ISO 22000 2005 Translated into Plain English

ISO 22000 2005 is an international food safety management standard.
Use it to establish and certify your food safety management system (FSMS).

This page presents a preview of ISO 22000. It doesn't present the entire standard.
ISO 22000 2005 defines a set of food safety requirements. These requirements are
listed in sections 4 to 8. Therefore, the following material starts with section 4.

 

4. Food Safety System Requirements

4.1
Establish a food
safety management
system (FSMS)

  • Develop an effective food safety management system.

  • Document your food safety management system.

  • Implement your food safety management system.

  • Maintain your food safety management system.

  • Evaluate your food safety management system.

  • Update your food safety management system.

4.2
Document your food
safety management
system (FSMS)

  • 4.2.1 Develop your food safety management documents.

  • 4.2.2 Control your food safety management documents.

    • Develop a procedure to control your FSMS documents.

    • Document your FSMS document control procedure.

  • 4.2.3 Control your food safety records.

    • Establish a set of records for your FSMS.

    • Develop a procedure to control your FSMS records.

    • Document your FSMS record control procedure.

 

 

5. Food Safety Management Requirements

5.1
Demonstrate a
commitment to
food safety

  • Make sure that your organization's top managers demonstrate a commitment to their food safety management system (FSMS).

  • Make sure that top managers support the establishment of a FSMS.

  • Make sure that top managers can prove that they support their FSMS.

5.2
Establish your
food safety policy

  • Make sure that your top managers establish a food safety policy.

  • Make sure that your top managers communicate their support for your organization's food safety policy.

  • Make sure that your top managers ensure that your food safety policy is implemented throughout your organization.

5.3
Plan your
food safety
management
system (FSMS)

  • Make sure that top managers plan the development of your FSMS.

  • Make sure that top managers plan the documentation of your FSMS.

  • Make sure that top managers plan the implementation of your FSMS.

  • Make sure that top managers plan the maintenance of your FSMS.

  • Make sure that top managers plan the evaluation of your FSMS.

  • Make sure that top managers plan the modification of your FSMS.

5.4
Clarify your FSMS
responsibilities
and authorities

  • Make sure that your top managers define your organization's FSMS responsibilities and authorities.

  • Make sure that your top managers communicate about FSMS responsibilities and authorities.           

  • Make sure that all personnel are responsible for reporting your organization's FSMS problems.

  • Make sure that designated personnel are given the responsibility and authority to solve FSMS problems.

5.5
Appoint a food
safety team leader

  • Give your team leader the job of managing your FSMS.

  • Give your team leader the authority to establish your FSMS.

  • Give your team leader the responsibility to report on your FSMS.

5.6
Establish your
communications

  • 5.6.1 Establish external communication arrangements.

    • Allocate the responsibility and authority to communicate externally about food safety.

    • Establish effective external communication arrangements to address food safety issues.

    • Implement effective external communication arrangements to address food safety issues.

    • Maintain effective external communication arrangements to address food safety issues.

  • 5.6.2 Establish internal communication arrangements.

    • Establish effective internal communication arrangements.

    • Implement effective internal communication arrangements.

    • Maintain effective internal communication arrangements.

5.7
Develop emergency
response procedures

  • Establish procedures to manage food safety emergencies and accidents.

  • Implement procedures to manage food safety emergencies and accidents.

  • Maintain procedures to manage food safety emergencies and accidents.

5.8
Carry out FSMS
management
reviews

  • 5.8.1 Review your organization's food safety management system.

  • 5.8.2 Examine management review inputs.

    • Review information (inputs) about your FSMS.

    • Ensure that review inputs allow top managers to see whether stated FSMS objectives are being achieved.

  • 5.8.3 Generate management review outputs.

    • Generate decisions and actions (outputs) that assure the safety of the food products that fall within your FSMS.

    • Generate decisions and actions (outputs) to improve the effectiveness of your organizationís FSMS.

    • Generate decisions and actions (outputs) to  update your organizationís food safety policy.

    • Generate decisions and actions (outputs) to  revise your organizationís food safety objectives.

    • Generate decisions and actions (outputs)  to address FSMS resource needs.                   

 

 

6. Food Safety Resource Requirements

6.1
Provide adequate
FSMS resources

  • Provide resources needed to establish your organization's FSMS.

  • Provide resources needed to implement your organization's FSMS.

  • Provide resources needed to maintain your organization's FSMS.

  • Provide resources needed to update your organization's FSMS.

6.2
Provide adequate
human resources

  • 6.2.1 Provide competent food safety personnel.

    • Make sure that food safety personnel are competent.

    • Maintain a record of the contracts and agreements you have with external food safety management system (FSMS) experts.

  • 6.2.2 Provide training and awareness programs.

    • Identify the competencies that personnel  who influence food safety must have.        

    • Deliver training to ensure that personnel  have the competencies they need.                   

    • Make personnel aware of how their individual  job performance influences food safety.              

    • Evaluate the effectiveness of FSMS  training and awareness activities.                  

    • Maintain a record of FSMS training.

6.3
Provide adequate
infrastructure

  • Establish the infrastructure needed to comply with ISO 22000.

