ISO 22000:2018

Introduction, not a requirement. Explains the purpose of adopting a food safety management system and its intended results.

Introduction, not a requirement. Sets out the principles: interactive communication, system management, prerequisite programmes and HACCP, together with the quality management principles.

Introduction, not a requirement. Brings together the general explanation of the process approach, the Plan-Do-Check-Act cycle and thinking based on risk.

Introduction, not a requirement. Explains the process approach and the two PDCA levels: the management system and the operational hazard control.

Introduction, not a requirement. Describes the PDCA cycle at the organizational and the operational level.

Introduction, not a requirement. Groups the general explanation and organizational risk management.

Introduction, not a requirement. Distinguishes organizational risk from operational hazard analysis.

Introduction, not a requirement. Explains risk and opportunity at the management system level.

The organization identifies the internal and external issues that matter to its purpose and influence whether its FSMS can deliver its intended results, and it identifies, reviews and updates information about them. Issues may be favourable or unfavourable and can concern the economic, social, cultural, market, competitive, technological and legal environment, food defence and deliberate contamination, food fraud, cybersecurity, and the organization's own performance and knowledge. Since Amendment 1:2024 the organization must also reach and record a decision on whether climate change is one of its relevant issues; where it is, effects such as heat on cold chains, flooding of sites, water scarcity, drought-driven shifts in raw material hazards (mycotoxins, pests) and supply disruption are expected to flow into hazard analysis, PRPs and emergency preparedness.

• Context analysis covering the listed issue areas including food fraud, food defence and cybersecurity
• Dated context entry recording the climate change decision (relevant or not) with the reasoning, as required since Amendment 1:2024
• Link from any climate-related issue to the hazard analysis, PRP and emergency preparedness records it affects
• Review and update records for the context information

• Context limited to market and legal issues, food fraud and defence never considered
• No recorded climate change decision since the 2024 amendment, or a bare yes or no with no reasoning
• Climate change judged relevant but heat, flood or raw material effects never reach the hazard analysis or emergency plans
• Context never reviewed after the initial certification

So that it can reliably supply products and services that meet the statutory, regulatory and customer food safety requirements that apply, the organization identifies which interested parties matter to its FSMS and what they require, and identifies, reviews and updates that information. Amendment 1:2024 adds a note that relevant interested parties may hold requirements connected with climate change, so the review considers, for example, authority rules on temperature control during heatwaves, retailer or customer climate clauses, and insurer or investor expectations.

• Register of the food chain's interested parties (authorities, customers, consumers, suppliers) with the food safety requirements of each
• Entry in the register for each climate-related requirement identified (customer codes, authority guidance, insurer conditions) or a recorded finding that none apply
• Review and update records

• Customer specifications treated as the only interested party requirements
• Regulatory requirements of export markets missing
• Climate-related requirements of customers or authorities not considered since the 2024 amendment
• Register static since certification

To define its scope, the organization determines the boundaries of its FSMS and where it applies. The scope names the products and services, the processes and the production sites covered, and takes in every activity, process, product or service that could affect whether its end products are safe. In setting it, the organization considers the issues identified under 4.1 and the requirements under 4.2. The scope is kept available as maintained documented information.

• Documented scope naming products, services, processes and sites
• Justification that every activity influencing end-product safety is inside the scope

• Scope excludes a warehouse, transport or outsourced process that affects product safety
• Scope names the company but not its products or sites

The organization sets up, puts into effect, maintains, updates and continually improves an FSMS, with the processes it needs and how they interact, as this document requires.

• System description identifying the processes and their interactions
• Evidence of system updating (10.3) and improvement over time

• System is a set of documents with no defined process interactions
• Updating happens only at recertification

When a nonconformity arises the organization responds: it acts to contain and correct it and deals with what follows from it, as applicable; it judges whether action is needed to remove the causes so the problem does not happen again or somewhere else, by examining the nonconformity, working out its causes and checking whether similar ones exist or might arise; it carries out whatever action is needed; it checks whether the corrective action worked; and it changes the system where necessary. Corrective actions match the effects of the nonconformities. Documented information is kept on what the nonconformities were, the actions taken and the outcome of corrective action.

• System-level nonconformity register (audit findings, complaints, system failures) distinct from product nonconformities under 8.9
• Root cause analyses and corrective action records with effectiveness reviews
• Checks for similar nonconformities elsewhere

• System nonconformities handled only as product corrections
• Effectiveness never reviewed
• Similar lines or sites not checked

The organization keeps improving how suitable, adequate and effective its food safety management system is. Top management makes sure this happens by means of communication, management review, internal audit, analysis of verification results, validation of control measures and their combinations, corrective action and updating of the system.

• Improvement actions traceable to communication, review, audit, verification analysis, validation, corrective action and updating
• Evidence of top management driving improvement
• Trend of system effectiveness over time

• Improvement limited to closing audit findings
• Verification analysis and validation never generate improvement
• Top management not involved

Top management makes sure the FSMS is kept up to date on an ongoing basis. At planned intervals the food safety team evaluates the system and considers whether the hazard analysis, the hazard control plan and the PRPs need reviewing. Updates draw on internal and external communication, any other information about how suitable, adequate and effective the system is, the outcome of analysing verification results and the outcome of management review. Updating activities are kept as documented information and fed into management review.

• Scheduled food safety team evaluations of the system with decisions on reviewing the hazard analysis, control plan and PRPs
• Inputs from communication, verification analysis and management review considered
• Updating records reported to management review

• Hazard analysis reviewed only at recertification
• Team evaluation not scheduled
• Updating decisions undocumented

Top management shows leadership of and commitment to the FSMS by: making sure the food safety policy and FSMS objectives are set and fit the organization's strategic direction; building FSMS requirements into business processes; making sure the resources the FSMS needs are in place; communicating why effective food safety management matters and why it is important to meet FSMS requirements, the statutory and regulatory requirements that apply and the customer food safety requirements that have been mutually agreed; making sure the FSMS is evaluated and maintained so it delivers what it is meant to; directing and supporting people to help make the FSMS effective; promoting continual improvement; and supporting other managers in showing leadership in their own areas.

