ISO 22000-2018 Workshop Newh PDF

ISO 22000:2018
Transition Workshop (Auditors)

What has changed?
• high level structure – consistent with all MS standards
• risk approach – different approach to understanding risk
consistent with other MS standards
• PDCA cycle – clarified to one for the FSMS and one for the
principles of HACCP
• operations – clearer differences between CCPs, OPRPs and
PRPs
• ‘Hazard Control Plan’ rather than OPRP and/or HACCP Plan
• more logical reorganisation of Standard’s clauses.
What else?
• FSMS principles common to ISO Management system
standards have been included
• elimination of redundant terms (eg suppliers & customers are
now all included under interested parties)
• number of definitions increased from 17 to 45; “significant food
safety hazard”; “elimination" of significant food safety hazards
has been removed, leaving only reduction or prevention”
definitions of CCPs and OPRPs have been enhanced;
clarification between validation, verification and monitoring
included; food, feed and animal food terms have also been
included.
And more…….
• organisational context – external and internal issues; needs
and expectations of interested parties
• “services” added to scope definition requirements
• the word "document" has been removed giving an open
decision how to manage the FSMS
• responsibilities of top management have been extended,
including demonstrable leadership and supporting other
relevant management roles
• responsibilities need to be understood
• new requirements for determining risks and opportunities
(events and their consequences relating to performance &
effectiveness of the FSMS).
And more……….
• food safety, statutory, regulatory and customer requirements
shall be taken into account when defining objectives
• consideration of capability & constraints of existing
resources (incl external resources – discussion of external
experts)
• control of providers of products and services in addition to
outsourced processes – now requirement for evaluation,
selection, monitoring of performance/re-evaluation
• competence rather than trained
• awareness of Policy, relevant objectives and affect of
nonconforming.
And more………..
• external communication relevant to FSMS not only food
safety
• documentation to include ID, description and format
• operational control now includes planned and unintended
charges and outsourced processes
• PRPs for supplier approval and product information,
consumer awareness
• traceability system must be verified and tested
• minimum info required to conduct hazard analysis, including
distribution and delivery.
And more!
• hazard ID to include regulatory/customer requirements
• “elimination” of food safety hazards removed; must ID ‘significant
food safety hazards’
• control measures to be managed as OPRPs or CCPs; Hazard
Control Plan rather than HACCP Plan; feasibility of establishing
control measures and timely corrections
• verification includes effectiveness of PRPs and impartiality of verifier
• action criteria (for OPRP) triggers correction/CA
• changes in FSMS and monitoring of PRPs may affect Audit Program
• more inputs to management review (performance/effectiveness)
• increased trend analysis for nonconformities.
Overarching Requirement
Must comply with local legislative and

regulatory requirements!
TQCSI Transition Arrangement
• clients will need to be certified to ISO 22000:2018 by 1 June 2021
• applications only for ISO 22000:2018 after 30 June 2019
• clients transferring to ISO 22000:2018 will need an audit with
same duration as for a Triennial Audit (recertification audit);
hence transition will normally coincide with next Triennial Audit
• certification expiry date will not normally change
• clients may opt to transition before the next scheduled Triennial
Audit but only when their respective auditors have been trained
and deemed competent
• from 1 January 2019, ISO 22000:2005 audits will include ISO
22000:2018 requirements as time allows but only Observations
will be raised.
High Level Structure
• the new standard adopts the high-level structure and terminology of
Annex SL (used for the development of all new ISO standards)
• High Level Structure - identical core text and common terms and
core definitions for use in all Management System Standards:
▫ purpose - enhance the consistency and alignment of different
management system standards
▫ organisations that integrate multiple standards (eg FSMS with
QMS, EMS, OHS, etc) will see the most benefit
▫ uses simplified language and writing styles to aid understanding
and consistent interpretations of requirements.
Common structure for MSS
Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organisation
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement.
Clause structure (4-6)
4. Context of the organisation
▫ Understanding the organisation and its context
▫ Understanding the needs and expectations of interested parties
▫ Determining the scope of the food safety management system
▫ Food safety management system
5. Leadership
▫ Leadership and commitment
▫ Policy
▫ Organisational roles, responsibilities and authorities
6. Planning
▫ Actions to address risks and opportunities
▫ Objectives of the FSMS and planning to achieve them
▫ Planning of changes.
7. Support
▫ Resources
▫ Competence
▫ Awareness
▫ Communication
▫ Documented information
8. Operation
▫ Operational planning and control
▫ Prerequisite programs (PRPs)
▫ Traceability system
▫ Emergency preparedness and response
▫ Hazard control
▫ Updating the information specifying the PRPs and the hazard control
plan
▫ Control of monitoring and measuring
▫ Verification related to PRPs and the hazard control plan
▫ Control of product and process nonconformities.
9. Performance evaluation
▫ Monitoring, measurement, analysis and evaluation
▫ Internal audit
▫ Management review
10. Improvement
▫ Nonconformity and corrective action
▫ Continual improvement
▫ Update of the food safety management system.
ISO 22000:2018
Food safety management systems –
Requirements for any organisations in the
food chain.
Introduction
• 0.1 General
Introduces the rationale
• 0.2 FSMS principles for the Standard - more
formally structured.
• 0.3 Process approach
• 0.4 Relationship with other

