ISO 22000 2018 Translated into Plain English

This page presents a detailed overview of ISO 22000 2018 and provides a PDF sample of our approach.

4. Context

4.1 Understand your organization and its unique context

•  Identify and understand your organization's context.

• Identify and understand your organization's context before
you establish its food safety management system (FSMS).

• Consider the external issues that are relevant to your organization's
purpose and think about the influence these issues could have on
its FSMS and the results it intends to achieve.

• Consider the internal issues that are relevant to your organization's
purpose and think about the influence these issues could have on
its FSMS and the results it intends to achieve.

•  Review information about your organization's context.

• Review the impact changes in context could have on your FSMS.

•  Update information about your organization's context.

• Update information about the external issues that could influence your FSMS.

• Update information about the internal issues that could influence your FSMS.

4.2 Clarify the needs and expectations of interested parties

•  Identify the interested parties who are relevant to your FSMS.

•  Identify the food safety requirements of these interested parties.

•  Monitor the changing needs and expectations of interested parties.

•  Review information about your organization's interested parties.

•  Update information about your organization's interested parties.

4.3 Define the scope of your food safety management system

•  Clarify boundaries and think about what your FSMS should apply to.

•  Use this boundary information to define the scope of your FSMS.

•  Document the scope and boundaries of your organization's FSMS.

•  Specify the products that must be part of your FSMS.

•  Specify the services that must be part of your FSMS.

•  Specify the activities that must be part of your FSMS.

•  Specify the processes that must be part of your FSMS.

•  Specify the production sites that must be part of your FSMS.

•  Maintain documented information defining the scope of your FSMS.

•  Control documented information that defines the scope of your FSMS.

4.4 Establish and maintain a food safety management system

•  Establish a FSMS in accordance with the ISO 22000 2018 standard.

•  Establish the processes that your organization's FSMS needs.

•  Implement your FSMS in accordance with the ISO 22000 2018 standard.

•  Maintain your FSMS in accordance with the ISO 22000 2018 standard.

•  Update your FSMS in accordance with the ISO 22000 2018 standard.

•  Improve your FSMS in accordance with the ISO 22000 2018 standard.

5. Leadership

5.1 Provide leadership by accepting responsibility for safety

•  Provide leadership by making a commitment to food safety.

•  Provide leadership by demonstrating a commitment to your FSMS.

•  Provide leadership by communicating a commitment to the FSMS.

•  Provide leadership by ensuring that your FSMS is evaluated regularly.

•  Evaluate how well your organization's FSMS achieves intended results.

•  Provide leadership by ensuring that your FSMS is properly maintained.

•  Make sure that your FSMS continues to achieve intended results.

5.2 Provide leadership by establishing a food safety policy

5.2.1 Provide leadership by developing a food safety policy

•  Develop an appropriate food safety policy.

•  Make sure that it is compatible with your organization's context.

•  Make sure that it is compatible with your organization's purpose.

•  Prepare your organization’s food safety policy.

•  Make a commitment to support food safety.

•  Implement your organization's food safety policy.

•  Maintain your organization's food safety policy.

5.2.2 Provide leadership by communicating food safety policy

•  Document your organization's food safety policy.

•  Maintain your organization's food safety policy.

•  Control your organization's food safety policy.

•  Communicate your organization's food safety policy.

•  Make your policy available at all levels within the organization.

•  Make your policy available to interested parties (when appropriate).

•  Apply your organization’s food safety policy.

•  Make sure that personnel follow your food safety policy.

5.3 Provide leadership by assigning organizational roles

5.3.1 Provide leadership by allocating responsibilities

•  Appoint a food safety team leader and food safety team members.

•  Assign all relevant food safety roles, responsibilities, and authorities.

•  Allocate responsibility and authority for your organization's FSMS.

•  Communicate all FSMS roles, responsibilities, and authorities.

5.3.2 Provide leadership by supporting food safety teams

•  Assign responsibilities to the leader of your food safety team.

•  Make your team leader responsible for establishing a FSMS.

•  Make your team leader responsible for managing a food safety team.

