ISO 22000 Safety Management Systems Your implementation guide ISO 22000 management systems How ISO 22000 works

The World Health Organization estimates that one Certification to the standard provides additional One of the key differences between the 2005 and 2018 versions is how the prescriptive content in ten people fall ill and 420,000 die because of benefits to organizations throughout the food chain: is structured. Annex SL was developed by ISO as a framework for a generic . 1 contaminated food every year. ISO 22000:2018 • Improved control over food safety activities It’s the framework for a generic management system and the blueprint for all new and revised works preventively to reduce this by helping food management system standards going forward. organizations implement food safety management • Customer, statutory and regulatory compliance systems that defend against the potential hazards • Facilitated market growth In addition to making ISO 22000 and the resulting and implementation is based on the principles of and risks that lead to contamination. From • Increased customer, stakeholder and consumer FSMS easier to integrate with other ISO management HACCP traditionally associated with food safety outbreaks to incorrect labelling, compromised confidence in products systems, the new version of the standard is based management. How they interrelate can be seen in the food products can negatively impact customer and on a process approach. By combining the Plan- diagram below. Reproduced from ISO 22000:2018. consumer confidence in your business and your brand. • Improved Do-Check-Act cycle to manage business risk • Integration with other ISO management systems with HACCP to identify, prevent and control food The potential benefits of combining risk-based Food safety hazards can occur at any stage in the safety hazards, ISO 22000 helps organizations thinking, PDCA and the process approach include: food chain making adequate control throughout Why was the standard revised? to reduce exposure to risk and improve safety. the food chain essential. By combining PDCA • Focussing your FSMS and activities on The expectation to deliver safe, sustainable and and risk-based thinking to manage business risk This combines both organizational and operational higher-risk processes socially responsible food has increased significantly with HACCP to identify, prevent and control food risk management into one management system. • Understanding how processes within your for the food sector since the standard was first safety hazards, ISO 22000 helps organizations Organizationally, this approach provides the organization are interdependent published in 2005. To help food sector organizations to reduce exposure to risk and improve safety. opportunity to consider all the different things that manage these challenges the standard has been • More effective use of resources might impact your company, both good and bad. updated to take them into account. This allows you to prioritize the objectives of your • Improved agility in meeting the requirements of Additionally, during the development process FSMS so that it’s implemented in a way that can new customers and/or meet new requirements the standard also adopted Annex SL. The high accommodate the effects of these risks should they established by existing customers level structure (HLS) was introduced to align the occur. On the operational side, risk-based thinking implementation process of ISO management systems so that it was easier to adopt multiple management systems within individual organizations. Contents Organizational planning and control What kind of businesses can benefit • How ISO 22000 works from the standard? • Core concepts An ISO 22000 food safety management system Plan (FSMS) Do (FSMS) Check (FSMS) Act (FSMS) • Key requirements (FSMS) can be implemented in small, medium and 4. Context of the organization 8. Operation 9. Performance 10. Improvement large-sized food organizations from all aspects of the • Top tips from our clients 5. Leadership evaluation food chain: • Your ISO 22000 journey 6. Planning • Food and ingredient manufacturers 7. Support (including control of • BSI Training Academy externally provided processes, • Retailers products or services) • BSI Business Improvement Software • Wholesalers • Agricultural producers • Transport, logistics and storage providers • Packers • Equipment and packaging manufacturers • Caterers 2 3 1 http://www.who.int/en/news-room/fact-sheets/detail/food-safety Key requirements of How ISO 22000 works ISO 22000

Operational planning and control

PRPs Hazard Validation Hazard control plan Verification Traceability system of control analysis (HACCP / OPRP planning measures Emergency prepardness & response plan)

Plan (food safety)

