ISO 22000:2018 - Minimum documentation requirements:
4.3 Determining the scope of the FSMS
The scope shall be available and maintained as documented information
5.2.2 Communicating the FS policy
The food safety policy shall:
a) Be available and maintained as documented information
6.2 Objectives of the FSMS and planning to achieve them
The organization shall retain documented information on the objectives of the FSMS.
7.1.2 People
Where the assistance of external experts is used for the development, implementation, operation or
competency, responsibility and authority of external experts shall be retained as documented
information
7.1.5 Externally developed elements of the FSMS
When an organization establishes, maintains, updates and continually improves its food safety
including PRPs and the hazard control plan, the organization shall ensure that the provided elements
are:
e) Retained as documented information
7.1.6 Control of externally provided processes, products or services
The organization shall:
d) Retain documented information of these activities and any necessary actions as a result of the
evaluations and re‐evaluations
7.2 Competence
The organization shall:
e) Retain appropriate documented information as evidence of competence
7.4.2 External communication
Evidence of external communication shall be retained as documented information
7.5.1 General
a) Documented information required by this document
b) Documented information determined by the organization as being necessary for the effectiveness of
c) documented information and food safety requirements required by statutory, regulatory authorities
and customers
7.5.3.2
Documented information of external origin determined by the organization to be necessary for the
controlled
8.2.4
Documented information shall specify the selection, establishment, applicable monitoring and
verification of the PRP(s)
Documented information as evidence of the traceability system shall be retained for a defined period
to include as a minimum shelf‐life of the end product. The organization shall verify and test the
8.4.1 General
Documented information shall be established and maintained to manage these situations and incidents
8.4.2 Handling of emergencies and incidents
The organization shall:
d) Review and, where necessary, update the documented information, in particular, after the
occurrence of any incident, emergency situation or tests
8.5.1.1 General
To carry out the hazard analysis, preliminary documented information shall be collected, maintained
and updated by the food safety team
8.5.1.2 Characteristics of raw materials, ingredients and product contact materials
The organization shall maintain documented information concerning all raw materials, ingredients and
product contact materials to the extent needed to conduct the hazard analysis (8.5.2), including the
following, as appropriate:
a) Biological, chemical and physical characteristics
b) Composition of formulated ingredients, including additives and processing aids
c) Source (e.g. animal, mineral or vegetable)
d) Place of origin (provenance)
e) Method of production
f) Method of packaging and delivery
g) Storage conditions and shelf life
h) Preparation and/or handling before use or processing
i) Food safety related acceptance criteria or specifications of purchased materials and ingredients
appropriate to their intended use
8.5.1.3 Characteristics of end products
The organization shall maintain documented information concerning the characteristics of end
products to the extent needed to conduct the hazard analysis, including information on the following,
as appropriate:
a) Product name or similar identification
b) Composition
c) Biological, chemical and physical characteristics relevant for food safety
d) Intended shelf life and storage conditions
e) Packaging
f) Labelling relating to food safety and/or instructions for handling
g) Method(s) of distribution and delivery
8.5.1.4 Intended use
The intended use, the reasonably expected handling of the end product, and any unintended but
reasonably expected mishandling and misuse of the end product shall be considered and shall be
maintained as documented information to the extent needed to conduct the hazard analysis.
8.5.1.5.1 Preparation of the flow diagrams
The food safety team shall establish, maintain and update flow diagrams as documented information
for the products or product categories and the processes covered by the FSMS.
8.5.1.5.2 On‐site confirmation of flow diagrams
The food safety team shall confirm on-site the accuracy of the flow diagrams, update the flow diagram
where appropriate and retain as documented information.
8.5.1.5.3 Description of processes and process environment
The descriptions shall be updated as appropriate and maintained as documented information.
8.5.2.2.1 The organization shall identify and document all food safety hazards that are reasonably
expected to occur in relation to the type of product, type of process and process environment.
8.5.2.2.3 The organization shall maintain documented information concerning the determination of
acceptable levels and the justification for the acceptable levels.
8.5.2.3 Hazard assessment
The methodology used shall be maintained, and the result of the hazard assessment shall be
maintained as documented information.
8.5.2.4.2
The decision-making process and results of the selection and categorization of the control measures
shall be maintained as documented information.
External requirements (e.g. statutory, regulatory and customer requirements) that can impact the
choice and the strictness of the control measures shall also be maintained as documented information.