5.3.3 Provide leadership by encouraging feedback

•  Identify persons authorized to receive reports about FSMS problems.

•  Assign responsibility for reporting your organization's FSMS problems.

6. Planning

6.1 Define actions to manage your FSMS risks and opportunities

6.1.1 Determine risks and opportunities when planning your FSMS

•  Plan the development of your food safety management system (FSMS).

•  Identify the risks and opportunities that could influence the overall
performance of your organization's FSMS or disrupt its operation.

• Consider how your organization's context could affect
how well its FSMS is able to achieve intended results.

• Consider how your organization's interested parties could
affect how well its FSMS is able to achieve intended results.

• Consider how the scope of your organization's FSMS could
affect how well it is able to achieve intended results.

•  Figure out what you need to do to address the risks and opportunities that could
influence the performance of your organization's FSMS or disrupt its operation.

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

•  Plan actions to address your organization's FSMS risks and opportunities.

•  Plan actions that you can take to address the risks and opportunities that could
influence the performance of your FSMS or disrupt or damage its operation.

•  Consider the potential impact on products and services when you define
the actions you plan to take to address FSMS risks and opportunities.

6.1.3 Consider requirements and impacts when selecting FSMS actions

•  Consider options when selecting actions to address FSMS risks and opportunities.

•  Consider avoiding the risks that could influence the performance
of your organization's FSMS or disrupt or damage its operation.

•  Consider reducing the risks that could influence the performance
of your organization's FSMS or disrupt or damage its operation.

•  Consider retaining the risks that could influence the performance
of your organization's FSMS or disrupt or damage its operation.

•  Consider sharing the risks that could influence the performance
of your organization's FSMS or disrupt or damage its operation.

•  Select actions to address risks and opportunities that could influence your FSMS.

•  Select actions that are appropriate and proportionate to the impact on requirements.

•  Select actions that are appropriate and proportionate to the impact on conformity.

6.2 Formulate FSMS objectives and develop plans to achieve them

6.2.1 Establish FSMS objectives at relevant functions and areas

•  Clarify criteria for setting your FSMS objectives.

•  Set FSMS objectives at relevant levels and functions.

•  Communicate your organization's FSMS objectives.

•  Maintain your organization's FSMS objectives.

6.2.2 Plan how to achieve your organization's FSMS objectives

•  Establish plans to achieve FSMS objectives.

•  Plan how you’re going to evaluate your results.

6.3 Control how FSMS changes are planned and implemented

•  Plan changes to your FSMS (including personnel changes).

•  Consider the purpose of the changes you intend to make.

•  Consider responsibilities and authorities whenever you make changes.

•  Consider the consequences that changes could potentially produce.

•  Consider the availability of resources whenever you make changes.

•  Consider the integrity of your FSMS whenever you make changes.

•  Implement changes to your FSMS (including personnel changes).

7. Support

7.1 Support your FSMS by providing the necessary resources

7.1.1 Supply internal and external resources for your FSMS

•  Consider the resources that your organization's FSMS needs.

•  Consider your organization's internal capabilities and constraints.

•  Consider what needs to be obtained from external resource providers.

•  Determine the resources that your organization's FSMS needs.

•  Identify the resources that are needed to establish your FSMS.

•  Identify the resources that are needed to implement your FSMS.

•  Identify the resources that are needed to maintain your FSMS.

•  Identify the resources that are needed to update your FSMS.

•  Identify the resources that are needed to improve your FSMS.

•  Provide the resources that your organization's FSMS needs.

7.1.2 Verify the competence of your Organization's FSMS people

•  Verify the competence of your organization's own FSMS personnel.

•  Verify the competence of external experts used to establish your FSMS.

•  Document the competence of external experts used to establish your FSMS.

•  Retain documents describing the competence of experts used to establish FSMS.

7.1.3 Provide the infrastructure that your FSMS needs to have

•  Provide the resources needed to support your FSMS infrastructure.

•  Provide resources needed to determine infrastructure requirements.

•  Determine your organization's FSMS infrastructure requirements.