• Top management approval of the policy and objectives and their link to strategy
• Executive communications on food safety importance and requirements
• Resource decisions traceable to the system's needs
• Evidence of top management evaluating the system (review participation)

• Food safety delegated wholly to the quality or technical manager
• Customer food safety requirements not communicated as management priorities
• Resources for the food safety team inadequate

Top management establishes and communicates a food safety policy. This clause groups establishing the policy (5.2.1) and communicating it (5.2.2).

• Food safety policy

• No policy

Top management sets, applies and maintains a food safety policy that suits the organization's purpose and context; gives a basis for setting and reviewing FSMS objectives; commits to meeting the food safety requirements that apply, including those of law and regulation and those agreed with customers; covers communication both inside and outside the organization; commits to improving the FSMS continually; and deals with the need to make sure food safety competencies are in place.

• Approved food safety policy carrying the six required elements
• Evidence of periodic policy maintenance

• Policy omits communication or competence
• Policy generic and not appropriate to the organization's context
• Policy never reviewed

The food safety policy is kept as maintained documented information; it is communicated across every level of the organization, where it is understood and put into practice; and it is made available to relevant interested parties where appropriate.

• Documented policy under control
• Evidence of communication at all levels (induction, displays, briefings) and of understanding (interviews)
• Availability to interested parties

• Operators cannot describe the policy
• Policy not available to customers or authorities on request

Top management makes sure that relevant roles have responsibilities and authorities that are assigned, communicated and understood across the organization, and it assigns responsibility and authority for: making sure the FSMS meets the requirements of this document; reporting to top management on how the FSMS is performing; appointing the food safety team and its leader; and naming people with defined responsibility and authority to start actions and record them. The food safety team leader is responsible for making sure the FSMS is set up, put into effect, maintained and kept current; for managing and organizing the team's work; for making sure the team has the training and competencies it needs; and for reporting to top management on how effective and suitable the FSMS is. Everyone is responsible for reporting FSMS problems to the people identified for that purpose.

• Appointment of the food safety team and team leader by top management
• Responsibility matrix including who may initiate and document actions
• Team leader reports to top management on effectiveness and suitability
• Defined route for anyone to report food safety problems, known to staff

• Food safety team not formally appointed
• Team leader lacks authority over the team's work
• Staff do not know to whom problems are reported

The organization plans, puts into effect, controls, maintains and updates the processes it needs to fulfil the requirements for producing safe products and to carry out the actions decided under 6.1. It does this by setting criteria for the processes, controlling them according to those criteria, and keeping as much documented information as needed to be confident they were carried out as planned. It controls planned changes, reviews what unintended changes lead to and acts to limit adverse effects where needed, and makes sure outsourced processes are under control.

• Process criteria and control records for the processes realising safe products
• Management of change records with consequences reviewed
• Controls over outsourced processes

• Process criteria undefined beyond the hazard control plan
• Unintended changes (equipment failure, supplier substitution) not reviewed
• Outsourced processes uncontrolled

The organization sets up, puts into effect, maintains and updates PRPs that help prevent or reduce contaminants, food safety hazards included, in products, in product processing and in the work environment. The PRPs suit the organization and its context and the size and type of operation and the nature of its products; they are applied throughout the production system, either generally or for particular products; and the food safety team approves them. When choosing and setting them up, the organization identifies the statutory and regulatory requirements that apply and the customer requirements agreed by both sides, and should consider the relevant part of ISO/TS 22002 and any relevant standards, codes of practice and guidelines. It takes into account: how buildings are constructed and laid out, with their utilities; how premises are laid out, including zoning, workspaces and staff faci

• PRP documentation covering the listed areas, referenced to ISO/TS 22002 or equivalent codes, approved by the food safety team
• Statutory, regulatory and customer requirements identified in PRP selection
• PRP monitoring and verification records

• PRPs limited to cleaning and pest control
• Supplier approval or product information programmes missing
• PRPs never approved by the food safety team or verified

The traceability system can identify, uniquely, the material coming in from suppliers and the first step of the end product's distribution route. At a minimum it takes account of how lots of received materials, ingredients and intermediates relate to end products, of rework of materials and products, and of end product distribution. The organization identifies the statutory, regulatory and customer requirements that apply, keeps documented information as evidence of traceability for a set period that at least covers the product's shelf life, and verifies and tests whether the system works, which is expected to include reconciling end product quantities against ingredient quantities.

• Traceability procedure linking incoming lots, rework and end-product distribution
• Traceability records retained for at least the shelf life
• Traceability tests with mass balance reconciliation and results

• Rework not traceable
• One-step-forward distribution records incomplete
• Traceability never tested or tested without reconciliation

The organization prepares for and responds to emergencies and incidents affecting food safety. This clause groups the general requirement (8.4.1) and handling of emergencies and incidents (8.4.2).

• Emergency procedures

• No emergency procedures

Top management makes sure procedures exist for responding to possible emergencies or incidents that could affect food safety and that are relevant to the organization's place in the food chain, and that documented information is set up and kept to manage such emergencies and incidents.

• Emergency and incident procedures approved by top management, covering scenarios relevant to the food chain role (utility failure, contamination, natural disaster, bioterrorism)

• Emergency plan covers fire only
• Loss of refrigeration or water supply not addressed

When an emergency or incident actually happens, the organization identifies the statutory and regulatory requirements that apply and communicates inside and outside (suppliers, customers, authorities, media); takes action to lessen the consequences in proportion to how serious the emergency or incident is and how it could affect food safety; tests its procedures periodically where this is practical; and after any incident, emergency or test reviews the documented information and updates it where necessary.