Implementation of the Clause 1: Scope system will apply. Additionally, Clause 4 requires you Verification activities Plan (food safety) to establish, implement, maintain and continually Updating of preliminary This clause details the scope of the international information and documents Control of monitoring improve the management system in accordance with standard. This includes requirements about planning, specifying the PRPs and the and measuring the requirements of the standard. hazard control plan Analysis of results of implementation, maintaining and updating an FSMS verification activities Control of product and as well as effective communications. process nonconformities Clause 5: Leadership Act (food safety) Check (food safety) Do (food safety) Clause 2: Normative references This clause is all about the role of “top management” which is the person or group of people who direct There are no normative references within the and control your organization at the highest level. standard. The clause is retained in order to maintain The purpose is to demonstrate leadership and Some of the core concepts of ISO 22000 include: the same numbering scheme as all the other commitment by integrating the FSMS into the ISO management system standards. business’ overall strategy.

Concept Comment Clause 3: Terms and definitions Top management must demonstrate a greater involvement in the management system and need to Listed in alphabetical order, this section provides establish the food safety policy, which can include Context of the The range of issues that can affect, positively or negatively, the way an organization formal definitions of important terms used organization manages its food safety responsibilities. commitments specific to your organization’s context throughout the standard. beyond those directly required. Issues Issues can be internal or external, positive or negative and include a number of things that either affect or are affected by the organization. Clause 4: Context of the organization There is also more focus on top management’s commitment to continual improvement of the Interested parties Much more detail about considering stakeholder needs and expectations, then This clause establishes the context of your FSMS deciding whether to adopt any of them as compliance obligations. management system. Communication is key and and underpins the rest of standard. You will need to top management have a responsibility to ensure its Leadership Requirements specific to top management; who are defined as a person or group of identify external and internal issues and the needs people who direct and control an organization at the highest level. structure and detail is made available, communicated, and expectations of your stakeholders and interested maintained and understood by all parties. Risk and opportunities Refined planning process replaces preventive action. Aspects and impacts now part of parties, as well as how value is delivered to them. It also risk model. partly addresses the concept of the creation of value. Finally, top management need to assign relevant Communication There are explicit and more detailed requirements for both internal and external responsibilities and authorities, to a food safety team communications. In this case the term ‘issue’ covers not only problems leader, as well support the people who are involved or potential problems, but also important topics Nonconformity and More detailed evaluation of both the nonconformities themselves and corrective as the system is developed, implemented and as for the system to address, such as changing corrective action actions required. it evolves. Depending on the skillset of the chosen circumstances, legal requirements and other implementation, maintenance and improvement Performance evaluation Covers the measurement of the FSMS to identify how operations could be improved obligations. or enhanced. team(s), management also has make sure that all This clause also includes determining the scope of team members have the appropriate experience and/ the food safety management system. The scope or receive training to successfully accomplish the is intended to clarify the boundaries to which the tasks they are assigned. 4 5 Clause 6: Planning its control, affects the management system’s This clause covers: Internal audits will need to be carried out, and performance, its ability to fulfil its obligations and there are certain “audit criteria” that are defined to This clause focuses on how an organization plans • Operational planning and control ensure they receive the appropriate training. ensure that the results of these audits are reported actions to address both the risks and opportunities • Prerequisite programmes (PRPs) to relevant management. Finally, management identified in Clause 4. It focuses on the development In addition, organizations need to ensure that all reviews will need to be carried out and “documented and use of a planning process, rather than a • Traceability people doing work under the organization’s control information” must be kept as evidence. procedure to address both a range of factors and the are aware of the food safety policy, how their work • Emergency preparedness and response risk associated with such factors. may impact this and implications of not conforming • Hazard control Clause 10: Improvement to the FSMS. There are also the requirements for Consideration of risks needs to be proportionate to • PRP and hazard control maintenance This clause requires organizations to determine and ‘documented information’ which relate to the creation, the potential impact they may have. Another key area identify opportunities for continual improvement updating and control of specific data. • Control of monitoring and measuring of this clause is the need to establish measureable of the management system. The requirement for • PRP and hazard control verification objectives and then communicate and monitor those A corporate relationship management plan that continual improvement has been extended to ensure objectives. Finally this clause states that the ‘who, captures this is also needed. It should define and link • Control of product and process nonconformities that its suitability and adequacy—as well as its what, where and when’ associated with achieving the to your other management and operational processes effectiveness— are considered in light of enhanced objectives must be identified. and procedures. Clause 9: Performance evaluation food safety performance. This is all about measuring and evaluating your Clause 7: Support Clause 8: Operation There are some actions that are required that cover food safety management system to ensure that it’s handling of corrective actions. Organizations need This clause is all about the execution of the plans This clause outlines the requirements your FSMS effective and helps you to continually improve. You to react to the nonconformities and take action AND and processes that will enable your organization to must meet for successful certification. Though they will need to consider what should be measured, the they need to identify whether similar nonconformities successfully complete their FSMS responsibilities. appear in a different clause number and sometimes methods employed and when data should be analysed exist or could potentially occur. This clause requires This is a very powerful requirement covering all in a different order, many of the concepts were in and reported on. you to determine and identify opportunities for management system resource needs. included in ISO 22000:2005. Our ISO 22000 Mapping continual improvement of the FSMS. Guide can be downloaded from bsigroup.com if As a general recommendation, organizations should Organizations will need to determine the necessary you’d like to better understand how the content has determine what information they need to evaluate competence of people doing work that, under been restructured. performance and effectiveness.