•  Provide resources needed to ensure infrastructure meets requirements.

•  Provide the resources needed to establish your FSMS infrastructure.

•  Provide the resources needed to maintain your FSMS infrastructure.

7.1.4 Establish a suitable work environment for your FSMS

•  Determine the resources needed to support your FSMS work environment.

•  Provide the resources needed to support your FSMS work environment.

•  Provide resources needed to identify work environment requirements.

•  Determine your organization's unique work environment requirements.

•  Provide the resources needed to establish your FSMS work environment.

7.1.5 Consider how external FSMS elements are used

•  Plan how externally developed FSMS elements are managed.

•  Control how externally developed FSMS elements are managed.

•  Control how externally developed FSMS elements are developed.

•  Control how these externally developed FSMS elements are applied.

•  Control how externally developed FSMS elements are maintained.

•  Control how externally developed FSMS elements are updated.

•  Document how externally developed FSMS elements are managed.

7.1.6 Control the use of external FSMS elements

•  Establish criteria to control external FSMS elements.

•  Establish criteria for the evaluation of external providers of FSMS elements.

•  Establish criteria for the selection of external providers of FSMS elements.

•  Establish criteria for the monitoring of external providers of FSMS elements.

•  Establish criteria for the re-evaluation of external providers of FSMS elements.

•  Control the use of externally provided FSMS elements.

•  Communicate your requirements to external providers.

•  Use criteria to control externally provided FSMS elements.

•  Document external provider evaluations and re-evaluations.

7.2 Support your FSMS by ensuring that people are competent

•  Consider work under your control that could affect food safety.

•  Clarify your organization's food safety competence requirements.

•  Acquire competence whenever gaps or deficiencies are discovered.

•  Evaluate results whenever actions are taken to acquire competence.

•  Document the competence of those who could influence food safety.

•  Periodically review the competence of people who affect food safety.

7.3 Support your FSMS by making people aware of their duties

•  Make all relevant persons aware of your organization's FSMS.

•  Share information with people under your organization's control.

•  Make all relevant persons aware of your organization's food safety policy.

•  Make all relevant persons aware of FSMS objectives relevant to their own work.

•  Make all relevant persons aware of how they can actively support food safety.

7.4 Support your FSMS by controlling relevant communications

7.4.1 Support your FSMS by establishing communication systems

•  Support your FSMS by managing FSMS communications.

•  Support your FSMS by establishing communication systems.

•  Support your FSMS by encouraging effective communication.

7.4.2 Support your FSMS by facilitating external communication

•  Establish external food safety communication arrangements.

•  Establish communication arrangements with regulatory authorities.

•  Establish communication arrangements throughout your food chain.

•  Implement external food safety communication arrangements.

•  Allocate authority to communicate externally about food safety.

•  Carry out effective communications throughout your food chain.

•  Maintain external food safety communication arrangements.

•  Maintain communication arrangements with external parties.

•  Maintain records of external food safety communications.

7.4.3 Support your FSMS by encouraging internal communication

•  Establish an internal food safety communication system.

•  Implement an internal food safety communication system.

•  Discuss food safety issues and concerns in a timely manner.

•  Consider food safety issues and concerns when you update FSMS.

•  Maintain an internal food safety communication system.

7.5 Support your FSMS by managing documented information

7.5.1 Support your FSMS by including necessary documents and records

•  Figure out how extensive documented FSMS information should be.

•  Consider your activities when you establish documents and records.

•  Consider your workers when you establish documents and records.

•  Consider your requirements when you establish documents and records.

•  Consider your processes when you establish documents and records.

•  Consider your products when you establish documents and records.

•  Select and include all necessary food safety documents and records.

•  Include all the information required by customers.

•  Include all the information that your organization needs.

•  Include all the information required by external authorities.

•  Include all the information required by the ISO 22000 standard.

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

•  Manage the creation and modification of your FSMS documents and records.

•  Make sure that documents and records are properly identified and described.

•  Make sure that documents and records are properly formatted and presented.

•  Make sure that documents and records are properly reviewed and approved.