• Incident records showing regulatory requirements identified and internal and external communication made
• Emergency drill and test records
• Post-incident and post-test reviews with procedure updates

• Procedures never tested
• Regulatory notification obligations not identified in advance
• No review after a real incident

The organization controls food safety hazards through preliminary information, hazard analysis, validation of its control measures and a hazard control plan. This clause brings together the preliminary steps (8.5.1), the hazard analysis (8.5.2), validation (8.5.3) and the HACCP/OPRP plan (8.5.4).

• HACCP study

• No hazard control

The food safety team gathers, maintains and updates the preliminary documented information the hazard analysis needs, covering the statutory, regulatory and customer requirements that apply, the products, processes and equipment of the organization, and the hazards relevant to them. For every raw material, ingredient and material that contacts the product, the organization identifies the statutory and regulatory food safety requirements that apply and documents: biological, chemical and physical characteristics; composition, additives and processing aids included; source and provenance; how it is produced; how it is packaged and delivered; storage conditions and shelf life; any preparation before use; and food safety acceptance criteria or specifications. For every end product it identifies the requirements that apply and documents: the product name or identification; composition; charac

• Raw material, ingredient and contact material specifications with the listed characteristics and regulatory requirements
• End product specifications and intended use statements identifying vulnerable consumer groups
• Flow diagrams per product or category, confirmed on site with dated confirmation records
• Process and environment descriptions including PRPs, parameters, external requirements and seasonal or shift variations

• Flow diagrams unverified on site or out of date
• Vulnerable consumer groups not identified
• Packaging and processing aids missing from specifications
• Outsourced processes absent from flow diagrams

Using the preliminary information, the food safety team carries out a hazard analysis to decide which hazards must be controlled and to what degree to keep food safe, applying combinations of control measures where suitable. The organization identifies and documents every food safety hazard that can reasonably be expected for the type of product, process and environment, drawing on the preliminary information, experience, internal and external information (for example epidemiological, scientific and historical data), information coming from the food chain about hazards relevant to the safety of end products, intermediates and food at the time of consumption, and statutory, regulatory and customer requirements, in enough detail to allow control measures to be assessed and selected. It identifies the step or steps where each hazard may be introduced, be present, persist or increase, taking

• Hazard identification per step covering biological, chemical, physical and allergen hazards with the information sources used
• Documented acceptable levels with justification
• Hazard assessment (likelihood and severity) with methodology and significant hazards identified
• Control measure selection and OPRP or CCP categorisation records showing the systematic approach and feasibility assessment
• External requirements affecting control measure choice documented

• Hazards identified generically rather than per process step
• Acceptable levels undocumented or unjustified
• Categorisation as CCP or OPRP not systematic
• Allergens or food fraud hazards missing
• Analysis not revisited when products or processes change

Before measures and combinations of measures are built into the hazard control plan, and after any change to them, the food safety team validates that the control measures chosen can control the significant food safety hazards to the degree intended. If validation shows a measure or combination cannot do so, the team modifies it and assesses it again. The team keeps the validation method and the evidence that the measures are capable as documented information.

• Validation studies for each CCP and OPRP control measure (scientific literature, trials, regulatory guidance) with methodology and evidence
• Re-validation after changes to measures, products, processes or distribution
• Records of measures modified after failed validation

• Validation confused with verification
• Critical limits taken from a generic plan with no evidence of capability
• No re-validation after changes

The organization sets up, carries out and maintains a hazard control plan, kept as documented information, that for every control measure at every CCP or OPRP records the food safety hazards it controls, the critical limits or action criteria, the monitoring procedures, the corrections to make if limits or criteria are missed, who holds responsibility and authority, and the monitoring records. CCP critical limits are measurable, and meeting them keeps the hazard within its acceptable level; OPRP action criteria are measurable or observable and help provide the same assurance; the reasoning behind both is documented. At each CCP a monitoring system picks up any departure from the critical limits through all scheduled measurements, and for each OPRP picks up failure to meet the action criterion; documented information covers measurements or observations that give results in time, the metho

• Hazard control plan per CCP and OPRP with hazards, limits or criteria, monitoring, corrections, responsibilities and records
• Documented rationale for critical limits and action criteria
• Monitoring records with timely results, calibration status, frequency and evaluation sign-off
• Correction and corrective action records for deviations showing product held and cause addressed

• Action criteria for OPRPs not measurable or observable
• Monitoring frequency too low to allow timely product isolation
• Visual OPRP checks with no instruction or specification
• Deviations corrected without identifying cause or preventing recurrence

Once the hazard control plan is in place, the organization updates where necessary the information on the characteristics of raw materials, ingredients and materials that contact the product, the characteristics of end products, the intended use, and the flow diagrams together with the descriptions of processes and of the process environment, and makes sure the hazard control plan and the PRPs are kept current.

• Revision history showing preliminary information, PRPs and the hazard control plan updated after the HACCP study and on change
• Current-status confirmation of the plan and PRPs

• Specifications and flow diagrams older than the control plan they support
• PRPs not revisited after the hazard analysis

The organization shows evidence that the methods and equipment it uses for monitoring and measuring are fit for the monitoring and measuring it performs for the hazard control plan and the PRPs. Equipment is calibrated or verified at set intervals before use; adjusted as needed; labelled so its calibration status can be seen; protected against adjustments that would make results invalid; and protected from damage and deterioration. Calibration and verification results are kept, and calibration is traceable to national or international measurement standards or, where none exist, the basis used is documented. If equipment or the process environment turns out not to conform, the organization assesses whether earlier results are still valid, acts appropriately on the equipment, the environment and any product affected, and documents the assessment and the action. Software used for monitoring

• Register of monitoring and measuring equipment with calibration intervals, status identification and traceability
• Calibration and verification records
• Assessments of previous results and product impact after out-of-calibration findings
• Software validation records and change authorisation for monitoring software

• Thermometers and metal detectors unverified before use
• Out-of-calibration findings not traced back to product
• Monitoring software and spreadsheets never validated

The organization verifies that its prerequisite programmes and hazard control plan are implemented and effective and analyses the results. This clause groups verification (8.8.1) and analysis of verification results (8.8.2).