  • Maintain the infrastructure needed to comply with ISO 22000.

6.4
Provide adequate
work environment

  • Establish the work environment needed to comply with ISO 22000.

  • Manage the work environment needed to comply with ISO 22000.

  • Maintain the work environment needed to comply with ISO 22000.

 

 

7. Food Safety Realization Requirements

7.1
Manage the
realization of
safe products

  • Plan the processes needed to realize safe products.

  • Develop the processes needed to realize safe products.

  • Implement the processes needed to realize safe products.

  • Operate the processes needed to realize safe products.

7.2
Establish your
prerequisite
programs (PRPs)

  • 7.2.1 Implement prerequisite programs (PRPs).

    • Establish PRPs for your organization.

    • Implement your organization's PRPs.

    • Maintain your organization's PRPS.

  • 7.2.2 Make sure that your PRPs are suitable.

    • Make sure that your PRPs meet your  organizationís unique food safety needs.

    • Make sure that your PRPs reflect and respect the  nature of your organization and how it operates.

    • Make sure that your PRPs meet legal requirements.

    • Make sure that your food safety team formally  approves your PRPs before they are implemented.

  • 7.2.3 Make sure that your PRPs are effective.

    • Consider appropriate information from external sources and use it to establish your organizationís PRPs.

    • Consider your organizationís circumstances and structure as you establish your particular PRPs.

    • Consider your organizationís service providers and suppliers as you establish your particular PRPs.

    • Consider how youíre going to ensure that your organizationís PRPs are implemented and effective.

7.3
Get ready to do
a hazard analysis

  • 7.3.1 Gather preliminary information.

    • Collect the information you will need in  order to conduct your hazard analysis.                        

    • Document all relevant information before  you carry out your hazard analysis.              

  • 7.3.2 Appoint a food safety team.

    • Appoint a multidisciplinary food safety team to  develop and implement your organizationís FSMS.

    • Maintain records that show that your food safety  team has the necessary knowledge and experience.

  • 7.3.3 Describe product characteristics.

    • 7.3.3.1 Describe ingredients and materials.

    • 7.3.3.2 Describe end product characteristics.

  • 7.3.4 Document the intended use of end products.

    • Describe the intended use of your end  products and document these descriptions.

    • Describe how you expect your end products to be handled under reasonable circumstances.

    • Identify user groups for each end product.

    • Make sure that your intended use documents are kept up to date.                           

    • Use your intended use documents  to prepare for your hazard analysis.                      

  • 7.3.5 Prepare flow diagrams and describe controls.

    • 7.3.5.1 Prepare flow diagrams for your products.

    • 7.3.5.2 Describe existing controls and procedures.

7.4
Perform your
organization's
hazard analysis

  • 7.4.1 Assess your food safety hazards and controls.

    • Make sure that your organizationís food  safety team carries out a hazard analysis.     

    • Make sure that your food safety team selects the measures that should be used to control hazards.

  • 7.4.2 Identify hazards and define acceptable levels.

    • 7.4.2.1 Identify your food safety hazards.

    • 7.4.2.2 Consider your hazard environment.

    • 7.4.2.3 Specify acceptable hazard levels.

  • 7.4.3 Assess your organization's food safety hazards.

    • Carry out a hazard assessment for each one  of your organizationís food safety hazards.

    • Describe your hazard assessment methodology.

    • Record results of your food safety hazard assessment.

  • 7.4.4 Select measures to control your hazards.

    • Use your hazard assessment to select control measures that are capable of controlling your organizationís food safety hazards.

    • Review your existing food safety control measures.

    • Study each control measure and decide whether you should use your operational PRPs or your HACCP plan to manage it.

    • Implement your food safety control measures.

    • Document the methodology and the parameters that were used to categorize your food safety control measures.

    • Record the results of your categorization decisions.

7.5
Establish your
operational
prerequisite
programs
(OPRPs)

7.6
Establish your
HACCP plan

  • 7.6.1 Document your organization's HACCP plan.

    • Establish an HACCP plan to control your organizationís food safety hazards.                 

  • 7.6.2 Identify your critical control points (CCPs).

    • Identify CCPs for each of the control measures  that will be used by your HACCP plan to manage  and control food safety hazards.                          

  • 7.6.3 Specify critical limits for each critical control point (CCP).

    • Specify critical limits for each CCP in order to  ensure that you do not exceed acceptable food  safety hazard levels for end products.                  

    • Explain why you have chosen your particular  critical limits and document your rationale.         

    • Use your critical limits to ensure that you do not exceed acceptable food safety hazard levels.        

  • 7.6.4 Monitor your critical control points (CCPs).

    • Establish a monitoring system for each CCP.

    • Establish procedures and instructions to help  you monitor your CCPs and critical limits.      

    • Establish a record keeping system to  track your CCP monitoring activities.         

  • 7.6.5 Respond to critical limit violations.

    • Use your HACCP plan to describe the actions you plan to take when you exceed or violate critical limits.     

    • Establish and maintain procedures to handle  products that are potentially unsafe.               

