ISO/TC 34/SC 17 - Management systems for food safety

This document specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRPs) for transport and storage in the food chain to assist in controlling food safety hazards. This document is applicable to all organizations, regardless of size or complexity, that are involved in transport and storage activities across the food supply chain and that wish to implement PRPs in such a way as to address the requirements specified in ISO 22000. This document is neither designed nor intended for use in other parts of the food supply chain or in isolation. In this document, transport and storage is aligned with ISO/TS 22003:2013, Annex A, Category G. This document includes all food and feed products and food packaging and packaging materials. Live animals are excluded from the scope of this document except when intended for direct consumption, e.g. molluscs, crustaceans and live fish.

This document specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain: a) to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use; b) to demonstrate compliance with applicable statutory and regulatory food safety requirements; c) to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them; d) to effectively communicate food safety issues to interested parties within the food chain; e) to ensure that the organization conforms to its stated food safety policy; f) to demonstrate conformity to relevant interested parties; g) to seek certification or registration of its FSMS by an external organization, or make a self-assessment or self-declaration of conformity to this document. All requirements of this document are generic and are intended to be applicable to all organizations in the food chain, regardless of size and complexity. Organizations that are directly or indirectly involved include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitation services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials. This document allows any organization, including small and/or less developed organizations (e.g. a small farm, a small packer-distributor, a small retail or food service outlet) to implement externally-developed elements in their FSMS. Internal and/or external resources can be used to meet the requirements of this document.

ISO/TS 22002-6:2016 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRPs) to assist in controlling feed safety hazards in feed and animal food and in materials intended for use in the production of feed and animal food. Feed safety hazards in this context relate to attributes that have a potential to affect adversely animal and/or human health. Prerequisite programmes are intended to ensure feed safety and to prevent, control and detect potential contamination including cross-contamination that could occur under the responsibility of the organization. ISO/TS 22002-6:2016 is applicable to all organizations regardless of size, location or complexity that are involved in the manufacturing and/or supply of feed and animal food and wish to implement a PRP. Feed and animal food operations are diverse in nature and not all of the requirements specified in this Technical Specification necessarily apply to an individual organization or process. Where exclusions are made or alternative measures are implemented, these need to be justified by a hazard assessment and verified to be effective. Any exclusions or alternative measures adopted should not affect the ability of an organization to comply with other requirements contained in this Technical Specification.

ISO/TS 22002‑4:2013 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRPs) to assist in controlling food safety hazards in the manufacture of food packaging. This Technical Specification is applicable to all organizations, regardless of size or complexities that manufacture food packaging and/or intermediate products.

ISO/TS 22003:2013 defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000 (or other sets of specified FSMS requirements). It also provides the necessary information and confidence to customers about the way certification of their suppliers has been granted.

ISO/TS 22002-2:2013 specifies the requirements for the design, implementation, and maintenance of prerequisite programmes (PRPs) to assist in controlling food safety hazards in catering. ISO/TS 22002-2:2013 is applicable to all organizations which are involved in the processing, preparation, distribution, transport, and serving of food and meals and wish to implement PRPs in accordance with the requirements specified in ISO 22000:2005, 7.2. The scope of ISO/TS 22002-2:2013 includes catering, air catering, railway catering, banquets, among others, in central and satellite units, school and industry dining rooms, hospitals and healthcare facilities, hotels, restaurants, coffee shops, food services, and food stores. Users of catering can belong to vulnerable groups, such as children, elderly and/or ill people. In some countries, the term "food services" is used synonymously with catering. The application of ISO/TS 22002-2:2013 does not exempt the user from compliance with current and applicable legislation. Where local legal requirements are in specified for parameters (temperatures, among others) given in ISO/TS 22002-2:2013, the local requirements shall be used by the food business. Catering operations are diverse in nature and not all of the requirements specified in ISO/TS 22002-2:2013 apply to an individual establishment or process. Although the use of ISO/TS 22002-2:2013 is not mandatory for complying with the requirements in ISO 22000:2005, 7.2, there is a requirement for deviations (exclusions made or alternative measures implemented) to be justified and documented when ISO/TS 22002-2:2013 is used as reference for the PRPs implemented. It is not intended for such deviations to affect the ability of the organization to comply with the requirements of ISO 22000. ISO/TS 22002-2:2013 specifies detailed requirements to be considered in relation to ISO 22000:2005, 7.2.3. In addition, ISO/TS 22002-2:2013 adds other aspects such as product recall procedures which are considered relevant to catering operations. ISO/TS 22002-2:2013 is intended to be used when establishing, implementing, and maintaining the PRPs specific to the organization(s) in accordance with ISO 22000.