• Verification programme

• No verification

The organization sets up, carries out and maintains verification activities, planned so that their purpose, methods, frequency and responsibilities are defined, to confirm that: the PRPs are in place and working; the hazard control plan is in place and working; hazard levels stay inside the acceptable levels identified; the inputs to the hazard analysis are kept current; and other actions the organization decided on are in place and working. The person who monitors an activity does not also verify it. Results are kept as documented information and communicated. Where verification testing of end product or process samples shows a hazard above its acceptable level, the lots affected are treated as potentially unsafe and corrective action is taken.

• Verification plan with purpose, methods, frequencies and responsibilities covering PRPs, the control plan, hazard levels and analysis inputs
• Verification records showing independence from the monitoring person
• Communication of results
• Handling of lots failing verification tests as potentially unsafe

• Verification performed by the same person who monitors
• Verification limited to record review with no product or environmental testing
• Failed verification tests not linked to product disposition

The food safety team analyses what verification activities have found, and that analysis feeds into the evaluation of how the FSMS is performing.

• Food safety team analysis of verification results (trends, recurring failures)
• Use of the analysis in performance evaluation and management review

• Verification results filed without analysis
• Trends across verification activities never examined

The organization controls nonconformities in product and process that arise from monitoring CCPs and OPRPs. This clause brings together the general requirement (8.9.1), corrections (8.9.2), corrective actions (8.9.3), dealing with potentially unsafe products (8.9.4) and withdrawal or recall (8.9.5).

• Nonconformity control

• No nonconformity control

The organization makes sure that monitoring data from OPRPs and CCPs are evaluated by designated, competent people who have the authority to start corrections and corrective actions.

• Designation of competent people with authority to evaluate monitoring data and initiate corrections and corrective actions
• Evidence of their evaluation of monitoring records

• Monitoring records signed but never evaluated
• Evaluators lack authority to hold product

Where a CCP critical limit or an OPRP action criterion is missed, the organization makes sure the products affected are identified and that their use and release are kept under control, and keeps documented information on how affected products are identified, assessed and corrected and how corrections are reviewed. Product affected when a CCP critical limit is missed is identified and treated as potentially unsafe. Where an OPRP action criterion is missed, the organization works out the causes of the failure and its consequences for food safety, identifies the product affected and handles it under 8.9.4, and keeps the evaluation results. Documented information records the corrections applied to nonconforming products and processes, including what the nonconformity was, why the failure happened and what it led to.

• Correction procedure for CCP and OPRP failures with product identification, assessment and review
• Records of corrections stating nature, cause and consequence per deviation
• OPRP failure evaluations with consequence and cause determined

• Product affected by a deviation not identified or quarantined
• OPRP failures corrected without evaluating consequences
• Correction records signed by operators but never checked by the food safety team leader

Whenever CCP critical limits or OPRP action criteria are missed, the need for corrective action is evaluated. The organization sets up and keeps documented information that specifies the actions to find and remove the cause of nonconformities detected, stop them recurring and bring the process back under control. These include reviewing nonconformities that come to light through complaints from customers or consumers and through reports of regulatory inspections, reviewing monitoring result trends that suggest control is being lost, finding causes, deciding and carrying out action to stop recurrence, documenting the outcome, and checking the action works. Documented information on every corrective action is kept.

• Corrective action procedure covering complaints, inspection reports and monitoring trends
• Corrective action records with cause, action, results and effectiveness verification
• Trend review of monitoring results

• Complaints and inspection findings not treated as nonconformity inputs
• Effectiveness of corrective action never verified
• Trends in monitoring not reviewed

The organization acts to keep potentially unsafe products out of the food chain unless it can show that the hazards concerned have been brought down to acceptable levels, will be brought down to them before the product enters the chain, or that the product still meets the acceptable levels in spite of the nonconformity; it keeps potentially unsafe products under its control until they have been evaluated and a disposition decided; where products already released turn out to be unsafe it informs the relevant interested parties and starts a withdrawal or recall; and it documents the controls, the responses from interested parties and the authorisations. Every affected lot is evaluated: product affected by a failure to meet a CCP critical limit is not released; product affected by a failure to meet an OPRP action criterion is released as safe only if other evidence shows the control measure

• Hold and release procedure with the release conditions for OPRP and CCP failures
• Quarantine and evaluation records per affected lot
• Disposition records naming the approving authority
• Notifications and recall initiation where released product was found unsafe

• Product released on an OPRP failure with no evidence of effectiveness
• CCP-failure product reworked without evaluation
• Disposition approval undocumented

The organization can make sure lots of end product identified as potentially unsafe are withdrawn or recalled promptly, by appointing competent people with the authority to start and carry out a withdrawal or recall, and it sets up and keeps documented information for informing the relevant interested parties (authorities, customers, consumers), for handling withdrawn or recalled products and products still held in stock, and for the order in which steps are taken. Withdrawn or recalled products and remaining stock are secured or kept under the organization's control until a disposition is decided. What caused a withdrawal or recall, how far it extended and how it turned out are documented and reported to top management as management review input, and the organization verifies that withdrawals and recalls are carried out and work, for example through mock recalls, and keeps the records.

• Withdrawal and recall procedure with appointed authorised people, notification lists and action sequence
• Mock recall records with timings, reconciliation and effectiveness evaluation
• Records of any actual recall with cause, extent and result reported to top management

• Mock recalls not performed or never reaching customers and quantities
• Notification lists out of date
• Recall results not reviewed by top management

The organization monitors, measures, analyses and evaluates how the FSMS performs and how effective it is. This clause brings together the general requirements (9.1.1) and analysis and evaluation (9.1.2).