7.5.3 Support your FSMS by controlling relevant documents and records

7.5.3.1 Control your organization's FSMS documents and records

•  Select all of the FSMS documents and records that you need to control.

•  Select all of the documents and records that you need in order to
protect the confidentiality, integrity, and use of FSMS information.

•  Select all the FSMS documents and records that ISO 22000 requires.

•  Control all necessary food safety documents and records.

•  Control all the food safety information required by your customers.

•  Control all the food safety information required by your organization.

•  Control all the food safety information required by external authorities.

•  Control all the information required by the ISO 22000 2018 standard.

7.5.3.2 Control how FSMS documents and records are controlled

•  Control how FSMS documents and records are controlled.

•  Control how FSMS documents and records are created.

•  Control how FSMS documents and records are identified.

•  Control how FSMS documents and records are distributed.

•  Control how FSMS documents and records are accessed.

•  Control how FSMS documents and records are retrieved.

•  Control how FSMS documents and records are stored.

•  Control how FSMS documents and records are used.

•  Control how FSMS documents and records are changed.

•  Control how FSMS documents and records are protected.

•  Control how FSMS documents and records are preserved.

8. Operations

8.1 Establish processes needed to realize safe products

•  Plan operational processes needed to meet food safety requirements.

•  Implement operational processes needed to meet food safety requirements.

•  Control operational processes needed to meet food safety requirements.

•  Maintain operational processes needed to meet food safety requirements.

•  Update operational processes needed to meet food safety requirements.

8.2 Establish suitable prerequisite programmes (PRPs)

8.2.1 Make sure that prerequisite programmes are developed

•  Prevent or reduce product contamination by developing PRPs.

•  Prevent or reduce product contamination by implementing PRPs.

•  Prevent or reduce product contamination by maintaining PRPs.

•  Prevent or reduce product contamination by updating PRPs.

8.2.2 Make sure that prerequisite programmes are implemented

•  Establish your organization's prerequisite programmes (PRPs).

•  Authorize your organization's prerequisite programmes (PRPs).

•  Make sure that PRPs have been approved by the food safety team.

•  Implement these PRPs throughout your entire production system.

8.2.3 Make sure that prerequisite programmes are acceptable

•  Consider external requirements as you develop your PRPs.

•  Consider relevant legal requirements when you develop your PRPs.

•  Consider relevant customer requirements when you develop your PRPs.

•  Consider relevant industry requirements when you develop your PRPs.

8.2.4 Make sure that prerequisite programmes are suitable

•  Ensure that your PRPs are appropriate to your circumstances.

•  Consider your organization's situation as you establish PRPs.

•  Consider your consumers as you establish your PRPs.

•  Consider contaminants as you establish your PRPs.

•  Consider your processes as you establish your PRPs.

•  Consider external inputs as you establish your PRPs.

•  Consider your infrastructure as you establish PRPs.

•  Consider your suppliers' constraints as you establish PRPs.

•  Ensure that PRP records and documents are established.

•  Document how your organization's PRPs should be managed.

8.3 Establish an effective product traceability system

•  Develop an effective material and product traceability system.

•  Implement your material and product traceability system.

•  Evaluate your material and product traceability system.

•  Maintain your material and product traceability system.

8.4 Establish emergency management arrangements

8.4.1 Formulate emergency response procedures

•  Establish procedures to respond to potential emergency situations and incidents.

•  Address situations and incidents that could have an impact on food safety.

•  Document your emergency response procedures and maintain a record of results.

•  Use your documents and records to support emergency response activities.

8.4.2 Respond to emergency situations and incidents

•  Consider relevant emergency response requirements.

•  Prepare for food safety incidents and emergencies.

•  Respond to food safety incidents and emergencies.

•  Mitigate the impact of all incidents and emergencies.

•  Periodically test your emergency response procedures.

•  Review your emergency response documents and records.

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

•  Plan and prepare for your food safety hazard analysis.

•  Assign planning responsibilities to your food safety team.

•  Collect information needed to conduct hazard analysis.

