ISO 22000 Gap Analysis

10 July 2018, version 1

Clause
2005
Introduction
0.1 General One general section specifying application and aim of the
0.2 FSMS Principles standard
New sub-section
0.3 Process Approach New sub-section
0.4 Relationship with other New sub-section
MSS
Food Safety Management Systems - Requirements for any organization in the food chain
1 Scope Existing section
2 Normative references Reference to ISO 9000:2000
3 Terms and definitions Existing section: Definitions have been revised
4. Context of the organization (New Title)
4.1 Understanding the New clause
organization
4.2 and itsthe
Understanding context
needs New clause
and exppectations
4.3 Determining theofscope of Requirements for scope defintion already included in 4.1,
the FSMSSafety Mgt. System however
4.4 Food further requirements
Already existing have
in 4.1 but more been added
extensive than in the new
The word d version. "The organization shall establish, document,
5.1 Leadership & Partially covered by clause 5.1 & 7.4.3
Commitmment
5.2 Policy Partially covered by 5.2
5.3 Organizational roles, Partially covered by 5.4, 5.5 and 7.3.2
responsibilities & authorities

6 Planning (New Title)

6.1 Actions to address risks New clause
and opportunites
6.2 Objectives of the FSMS Partially covered by 5.3
and planning to achieve
6.3 Planning of Changes Partially covered by 5.3
7 Support (New Title)
7.1.1 General Partially coverede by clause 6.1
7.1.2 People Partially covered by 6.2, 6.2.2.
7.1.3 Infrastructure Partially covered by clause 6.3
7.1.4 Work Enviroment Partially covered by clause 6.4
7.1.5. Externally developed Partially covered by 1
elements of the FSMS
7.1.6 Control of externally Partially covered by 4.1
provided processes, products
or services

7.2 Competence Partially covered by clauses 6.2.1, 6.2.2, 7.3.2. No , all

7.3 Awareness the information
Partially coveredis by
in chapter
6.2.2. No6.2.2 of the
, all the iso 22000-2005.
information is in
7.4.1 Communication - chapter 6.2.2 of the iso
Partially covered by 6.2.2 22000-2005.
General
7.4.2 External Partially covered by 5.6.1
Communication
7.4.3 Internal 5.6.2 All existing requirements have been maintained
Communication
7.5.1 Documented Partially covered by 4.2.1, 5.6.1,
Information General
7.5.2 Creating and Updating Partially covered by 4.2.2
7.5.3 Control of documented Partially covered by 4.2.2, 4.2.3
information
8 Operation (New Title)
8.1 Operational Planning and Partially covered by 7.1a and covered in the chapter
Control
8.2 Pre-Requisite programs 8.3 and covered
Partially 8.5.2 by 7.2
8.3 Traceability system Partially covered by 7.9
8.4 Emergency preparedness Partially covered by 5.7
and response
8.5.1 Preliminary steps to Partially covered by 7.3
enable hazardanalysis
8.5.2 Hazard analysis Description of process
Partially covered steps and control measures
by , 7.4,

8.5.3 Validation Partially covered by 8.2 and 7.6

8.5.4 Hazard Control Plan Partially covered by 7.5 and 7.6
8.6 Updating the information Partially covered by 7.7
specifying
8.7 Controlthe PRP and
of monitoring Partially covered by 8.3
andVerification
8.8 measuring related to Partially covered by 7.8, 8.4.2
PRP and the hazard control
8.9 Control of product and Partially covered by 7.10
process
9. nonconformities
Performance Evaluation (new title)
9.1 Monitoring, measuring, Partially covered by 8.4.2, 8.4.4 + new subclause
analysis andAudits
9.2 Internal evaluation Partially covered by 8.4.1
9.3 Management Review Partially covered by 5.2, 5.8
10. Improvement
10.1 Non conformity and New
corrective
10.2 action
Continual Improvement Partially covered by 8.1 , 8.5.1
10.3 Update of the FSMS 8.5.2
 New Tekst
Text change
Text deletion
2018
Overview of Main Changes