• Monitoring programme

• No performance evaluation

The organization decides which things it will monitor and measure; the methods it will use to monitor, measure, analyse and evaluate so that results are valid; when monitoring and measurement take place; when results are analysed and evaluated; and by whom. It keeps documented information showing the results and evaluates how the FSMS performs and how effective it is.

• Monitoring and measurement plan naming parameters, methods, timing and responsible evaluators
• Records of results
• Evaluation of system performance and effectiveness

• Monitoring limited to CCPs with no system-level measures
• Responsibility for analysis undefined
• Effectiveness of the system never evaluated

The organization analyses and evaluates the data and information that monitoring and measurement produce, including verification results for the hazard control plan and the PRPs and the results of internal and external audits, in order to: confirm that overall performance matches planned arrangements and FSMS requirements; find where the system needs updating or improving; spot trends pointing to more frequent potentially unsafe products or process failures; gather information for planning the internal audit programme according to the status and importance of the areas to be audited; and show that corrections and corrective actions work. The analysis results and the activities arising from them are kept as documented information, passed to top management, and serve as input both to management review and to updating the FSMS.

• Periodic analysis of monitoring, verification and audit data with trends in unsafe product and process failures
• Use of the analysis for audit planning and for evidencing corrective action effectiveness
• Reporting to top management and input to management review and system updating

• Data collected but never analysed for trends
• Audit programme not informed by performance data
• Analysis not reported to top management

The organization carries out internal audits at planned intervals to find out whether the FSMS meets its own requirements and those of this document and whether it is effectively implemented and maintained. It plans, sets up, runs and maintains an audit programme, covering how often audits happen, how they are done, who is responsible, planning requirements and reporting, that reflects how important the processes are, changes in the FSMS, and what monitoring, measurement and earlier audits have shown; sets the criteria and scope of each audit; chooses competent auditors and runs audits so that they are objective and impartial; reports results to the food safety team and the managers concerned; keeps documented information as evidence of the programme and its results; makes the needed corrections and takes corrective action within the time agreed; and decides whether the FSMS fulfils what

• Audit programme weighted by process importance, changes and monitoring and previous results
• Audit plans with criteria and scope, auditor competence and impartiality records
• Audit reports to the food safety team and management with a judgement on policy and objectives
• Corrective action within agreed time frames and verification of actions

• Same audit scope every year regardless of performance data
• Auditors auditing their own area
• Findings closed without verification
• No judgement on whether the system meets the policy's intent

Top management reviews the food safety management system at planned intervals. This clause groups the general requirement (9.3.1), review inputs (9.3.2) and review outputs (9.3.3).

• Management review records

• No review

On a planned schedule, top management examines the FSMS as a whole and concludes whether it is still suitable, adequate and effective for the organization.

• Management review schedule and attendance showing top management participation
• Conclusions on suitability, adequacy and effectiveness

• Review delegated to the food safety team
• Intervals set but not kept

Management review takes into account: where actions from earlier reviews stand; changes in internal and external issues, the organization and its context included; information on how the FSMS is performing and how effective it is, including trends in the results of system updating, monitoring and measurement results, analysis of the verification results for the hazard control plan and the PRPs, nonconformities and corrective actions, internal and external audit results, inspections by customers and regulators, how external providers are performing, how risks and opportunities were reviewed and whether the actions taken on them worked, and how far the FSMS objectives have been achieved; whether resources are adequate; any emergency, incident, withdrawal or recall that took place; relevant information from internal and external communication, including interested parties' requests and comp

• Management review input pack covering every listed input, including inspections, external provider performance, incidents and recalls
• Presentation of data against the system's objectives

• Verification analysis and external provider performance absent from inputs
• Incidents and recalls not reviewed
• Data presented without reference to objectives

Management review produces decisions and actions on opportunities for continual improvement and on any updates or changes the FSMS needs, including resource needs and revising the food safety policy and the FSMS objectives. Documented information is kept to show what the reviews concluded.

• Review minutes recording decisions on improvement, updates, resources, policy and objectives
• Action tracking from review outputs

• Minutes record discussion but no decisions
• Resource needs not decided
• Actions not tracked to the next review

In planning its FSMS the organization takes into account the issues identified under 4.1 and the requirements under 4.2 and 4.3, and determines which risks and opportunities it must address to be confident the system will deliver what it is meant to, to increase wanted effects, to prevent or lessen unwanted ones, and to improve continually. Here, risks and opportunities are confined to events that bear on how well the system performs and how effective it is; food safety hazards are dealt with under clause 8. The organization plans how it will address them, how it will build those actions into its processes and carry them out, and how it will judge whether they worked. Actions are in proportion to their effect on food safety requirements, on whether products and services conform for customers, and on what interested parties along the food chain require, and may include avoiding, taking, r

• Risk and opportunity register at management system level, distinct from the hazard analysis
• Planned actions integrated into processes with effectiveness evaluation
• Proportionality rationale for actions

• Hazard analysis presented as the risk assessment for the system
• Opportunities never identified
• Effectiveness of actions not evaluated

The organization sets FSMS objectives for relevant functions and levels. They are in line with the food safety policy, measurable where this is practical, reflect the food safety requirements that apply (statutory, regulatory and customer ones included), are monitored and verified, are communicated, and are kept current and updated as needed; documented information on them is retained. When planning to meet them, the organization decides what will be done, what resources are needed, who is responsible, the completion date and how results will be evaluated.

• Documented objectives at relevant functions and levels, measurable, linked to the policy
• Monitoring and verification records against the objectives
• Action plans with resources, owners, dates and evaluation method

• Objectives are slogans without measures
• Objectives set centrally with nothing at production level
• No plan behind the objectives

Where the organization decides the FSMS needs to change, personnel changes included, the change is made and communicated according to a plan that considers why the change is being made and what it might lead to, whether the system stays intact, whether resources are available to make the change work, and how responsibilities and authorities are allocated or reallocated.