management system
standards
0.1 General
• improving performance in food safety

• process approach
• risk based thinking.
0.2 FSMS principles
• adequate control throughout the food chain through
interactive communication, system management, prerequisite
programmes and HACCP principles
• principles common to ISO management standards:
▫ customer focus
▫ leadership
▫ engagement of people
▫ process approach
▫ improvement
▫ evidence-based thinking
▫ relationship management.
0.3 Process approach
• adoption of process approach

• managing inter-related processes as a System
• recognition of role and position within the food chain is
essential to ensure effective communication
• PDCA cycle – see over.
PDCA cycle at two levels
0.4 Relationship with other
management system standards
• ISO 22000:2018 conforms to the high level structure
(identical core text and common terms with core definitions)
• facilitates integrating multiple systems
• embraces risk based thinking
• role of prerequisite programmes;
0.4 Prerequisite programs
• ISO/TS 22002-1:2009, Food manufacturing

• ISO/TS 22002-2:2013, Catering
• ISO/TS 22002-3:2011, Farming
• ISO/TS 22002-4:2013, Food packaging manufacturing
• ISO/TS 22002-6:2016, Feed and animal food production
• PAS 221:2013, Retail/supermarkets
• NEN/NTA 8059:2016, Transport and storage (ISO 22002-5 in
Oct 19).
Section 1 - Scope
• minor change
• applicable to any organisation
• products and services.
Section 2 – Normative references
• nil!
• maintains clause numbering consistency.
Section 3 – Terms and Definitions
• action criteria – measureable or observable specification for the
monitoring of an OPRP
• animal food – single or multiple products, whether processed,
semi-processed or raw, which are intended to be fed to non-food
producing animals
• contamination – introduction or occurrence of a contaminant,
including a food safety hazard in a product or processing
environment
• control measure - action or activity that is essential to prevent a
significant food safety hazard or reduce it to an acceptable level
• correction - action to eliminate a detected nonconformity
• corrective action - action to eliminate the causes of a
nonconformity and to prevent recurrence.
Terms and Definitions…cont.
• critical control point (CCP) - step in the process at which
control measures are applied to prevent or reduce a
significant food safety hazard to an acceptable level, and
defined critical limits and measurement enable the
application of corrections
• critical level – measureable value which separates
acceptability from unacceptability
• end product – product that will undergo no further
processing or transformation by the organisation.
• feed – single or multiple products, whether processed, semi-
processed or raw, which are intended to be fed to food producing
animals
• food – substance (ingredient), whether processed, semi-
processed or raw, which is intended for consumption, and
includes drink, chewing gum, and any substance, which has been
used in the manufacture, preparation or treatment of food but
does not include cosmetics or tobacco or substances
(ingredients) used only as drugs
• flow diagram – schematic and systematic presentation of the
sequence and interactions of steps in the process
• food safety hazard - biological, chemical or physical agent in
food with the potential to cause an adverse health effect.
• nonconformity – non-fulfilment of a requirement

