3. Who is ISO?
• The International Organization for Standardization
(ISO) creates many different types of standards.
– ISO is made up of Standards Institutes from 154 different
countries.
– Member countries work together to develop and approve
standards.
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4. What is ISO 22000?
• It is a Food Safety Management System (FSMS)
that uses a management system approach and
HACCP requirements.
• The goal is to provide one internationally
recognized standard for a food safety management
system that can be applied to any organization in
the food chain.
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5. What is FSSC 22000?
• FSSC 22000 is a Food Safety Certification that
uses ISO 22000 and PAS 220
• PAS 220 gives the requirements for Prerequisite Programs for
food manufacturers.
• This document was added to ISO 22000 to create a system that
could be benchmarked by the Global Food Safety Initiative
(GFSI)
• Some large retailers require suppliers to have a GFSI
benchmarked scheme.
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6. FSSC 22000 or ISO 22000?
• If your customers want a GFSI registration scheme,
then you will use FSSC 22000
• FSSC 22000 applies only to food manufacturers, so
if you are not a manufacturer, you will use ISO
22000
• Manufacturers will need to evaluate the market and
determine which standard is most appropriate for
them
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7. How does an organization become
22000 registered?
• You need to decide if your goal is ISO 22000
compliance-
– You will implement the system and follow it, and
use self-assesment to demonstrate conformity
• If your goal is ISO 22000 Registration
– You will implement the ISO 22000 system in your
organization,
• If your goal is FSSC 22000 Registration
– You will implement the ISO 22000 system, and the
PAS 220 prerequisite programs
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9. Implementation of ISO 22000 or FSSC 22000
• You will need to develop an implementation plan that
covers:
– Education on the contents of the standard
– A comparison of your current system to the requirements of ISO
22000, often called a gap analysis
– A comparison of your current prerequisite programs against the
requirements of PAS 220 (for FSSC 22000)
– A timeline of the implementation steps based on the gap analysis
– Time to run the Food Safety Management System, collect records
and make improvements before your registration audit.
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10. Implementation Steps
• Assign a Food Safety Management Team
– This team will be active in the design and development of the FSMS
and participate in the continued management of the system.
• Assign a Management Team (22000 Steering Team)
– This team will also be active in both the design and development and
the ongoing management of the system.
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11. Implementation Steps:
• The Management Team will act as a steering team
for the project, assigning responsibilities, providing
resources and coordinating the project.
– The Management Team can assign task teams to work
on specific processes that must be designed and
documented for the FSMS.
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12. Implementation Steps:
• Each task team will evaluate the current process
that they are assigned to and the requirements of
the standard.
– A new or modified process will be developed,
documented and submitted to the Management Team for
review and approval.
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13. Implementation Steps
• After the task teams have designed and
documented a new or modified process, it must be
implemented. Train all employees that are involved
in the process
• When the required processes have been
implemented, start your internal audit program and
management review meetings.
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14. Implementation Steps
• Use information from internal audits and
management review to make improvements to the
FSMS. Run your system long enough to generate
records for the Registrar to audit.
• Make sure all employees are trained on your 22000
FSMS
• Have a Registrar conduct your Registration Audit.
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16. Overview of Requirements:
General
• The organization must develop an
effective system that meets the
requirements of the Standard, document,
implement and maintain the system.
• The system must be evaluated and
updated to stay current.
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17. Overview of Requirements:
Management
• Management must be involved in and committed to the
FSMS. They will write the Food Safety Policy and be
responsible for making sure it is communicated and
implemented.
• Top Management must be involved in the design and
implementation of the FSMS. Many specific responsibilities
are assigned to Top Management to ensure their input and
participation.
• After implementation Management will conduct
management review to ensure continued effectiveness of
the system.
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18. Overview of Requirements:
Resources
• The FSMS must clarify what resources, human and
physical are required to create safe product.
• During development of the system you will
determine how to ensure competent personnel,
identify training that is required, and identify the
infrastructure and work environment required
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19. Overview of Requirements:
Making your product
• Your organization will need to plan all of the
processes that go into making your product to
ensure safe product.
• Prerequisite programs will be established,
implemented and evaluated on an ongoing basis. If
you are looking for FSSC 22000 Certification, your
prerequisite programs must meet the requirements
of PAS 220.
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20. Overview of Requirements:
Making your product
• Establish and document a system for:
– Collecting preliminary information for hazard analysis
– Conducting hazard analysis
– Establishing the HACCP Plan
– Conducting verification activities
– Tracing product, materials and distribution
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21. Overview of Requirements:
Nonconforming Product
• Establish and document a system for controlling all
nonconforming product
– When a Critical Control point is exceeded potentially
unsafe product must be identified, assessed, controlled
and dispositioned appropriately. An established
withdrawal process is necessary so quick action can be
taken if needed.
– Identify corrections and corrective actions to be taken to
eliminate the nonconformity and the cause of
nonconformity.
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22. Overview of Requirements:
Validation
• Establish and document a process to validate
control measures before they are implemented.
Plan for revalidation when changes are made.
• Ensure that all measuring and monitoring devices
and methods are capable of providing the accuracy
needed.
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23. Overview of Requirements:
Verification
• Establish and document an internal audit process.
Train auditors, and plan internal audits to establish
an audit program that will determine if the FSMS is
effective and up to date.
• Implement a process for the Food Safety Team to
evaluate and analyze verification results and take
any necessary actions.
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24. Overview of Requirements:
Improvement
• Continually improve the FSMS through the use of:
– Management review
– Internal audits
– Corrective actions
– Verification results
– Validation results
• Update the FSMS
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26. www.22000-Tools.com
• 22000 Food Safety Management Systems
– Start your project with our professionally designed
documentation.
– Our 22000 FSMS Document package provides you with
Microsoft Word and Excel documents to use as a
foundation for your FSMS.
– Customize these procedures, forms and Food Safety
Manual to save time and ensure an efficient, effective
system.
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27. Step by Step Workbook and Presentations
22000 Workbook and Presentation Package
• Detailed checklists, exercises and training
presentations to help you lead your team through
the implementation process
• Five sections, each with a training presentation
guide you through:
• The Project Plan
• Introduction to ISO 22000
• GMP-CODEX-HACCP
• Your HACCP Plan
• ISO 22000 Registration
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28. ISO 22000 Computer-based Training
• “Understanding ISO 22000 Food Safety
Management Systems”
• A computer based training program that your team or employees
can work through on their own to learn the requirements of
ISO 22000.
• A training certificate is provided after the participant passes the
final test.
• Use this training to train your management team, those involved
in the implementation and all of your employees.
• This training can be customized with your company name, logo
and food safety policy as well as other customizing you request.
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29. Get all our Tools in a Value Package:
• ISO 22000 Complete Package
• Introduction to ISO 22000: Computer Training
• Step by Step Workbook and Presentation Package
• Gap Analysis/Internal Audit Checklist
• ISO 22000 PowerPoint Presentation with speaker notes
• ISO 22000 Documentation Package
» Procedures
» Forms
» Food Safety Manual
• ISO 22000 Internal Auditor Training CD
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30. Internal Auditor Training on CD
• This computerized training program will prepare
your internal audit team to conduct internal audits
of your Food Safety Management System
• The training include 4 sections:
» Requirements of ISO 22000
» Principles of HACCP
» Prerequisite Programs
» Internal Auditing
• The Internal Audit section will teach audit techniques and
procedures and coach the participant through a practice audit at
your facility.
• The training includes audit forms as well as procedures and
checklists for the practice audit.
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31. For more information visit us at:
www.22000-Tools.com
952-250-7172
www.22000-Tools.com
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