• Change planning records covering purpose, consequences, integrity, resources and responsibilities
• Communication of changes, including personnel changes affecting food safety roles

• Personnel changes in food safety roles unplanned and uncommunicated
• Equipment or product changes made without assessing system integrity

OH&S policy and commitment. Control from ISO 22000 framework, domain: ISO 22000: OH&S Policy & Planning.

• emergency response plan
• internal audit report
• OHS policy
• hazard identification register
• PPE issue records

• weak contractor onboarding
• insufficient incident root cause analysis
• gaps in legal compliance tracking

Hazard identification and risk assessment. Control from ISO 22000 framework, domain: ISO 22000: OH&S Policy & Planning.

• internal audit report
• OHS policy
• hazard identification register
• PPE issue records
• incident investigation reports
• emergency response plan

• weak contractor onboarding
• insufficient incident root cause analysis
• gaps in legal compliance tracking
• incomplete hazard register

Legal and regulatory compliance. Control from ISO 22000 framework, domain: ISO 22000: OH&S Policy & Planning.

• incident investigation reports
• emergency response plan
• internal audit report

• insufficient incident root cause analysis
• gaps in legal compliance tracking
• incomplete hazard register
• missing worker consultation evidence
• weak contractor onboarding

OH&S objectives and action plans. Control from ISO 22000 framework, domain: ISO 22000: OH&S Policy & Planning.

• emergency response plan
• internal audit report
• OHS policy
• hazard identification register
• PPE issue records
• incident investigation reports

• gaps in legal compliance tracking
• incomplete hazard register
• missing worker consultation evidence
• weak contractor onboarding

Worker consultation and participation. Control from ISO 22000 framework, domain: ISO 22000: OH&S Policy & Planning.

• internal audit report
• OHS policy
• hazard identification register

• missing worker consultation evidence
• weak contractor onboarding
• insufficient incident root cause analysis
• gaps in legal compliance tracking
• incomplete hazard register

Elimination and substitution of hazards. Control from ISO 22000 framework, domain: ISO 22000: Operational Controls.

• incident investigation reports
• emergency response plan
• internal audit report

• incomplete hazard register
• missing worker consultation evidence
• weak contractor onboarding

Engineering and administrative controls. Control from ISO 22000 framework, domain: ISO 22000: Operational Controls.

• hazard identification register
• PPE issue records
• incident investigation reports

• insufficient incident root cause analysis
• gaps in legal compliance tracking
• incomplete hazard register
• missing worker consultation evidence

Personal protective equipment management. Control from ISO 22000 framework, domain: ISO 22000: Operational Controls.

• incident investigation reports
• emergency response plan
• internal audit report
• OHS policy
• hazard identification register

• incomplete hazard register
• missing worker consultation evidence
• weak contractor onboarding

Emergency preparedness and response. Control from ISO 22000 framework, domain: ISO 22000: Operational Controls.

• OHS policy
• hazard identification register
• PPE issue records
• incident investigation reports
• emergency response plan
• internal audit report

• gaps in legal compliance tracking
• incomplete hazard register
• missing worker consultation evidence

Contractor and visitor safety management. Control from ISO 22000 framework, domain: ISO 22000: Operational Controls.

• hazard identification register
• PPE issue records
• incident investigation reports

• insufficient incident root cause analysis
• gaps in legal compliance tracking
• incomplete hazard register
• missing worker consultation evidence

Identify nonconformities, take action to control and correct, and address root causes.

• NC log
• RCA
• CAPA records

• RCA shallow
• CAPA recurring

Continually improve the suitability, adequacy, and effectiveness of the FSMS.

• Improvement log
• Metrics trend
• Project records

• No improvement programme
• Metrics flat

Incident investigation and reporting. Control from ISO 22000 framework, domain: ISO 22000: Performance & Improvement.

• incident investigation reports
• emergency response plan
• internal audit report
• OHS policy

• insufficient incident root cause analysis
• gaps in legal compliance tracking
• incomplete hazard register
• missing worker consultation evidence

OH&S monitoring and measurement. Control from ISO 22000 framework, domain: ISO 22000: Performance & Improvement.

• PPE issue records
• incident investigation reports
• emergency response plan
• internal audit report

• missing worker consultation evidence
• weak contractor onboarding
• insufficient incident root cause analysis
• gaps in legal compliance tracking

Internal OH&S audit program. Control from ISO 22000 framework, domain: ISO 22000: Performance & Improvement.

• incident investigation reports
• emergency response plan
• internal audit report

• missing worker consultation evidence
• weak contractor onboarding
• insufficient incident root cause analysis
• gaps in legal compliance tracking
• incomplete hazard register

Management review and continual improvement. Control from ISO 22000 framework, domain: ISO 22000: Performance & Improvement.

• incident investigation reports
• emergency response plan
• internal audit report
• OHS policy

• gaps in legal compliance tracking
• incomplete hazard register
• missing worker consultation evidence
• weak contractor onboarding
• insufficient incident root cause analysis

Corrective actions and lessons learned. Control from ISO 22000 framework, domain: ISO 22000: Performance & Improvement.

• internal audit report
• OHS policy
• hazard identification register
• PPE issue records
• incident investigation reports

• missing worker consultation evidence
• weak contractor onboarding
• insufficient incident root cause analysis

Determine internal and external issues relevant to food safety and the FSMS.

• Context analysis
• PESTLE
• Issue register

• Context generic
• Food safety issues missed

Identify interested parties relevant to the FSMS and their requirements including statutory and customer.

• Stakeholder register
• Requirements log
• Compliance obligations

• Customer specs not captured
• Regulatory list stale

Define scope including products, processes, sites, and end-to-end activities covered.

• Scope statement
• Site list
• Process map

• Scope ambiguous
• Outsourced steps excluded

Top management demonstrates commitment to food safety with policy, resources, and accountability.