Benefits of the FSMS, reference to PDCA and clarification in verbal forms (shall, should, may, can) have been included
Key elements moved from the Introduction section (2005) to a separate subsection. Principles common to ISO Management s
included
Process approach, PDCA cycle and risk-based thinking (including relationship with HACCP) explanations included
Introduction to the relationship with the High Level Structure and document framework
n in the food chain
General requirements are the same, but the wording had been changed for clarification or elimination of redundant terms (e.g.
now all included
Reference undereliminated
has been interested parties)
Reference to ISO and IEC terminology databases has been included. Number of definitions has been increased from
Significant food safety hazard has been included and linked to the definition of control measures. "Elimination" o
Requirements to determinte the external and internal issues relevant to the organization's purpose and ability to achieve intend
included; as well
Requirements to as the review
determine the and update
needs of the information
and expectations of interested parties have been included, as well as the review and up
The term "services" has been added to the scope definition requirement, as well as "activities..... that can have an i
safety
Generalofrequirements
the end products
related of
to the organization".
the food Link to requirements
safety management defined
system, have been in 4.1inand
resumed 4.2 has
a single beenclause.
general addedThe
when
wo
removed giving an open decision how to manage the FSMS . "The organization shall establish, implement, maintain
Responsibilites of top management have been extended, including demonstrable leadership and supporting other elevan
The organization shall establish, implement, maintain, update and continually improve a FSMS, including the processes neede
accordance withand
Responsibilites the authorities
requirements of this document.
for relevant roles shall also be "understood", not only defined and communicated (new re
Additional requirements have been assigned to top management, related to the assignation of specific responsibili
the FSMS.

New requirements added related to determining risks and opportunities, actions to address them and their planning . Importa
clarify the specific
Additional conceptrequirements
of risks andfor
opportunities in objectives
the definiton of the context of been
have the standard (events
incorporated and their
(SMART), consequences
as well relating
as requirements rela
them. New requirement: Food safety, statutory, regulatory and customer requirements shall be taken into account
The general requirement in clause 5.3 (V2005) has been extended to include additional considerations when planning and car
FSMS
Consideration of capability & constraints of existing resources as well as the need for external resources in the de
needed,
Separatedhas
as been added under
a sub-clause as a requirement
resources, requirements applicable to external experts have been included under this sub-cl
competency
Wording has in the agreement/contracts
been changed slightly and with external
a note addedexperts has been added.
Wording has been changed slightly and a note added, in the note, the social part has been included
Specific requirements applicable to externally developed elements have been introduced under this clause
 Version 2005 required the definition and documentation of the control of outsourced processes, however under version 2018
extended to also providers of products and services. Requirements have also been enhanced and made more specific. Requir
selection, monitoring of performance/ re evauation of external providers have been added as well as requiremen
communication. Performance of external providers has also been added as an input for Management Review.

Food safety team competence has been included under this clause, scope of necessary completence includes now
providers. requirements previously mentioned in clause 6.2.2 e) have been moved to clause 7.3 and extended with specific a
Awareness
safety policy,
Additional objectives
requirements (relevant
regarding theto theiroftasks),
scope improved
the internal safety performance
and external and
communications implications
have of Understanding
been added. non-conformingof
requirements have beenhave
Additional requirements included
beenunder
addedthis
in clause.
regards to the external communication related to customers/consumers.
The term "suppliers" has been subtituted by
"Personnel qualification" has been substituted "external provider". g).
by "competencies"
Requirement for documented information required by statutory, regulatory authorities and customers has been add
Documented statements
Requirement made of to
applicable theallfood
typessafety policy and
of documented objectives
information are not records).
(including longer mentioned separatedly under this c
Requirements for identification,
Scope extended for all types ofdescription
documented and format
information