6 7 Top tips on making ISO 22000 Your ISO 22000 Journey effective for you Whether you’re new to management systems or looking to enhance your current system, we have the right resources and training courses to help you understand and implement ISO 22000. But our support Every year we have interactions with tens of thousands of clients. Here are their doesn’t stop there. We can help make sure your FSMS delivers the best for your business. suggestions for maximizing your implementation and certification.

You We  Top management commitment is key to making your FSMS need to: help you: effective and successful. • Buy the standard and read it; understand the • Discover information on our website about the content, your requirements and how it will standard and sign up for webinars Keep staff informed of what’s improve your business • Enrol in BSI’s Introduction to ISO 22000 Food going on, create a team or assign • Contact us, whether you’ve got year of Safety Management Systems training course a champion, as this will increase Understand Understand and prepare experience with food safety management • Visit bsigroup.com motivation. This could include systems or it’s still really new, BSI can help a well communicated plan of activities and timescales. Think about how different departments work together • Ensure your organization understands the • Enrol in BSI’s Implementing ISO 22000 Food to avoid silos. Make sure the principles of ISO 22000 and the roles individuals Safety Management Systems training course organization works as a team for will need to play, and review your activities and • BSI Business Improvement Software helps ISO the benefit of customers and the processes against the standard 22000 implementation See how • Book a BSI gap assessment to see what

organization. ready you are Review systems, policies, modifications you might still need to make to procedures and processes meet all of the standard’s requirements you have in place – you may already do much of what’s in the standard and make it work for your business. • Contact us to book your certification assessment • Your BSI certification assessment Speak to your customers and • Ensure all the right people are available and • BSI Business Improvement Software helps you prepared for the audit visit(s) effectively manage your FSMS suppliers. They may be able to certified • This generally involves more than one visit, suggest improvements and give get and Review duration will be based on the size of your feedback on your service. organization

Train your staff to carry out internal audits. This can help with their understanding, but it could also provide valuable feedback Continually improve and make excellence a habit on potential problems or opportunities for improvement.

And finally, when you gain Your journey doesn’t stop with certification. We can help you to fine-tune your organization so it performs at its best. certification celebrate your • Celebrate and promote your success – download • Your BSI Client Manager will visit you regularly achievement and use the and use the BSI Assurance Mark to show you are to make sure you remain compliant and BSI Assurance Mark on certified. support your continual improvement. your literature, website and • BSI Business Improvement Software will help you to promotional material. manage systems and drive performance.