• prerequisite programme (PRP) - basic conditions and
activities that are necessary within the organisation and
throughout the food chain to maintain food safety
• operational prerequisite programme (OPRP) – control
measure or combination of control measures applied to
prevent or reduce a significant food safety hazard to an
acceptable level, and where action criteria and measurement
or observation enable effective control of the process and/or
product.
• significant food safety hazard – food safety hazard,

identified through the hazard assessment, which needs to
be controlled by control measures.
• verification – obtaining evidence that a control measure
(or combination of control measures) will be capable of
effectively controlling the significant food safety hazard
• validation – confirmation, through the provision of
objective evidence, that specified requirements have been
fulfilled.
Section 4 – Context of the Organisation
• 4.1 Understanding the • this is a new clause and

organisation and its context
provides a key insight into
• 4.2 Understanding the needs the organisation
and expectations of interested
parties
What determines the
• 4.3 Determining the scope of
the food safety management
organisation’s food safety
system management system.
• 4.4 Food safety management
system
Section 4 – Context of the organisation
• 4.1 Understanding the organisation 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
• determine external and internal issues relevant to the FSMS

• identify, review and update relevant information.
2005 – No equivalent
• 4.2 Understanding the needs and expectations of interested
parties
• determine interested parties relevant to the FMS

• determine their needs and requirements
• identify, review and update relevant information.
• 4.3 Determining the scope of the food safety management
system
• establish scope by determining boundaries and applicability of the FSMS

• consider external/internal issues, interested parties and their
requirements
• scope must be documented and available.
2005 – clause 4.1

• must establish, implement, maintain, update and continually improve

the FSMS.
2005 – clause 4.1

Section 5 - Leadership
• 5.1 Leadership and commitment
• top management’s
• 5.2 Policy involvement in the FSMS
• 5.3 Organisational roles,

What is required by top
responsibilities and authorities
management.
Section 5 – Leadership
• 5.2 Policy
• 5.3 Organisational roles, responsibilities and authorities
• ensure food safety and objectives are established

• FSMS integrated into business processes
• resources
• communicating importance of effective FSMS and compliance
• evaluate and maintained
• supporting contributions to the FSMS
• promoting continual improvement
• supporting all managers to demonstrate leadership.
2005 – clauses 5.1 & 7.4.3

Section 5 - Leadership
• 5.2 Policy
• 5.2.1 Establishing the food safety policy
• 5.2.2 Communicating the food safety policy
• appropriate
• provides a framework for setting and reviewing FSMS objectives
• commitment to food safety requirements, including
statutory/regulatory and customer requirements
• addresses internal and external communication
• commitment to continual improvement
• ensure food safety competencies.
2005 – clause 5.2
• 5.2 Policy
• 5.2.1 Establishing the food safety policy
• 5.2.2 Communicating the food safety policy
• documented and available

• communicated, understood and applied within the organisation
• available to interested parties.
2005 – clause 5.2

• 5.2 Policy
• responsibilities and authorities are assigned, communicated and

understood, ensuring:
▫ FSMS conformance to ISO 22000
▫ reporting on FSMS performance
▫ appointing FST and FST Leader
▫ initiate and document actions;
2005 – clauses 5.4, 5.5 & 7.3.2

• 5.2 Policy
• FST Leader must be responsible for:

▫ ensuring FSMS is established, maintained and updated
▫ managing and organising work for FST
▫ ensuring relevant training and competencies of the FST
▫ reporting on effectiveness and of FSMS.
• everyone must have responsibility to report problems.
2005 – clauses 5.4, 5.5 & 7.3.2

Section 6 - Planning
• 6.1 Actions to address risks and

opportunities • introduces risk based approach to
planning
• 6.2 Objectives of the food safety
management system and planning • addresses food safety objectives
to achieve them
How food safety management is
• 6.3 Planning of changes planned.
Section 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
• must consider external/internal issues and interested parties

• must determine and address risks and opportunities
• assurance that FSMS can work, enhance desirable effects, prevent
undesired effects and achieve continual improvement
• action taken is to be proportionate to the impact on food safety,
conformity and requirements of interested parties in food chain.
2005 – no equivalent
• 6.2 Objectives of the food safety management system and
planning to achieve them
• FSMS objectives must be established and documented

• must be consistent with Food Safety Policy, measureable, compliant,
monitored and verified, communicated, maintained and updated
• objectives must include what, resources, who, when and evaluation.
2005 – clause 5.3

• 6.2 Objectives of the food safety management system and planning to
achieve them
• changes to FSMS, including personnel, must be planned and

communicated
• consider:
▫ purpose of change and potential consequences
▫ continued integrity of FSMS
▫ availability of resources
▫ responsibilities and authorities.
2005 – clause 5.3