8.5.4.1 General
The organization shall establish, implement and maintain a hazard control plan. The hazard control
plan shall be maintained as documented information and shall include the following information for
each control measure at each CCP or OPRP:
a) Food safety hazard(s) to be controlled at the CCP or by the OPRP
b) Critical limit(s) at CCP or action criteria for OPRP
c) Monitoring procedure(s)
d) Correction(s) to be made if critical limits or action criteria are not met
e) Responsibilities and authorities
f) Records of monitoring
8.5.4.2 Determination of critical limits and action criteria
Critical limits at CCPs and action criteria for OPRPs shall be specified. The rationale for their
determination shall be maintained as documented information.
8.5.4.3 Monitoring systems at CCPs and for OPRPs
The monitoring system, at each CCP and for each OPRP, shall consist of documented information
including:
a) Measurements or observations that provide results within an adequate time frame
b) Monitoring methods or devices used
c) Applicable calibration methods or, for OPRPs, equivalent methods for verification of reliable
measurements or observations (8.7)
d) Monitoring frequency
e) Monitoring results
f) Responsibility and authority related to monitoring
g) Responsibility and authority related to evaluation of monitoring results
8.5.4.5 Implementation of the hazard control plan
The organization shall implement and maintain the hazard control plan, and retain evidence of the
implementation as documented information.
8.7 Control of monitoring and measuring
The results of calibration and verification shall be retained as documented information. The calibration
of all the equipment shall be traceable to international or national measurement standards; where no
standards exist, the basis used for calibration or verification shall be retained as documented
information. The assessment and resulting action shall be maintained as documented information.
validated by the organization, software supplier, or third party prior to use. Documented information
on validation activities shall be maintained by the organization and the software shall be updated in a
timely manner.
Whenever there are changes, including software configuration/modifications to commercial off‐the
shelf software they shall be authorized, documented and validated before implementation.
8.8.1 Verification
Verification results shall be maintained as documented information and shall be communicated.
8.9.2.1 The organization shall ensure that when critical limits at CCP(s) and/or action criteria for
OPRPs are not met, the products affected are identified and controlled with regard to their use and
release.
The organization shall establish, maintain and update documented information that includes:
a) Method of identification, assessment, correction for affected products to ensure their proper
handling
b) Arrangements for review of the corrections carried out
8.9.2.3 The organization shall retain results of the evaluation as documented information.
8.9.2.4 Documented information shall be retained to describe corrections taken on nonconforming
products and processes including:
a) The nature of the nonconformity
b) The cause(s) of the nonconformity
c) The consequences as a result of the nonconformity
8.9.3 Corrective actions
The organization shall establish and maintain documented information that specifies appropriate
actions to identify and eliminate the cause of detected nonconformities, to prevent recurrence, and to
return the process to control after a nonconformity is identified.
These actions shall include:
e) Documenting the results of corrective actions taken
The organization shall retain documented information on all corrective actions.
8.9.4.1 General
The controls and related responses from relevant interested parties and authorization for dealing with
potentially unsafe products shall be retained as documented information.
8.9.4.2 Evaluation for release
Results of evaluation for release of products shall be retained as documented information.
8.9.4.3 Disposition of nonconforming products
Documented information on the disposition of nonconforming products including the identification of
the person(s) with approving authority shall be retained.
8.9.5 Withdrawal/Recall
The organization shall establish and maintain documented information for:
a) Notifying relevant interested parties (e.g. statutory and regulatory authorities, customers and/or
consumers)
b) Handling withdrawn/recalled products as well as products still in stock
c) Performing the sequence of actions to be taken
The cause, extent and result of a withdrawal/recall shall be retained as documented information and
reported to the top management as input for the management review.
The organization shall verify the implementation and effectiveness of withdrawals/recalls through the
use of appropriate techniques (e.g. mock withdrawal/recall or practice withdrawal/recall) and retain
documented information.
9.1.1 General
The organization shall retain appropriate documented information as evidence of the results.
9.1.2 Analysis and evaluation
The results of the analysis and any resulting activities shall be retained as documented information.
The results shall be reported to top management and used as input to the management review and
the updating of the FSMS.
9.2.2 The organization shall:
e) Retain documented information as evidence of the implementation of the audit programme and
the audit results
9.3.3 Management review output
The organization shall retain documented information as evidence of the results of management
review.
10.1.2 The organization shall retain documented information as evidence of:
a) The nature of the nonconformities and any subsequent actions taken
b) The results of any corrective action
System updating activities shall be retained as documented information and reported as input to the
management review.
PS: ISO 22000:2018 requires the organization to keep specific documented information, this is defined
throughout in the relevant clauses using the following or similar terms:
• Shall maintain documented information
• Shall retain documented information
• Shall retain appropriate documented information
) list in posts 3-5 was primarily based on a search and interpreting the Master List of Documents" as to be defined by the key words "documented", "Procedure"