•  Document information needed to conduct hazard analysis.

8.5.1.2 Consider raw materials and ingredients

•  Consider all applicable food safety requirements.

•  Consider information needed to do a hazard analysis.

•  Consider all applicable information about ingredients.

•  Consider all applicable information about raw materials.

•  Consider all applicable information about product contact materials.

•  Consider all applicable information about storage conditions and shelf life.

•  Consider all applicable information about your production methods.

•  Consider all applicable information about preparation and handling.

•  Consider all applicable information about packaging methods.

•  Consider all applicable information about delivery methods.

•  Consider all applicable information about acceptance criteria.

•  Consider all applicable information about place of origin.

•  Consider all applicable information about sources.Vaed.

8.5.1.3 Consider all end product characteristics

•  Prepare for hazard analysis by considering end product characteristics.

•  Identify all relevant legal food safety requirements for end products.

•  Document characteristics for the end products you intend to produce.

8.5.1.4 Consider intended use of end products

•  Maintain information that documents end product handling and use.

•  Identify groups of consumers and users for each type of end product.

•  Prepare for hazard analysis by considering end product handling and use.

•  Prepare by considering the intended use and handling of your end products.

•  Prepare by considering the unintended use and mishandling of end products.

8.5.1.5 Consider your process flow diagrams

8.5.1.5.1 Prepare product and process flow diagrams

•  Make food safety team responsible for flow diagrams.

•  Prepare appropriate flow diagrams for your FSMS.

•  Maintain flow diagrams for your organization’s FSMS.

•  Use flow diagrams to prepare for your hazard analysis.

8.5.1.5.2 Confirm the accuracy of process flow diagrams

•  Expect your food safety team to maintain FSMS flow diagrams.

•  Expect your team to confirm the accuracy of their diagrams.

•  Expect team to retain diagrams as documented information.

8.5.1.5.3 Describe processes and process environment

•  Assign responsibility for describing processes and environment.

•  Describe your FSMS processes and your process environment.

•  Describe the layout of premises including food handling areas.

•  Describe processing equipment and associated processing aids.

•  Describe steps taken to manage and control food safety hazards.

•  Describe variations or patterns that could influence food safety.

•  Describe external requirements that can impact control measures.

8.5.2 Perform your organization's hazard analysis

8.5.2.1 Assign responsibility for hazards and controls

•  Assign responsibility for hazard analyses.

•  Make food safety team responsible for this.

•  Review information prior to your analysis.

•  Carry out your food safety hazard analysis.

8.5.2.2 Identify hazards and define acceptable levels

8.5.2.2.1 Identify your food safety hazards

•  Review information prior to your hazard analysis.

•  Consider the context of your hazard analysis.

•  Identify and document your food safety hazards.

•  Identify hazards that are reasonably expected to occur.

•  Document hazards that are reasonably expected to occur.

8.5.2.2.2 Consider your hazard environment

•  Identify the steps or stages where food safety hazards occur.

•  Identify receiving steps or stages where hazards could occur.

•  Identify processing steps or stages where hazards could occur.

•  Identify distribution steps or stages where hazards could occur.

•  Identify delivery steps or stages where hazards could occur.

•  Consider food safety hazards in your organization’s situation.

•  Identify food safety hazards at all relevant stages and steps.

•  Identify food safety hazards in your organization’s infrastructure.

8.5.2.2.3 Define acceptable levels for hazards

•  Determine an acceptable hazard level for each end product.

•  Consider relevant information as you review food safety hazards.

•  Maintain documents that describe acceptable hazard levels.

8.5.2.3 Assess your organization's food safety hazards

•  Conduct a hazard assessment for each identified safety hazard.

•  Assess each one of your organization’s food safety hazards.

•  Identify and document all significant food safety hazards.

•  Describe the methods used to conduct hazard assessments.

8.5.2.4 Select measures to control your safety hazards

8.5.2.4.1 Select and categorize each control measure

•  Select measures to control your food safety hazards.

•  Consider external requirements when you select control measures.

•  Study your hazard assessment and select suitable control measures.