Section 7.1- Support
• 7.1 Resources • much of the previous Clause

• 7.2 Competence 6 has been written into this
newly constructed clause
• 7.3 Awareness
• 7.4 Communication The support required to

• 7.5 Documented Information
meet the organisation’s food
safety goals.
Section 7 - Support
• 7.1 Resources
• 7.1.1 General
• 7.1.2 People
• 7.1.3 Infrastructure
• 7.1.4 Work environment
• 7.1.5 Externally developed elements of the FSMS
• 7.1.6 Control of externally provided processes, products and services
• must determine and provide resources required for FSMS

• consider capability and constraints of internal resources and need for
external resources.
2005 – clause 6.1

Section 7.1 - Support
• 7.1 Resources
• 7.1.1 General
• 7.1.2 People
• 7.1.4 Work Environment
• must ensure competence

• if using external experts, evidence of agreements or contracts defining
the competence and responsibility must be documented.
2005 – clauses 6.2

• 7.1 Resources
• 7.1.1 General
• 7.1.2 People
• infrastructure must be maintained to ensure conformity with the FSMS.
2005 – clause 6.3

• 7.1 Resources
• 7.1.1 General
• 7.1.2 People
• must determine, provide and maintain resources for work environment.
2005 – clause 6.4

• 7.1 Resources
• 7.1.1 General
• 7.1.2 People
• when using externally developed elements of a FSMS (eg PRPs, hazard

analysis and hazard control plan), must ensure the provided elements:
▫ developed in conformance with ISO 22000
▫ applicable and specifically adapted
▫ documented.
2005 – no equivalent
• 7.1 Resources
• 7.1.1 General
• 7.1.2 People
• must establish and apply criteria for evaluation, selection, monitoring of

performance and re-evaluation of external providers
• ensure adequate communication
• ensure externally provided process, products or services don’t adversely
affect FSMS
• records required.
2005 – clause 4.1

Section 7- Support
• 7.1 Resources
• 7.2 Competence
• 7.3 Awareness
• 7.4 Communication
• must determine competency, including external providers and FST

• ensure FST has multi-disciplinary knowledge and experience
• records required.
2005 – clauses 6.2 & 7.3.2

• 7.1 Resources
• 7.2 Competence
• 7.3 Awareness
• must ensure awareness of:

▫ Food Safety Policy
▫ FSMS objectives
▫ individual contribution to FSMS
▫ implications of not conforming with FSMS.
2005 – clause 6.2.2

Section 7- Support
• 7.4.1 General
• 7.4.2 External communication
• 7.4.3 Internal communication
• must determine what internal and external communication is

relevant to FSMS, including who, what, when, who to and how
• must ensure the requirements for effective communication is
understood.
2005 – clause 6.2.2

• 7.4.1 General
• must ensure sufficient information is communicated and available to

the food chain, including:
▫ external providers and contractors
▫ customers and consumers (product information, food safety
hazards requiring control, contractual arrangements, feedback and
complaints)
▫ statutory and regulatory authorities
▫ other organisations impacting the FSMS
• must define responsibilities and authorities for external commutation
• records of external communication must be retained.
2005 – clause 5.6.1
• 7.4.1 General
• must establish, implement and maintain effective communication

regarding food safety
• FST must be informed of various requirements listed in the clause
• FST must ensure information is included when updating the FSMS.
2005 – clause 5.6.2

Section 7 - Support
• 7.5.1 General
• 7.5.2 Creating and updating
• 7.5.3 Control of documented information
• FSMS must include:

▫ documents and records required by ISO 22000
▫ documents and records required by the organisation
▫ documents, records and food safety requirements required by regulatory
authorities and customers.
2005 – clauses 4.2.1 & 5.6.1

Section 7 - Support
• 7.5.1 General
• documented information requires:

▫ identification and description
▫ format and media
▫ review and approval.
2005 – clause 4.2

Section 7 - Support
• 7.5.1 General
• documented information (including external origin) is to be controlled to
ensure:
▫ availability and suitability
▫ adequate protection
• must address:
▫ distribution, access, retrieval and use
▫ storage and preservation
▫ version control
▫ retention and disposition.
2005 – clauses 4.2.2 & 4.2.3

Section 8 - Operation
• 8.1 Operational planning and control
• specific section created for
• 8.2 Prerequisite programmes (PRPs)
operational planning,
• 8.3 Traceability system
controlling food safety and
• 8.4 Emergency preparedness and response
dealing with emergencies
• 8.5 Hazard control
• 8.6 Updating the information specifying the

PRPs and hazard control plan
• 8.7 Control monitoring and measuring How to control operations.