8 9 Train with BSI BSI Business Improvement Software

BSI is a world leader in helping clients develop the knowledge and skills they need to embed excellence Accelerate implementation time and It can help you to: in their organizations. Whether your organization is going to certify or is simply looking to implement deliver continual improvements a management system for food safety, our training can make sure the people responsible for making • Accelerate implementation time by up to 50% things happen understand all the important and relevant details. The decision to implement the new ISO 22000 management system standard is a huge opportunity • Effectively manage your document control Using the latest research, our accelerated learning approach is proven to fast-track learning and to drive business improvement; but initiating, • Provide company-wide visibility on the status of implementing, and maintaining this can also be a improves knowledge retention. Our experienced tutors can help you get to grips with the matters that your implementation of the standard so you know challenge. Ensuring you get the most from your concern you and your organization directly, whether the course is delivered in-house or as part of a exactly where you are at any one time public course where other delegates can share their experience. investment is a key driver to your future success. BSI Business Improvement Software provides a • Easily and accurately input actions related to solution that can significantly reduce the cost and audits, incidents/events, risk and performance Our courses that can help you understand, implement and effort to an effective management system such as successfully certify to ISO 22000 include: ISO 22000. It can be configured to the requirements • Have insight into trends that help you of ISO 22000 and provide your organization with make business decisions early on and drive Transition-specific courses the tools necessary to manage essential elements of improvement through its customizable ISO 22000. The start of your ISO 22000 journey is an dashboards and reporting tools These courses are designed for organizations already ideal time to implement BSI Business Improvement certified to ISO 22000:2005 who want to make their Software to support your management system. transition to the new standard as: • ISO 22000:2018 Senior Management Briefing (half-day) • ISO 22000:2018 Transition Briefing (one day) • ISO 22000:2018 Transition Seminar (half-day)

10 11 Our products and services and products Our international levels. standards atlocal,regionaland experts fromindustrytoshape expert body,bringingtogether to buildourreputationasan standards arenawecontinue and imparttoourclients.Inthe on theknowledgethatwecreate The coreofourbusinesscentres Knowledge comes from. how it’smade,itsimpactonecosystemsandwhereit increasingly consciousaboutwhatgoesintotheirfood, food willincrease70%by2050.And,consumersare increasing middleclasssuggestthatthedemandfor the world.Populationgrowthprojectionsandan ill andisthecauseofdeathformillionsaround Each year,food-borneillnessmakesoneintenpeople But thefoodsectoralsofacessignificantchallenges. (valued atUS$48trillionbytheWorld Bank). Economically, foodrepresents10%ofGlobal GDP a vitalroleinallofourday-to-daylivesandculture. and availabilityofgoods,noothersectorplayssuch differ dependingonthegeography,wealth,age,gender Though whattheworld’spopulationmayeat The foodindustryimpactseverypersonontheplanet. Why BSI? Why of they maximizethebenefits auditing techniquestoensure class implementationand We trainourclientsinworld- to ahighlevelofexcellence. ensures thatourclientsperform product toaparticularstandard the conformityofaprocessor Independent assessmentof Assurance standards. survive andprosperintoday’sworld. high-profile globalbrandstosmalllocalcompanies, Our missionistohelpour80,000clients,rangingfrom expertise, integrityandprofessionalismofourpeople. Working in172countries,weprideourselvesonthe more resilient. standards thatworktogethertomakeorganizations safety standards,butotherbusinessimprovement and certificationtonotonlythemostpopularfood best practice,supplychainsolutionsaswelltraining food sectorbydevelopingandpublishingstandardsof sustainable andsociallyresponsible.We supportthe BSIbelievestheworlddeservesfoodthatissafe, email For moreinformation onI visit bsigroup.com/en-au which helpfacilitatethisprocess. differentiated managementtools provide arangeofservicesand becomes anembeddedhabit.We market needorstandardsothatit ongoing compliancetoaregulation, benefits, ourclientsneedtoensure To experiencereal,long-term Compliance inf [email protected] 22000:2018 S o O r

© BSI Group BSI/AU/1342/SC/0618/EN/PD