ISO 22000 2018 Structure

ISO 22000 2018 is an international food safety management standard.
This page outlines the structure of this standard. For a more detailed version,
please
see ISO 22000 2018 Food Safety
Management Translated into Plain English.

Plain English Outline of ISO 22000 2018

4. Context

4.1 Understand your organization and its unique context.

4.2 Clarify the needs and expectations of interested parties.

4.3 Define the scope of your food safety management system.

4.4 Establish and maintain a food safety management system.

5. Leadership

5.1 Provide leadership by accepting responsibility for safety.

5.2 Provide leadership by establishing food safety policy.

5.2.1 Provide leadership by developing  a food safety policy.

5.2.2 Provide leadership by communicating food safety policy.

5.3 Provide leadership by assigning organizational roles.

5.3.1 Provide leadership by allocating responsibilities.

5.3.2 Provide leadership by supporting safety teams.

5.3.3 Provide leadership by encouraging feedback.

6. Planning

6.1 Define actions to manage your FSMS risks and opportunities.

6.1.1 Determine risks and opportunities when planning your FSMS.

6.1.2 Plan how you're going to address FSMS risks and opportunities.

6.1.3 Consider requirements and impacts when selecting FSMS actions.

6.2 Formulate FSMS objectives and develop plans to achieve them.

6.2.1 Establish FSMS objectives at relevant functions and levels.

6.2.2 Plan how to achieve your organization's FSMS objectives.

6.3 Control how FSMS changes are planned and implemented.

7. Support

7.1 Support your FSMS by providing the necessary resources.

7.1.1 Supply internal and external resources for your FSMS.

7.1.2 Verify the competence of your organization's FSMS people.

7.1.3 Provide the infrastructure needed to support your FSMS.

7.1.4 Establish a suitable work environment for your FSMS.

7.1.5 Consider how external FSMS elements are used.

7.1.6 Control the use of external FSMS elements.

7.2 Support your FSMS by ensuring that people are competent.

7.3 Support your FSMS by making people aware of their duties.

7.4 Support your FSMS by controlling relevant communications.

7.4.1 Support your FSMS by establishing communication systems.

7.4.2 Support your FSMS by facilitating external communication.

7.4.3 Support your FSMS by encouraging internal communication.

7.5 Support your FSMS by managing documented information.

7.5.1 Support your FSMS by including necessary documents and records.

7.5.2 Support your FSMS by managing the use of documents and records.

7.5.3 Support your FSMS by controlling relevant documents and records.

7.5.3.1 Control your organization's FSMS documents and records.

7.5.3.2 Control how FSMS documents and records are controlled.

8. Operations

8.1 Establish processes needed to realize safe products.

8.2 Establish suitable prerequisite programmes (PRPs).

8.2.1 Make sure that prerequisite programmes are developed.

8.2.2 Make sure that prerequisite programmes are implemented.

8.2.3 Make sure that prerequisite programmes are acceptable.

8.2.4 Make sure that prerequisite programmes are suitable.

8.3 Establish an effective product traceability system.

8.4 Establish emergency management arrangements.

8.4.1 Formulate emergency response procedures.

8.4.2 Respond to emergency situations and incidents.

8.5 Establish measures to control food safety hazards.

8.5.1 Get ready to do a food safety hazard analysis.

8.5.1.1 Consider the context of hazard analysis.

8.5.1.2 Consider raw materials and ingredients.

8.5.1.3 Consider end product characteristics.

8.5.1.4 Consider end use of end products.

8.5.1.5 Consider process flow diagrams.

8.5.1.5.1 Prepare product and process flow diagrams.

8.5.1.5.2 Confirm the accuracy of process flow diagrams.

8.5.1.5.3 Describe processes and process environment.

8.5.2 Perform your organization's hazard analysis.

8.5.2.1 Assign responsibility for hazards and controls.

8.5.2.2 Identify hazards and define acceptable levels.

8.5.2.2.1 Identify your food safety hazards.

8.5.2.2.2 Consider your hazard environment.

8.5.2.2.3 Define acceptable levels for hazards.

8.5.2.3 Assess your organization's food safety hazards.

8.5.2.4 Select measures to control your safety hazards.

8.5.2.4.1 Select and categorize each control measure.

8.5.2.4.2 Consider how each control can be supported.

8.5.3 Validate food safety control measures.

8.5.4 Establish your hazard control plan.

8.5.4.1 Document your hazard control plan.

8.5.4.2 Create critical limits and action criteria.

8.5.4.3 Develop monitoring systems for controls.

8.5.4.4 Specify corrections and corrective actions.

8.5.4.5 Implement your hazard control plan.

8.6 Establish up-to-date information if plan changes.

8.7 Establish control of your monitoring and measuring.

8.8 Establish and maintain food safety verification activities.

8.8.1 Plan and perform food safety verification activities.

8.8.2 Analyze results of food safety verification activities.

8.9 Establish control of product and process nonconformities.

8.9.1 Evaluate data derived from OPRP and CCP monitoring.

8.9.2 Make corrections whenever products or processes fail.

8.9.2.1 Control products when nonconformities occur.

8.9.2.2 Handle products as potentially unsafe if CCPs fail.

8.9.2.3 Evaluate what happened whenever your OPRPs fail.

8.9.2.4 Document corrections made on your nonconformities.

8.9.3 Document how corrective actions should be taken.

8.9.4 Control all food products that are potentially unsafe.

8.9.4.1 Prevent release or regain control of all unsafe products.

8.9.4.2 Evaluate lots of products affected by nonconformities.

8.9.4.3 Control the disposition of all nonconformity products.

8.9.5 Withdraw, recall, and secure all unsafe food products.

9. Evaluation

9.1 Monitor, measure, analyze, and evaluate your FSMS.

9.1.1 Plan how to monitor, measure, analyze, and evaluate.

9.1.2 Analyze and evaluate the performance of your system.

9.2 Use internal audits to examine conformance and performance.

9.2.1 Conduct internal audits of your FSMS at planned intervals.

9.2.2 Establish and maintain an internal FSMS audit programme.

9.3 Carry out management reviews and document your results.

9.3.1 Review suitability, adequacy, and effectiveness of your system.

9.3.2 Plan and perform management reviews at planned intervals.

9.3.3 Create management review outputs and document results.

10. Improvement

10.1 Control nonconformities and take appropriate corrective action.

10.1.1 Make corrections and take action when nonconformities occur.

10.1.2 Document all nonconformities and the actions that are taken.

10.2 Enhance the suitability, adequacy, and effectiveness of your FSMS.

10.3 Evaluate and update the FSMS and document your activities.

 

 If you'd like to see how we've translated each of the above sections into
Plain English, please check out our more detailed ISO 22000 2018 webpage.

OTHER ISO 22000 PAGES

Introduction to ISO 22000 2018

Food Safety Management Principles

Plain English Food Safety Management Definitions

Overview of ISO 22000 2018 Food Safety Management Standard

ISO 22000 2018 Food Safety Standard Translated into Plain English

Plain English Food Safety Management Gap Analysis Process

ISO 22000 2018 Food Safety Management Audit Tool

Plain English Food Safety Management Checklist

ISO 22000 2005 Translated into Plain English

ISO 22000 2018 versus ISO 22000 2005

Our Plain English Approach

Updated on August 23, 2019. First published on August 23, 2019.

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