•  Describe how measures were selected and document your results.

•  Retain relevant external requirements as documented information.

•  Categorize measures to control food safety hazards.

8.5.2.4.2 Consider how each control can be supported

•  Consider what can be done to enhance and support control measures.

•  Consider if critical limits or observable action criteria are feasible.

•  Consider if monitoring methods can be used to detect control failures.

•  Consider if corrections can be applied quickly when failures occur.

8.5.3 Validate food safety control measures

•  Assign responsibility for the validation of your control measures.

•  Confirm that each control measure can achieve intended results.

•  Reconsider your options if control measures fail to work as intended.

•  Consider modifying control measures if they fail to achieve intended results.

•  Consider modifying your approach if control measures fail to work properly.

•  Reassess your control measures whenever modification are made.

8.5.4 Establish your hazard control plan

8.5.4.1 Document your hazard control plan

•  Establish and maintain your hazard control plan.

•  Document your organization’s hazard control plan.

•  Document responsibilities and authorities for each CCP.

•  Document responsibilities and authorities for each OPRP.

8.5.4.2 Create critical limits and action criteria

•  Specify measurable critical limits for each of your CCPs.

•  Use critical limits to ensure that acceptable levels are not exceeded.

•  Specify measurable or observable action criteria for each OPRP.

•  Use action criteria to ensure that acceptable levels are not exceeded.

8.5.4.3 Develop a monitoring system for controls

•  Establish a monitoring system for each control or combination of controls.

•  Establish monitoring system for each control (or set of controls) at each CCP.

•  Establish monitoring system for each control (or set of controls) and OPRP.

•  Use monitoring systems to see whether or not control measures are working.

•  Use monitoring systems to detect failure to remain within critical limits.

•  Use monitoring systems to detect failure to meet relevant action criteria.

8.5.4.4 Specify corrections and corrective actions

•  Specify the steps that must be taken when controls fail to work.

•  Specify corrections that must be made when controls fail to work.

•  Specify corrective actions that must be taken when controls fail to work.

•  Take remedial steps whenever controls fail to work as planned.

•  Prevent the release of potentially unsafe food products.

•  Identify the cause of safety failures and nonconformities.

•  Return safety parameters back to where they should be.

8.5.4.5 Implement your hazard control plan

•  Implement your organization’s hazard control plan.

•  Maintain your organization’s hazard control plan.

•  Document your organization’s hazard control plan.

8.6 Establish up-to-date information if plan changes

•  Update information whenever hazard control plan is updated (if necessary).

•  Update related product documents whenever hazard control plan changes.

•  Update related process documents whenever hazard control plan changes.

•  Update related control documents whenever hazard control plan changes.

8.7 Establish control of your monitoring and measuring

•  Prove that your monitoring and measuring methods and equipment are adequate.

•  Prevent changes to monitoring and measuring equipment that invalidate results.

•  Assess the validity of previous measurements whenever failures are discovered.

•  Take appropriate action whenever your measurements fail to meet requirements.

•  Control use and validation of software used to carry out monitoring and measuring.

8.8 Establish and maintain food safety verification activities

8.8.1 Plan and perform food safety verification activities

•  Establish food safety verification activities.

•  Plan your food safety verification activities.

•  Perform your food safety verification activities.

•  Communicate food safety verification activities.

•  Maintain your food safety verification activities.

8.8.2 Analyze results of food safety verification activities

•  Assign responsibility for analyzing food safety verifications.

•  Make food safety team responsible for analyzing verification results.

•  Analyze the results of your food safety verification activities.

•  Use your analytical results to help evaluate the performance of FSMS.

8.9 Establish control of product and process nonconformities

8.9.1 Evaluate data derived from OPRP and CCP monitoring

•  Appoint competent people to evaluate data from monitoring OPRPs and CCPs.

•  Give them the authority they need to initiate corrections and corrective actions.

•  Evaluate the data derived from the monitoring of your OPRPs and at CCPs.

8.9.2 Make corrections whenever products or processes fail

8.9.2.1 Control products when nonconformities occur

•  Establish ways of managing affected products when nonconformities occur.

