
ISO 22000:2005 AND ISO 22000:2018
Prepared by-
PRATHAMESH PAWALE

2. ISO 22000
 ISO 22000 is a globally accepted international standard, which
specifies the requirements for food safety management systems.
 ISO 22000 is applicable to all organizations involved in the food chain,
whose main objective is to ensure food safety.
 ISO is an independent, non-governmental international organization
with a membership of 165 national standards bodies.
 Through its members, it brings together experts to share knowledge
and develop voluntary, consensus-based, market relevant
International Standards that support innovation and provide solutions
to global challenges.
 Central Secretariat in Geneva, Switzerland.

3. ISO Structure

4. ISO Partners
 ISO work closely with two other international standards
development organizations,
The International Electro technical Commission (IEC) and
International Telecommunication Union (ITU).
 In 2001, ISO, IEC and ITU formed the World Standards
Cooperation (WSC) in order to strengthen the standards
systems of the three organizations.
 The WSC also promotes the adoption and implementation of
international consensus-based standards worldwide.

5. ISO Partners
 In addition, ISO also have a close relationship with
the World Trade Organization (WTO), which particularly
appreciates the contribution of International Standards
to reducing technical barriers to trade.
 In total, ISO collaborates with over 700 international,
regional and national organizations.
 These organizations take part in the standards
development process as well as sharing expertise and best
practices.

6. How is ISO financed?
 ISOs national members pay subscriptions that meet the operational
costs of the Central Secretariat.
 The subscription paid by each member is in proportion to the
country’s gross national income and trade figures.
 Another source of revenue is the sale of standards.
 However, the operations of ISO’s Central Secretariat represent only
about one fifth of the cost of the system’s operation. Other costs are
related to specific standards development projects and technical
work.
 These costs are borne by member bodies and business
organizations that allow their experts to participate and pay their
travel expenses.

7. ISO 22000 Introduction
 Whatever their size, or product, all food producers have a
responsibility to manage the safety of their products and the well-
being of their consumers. That’s why ISO 22000 exists.
 The consequences of unsafe food can be serious. ISO’s food
safety management standards help organizations identify and
control food safety hazards, at the same time as working together
with other ISO management standards, such as ISO 9001.
 ISO 22000 sets out the requirements for a food safety
management system and can be certified to it.
 It maps out what an organization needs to do to demonstrate its
ability to control food safety hazards in order to ensure that food
is safe. It can be used by any organization regardless of its size or
position in the food chain.

8. Introduction
 ISO 22000 ensures fair competition.
 ISO 22000 consolidates that conditions regarding trade,
communication, requirements etc. originates from a common frame.
 However the global food industry is constantly developing and there is
a need for a generic standard as ISO 22000 to fit the entire food chain
from primary production to consumer.
 ISO 22000 has the advantage over the many private standards as it
covers the whole organization.
 ISO 22000 contributes to ensure food safety hazards throughout the
whole food chain from farm-to-table.
 This becomes essential as hazards occur at any stage of the food chain.
 Last but not least ISO 22000 supports the UN Sustainable Development
Goals by reducing foodborne diseases and supporting better public
health.

9. ISO 22000:2005
 ISO 22000 – Food Safety Management System (FSMS)- is a
management system designed to enable organizations to control
food safety hazards along the food chain in order to ensure that
food is safe at the time of consumption
 These standards developed by ISO/Technical Committee 34 and
published on Sep 2005 so called as ISO 22000:2005
 These standards are only for food safety concerns
 It is developed as an auditable standard
 It is Applicable to all types of producer, ISO 22000 provides a layer
of reassurance within the global food supply chain, helping products
cross borders and bringing people food that they can trust.

10. Benefits of FSMS
 Preventive approach to food safety
 Conformance to legal and regulatory requirements
 Increase creditability and reputation
 Improves customer satisfaction
 Increase in profitability of the company

11. ISO 22000 based on PDCA
PLAN
Establish Objectives, programs
and processes necessary to
deliver results in accordance
with the organizations FSMS
policy
DO
Implement the processes of
the FSMS
CHECK
Monitor and measure activities
and processes with regards to
the FSMS policy and objectives,
and report the results
ACT
Take actions to continually
improve the FSMS
performance to achieve the
target

12. Key Elements of ISO 22000

13. Key Element
 Food Safety Management System
The most effective food safety systems work using structured management
systems that integrate with and supplement the management activities of
the organization
This provides maximum benefit for the organization, its suppliers and
customers
The ISO 22000 standard is compatible with ISO 9001
 Interactive Communication
ISO 22000 accommodates communication along the food chain and within
the organization.
Communication is substantial to secure that all relevant food safety
hazards are identified and adequately controlled at each step within the
food chain. This implies communication between organizations both
upstream and downstream in the food chain.