• 8.8 Verification related to PRPs and the
hazard control plan
• 8.9 Control of product and process

nonconformities
• 8.2 Prerequisite Programmes (PRPs)
• 8.6 Updating the information specifying the PRPs and hazard control plan
• 8.7 Control monitoring and measuring
• 8.8 Verification related to PRPs and the hazard control plan
• 8.9 Control of product and process nonconformities
• must control processes to ensure safe food by establishing criteria,

implementing controls and retaining records to have confidence in the controls
• must control changes
• must control outsourced processes.
• 8.2 Prerequisite plans (PRPs)
• 8.6 Updating the information specifying the PRPs and the hazard control plan
• 8.7 Control of monitoring and measuring
• must implement PRPs to prevent/reduce contaminants, including food safety
hazards
• PRPs must be appropriate, implemented across entire production system and
approve by FST
• must consider applicable ISO 22002 and other standards/codes/guidelines
• required considerations for establishing PRPs are listed in the clause
• procedures are required.
2005 – clause 7.2
• must be able to uniquely identify incoming material and first stage of

distribution route for end product
• records required to prove traceability system for shelf life of product
• traceability system must be verified and tested.
2005 – clause 7.9
• see over.
2005 – clause 7.9

• 8.4.1 General
• 8.4.2 Handling emergencies and incidents
• procedures are required to respond to emergency situations that can affect

food safety.
2005 – clause 5.7

• 8.4.1 General
• 8.4.2 Handling emergencies and incidents
• must respond to actual emergencies, including ensuring compliance and

communicating internally and externally
• must mitigate potential food safety impact
• test procedures with practical
• review procedures after any emergency or test.
• see over.
2005 – clause 7.9

• 8.5.1 Preliminary steps to enable hazard analysis
• 8.5.1.1 General
• 8.5.1.2 Characteristics of raw materials, ingredients and product contact materials
• 8.5.1.3 Characteristics of end products
• 8.5.1.4 Intended use
• 8.5.1.5 Flow diagrams and descriptions of processes
• documented information must be collected, maintained and updated,

including complying with conformance and/or customer requirements;
organisation’s products, process and equipment; and food safety hazards.
2005 – clause 7.3.1

• 8.5.1.1 General
• must ensure statutory/regulatory food safety requirements are met for raw
materials, ingredients and packaging
• records must be retained to facilitate hazard analysis, including criteria described
in the clause.
2005 – clause 7.3.3.1

• 8.5.1.1 General
• must ensure statutory/regulatory food safety requirements are met for end
products
• records must be retained to facilitate hazard analysis, including information
described in the clause.
2005 – clause 7.3.3.2

• 8.5.1.1 General
• must document to facilitate hazard analysis of the end product’s:

▫ intended use (including reasonably expected handling)
▫ unintended use (but reasonably expected mishandling and misuse)
• consumer groups may be identified, particularly if they are especially

vulnerable.
2005 – clause 7.3.4

• 8.5.1.1 General
• 8.5.1.5 Flow diagrams and description of processes
• see over.
2005 – clause 7.3.5.1

• 8.5.1.5.1 Preparation of the flow diagrams
• 8.5.1.5.2 On-site confirmations of flow diagrams
• 8.5.1.5.3 Description of processes and process environment
• documented flow diagrams for products or product categories and processes

• flow diagrams must include:
▫ sequence and interaction of steps in operation
▫ any outsourced processes
▫ where raw materials, ingredients, processing aids, packaging, utilities, etc enter the flow
▫ where reworking or recycling occurs
▫ where end products, intermediate products, by-products and waste are removed.
2005 – clause 7.3.5.1
• 8.5.1.5.1 Preparations of the flow diagrams
• 8.5.1.5.2 On-site confirmation of flow diagrams
• FST must confirm accuracy of flow diagrams.
2005 – clause 7.3.5.1

• 8.5.1.5.1 Preparations of the flow diagrams
• 8.5.1.5.2 On-site confirmation of flow diagrams
• must document:
▫ layout of premises
▫ processing equipment and contact materials, processing aids
▫ existing PRPs and procedures, process parameters and control measure.
▫ any external requirements
▫ any variations resulting from seasonal changes or shift patterns.
2005 – clauses 7.2.4 & 7.3.5.2