•  Establish methods of controlling products when nonconformities occur.

•  Establish arrangements for reviewing corrections that are carried out.

•  Identify and control affected products whenever nonconformities occur.

•  Identify and control products when critical limits at CCPs aren't met.

•  Identify and control products when action criteria for OPRPs aren't met.

8.9.2.2 Handle products as potentially unsafe if CCPs fail

•  Identify affected products whenever critical limits at CCPs aren't met.

•  Treat affected products as potentially unsafe when critical limits aren't met.

8.9.2.3 Evaluate what happened whenever your OPRPs fail

•  Evaluate what happened whenever action criteria for OPRPs are not met.

•  Document what happened whenever action criteria for OPRPs are not met.

8.9.2.4 Document corrections made on your nonconformities

•  Document and retain corrections made on nonconforming products.

•  Document and retain your analysis of nonconforming products.

•  Document and retain corrections made on nonconforming processes.

•  Document and retain your analysis of nonconforming processes.

8.9.3 Document how corrective actions should be taken

•  Document actions taken to identify nonconformities related to CCPs and OPRPs.

•  Evaluate the need for corrective action whenever nonconformities are identified.

•  Review your evaluation and determine whether corrective action must be taken.

•  Retain and maintain documents that describe your corrective action process.

8.9.4 Control all food products that are potentially unsafe

8.9.4.1 Prevent release or regain control of all unsafe products

•  Take action to prevent potentially unsafe products from entering food chain.

•  Release products only if safety hazards are reduced to acceptable levels.

•  Retain control of potentially unsafe products until they've been evaluated.

•  Regain control of unsafe products that previously left your control.

•  Withdraw or recall unsafe products that have left your control.

8.9.4.2 Evaluate lots of products affected by nonconformities

•  Identify and evaluate product lots that were affected by nonconformities.

•  Evaluate products affected by failure to remain within critical limits at CCPs.

•  Prevent release of products affected by failure to remain within limits.

•  Evaluate products affected by the failure to meet action criteria for OPRPs.

•  Release products only if good evidence shows that controls were effective.

•  Document the evaluation of product releases and retain these documents.

8.9.4.3 Control the disposition of all nonconforming products

•  Control the disposition of food products that are not acceptable for release.

•  Reprocess products to ensure that hazard is reduced to acceptable level.

•  Redirect products for another use as long as safety is not compromised.

•  Destroy or dispose as waste if they can't be reprocessed or safely reused.

•  Document disposition of nonconforming products and retain documents.

•  Record the identity of people who approve and authorize dispositions.

8.9.5 Withdraw, recall, and secure all unsafe food products

•  Appoint competent people to withdraw or recall lots of unsafe end products.

•  Document how potentially unsafe end products are withdrawn and recalled.

•  Secure or control withdrawn, recalled, or potentially unsafe products still in stock.

•  Establish and retain a record of unsafe end product withdrawals and recalls.

•  Verify the effectiveness of your end product withdrawal and recall activities.

•  Report all unsafe product withdrawals and recalls to your top management.

9. Evaluation

9.1 Monitor, measure, analyze, and evaluate

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

•  Plan how you're going to monitor, measure, analyze, and evaluate your FSMS.

•  Monitor, measure, analyze, and evaluate FSMS performance and effectiveness.

•  Measure the performance and effectiveness of your organization's FSMS.

•  Analyze the performance and effectiveness of your organization's FSMS.

•  Evaluate the performance and effectiveness of your organization's FSMS.

9.1.2 Analyze and evaluate the performance of your system

•  Analyze and evaluate appropriate FSMS data and information.

•  Analyze and evaluate your organization’s FSMS monitoring results.

•  Analyze and evaluate your organization’s FSMS measurement results.

•  Analyze and evaluate your organization’s FSMS verification results.

•  Analyze and evaluate your organization’s FSMS audit results.

•  Examine the results of your analytical and evaluation activities.

•  Document the results of analytical and evaluation activities.