14. • Prerequisite Program(PRPs)
There are 2 categories of PRPs
Infrastructure & Maintenance PRPs and Operational PRPs
PRPs are established, implemented, maintained, reviewed, improved and
updated to assist in-
To eliminate all type of contaminants of the food and
To control and prevent food safety hazards in finished products and
processing environment.
• HACCP (Hazard Analysis Critical Control Point) Plan
The HACCP plan shall be documented and shall include the following
information for each identified CCP:
a) food safety hazard(s) to be controlled at the CCP
b) control measure(s)
c) critical limit(s)
d) monitoring procedure(s)
e) corrective action(s) to be taken if critical limits are exceeded
f) responsibilities and authorities
g) record(s) of monitoring.

15. ISO 22000:2005 Certification
Process
Implementation of
FSMS
Conduct internal
Audit
Review result of the
Audit by Top
Management
Selection of a
Certification Body
Stage I Audit
Stage II Audit
Conformation of
Registration
Continual
Improvement and
Surveillance Audit

16. ISO 22000:2005 Standard
Consist of
Section I :Scope
Section II :Normative References
Section III :Terms and Definitions
Section IV :Food Safety Management System
Section V :Management Responsibility
Section VI :Resource Management
Section VII :Planning and Realization of Safe Products
Section VIII: Verification, Validation and Improvement of the Food Safety
Management System

17. ISO 22000:2018
 ISO 22000:2018, Food safety management systems – Requirements
for any organization in the food chain, sets out the requirements for a
food safety management system.
 It defines what an organization must do to demonstrate its ability to
control food safety hazards and ensure that food is safe for
consumption.
 The revised standard of ISO22000:2018 was published 0n 19 June
2018.
 It is applicable to all organizations in the food and feed industries,
regardless of size or sector.
 Following the same High-Level Structure (HLS) as other ISO
management system standards, such as ISO 9001 (quality
management), it is designed in a way that it can be integrated into an
organization’s existing management processes but can also be used
alone.

18. Why was it Revised?
 All ISO standards are reviewed and revised regularly to make sure
they remain relevant to the marketplace.
 ISO 22000:2018 encompasses the latest trends and food safety
requirements, and is a timely response to the rising global
challenges facing the food industry.
 It will also help address the growing need to ensure we can trust
current food security systems and that they are sustainable.
 ISO 22000:2018 includes improvements to definitions, including
those that align with Codex Alimentarius.
 It also provides a new understanding of the concept of risk,
distinguishing between risk at the operational level and the strategic
level of a management system.

19. An important new clause
Clause 4: Context of the organization
 The intent of this clause is to provide a high-level, strategic
understanding of the important issues that can affect, either
positively or negatively, the way your organization manages
food safety.
 It gives your organization the opportunity to identify and
understand factors and parties that affect the intended
outcome(s) of the FSMS.
 It also addresses the concept of preventive action.
 Once the context has been established, the scope of the FSMS
has to be determined in relation to various additional factors.

20. Key Changes
 A stronger emphasis on the responsibility of leadership
 Applies a risk-based approach to the development of the FSMS
 Clarification of key concepts including:
 The Plan-Do-Check-Act cycle, by having two separate cycles in the
standard working together with one covering the management
system and the other covering the principles of HACCP
 The differentiation of key terms including critical control points
(CCPs), operational prerequisite programmes (ORPs) and
prerequisite programmes (PRPs)
 Improved compatibility with other ISO management system
standards through the realignment of the content of the standard to
the high level structure

21. Leadership and empowerment
 There is a much greater focus on top management to
demonstrate leadership and commitment with respect to the
FSMS and food safety policy.
 Additionally, top management needs to make sure that all
responsibilities have been assigned, communicated and
understood across your organization.
 Top management have a responsibility to ensure that the
importance of effective food safety is communicated and
understood by all parties and ensuring that the FSMS achieves its
intended outcomes

22. An integrated approach
 ISO 22000:2018 is based on Annex SL – the ISO high level structure
(HLS) that brings a common framework to all management
 This helps to keep consistency, align different management system
standards, offer matching sub-clauses against the top-level
structure and apply common language across all standards.
 With the new standard in place, organizations will find it easier to
incorporate their food safety management system into core
business processes and get more involvement from senior
management.

23. ISO 22000:2018 Standard
Consist of
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement

24. ISO22000:2005andISO
22000:2018Difference

26. ISO 22000:2018 based on PDCA at 2 levels

27. ISO 22000:2018 Certification
Process
Request for
Registration
Document Review
Pre-Assessment
The Registration
Audit
Take Corrective
Actions
Registration Decision
Certification and
Publicizing
Registration
Maintaining
registration and
Surveillance Audits

28. Benefits of ISO 22000:2018
 Enhanced utilization of resources in the world level
 Improved profits in companies
 Greater quality jobs in the food industry
 Improved economic growth
 Safer food insurance
 Reduced rates in food borne disease
 Effective documentation of techniques, procedures and methods
 A potential harmonization of national food standards is provided
 This is an effective international standard
 For regulators, it is the most appropriate system