7.7
Update preliminary
documents and
programs

7.8
Plan and perform
your verification
activities

  • Plan your organization's FSMS verification activities.

  • Verify that your FSMS has been implemented.

  • Record the results of your verification activities.

  • Report verification results to your food safety team.

7.9
Establish a product
traceability system

  • Make sure that your system can trace product lots.

  • Make sure that your system can trace supplied materials.

  • Make sure that your system can trace product distribution.

7.10
Control your
nonconforming
products

  • 7.10.1 Identify and correct nonconforming products.

    • Identify and control the use and release  of all nonconforming products.                    

    • Establish a procedure to manage and  control your nonconforming end products.   

    • Manage and control your product corrections.

  • 7.10.2 Evaluate data and take corrective actions.

    • Evaluate data derived from the monitoring  of food safety hazards and control measures.

    • Establish and maintain corrective action procedures.

    • Use your procedures to take corrective actions.

    • Record the corrective actions you have taken.

  • 7.10.3 Manage potentially unsafe products.

    • 7.10.3.1 Control potentially unsafe products.

    • 7.10.3.2 Evaluate potentially unsafe products.

    • 7.10.3.3 Reprocess or dispose of unsafe products.

  • 7.10.4 Withdraw and secure unsafe products.

    • Appoint personnel and give them the authority to manage the withdrawal of unsafe end product lots.

    • Establish and maintain a procedure to control  the withdrawal of unsafe end product lots.

    • Use your procedure to withdraw unsafe product lots.

    • Secure or supervise all withdrawn end product lots.

    • Record your unsafe product withdrawal activities.

    • Report unsafe product withdrawals to top management.

    • Use appropriate techniques to verify the effectiveness of your organizationís product withdrawal program.

    • Record the effectiveness of your withdrawal program.

 

 

8. Food Safety Confirmation Requirements

8.1
Confirm and improve
food safety methods

  • Plan how to confirm that food safety methods are working.

  • Implement plans to confirm that food safety methods are working.

8.2
Validate food safety
control measures

  • Validate your control measures before you implement them.

    • Make sure that your validations can confirm that  your food safety control measures are effective.

  • Revalidate your control measures whenever you change them.

8.3
Control your
monitoring and

measuring methods

  • Prove that monitoring and measuring methods are adequate.

  • Verify your organization's measuring methods and equipment.

  • Validate your monitoring and measuring software.

8.4
Verify your food
safety management
system (FSMS)

  • 8.4.1 Perform regular internal audits.

    • Establish an internal audit program.

    • Plan your internal audit projects.

    • Perform regular internal audits of your FSMS.

    • Make sure that your managers solve problems discovered in their areas by internal auditors.     

    • Follow up on the actions taken by managers to  solve problems discovered during internal audits.     

  • 8.4.2 Evaluate your verification results.

    • Make sure that your food safety team evaluates the specific results of previous verification activities.

    • Take action if your evaluation shows that your FSMS fails to comply with your planned arrangements.

  • 8.4.3 Analyze your verification results.

    • Make sure that your food safety team analyses the specific results of previous verification activities.

    • Confirm that your FSMS meets requirements.

    • Figure out if your FSMS needs to be changed.

    • Identify potentially unsafe product trends.

    • Collect information to help you plan internal audits.

    • Collect evidence that proves that actions taken  to address nonconformities are effective.        

    • Record the results of your verification analysis  and the activities that result from your analysis.

    • Report the results of your verification analysis  and the activities that result from your analysis.

    • Use your analytical results and activities as input  to help you update your organizationís FSMS.

8.5
Improve your food
safety management
system (FSMS)

  • 8.5.1 Continually improve your organization's FSMS.

    • Use communication to help you continually  improve the effectiveness of your FSMS.

    • Use management reviews to help you continually improve the effectiveness of your FSMS.            

    • Use internal audits to help you continually  improve the effectiveness of your FSMS.               

    • Use corrective actions to help you continually improve the effectiveness of your FSMS.        

    • Use verification studies and research to help you continually improve the effectiveness of your FSMS.

    • Use control measure validation results to help you continually improve the effectiveness of your FSMS.

  • 8.5.2 Continually update your organization's FSMS.

    • Make sure that top management actively ensures  that your organization continually updates its FSMS.

    • Make sure that your food safety team  evaluates your FSMS at planned intervals.

    • Make sure that your food safety team studies their evaluation reports and then decides whether food safety programs and plans should be reviewed.

    • Update your organizationís FSMS.

    • Record your FSMS updating activities.

    • Report your FSMS updating activities.

 


Attention

This page summarizes the ISO 22000 2005 standard. It highlights
the main points. It does not present detail. To get the complete
plain English standard, please consider purchasing our
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MORE ISO 22000 PAGES

Introduction to Food Safety Management

Plain English Food Safety Management Definitions

Food Safety Management System Development Plan

Food Safety Management Gap Analysis Tool

Food Safety Management Audit Program

Our Plain English Approach

OTHER RELATED STANDARDS

Global Auditing Standard

Generic Risk Management Standard

Occupational Health and Safety Standard

Information Security Management Standard

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Updated on December 1, 2013. First published on November 30, 2006.

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