• 8.5.2 Hazard analysis
• 8.5.2.1 General
• 8.5.2.2 Hazard identification and determination of acceptable levels
• 8.5.2.3 Hazards assessment
• 8.5.2.4 Selection and categorisation of control measures
• hazard analysis is to be conducted to determine the hazards that need to be

controlled.
2005 – clause 7.4

• 8.5.2.1 General
• must document all food safety hazards expected based on:
▫ preliminary information
▫ experience
▫ internal and external information
▫ information from the food chain
▫ statutory/regulatory and compliance requirements
• the steps at which food safety hazards occur must be identified

• the acceptable level in end product of each food safety hazard is to be determined and
documented
• acceptable levels must be justified.
2005 – clause 7.4.2

• 8.5.2.1 General
• hazard assessment is to be conducted to determine whether each food safety hazard’s

prevention or reduction to an acceptable level is essential
• assessment is to include:
▫ likelihood of occurrence in end product without controls
▫ severity of health effects
• assessment methodology is to be documented and records of the hazard assessment are

to be retained.
2005 – clauses 7.4.3 & 7.6.2

• 8.5.2.1 General
• appropriate control measures or combination of control measures capable of preventing or reducing

the food safety hazards to an acceptable level are to be selected using a systematic approach
• control measures are to be managed as OPRPs or CCPs
• for each control measure, there is to be an assessment for:
▫ likelihood of failure
▫ severity of consequence
• for each control measure there is to be an assessment of feasibility of:
▫ establishing measurable critical limits and/or measureable, observable action criteria
▫ monitoring
▫ timely corrections
• the selection and categorization of control measures is to be documented, including any external
requirements.
2005 – clauses 7.3.5.2 & 7.4.4

• 8.5.3 Validation of control measures and combinations of control measures
• control measures are to be validated

• validation methodology and evidence of the control measures capability is to be
documented.
2005 – clause 8.2

• 8.5.4 Hazard control plan (HACCP/OPRP plan)
• 8.5.4.1 General
• 8.5.4.2 Determination of critical limits and action criteria
• 8.5.4.3 Monitoring systems at CCPs and for OPRPs
• 8.5.4.4 Actions when critical limits or actions criteria are not met
• 8.5.4.5 Implementation of the hazard control plan
• hazard control plan is to be documented and include the following for each:
▫ food safety hazard
▫ critical limit for CCP or action criteria for OPRP
▫ monitoring procedure
▫ corrections to be made if critical limits or action criteria are not met
▫ responsibilities or authorities
▫ records of monitoring.
2005 – clause 7.5 & 7.6.1

• 8.5.4.1 General
• rationale for determining critical limits and action criteria is to be documented

• critical limits for CCPs are to be measurable
• action criteria for OPRPs is to be measurable or observable.
2005 – clause 7.6.3

• 8.5.4.1 General
• CCPs and OPRPs are to be monitored and documented, including:

▫ the measurements or observations
▫ the monitoring methods or devices used
▫ applicable calibration methods (for OPRPs, equivalent methods of verification)
▫ monitoring frequency
▫ monitoring results
▫ responsibilities or authorities
▫ responsibility and authority for evaluation results
• monitoring of CCPs must be timely

• monitoring of OPRPs are to be proportionate to the likelihood and severity.
2005 – clauses 7.6.3 & 7.6.4

• 8.5.4.1 General
• corrections and corrective action is to be taken when critical limits or action criteria
are not met.
2005 – clause 7.6.5

• 8.5.4.1 General
• the hazard control plan is to be implemented and records retained accordingly.
2005 - No equivalent
• when the hazard control plan is implemented, preliminary information is to be

updated
• the hazard control plan and PRPs are to be up to date.
2005 – clause 7.7

• monitoring and measuring equipment is to be calibrated or verified at specified
intervals, adjusted if necessary, identified and safeguarded from adjustments and
protected
• results of calibration and verification are to be retained
• calibration is to be traceable to international or national standards
• equipment found nonconforming is to be validated for previous measurements
• software used for monitoring and measuring is to be validated.
2005 – clause 8.3
• see over.
• 8.8.1 Verification
• 8.8.2 Analysis of results of verification activities
• verification of PRPs and hazard control plan is to be planned and implemented