• Management commitment statement
• Budget
• Org chart

• Token leadership
• Under-resourced FSMS

Establish a food safety policy appropriate to purpose, communicated and reviewed.

• Food safety policy
• Communication records
• Review minutes

• Policy not communicated to all
• No review cycle

Define and communicate FSMS roles including food safety team leader and team responsibilities.

• RACI
• FS team charter
• Job descriptions

• No nominated team leader
• Authority unclear

Plan actions to address food safety risks and opportunities and integrate into FSMS processes.

• Risk register
• Opportunity log
• Action plan

• Risk treated as HACCP only
• No opportunities captured

Set measurable food safety objectives and plan how to achieve them with resources and timelines.

• Objectives register
• Plans
• Resource allocation

• Objectives not SMART
• No accountability

Provide resources for the FSMS including people, infrastructure, work environment, and external development.

• Resource plan
• Facility specs
• Environment monitoring

• Old equipment
• Environmental controls weak

Ensure persons doing work affecting food safety are competent with training, education, and experience.

• Training matrix
• Records
• Assessments

• Refresher overdue
• Contractors untrained

Establish internal and external communication relevant to food safety including supplier and customer channels.

• Comms plan
• Supplier portal
• Recall channel

• No recall comms plan
• Supplier issues unreported

Control documented information required by the FSMS for creation, update, distribution, and retention.

• Document control procedure
• DMS
• Retention schedule

• Uncontrolled docs in use
• No retention

Establish, implement, and maintain PRPs to support control of food safety hazards.

• PRP register
• Cleaning schedules
• Pest control records

• PRPs not verified
• Pest records missing

Establish a traceability system to uniquely identify incoming materials and outgoing products.

• Traceability procedure
• Lot records
• Mock recall results

• Mock recall not annual
• Lot codes inconsistent

Plan for and respond to emergencies affecting food safety including communication and recovery.

• Emergency plan
• Drill records
• After-action reports

• No drills
• Plan not tested

Conduct hazard analysis, determine CCPs and OPRPs, set critical limits, monitor, and verify.

• Hazard analysis
• HACCP plan
• CCP logs

• CCP limits unjustified
• Monitoring gaps

Update PRPs and the hazard control plan based on new information, changes, or verification results.

• Change log
• Updated plans
• Verification records

• Plans static
• Changes not triggered

Ensure monitoring and measurement equipment is fit for purpose and calibrated.

• Calibration schedule
• Certificates
• Verification logs

• Out-of-cal equipment in use
• No traceable standards

Identify, evaluate, and control potentially unsafe products to prevent unintended release.

• NC procedure
• Hold log
• Recall procedure

• No formal hold/release
• Recall untested

Monitor and measure FSMS performance, evaluate effectiveness, and analyse data.

• KPI dashboard
• Trend analysis
• Reports

• No trend analysis
• KPIs not reviewed

Conduct internal audits to confirm FSMS conformance and effectiveness on a planned schedule.

• Audit programme
• Reports
• CAPA log

• Audits incomplete
• CAPA overdue

Top management reviews the FSMS at planned intervals using defined inputs and outputs.

• Review minutes
• Input packs
• Action register

• Inputs incomplete
• Actions not tracked

The organization provides what the FSMS needs in resources. This clause brings together the general requirement (7.1.1), people (7.1.2), infrastructure (7.1.3), the work environment (7.1.4), FSMS elements developed externally (7.1.5), and control of processes, products and services supplied from outside (7.1.6).

• Resource provision

• Resources not determined

The organization determines and provides the resources it needs to set up, put into effect, maintain, update and keep improving the FSMS, taking into account what its current internal resources can do and where they are limited, and what it needs to obtain from outside.

• Resource determination covering internal capability, constraints and external needs
• Budget and staffing for the food safety management system

• Resource needs never assessed against constraints
• External expertise needed but not sourced

The organization makes sure that the people it needs to run and keep up an effective FSMS are competent. Where outside experts help develop, implement, operate or assess the system, documented information is retained as evidence of the agreements or contracts that set out their competency, responsibility and authority.

• Competence evidence for people operating and maintaining the system
• Contracts or agreements with external experts defining competency, responsibility and authority

• Consultants used without defined responsibility or competence evidence
• Key food safety roles filled by untrained staff

The organization provides the resources to determine, set up and maintain the infrastructure it needs to meet the FSMS requirements. Infrastructure may take in land, vessels, buildings and utilities, equipment (hardware and software included), transport, and ICT.

• Infrastructure determined against the system's needs (premises, equipment, utilities, transport, ICT)
• Maintenance programme for food safety critical infrastructure

• Equipment maintenance reactive, affecting hygiene and control
• Transport and ICT excluded from infrastructure planning

The organization determines, provides and maintains the resources to set up, manage and keep the work environment needed to meet the FSMS requirements. That environment combines human and physical factors, such as social, psychological and physical conditions (for example temperature, humidity, light, air flow, hygiene and noise), as relevant to the products and services.

• Work environment requirements defined for food safety (temperature, humidity, hygiene, air flow) and monitored
• Consideration of human factors affecting food safety behaviour

• Environmental conditions affecting product safety not specified or monitored
• Human factors ignored

Where the organization adopts FSMS elements developed outside it, such as PRPs, a hazard analysis or a hazard control plan, it makes sure they were developed in line with this document, suit its own sites, processes and products, have been tailored to its processes and products by the food safety team, and are put into effect, maintained and kept up to date as this document requires, and that they are kept as documented information.

• Record of externally developed elements in use (generic HACCP plans, sector PRPs) and their source
• Evidence of adaptation by the food safety team to the organization's own processes and products
• Maintenance and update of adopted elements

• Generic HACCP plan adopted without site-specific adaptation
• Adopted elements never updated

The organization sets and applies criteria for assessing, choosing, monitoring the performance of and reassessing external providers of processes, products and services; makes sure its requirements are properly conveyed to them; makes sure what they supply does not harm its capacity to meet the FSMS requirements consistently; and keeps documented information on these activities and on any action that results from assessments and reassessments.