9.2 Use internal audits to examine conformance and performance

9.2.1 Conduct internal audits of your FSMS at planned intervals

•  Conduct internal FSMS audits at planned intervals.

•  Determine if your organization's FSMS meets requirements.

•  Determine if your FSMS meets the ISO 22000 2018 requirements.

•  Determine if your FSMS meets your organization’s own requirements.

•  Examine the effectiveness of your organization's FSMS.

9.2.2 Develop an internal audit program for your organization

•  Plan the development of an internal audit programme.

•  Establish your organization's internal audit programme.

•  Establish internal audit responsibilities.

•  Establish internal audit methodologies.

•  Establish internal audit planning requirements.

•  Establish internal audit reporting requirements.

•  Establish internal audit work schedules.

•  Implement your organization's internal audit programme.

•  Maintain your organization's internal audit programme.

9.3 Carry out management reviews and document your results

9.3.1 Review suitability, adequacy, effectiveness, of your system

•  Ask top management to do food safety management system reviews.

•  Carry out food safety management system reviews at planned intervals.

9.3.2 Plan and perform management reviews at planned intervals

•  Plan your organization's food safety management reviews.

•  Prepare to review your food safety management system.

•  Review your organization’s food safety management system.

•  Review the performance and effectiveness of your FSMS.

•  Determine how well FSMS objectives are being met.

9.3.3 Create management review outputs and document results

•  Generate suitable management review outputs.

•  Identify and describe FSMS needs and requirements.

•  Identify and describe any FSMS changes that need to be made.

•  Identify and describe FSMS resource needs and requirements.

•  Make decisions to exploit improvement opportunities.Gets.

•  Document the results of your management reviews.Dows.

10. Improvement

10.1 Control nonconformities and take appropriate corrective action

10.1.1 Make corrections and take action when nonconformities occur

•  React to nonconformities when they occur.

•  Correct and control your nonconformities.

•  Evaluate the need for corrective action.

•  Develop appropriate corrective actions.

•  Implement appropriate corrective actions.

•  Review the effectiveness of actions taken.

10.1.2 Document all nonconformities and the actions that are taken

•  Document your organization's nonconformities.

•  Document actions taken to address nonconformities.

•  Document your organization's corrective action results.

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

•  Continually improve the suitability of your organization’s FSMS.

•  Continually improve the adequacy of your organization’s FSMS.

•  Continually improve the effectiveness of your organization’s FSMS.

•  Ask top management to encourage FSMS effectiveness.

•  Use communication to make the FSMS more effective.

•  Use internal audit results to make the FSMS more effective.

•  Use management reviews to make the FSMS more effective.

•  Use verification results to make the FSMS more effective.

•  Use validation results to make the FSMS more effective.

•  Use corrective actions to make the FSMS more effective.

•  Use system updates to make the FSMS more effective.

10.3 Evaluate and update the FSMS and document your results

•  Ask top management to ensure that the FSMS is continually updated.

•  Assign responsibility for evaluating your system at planned intervals.

•  Prepare to update your organization’s food safety management system.

•  Consider the suitability, adequacy, and effectiveness of your system.

•  Update your food safety management system when necessary.

•  Record your food safety management system update activities.

•  Report food safety management system updates to management.


 
Attention

This page summarizes the ISO 22000 2018 standard. It highlights
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OTHER ISO 22000 PAGES

Introduction to ISO 22000 2018

Food Safety Management Principles

ISO 22000 2018 versus ISO 22000 2005

Plain English Food Safety Management Definitions

Overview of ISO 22000 2018 Food Safety Management Standard

Structure of the ISO 22000 2018 Food Safety Management Standard

Plain English Food Safety Management Gap Analysis Process

ISO 22000 2018 Food Safety Management Audit Process

Plain English Food Safety Management Checklist

ISO 22000 2005 Translated into Plain English

Our Plain English Approach

OTHER STANDARDS

Internal Auditing Standard

Risk Management Standard

Quality Management Standard

Business Continuity Standard

Service Management Standard

Process Management Standard

Environmental Management Standard

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