The requirements originally included under 7.1 were extended to take into consideration the implementation of actions defi
opportunities
Wording has been(6.1).
changed slightly and appropriateness of the PRP linked to the context of the organization.
Reference to consider
Wording has been changed, ("should") the applicable
minimum requirementsISO/TS
whendocument
establishinginathe definition
traceability of PRP
system hasbeen
have been added.
added (including rewor
Requirement for verification and testing of the effectiveness of the traceability system has
Responsibility is still assigned to top management. Word "accidents" has been changed to "incidents". been added.
A requirement
Requirements for documented
related information
to the competence regarding
of the Food Safety the
Teammanagement of thesetosituations
have been relocated Clause 7.2has been included. Pro
Competence.
General:identificacion
Hazard Minimum relevant information
& acceptable tointernal
levels: be considered when conducting
epidemiological/ thehistorical
scientific/ HA has been
dataadded.
shall also be used as
identification of hazards, as well as statutory/regulatory/customer requirements. Clarification Notes have been ad
consider hazards in sufficient detail has been added. Requirement to use the pre-defined flow diagram has been a
Codex ).
Hazard Assessment: The word "elimination"of food safety hazards has been removed. Requirement to identify sign
has been included.
Selection of control measures: The word "elimination"of food safety hazards has been removed and the wording "
hazards"has been added to the scope of application of this sub-clause. Also clarification on control measures to be
CCPs, ( replacement of the words HACCP plan, CCP and OPRP to be managed via a Hazard Control Plan ). Inputs for
assessment & categorization of control measures have been extended to include also feasibility of establishing mea
applicability of timely corrections. External requirements that can impact the choice and strictness of control meas

Wording has been changed to clarify that validation applies to both: single control measures and combinations of control
Requirement
The HACCP planto maintain
and OPRPthe validation
document havemethodology andinevidence
been combined of capability
a single document calledhas beenControl
Hazard added. Plan. Requireme
(monitoring, critical
Change in wording limits/action
to subsitute HACCPcriteria/
Plan &corrections/corrective
OPRP for Hazard Controlactions)
Plan.have been combined under this clause (8.
Additional
The scope of information has
application of 8.7been added
has been in the outputs
clarified: methodsofandtheequipment
update process
related to PRP and hazard control plan.
Frequency
The activitiesoftocalibration/verification has been
be covered by the verification modified
activities to "specified
have been extended:intervals prior to
effectiveness of use".
PRP's has been added and h
been included in place of HACCP plan/ oprp. Requirement for impartiality of person conducting the verification has
Corrections/ Corrective Actions: Actions to review the NC identified by regulatory inspections reports & consume
added. The term "action criteria" has been defined as a trigger of corrections/ CA.
General: New requirements introduced related to the organization responsibility to detemine the measuring & mo
as goalforthe
Inputs evaluation
generating theof theprogram
audit performance & effectiveness
have been of the FSMS.
extended: changes in the FSMS & results of monitoring and measurem
account to develop the audit program.
Mgt. Review inputs: The structure and number of inputs for the management review have been ammended. Additional inputs h
number of inputs grouped under a general input of "information on the performance & effectiveness of the FSMS".
New clause specifying requirements to deal with Non Conformities within the organization, including the requirement to dete
conformities could potentially
Requirement extended to include occur (preventive
the improvement of actions)
the suitability and adequacy of the FSMS, besides the effectivenes
Wording of inputs changes due to the inclusion of new titles of the clauses (e.g. analysis of resuts of verification acti
Wording changes slightly according to new terms & titles.
 Nature of Change

Alignment to HLS
Alignment to HLS
Alignment to HLS
Aligment to HLS

Clarification and improvement of

the
- tekst
Revision/ improvement of the
standard
Alignment to HLS
Alignment to HLS
Alignment to HLS
Alignment to HLS

Alignment to HLS
Alignment to HLS and Revision/
improvement of the standard
Alignment to HLS

Alignment to HLS
Alignment to HLS
Alignment to HLS

Revision/ improvement of the

standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard

Alignment to HLS and Revision/

improvement of the standard
Alignment to HLS
Alignment to HLS
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Alignment to HLS
Alignment to HLS
Alignment to HLS