ISO/TS 22002-3:2011 specifies requirements and guidelines for the design, implementation, and documentation of prerequisite programmes (PRPs) that maintain a hygienic environment and assist in controlling food safety hazards in the food chain. ISO/TS 22002-3:2011 is applicable to all organizations (including individual farms or groups of farms), regardless of size or complexity, which are involved in farming steps of the food chain and wish to implement PRPs in accordance with ISO 22000:2005, 7.2. If an organization is using ISO/TS 22002-3:2011 as a reference for the purpose of making a self-declaration of conformity with or seeking certification to ISO 22000:2005, deviations therefrom (i.e. where exclusions are made or alternative measures are implemented) need to be justified and documented. It is expected that such deviations will not affect the ability of the organization to comply with the requirements of ISO 22000. ISO/TS 22002-3:2011 is applicable to the farming of crops (e.g. cereals, fruits, vegetables), living farm animals (e.g. cattle, poultry, pigs, fish) and the handling of their products (e.g. milk, eggs). It is not applicable to activities such as picking of wild fruits, vegetables and mushrooms, fishing, hunting, which are not considered as organized farming activities. All operations related to farming are included in the scope (e.g. sorting, cleaning, packing of unprocessed products, on-farm feed manufacturing, transport within the farm). However, ISO/TS 22002-3:2011 is not applicable to processing activities carried out on farm premises (e.g. heating, smoking, curing, maturing, fermenting, drying, marinating, extraction, extrusion or a combination of those processes). Neither is ISO/TS 22002-3:2011 applicable to products or animals that are being transported to or from the farm. Farming operations are diverse in nature according to size, type of products, production methods, geographical and biological environment, related statutory and regulatory requirements etc. Therefore, the need, intensity and nature of PRPs will differ between organizations. Established PRPs can also change as the result of the review procedures stated in ISO 22000:2005, 8.2. ISO/TS 22002-3:2011 focuses on the requirements for the management of PRPs, while the design of the exact PRPs is left to the user. The management of PRPs includes assessment of the need, selection of measures that meet the identified needs and required records. The specific examples of PRPs listed in ISO/TS 22002-3:2011 are intended for guidance only, and are aimed for application with due regard to the overall objective of producing food which is safe and suitable for consumption. It is possible for ISO/TS 22002-3:2011 to be applied by other organizations willing to develop codes of practice and other types of supplier-buyer relationship based on ISO 22000.

ISO/TS 22002-1:2009 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards. ISO/TS 22002-1:2009 is applicable to all organizations, regardless of size or complexity, which are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in ISO 22000:2005, Clause 7. ISO/TS 22002-1:2009 is neither designed nor intended for use in other parts of the food supply chain. Food manufacturing operations are diverse in nature and not all of the requirements specified in ISO/TS 22002-1:2009 apply to an individual establishment or process. Where exclusions are made or alternative measures implemented, these need to be justified and documented by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted should not affect the ability of the organization to comply with these requirements. Examples of such exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and 5) below. ISO/TS 22002-1:2009 specifies detailed requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3: a) construction and layout of buildings and associated utilities; b) layout of premises, including workspace and employee facilities; c) supplies of air, water, energy, and other utilities; d) supporting services, including waste and sewage disposal; e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance; f) management of purchased materials; g) measures for the prevention of cross-contamination; h) cleaning and sanitizing; i) pest control; j) personnel hygiene. In addition, ISO/TS 22002-1:2009 adds other aspects which are considered relevant to manufacturing operations: 1) rework; 2) product recall procedures; 3) warehousing; 4) product information and consumer awareness; 5) food defence, biovigilance, and bioterrorism.

ISO 22005:2007 gives the principles and specifies the basic requirements for the design and implementation of a feed and food traceability system. It can be applied by an organization operating at any step in the feed and food chain. It is intended to be flexible enough to allow feed organizations and food organizations to achieve identified objectives. The traceability system is a technical tool to assist an organization to conform with its defined objectives, and is applicable when necessary to determine the history or location of a product or its relevant components.

ISO 22004:2014 provides generic advice on the application of ISO 22000. ISO 22004:2014 does not create, alter or replace any of the requirements in ISO 22000. As individual organizations are free to choose the necessary methods and approaches to fulfil the requirements of ISO 22000, the guidance provided by this ISO 22004:2014, are under no circumstances, to be considered a requirement.

ISO/TS 22003:2007 defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000:2005 (or other sets of specified FSMS requirements), and provides the necessary information and confidence to customers about the way certification of their suppliers has been granted. FSMS certification does not attest to the safety or fitness of the products of an organization within the food chain. However, ISO 22000:2005 requires an organization to meet all applicable food-safety-related statutory and regulatory requirements through its management system.

ISO/TS 22004:2005 provides generic guidance that can be applied in the use of ISO 22000.

ISO 22000:2005 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption. It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/or external resources. ISO 22000:2005 specifies requirements to enable an organization -- to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer, -- to demonstrate compliance with applicable statutory and regulatory food safety requirements, -- to evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction, -- to effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain, -- to ensure that the organization conforms to its stated food safety policy, -- to demonstrate such conformity to relevant interested parties, and -- to seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000:2005.