• Supplier evaluation, selection, monitoring and re-evaluation criteria and records
• Communicated requirements to providers (specifications, contracts)
• Actions taken on provider performance

• Approved supplier list with no re-evaluation
• Service providers (pest control, laundry, transport) not evaluated
• Requirements never communicated in writing

The organization determines what competence is needed by people under its control, external providers included, whose work affects its food safety performance and how effective the system is; it makes sure those people, the food safety team and the operators of the hazard control plan among them, are competent through education, training and/or experience; it makes sure the food safety team brings together knowledge and experience from several disciplines in building and running the FSMS, covering the products, processes, equipment and hazards within scope; where needed it acts to gain the competence and evaluates whether that action worked; and it keeps documented information to evidence competence.

• Competence requirements per role including external providers and CCP or OPRP monitoring staff
• Food safety team competence matrix showing multi-disciplinary coverage
• Training and competence records with effectiveness evaluation

• Food safety team lacks product, process or equipment expertise
• CCP monitors trained but effectiveness never evaluated
• Contractor competence not verified

The organization makes sure every relevant person working under its control knows the food safety policy, knows the FSMS objectives that bear on their tasks, understands how they personally contribute to the system working, including what better food safety performance brings, and understands what follows from failing to meet the system's requirements.

• Awareness programme covering policy, task-relevant objectives, contribution and consequences
• Interview evidence that operators know the objectives relevant to their tasks

• Awareness limited to hygiene induction
• Operators unaware of the objectives that apply to their line

The organization determines and keeps up the communication that the FSMS needs. This clause brings together the general requirements (7.4.1), communication with outside parties (7.4.2) and communication inside the organization (7.4.3).

• Communication arrangements

• No defined communication

The organization determines what internal and external communication the FSMS needs, including the content, the timing, the audience, the method and who does the communicating, and makes sure everyone whose work affects food safety understands that communication has to be effective.

• Communication plan (what, when, whom, how, who)
• Evidence that people affecting food safety understand the need to communicate

• No defined communication responsibilities
• Shift-to-shift communication of food safety issues informal

The organization makes sure enough information is communicated outside it and is available to interested parties along the food chain, and sets up, runs and maintains effective communication with: external providers and contractors; customers and consumers, covering product information that allows the product to be handled, displayed, stored, prepared, distributed and used safely, hazards that others in the chain or consumers must control, contractual arrangements, enquiries and orders and changes to them, and feedback, complaints included; statutory and regulatory authorities; and other organizations that affect or are affected by the FSMS. Named people hold defined responsibility and authority for communicating food safety information externally. Relevant information received from outside is used as input to management review and when the system is updated. Evidence of external communi

• Designated persons authorised for external food safety communication
• Product information and hazard communication to customers and consumers (labels, specifications)
• Communication records with suppliers, customers, authorities, including complaints
• External inputs fed to management review and system updating

• Hazards that downstream customers must control never communicated
• Regulatory communications handled ad hoc
• Complaints not fed into management review

The organization sets up, runs and maintains an effective way of communicating matters that affect food safety, and makes sure the food safety team hears promptly about changes to any of the following: existing or new products; ingredients, raw materials and services; equipment and production systems; the premises, where equipment is located and the surroundings; programmes for cleaning and sanitation; systems for packaging, storing and distributing; competencies, and how responsibilities and authorizations are allocated; the statutory and regulatory requirements that apply; what is known about hazards and control measures; requirements from customers, the sector and elsewhere; enquiries and communications received from outside parties; complaints and alerts that point to hazards in the end product; and anything else that affects food safety. The team makes sure this information is taken

• Internal communication procedure ensuring the food safety team learns of the listed changes in time
• Change notifications received by the team and their consideration in system updating
• Information flow into management review

• New ingredients or equipment introduced before the food safety team hears of them
• Complaints and alerts not reaching the team
• Changes in responsibilities uncommunicated

The food safety management system includes the documented information required by the standard, by the organization and by statutory, regulatory authorities and customers. This clause groups the general requirement (7.5.1), creating and updating (7.5.2) and control (7.5.3).

• Document control

• Uncontrolled documents

The FSMS includes the documented information this document calls for, the documented information the organization itself judges necessary for the system to be effective, and the documented information and food safety requirements that customers and statutory and regulatory authorities require. How much is needed depends on the organization's size and activities, how complex its processes are and how they interact, and how competent its people are.

• Master list of the documented information the system requires including regulator- and customer-required documents
• Rationale for the extent of documentation

• Customer-required records not identified as system documents
• Mandatory documented information (hazard analysis, control plan, PRPs, traceability, verification) incomplete

Whenever it writes or revises documented information, the organization gives each item a suitable identity and description (for example its title, issue date, author, or a reference code), chooses a fitting format and medium, and has the item checked and approved so that it is fit for purpose and complete enough before it is issued.

• Identification convention on system documents
• Review and approval records for procedures, plans and specifications

• Unapproved working versions on the floor
• Specifications without version or date

Documented information that the FSMS and this standard call for is kept under control so that the right version can be found and used at the point and time of need, and so that it is guarded against disclosure, misuse and corruption. As applicable the organization deals with how documents are distributed, accessed, retrieved and used; how they are stored and kept legible; how changes and versions are controlled; and how long they are kept and how they are disposed of. Externally sourced documents the organization judges necessary for planning and running the system are identified and controlled as appropriate, and records kept as evidence of conformity are protected against unintended change.

• Document control procedure with distribution, access, storage, change and retention rules
• Controlled external documents (regulations, customer specifications, codes of practice)
• Protection of records (monitoring, verification, traceability) from alteration

• Superseded procedures in use
• Monitoring records alterable after the fact
• Retention shorter than shelf life or legal minimum