Alignment to HLS
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard

Revision/ improvement of the

standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Revision/ improvement of the
standard
Alignment to HLS
Alignment to HLS and Revision/
improvement of theand
Alignment to HLS standard
Revision/
improvement of the standard
Alignment to HLS
Alignment to HLS and Revision/
improvement of the standard
Revision/ improvement of the
standard
 ISO 22000:2018
Introduction
0.1 General
0.2 FSMS Principles
0.3 Process Approach
0.4 Relationship with other MSS
Food Safety Management Systems - Requirements for any organization
in the food chain
1 Scope
2 Normative references
3 Terms and definitions
4. Context of the organization (New Title)
4.1 Understanding the organization and its context
4.2 Understanding the needs and exppectations of interested parties
4.3 Determining the scope of the FSMS
4.4 Food Safety Mgt. System
5. Leadership (New Title)
5.1 Leadership & Commitmment
5.2 Policy
5.3 Organizational roles, responsibilities & authorities
6 Planning (New Title)
6.1 Actions to address risks and opportunites
6.2 Objectives of the FSMS and planning to achieve them
6.3 Planning of Changes
7 Support (New Title)
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information
8 Operation (New Title)
8.1 Operational Planning and Control
8.2 Pre-Requisite programs
8.3 Traceability system
8.4 Emergency preparedness and response
8.5 Hazard Control
8.6 Updating the information specifying the PRP and Hazard control
plan
8.7 Control of monitoring and measuring
8.8 Verification related to PRP and the hazard control plan
8.9 Control of product and process nonconformities
9. Performance Evaluation (new title)
9.1 Monitoring, measuring, analysis and evaluation
9.2 Internal Audits
9.3 Management Review
10. Improvement
10.1 Non conformity and corrective action
10.2 Continual Improvement
10.3 Update of the FSMS
 ISO 22000:2005
Introduction
General
New
New
New
Food Safety Management Systems - Requirements for any organization in the
food chain
1 Scope
2 Normative references
3 Terms and definitions
New Heading
New
New
4.1 + New
4.1
New Heading
5.1, 7.4.3 + new
5.2 + new
5.4, 5.5, 7.3.2 + new
New Heading
new
5.3 + new
5.3 + new
New Heading
1, 4.1, 6.2, 6.3, 6.4 + new
6.2, 7.3.2 + new
6.2.2.
5.6, 6.2.2
4.2, 5.6.1
New Heading
New
7.2 + new
7.9 + new
5.7 + new
7.3, 7.4, 7.5, 7.6, 8.2 and new
7.7
8.3
7.8, 8.4.2
7.10
New Heading
8.4.2, 8.4.3 + new
8.4.1
5.8, 5.2 + new
New Heading
New
8.1, 8.5.1
8.5.2
 ISO 22000:2005
Introduction
General
Food Safety Management Systems - Requirements for any
organization
1 Scope in the food chain
2 Normative references
3 Terms and definitions
4. Food Safety Management System
4.1 General requirements
4.2 Documentation Requirements
5. Management responsibility
5.1 Management Committment
5.2 Food Safety Policy
5.3 FSMS planning
5.4 Responsibility & Authority
5.5 Food safety team leader
5.6 Communication
5.7 Emergency preparedness and response
5.8 Management review
6. Resource Management
6.1 Provision of resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
7 Planning and realization of new products
7.1 General
7.2 Pre requisite programms
7.3 Preliminary steps to enable hazard analysis
7.4 Hazard analysis
7.5 Establishing the OPRP
7.6 Establishing the HACCP Plan
7.7 Updating the preliminary information
7.8 Verification Planning
7.9 Tracebility system
7.10 Control of non conformity
8. Validation, verification and improvement of the FSMS
8.1 General
8.2 Validation of Control Measures
8.3 Control of measuring and monitoring
8.4 FSMS verification
8.5 Improvement
 ISO 22000:2018
Introduction
0.1 General
Food Safety Management Systems - Requirements for any
organization
1 Scope in the food chain
2 Normative references
3 Terms and definitions
-
4.3, 4.4, 7.1,
7.5
-
5.1
5.2, 9.3
6.2, 6.3
5.3
5.3
7.4
8.4
9.3

7.1
7.1, 7.2, 7.3, 7.4
7.1
7.1

-
8.2
8.5
8.5
8.5
8.5
8.6
8.8
8.3
8.9

10.2
8.5
8.7
9.2, 8.8, 9.1,
10.2, 10.3