• verification records are to be retained
• end product tested and identifying nonconformities is to be treated as potentially
unsafe product and corrective action is to be implemented.
2005 – clauses 7.8 & 8.4.2

• 8.8.1 Verification
• 8.8.2 Analysis of results of verification activities
• FST is to analyse results of verification.
2005 – clause 8.4.3

• see over.
2005 – clause 7.10

• 8.9.1 General
• 8.9.2 Corrections
• 8.9.3 Corrective actions
• 8.9.4 Handling of potentially unsafe products
• 8.9.5 Withdrawal/recall
• CCP and OPRP monitoring data is to be evaluated by persons with the authority to
initiate corrections and corrective action.
2005 – clauses 7.10.1 & 7.10.2

• 8.9.1 General
• when critical limits or action criteria are exceeded, the product affected is to be identified and
controlled (potentially unsafe product)
• procedures required to document:
▫ the method of identification, assessment and correction
▫ review of corrections
• records are to be retained on corrections of nonconforming product and processes, including

▫ nature of nonconforming
▫ cause of the failure
▫ consequences.
2005 – clause 7.10.1
• 8.9.1 General
• need for corrective action is to be evaluated when critical limits or action criteria are
exceeded
• actions to identify and eliminate cause of nonconformities is to be documented,
including trend analysis, root cause analysis, corrective action and verification of
corrective action.
2005 – clauses 7.10.2

• 8.9.1 General
• see over.
2005 – clause 7.10.3

• 8.9.4.1 General
• 8.9.4.2 Evaluation for release
• 8.9.4.3 Disposition of nonconforming products
• acceptable levels must be met before food can enter the food chain
• potentially unsafe products must be controlled
• if potentially unsafe products have entered the food chain, must notify relevant
interested parties and initiate withdrawal/recall
• records must be retained of all relevant information and communication.
2005 – clauses 7.10.3.1

• 8.9.4.1 General
• each lot/batch of products affected by the nonconformity is to be

evaluated
• if product is outside critical limits (CCPs), they are not to be released
• if product is outside action criteria (OPRPs), they are not to be released
unless other evidence proves it is safe
• records of evaluation for release of products is to be retained.
2005 – clause 7.10.3.2

• 8.9.4.1 General
• product that cannot be released is to be:

▫ reprocessed to acceptable limits
▫ redirected for other use as long as safe to do so
▫ destroyed or disposed as waste
• records must be retained, including identification of the approver.
2005 – clause 7.10.3.3

• 8.9.1 General
• must be able to withdraw/recall competently

• records must be retained of:
▫ communicating with interested parties
▫ handling withdrawn/recalled products and product in stock
▫ the withdrawal/recall process
▫ the cause, extent and result of the withdrawal/recall
• withdrawn/recalled product and product in stock must be controlled

• mock recalls or similar must be conducted and recorded.
2005 – clause 7.10.4

Section 9 – Performance evaluation
• performance is to be monitored
• 9.1 Monitoring, measurement, and analysed
analysis and evaluation • conducting internal audits and
management review
• 9.2 Internal audit
• 9.3 Management review How food safety performance is

evaluated.
Section 9 – Performance Evaluation
• 9.1 Monitoring, measurement, analysis and evaluation
• 9.1.1 General
• 9.1.2 Analysis and evaluation
• must determine what, how, when needs to be measured and how

results are analysed and evaluated
• records must be retained and reported
• must evaluate the performance and effectiveness of the FSMS.
• 9.1.1 General
• 9.1.2 Analysis and evaluation
• must analyse and evaluate monitoring and measurement data,

including verification activities and internal and external audits
• results of analysis must be recorded and reported.
2005 – clauses 8.4.2 & 8.4.3

• 9.3 Management review
• planned intervals
• must plan audit program, including frequency, methods, responsibilities,
planning and reporting based on risk, changes to FSMS, results of
monitoring and audits
• competent, objective and impartial
• report results to FST
• records retained
• take appropriate action
• determine if FSMS meets Food Safety Policy and objectives.
2005 – clause 8.4.1
• 9.3 Management review
• planned intervals
• increased agenda items
• evidence of management review results, including decisions and
actions, and changes to the FSMS, must be documented.
2005 – clause 5.8

