DOCUMENTATION

ISO 22000:2005
FOOD SAFETY MANAGEMENT SYSTEM

ISO 22000 DOCUMENTATION TRAINING QUARANCE CONSULTING IPB JULY 2013

ISO 22000:2005
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

ISO 22000:2005, clause 1

Process Approach

A desired result is achieved

Act
•How to improve
Plan
•What to do?
more efficiently when
next time? •How to do it? related resources and
activities are managed as a
process

Check
•Did things happen
Do
•Do what was
according to plan? planned
Process Approach
FSMS Process model
Key elements

ISO 22000:2005

Interactive Systems Approach Pre-requisite HACCP

Communication to FSM Programs Principles

Control Food Safety

Hazards
ISO 22000 standard - Requirements
 Section 4: Food Safety Management System
(FSMS) – General Requirements
 Section 5: Management Responsibility

 Section 6: Resource Management

 Section 7: Planning and Realization of Safe
Products
 Section 8: Validation, Verification and Improvement
of the Food Safety Management System
Section 4 – General Requirements
 Scope of the Food Safety Management System

 Documentation requirements

 More than twenty six types of documents required

by ISO 22000:2005

 Twenty eight mandatory records required by ISO

22000:2005

 Documents needed by the organization to ensure

effective development, implementation and updating
of the FSMS
Section 4 – Documentation requirement
 Mandatory documented procedures specified by
ISO 22000:2005

– Control of documents
– Control of records
– Corrections
– Corrective actions
– Handling potentially unsafe product
– Withdrawals
– Internal audits
Planning of safe food
Decision tree
Mandatory documentation for ISO 22000 Food
safety management system

• 1) Food Safety Policy

• 2) Food Safety Objectives
• 3) Identification and Control of Outsourced
Processes
• 4) Document control
• 5) Record control
• 6) Documents that specify how prerequisite
programme activities are managed
• 7) Information required to conduct the hazard
analysis
• 8) Descriptions of raw materials to the extent
needed to conduct the hazard analysis
• 9) Descriptions of Ingredients to the extent
needed to conduct the hazard analysis
• 10) Descriptions of product-contact materials
to the extent needed to conduct the hazard
analysis
• 11) The characteristics of end products
• 12) Descriptions of the intended use to the extent needed to
conduct the hazard analysis
• 13) Descriptions of the reasonably expected handling of the
end product to the extent needed to conduct the hazard
analysis
• 14) Descriptions of any possible unintended but reasonably
expected mishandling and misuse of the end product to the
extent needed to conduct the hazard analysis
• 15) Descriptions of the methodology and parameters used for
the categorization of control measures as belonging to the
HACCP plan or Operational prerequisite programmes
• 16) The food safety hazard or hazards to be
controlled by each operational prerequisite
programme
• 17) The food safety hazard or hazards to be
controlled by each operational prerequisite
programme
• 18) The control measures used by each
operational prerequisite programme
• 19) The monitoring procedures used in each
operational prerequisite programme
• 20) The corrections and corrective actions for
each operational prerequisite programme
• 21) The responsibilities and authorities for
each operational prerequisite programme
• 22) Records for each operational prerequisite
programme
• 23) The HACCP plan and identified critical
control points (CCPs)
• 24) The food safety hazards to be controlled at
each critical control point
• 25) The control measures used at each critical
control point
• 26) The monitoring procedures used at each
critical control point
• 27) The critical limits applied at each critical
control point
• 28) The rationale for the chosen critical limits
• 29) The corrections and corrective action to be
taken if critical limits are exceeded for each
critical control point
• 30) The responsibilities and authorities for
each aspect of the critical control point
• 31) Critical control point monitoring records
• 32) Procedures for the handling of potentially unsafe
products, including the controls, methods and
authorization levels.
• 33) Procedures for withdrawing products including
notification to relevant interested parties, handling
of withdrawn products as well as affected products
in stock and the sequence of actions to be taken.
• 34) Procedure for Corrections including the
identification and assessment of affected end
products
• 35) Records of the review of corrections carried out
• 36) Procedure for Corrective Action that specifies the
appropriate actions to identify and eliminate the cause of
detected nonconformities, to prevent recurrence, and to bring
the process or system back into control after nonconformity is
encountered.
• 37) The corrective action procedure must include a review of
non-conformances including customer complaints
• 38) The corrective action procedure must include a review of
trends in monitoring results that may indicate development
towards loss of control
• 39) The corrective action procedure must include a review to
determine the causes of non-conformances
• 40) The corrective action procedure must include an
evaluation of the need for action to ensure that
nonconformities do not recur
• 41) The corrective action procedure must include a
how the actions needed are determined
• 42) The corrective action procedure must include a
how the actions needed are implemented
• 43) Records of corrective actions
• 44) Records of the review of corrective actions taken
to ensure that they are effective
• 45) Procedure for Internal Auditing including
responsibilities and requirements for planning and
conducting audits, for reporting results and
maintaining records.
• 46) Internal Audit records
• 47) External documents relevant for the food
safety activities including statutory, regulatory
and customer requirements.
• The extent of the documentation will differ
from one organization to another depending
on the size and complexity of the operation
and the competence of personnel.
 Record Review
• Monitoring activities have been performed at the
locations specified in the FSMS plan
• Monitoring activities have been performed at the
frequencies specified in the FSMS plan
• Corrective actions have been performed whenever
monitoring indicated deviation from critical limits
• Equipment has been calibrated at the frequencies
specified in the FSMS plan