Key Changes in ISO 22000

Key changes in ISO 22000:2018
These are some of the key changes to consider:

1) Changes due to the adoption of HLS
 Business Context and interested parties: Chapter 4.1, external and

internal issues, introduces new clauses for systematic determination and
monitoring of the business context, and Chapter 4.2, needs and
expectations of interested parties, introduces demands to identify and
understand factors that can (potentially) affect the ability of Management
System to reach the intended results.
 Strengthened emphasis on leadership and management
commitment: Chapter 5.1 now includes new demands to actively
engage and take accountability for the effectiveness of the management
system.
 Risk management: - Chapter 6.1 now requires companies to
determine, consider and, where necessary, take action to address any
risks that may impact (either positively or negatively) the ability of the
management system to deliver its intended results.
 Strengthened focus on objectives as drivers for
improvements: these changes can be found in Chapter 6.2, and
performance evaluation chapter 9.1.
 Extended requirements related to communications: Chapter 7.4
is now more prescriptive in respect to the “mechanics” of
communication, including determination of what, when and how to
communicate.
 Less strict requirements for a food safety manual: – the change is
introduced in chapter 7.5. It is still required to have documented
information. Documented information shall be controlled to ensure it is
adequately protected (ref. 7.5.3). The explicit requirement to have a
documented procedure has been removed.
2) Other changes that are specific to ISO 22000 and food safety
management
 The PDCA cycle: the standard clarifies the Plan-Do-Check-Act cycle, by

having two separate cycles in the standard working together: one
covering the management system and the other, covering the principles
of HACCP.
 The scope now specifically includes animal food: food for animals
not producing food for human consumption. Feed is intended to be fed to
food producing animals.
 Some important changes in the definitions: ‘Harm’ is replaced by
‘adverse health effect’ to ensure consistency with definition of food safety
hazard. The use of ‘assurance’ highlights the relationship between the
consumer and the food product, based on the assurance of food safety.
 Communicating the food safety policy - Chapter 5.2.2: Explicitly
requires the management to facilitate understanding of the food safety
policies by employees.
 Food Safety Management System Objectives: Establishing
objectives for the food safety management system is further specified in
Chapter 6.2.1 and includes items as e.g. ‘consistent with customer
requirements’, ‘monitored’ and ‘verified’.
 Control of externally-provided processes, products or services
- Chapter 7.1.6: This clause introduces the need to control the suppliers
of products, processes and services (including outsourced processes) and
to ensure adequate communication of relevant requirements, to meet the
food safety management system requirements.
ISO 22000:2018, the international food safety management system standard that
specifies the requirements to ensure safe production within the entire food chain,
from farm to fork, was published by ISO on June 19th, 2018.
Aimed at all organizations in the food and feed industries, regardless of size,
sector or geographical location, ISO 22000:2018 is structured to provide process
improvements and its design delivers a prevention control and risk based
approach to food safety.
The 12 key changes under ISO 22000:2018 are:
 Adoption of Annex SL – the High-Level Text and Structure common to all ISO

management system standards, making it easier for organizations to combine
ISO 22000 with other management systems such as ISO 9001 (Quality) or
ISO 14001 (Environmental) thereby potentially saving time and money
 A new approach to risk – as a vital concept in the food/beverage business – which
distinguishes between risk at the operational level – HACCP Plan and at the
strategic level of the food safety management system
 Strong links to the Codex Alimentarius, an intergovernmental body, within the
framework of the Joint Food Standards Program established by the Food and
Agriculture Organization of the United Nations (FAO) and the World Health
Organization (WHO), with the purpose of protecting the health of consumers and
ensuring fair practices in the food trade. The Commission also promotes
coordination of all food standards work undertaken by international governmental
and non- governmental organizations.
 A clear description is given of the differences between key terms such as: Critical
Control Points (CCPs), Operational Prerequisite Programs (OPRPs) and
Prerequisite Programs (PRPs)
 The HACCP and OPRP plan are put together in a Hazard Control Plan with action
criteria to be defined for the identified OPRPs and critical limits (as usual) for
CCPs
 The validation of control measures must be documented and conducted before the
implementation of the HACCP plan
 For both, traceability system and emergency preparedness and response, further
details regarding what needs to be considered are now mentioned within 8.3 and
8.4 clauses respectively
 Processing aids, packaging and utilities are also to be added to the required
documented flow diagrams
 Within the characteristics of raw materials, ingredients and packaging, the source
of each product needs now also to be defined and documented
 There are further aspects to be discussed during management review meetings,
such as performance of external providers (suppliers), review of risks and
opportunities and effectiveness of actions taken to address them, opportunities for
continual improvement, the adequacy of resources, etc.
 There is also a new clause that includes mandatory documented information and
evaluation of effectiveness regarding results from monitoring and measurement
verification
 There are also some additional requirements to be reviewed during the
management review of the food safety management system
“These are exciting new additions/enhancements for ISO 22000. Whilst Annex SL
has been expected, what is interesting is the new approach to risk and preventive
control which we see as fundamental in driving and enhancing global food
safety” – Gerard Kelly, CEO, Kelmac Group®.
Together with FSSC 22000, this version of the standard is an important step in
preventing the disastrous consequences unsafe food can have, both for
consumers and businesses worldwide. With many of today’s food and beverage
products repeatedly travelling across national boundaries, ISO 22000 and FSSC
22000 is more essential than ever to the safety of the global food supply chain.
Now the ISO 22000 standard has been substantially revised to ensure it stays
relevant to modern society needs. FSSC 2200 V4.1 does not currently include
ISO 22000:2018 but ISO 22000:2018 replaces ISO 22000:2005. According to ISO,
organizations certified to the standard have three years from the date of
publication to transition to the new version.
Many people are unaware that Kelmac Group® was fundamental in establishing
the first food safety management system training scheme with CQI-IRCA and the
Irish Food Safety Authority, FSAI. Today we are the oldest Accredited CQI-IRCA
Training Provider of ISO 22000 Auditor Training globally. Kelmac Group® are
considered trusted experts in the food and beverage industry by leading food and
beverage organizations, global regulatory agencies and partner organization’s
such as the IFC, World Bank. We believe this version of the standard will further
strengthen the food safety solutions available to organizations within the food
and beverage industry.
Kelmac Group are offering CQI, IRCA & FSSC Certified public ISO & FSSC 22000
Lead Auditor Training Courses in Chicago, IL and Fullerton, CA – to learn more,
consider registering for one of these market-leading courses!

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Key changes in ISO 22000:2018

These are some of the key changes to consider:

 Business Context and interested parties: Chapter 4.1, external and

 The PDCA cycle: the standard clarifies the Plan-Do-Check-Act cycle, by

The 12 key changes under ISO 22000:2018 are:

 Adoption of Annex SL – the High-Level Text and Structure common to all ISO

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