Section 10 - Improvement
• 10.1 Nonconformity and corrective • nonconformities must be identified
action
and reacted to
• 10.2 Continual improvement
• corrective action must be
• 10.3 Update of the food safety considered
management system
• FSMS must continually improve
Continual improvement remains a

core focus of the FSMS.
Section 10 – Improvement
• 10.1 Nonconformity and corrective action
• 10.3 Update of the food safety management system
When nonconformities occur, must:

• react to the nonconformity
• evaluate need for corrective action
• take appropriate action
• review effectiveness of any corrective action
• change FSMS, if necessary
• retain records of nonconformities and subsequent action, and
results of corrective action.
• must continually improve the FSMS!
2005 – clauses 8.1 & 8.5.1

• FSMS must be continually updated through the FST

• updates must be documented and retained.
2005– clause 8.5.2

Annex A (informative)
Cross references between the CODEX HACCP and
ISO 22000:2018.
Annex B (informative)
Cross reference between ISO 22000:2018 and

ISO 22000:2005.
Auditing Requirements
• ISO 22003:2013, Food safety management systems –

Requirements for bodies providing audit and certification
of food safety management systems
• currently being reviewed.
Food Defence & Food Fraud
• Food Defence Plan and Food Fraud Vulnerability Plan are not
specifically required, unlike FSSC 22000
• however, Clause 6.1 requires clients to determine and address
risks, prevent undesired effects and action taken is to be
proportionate to the impact on food safety and requirements of
interested parties in food chain
• so its subjective and depends on the business
• risks must be considered and acted upon but not a full
TACCP/VACCP unless circumstances require it.
Summary of Changes
• better format and ease of integration
• context of organisation
• risks and opportunities
• clearer differences between OPRP, CCP & PRP
• critical limits (CCPs) vs action criteria (OPRPs)
• Hazard Control Plan in lieu of OPRP/HACCP Plan
• external provider evaluation
• competence in lieu of training
• use of PRPs
• greater inputs to management review.
Any Questions?

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ISO 22000:2018

Transition Workshop (Auditors)

Must comply with local legislative and

• 0.4 Relationship with other

• improving performance in food safety

• adoption of process approach

• ISO/TS 22002-1:2009, Food manufacturing

• nonconformity – non-fulfilment of a requirement

• significant food safety hazard – food safety hazard,

• 4.1 Understanding the • this is a new clause and

• determine external and internal issues relevant to the FSMS

• determine interested parties relevant to the FMS

• establish scope by determining boundaries and applicability of the FSMS

2005 – clause 4.1

• must establish, implement, maintain, update and continually improve

2005 – clause 4.1

• 5.3 Organisational roles,

• ensure food safety and objectives are established

• supporting all managers to demonstrate leadership.

2005 – clauses 5.1 & 7.4.3

• documented and available

2005 – clause 5.2

• responsibilities and authorities are assigned, communicated and

2005 – clauses 5.4, 5.5 & 7.3.2

• FST Leader must be responsible for:

2005 – clauses 5.4, 5.5 & 7.3.2

• 6.1 Actions to address risks and

• must consider external/internal issues and interested parties

• FSMS objectives must be established and documented

2005 – clause 5.3

• changes to FSMS, including personnel, must be planned and

2005 – clause 5.3

• 7.1 Resources • much of the previous Clause

• 7.4 Communication The support required to

• must determine and provide resources required for FSMS

2005 – clause 6.1

• must ensure competence

2005 – clauses 6.2

• infrastructure must be maintained to ensure conformity with the FSMS.

2005 – clause 6.3

• must determine, provide and maintain resources for work environment.

2005 – clause 6.4

• when using externally developed elements of a FSMS (eg PRPs, hazard

• must establish and apply criteria for evaluation, selection, monitoring of

2005 – clause 4.1

• must determine competency, including external providers and FST

2005 – clauses 6.2 & 7.3.2

• must ensure awareness of:

2005 – clause 6.2.2

• must determine what internal and external communication is

2005 – clause 6.2.2

• must ensure sufficient information is communicated and available to

• must establish, implement and maintain effective communication

2005 – clause 5.6.2

• FSMS must include:

2005 – clauses 4.2.1 & 5.6.1

• documented information requires:

2005 – clause 4.2

2005 – clauses 4.2.2 & 4.2.3

• 8.6 Updating the information specifying the

• 8.7 Control monitoring and measuring How to control operations.

• 8.9 Control of product and process

• must control processes to ensure safe food by establishing criteria,