Fssc 22000 scheme food safety management system

Developed through extensive and open consultation with global stakeholders, the FSSC 22000 scheme uses international and independent standards such as ISO 22000, ISO 9001, ISOTS 22003, and technical specifications for sectorspecific PreRequisite Programs (PRPs), including ISOTS 220021.

The Scheme

The FSSC 22000 certification scheme establishes the criteria for auditing and certifying food safety management systems (FSMS) and quality management systems (QMS) within the food supply chain This certification verifies that an organization's FSMS (FSSC 22000) or combined FSMS and QMS (FSSC 22000-Quality) meets the specified requirements of the Scheme.

The Scheme is based on the publicly available standards/technical specifications:

• ISO 22000:2018 requirements for any organization in the food chain;

• ISO 9001 requirements (where FSSC 22000-Quality is required);

• Relevant prerequisite programs (PRPs) based on technical specifications for the sector (e.g., ISO/TS 22002-x; PAS xyz); and

• FSSC 22000 Additional Requirements as determined by our stakeholders

When the Foundation decides that updates or changes to the Scheme are necessary, requirements for communication and implementation will be published separately

The Scheme offers a voluntary certification model applicable across various sectors of the food supply chain, incorporating sector-specific prerequisite programs (PRPs) that are recognized as part of its normative documents The classification of food chain categories within this Scheme aligns with ISO/TS 22003:2013 and ISO 22003-1:2022 standards, ensuring a comprehensive framework for certification.

As of February 2010, the Scheme has been benchmarked and recognized by the Global Food Safety Initiative (GFSI) confirming global food industry recognition and acceptance

As of March 2021, the Scheme has been endorsed as a sub-scope of the IAF MLA which is a demonstration of the technical rigor and consistency of the Scheme.

Ownership and Governance

The Foundation FSSC owns all Scheme-related documentation and holds agreements with Certification Bodies, Accreditation Bodies, and Training Organizations.

The Foundation's Statutes outline essential provisions and governance requirements for the Foundation and the Scheme, which are publicly accessible in the Register of the Chamber of Commerce in Gorinchem, Netherlands, under number 64112403 These provisions are integral to the Scheme, particularly concerning the rights and obligations of both direct and indirect stakeholders.

Language

English is the official and valid version of the Scheme

Aim and Objectives

The aim of the Scheme is to ensure that it continuously meets international food industry requirements resulting in a certification that assures that organizations provide safe food to their customers

The Scheme aims to recognize organizations that comply with its requirements by maintaining a reliable public register of certified entities It seeks to promote the accurate application and acceptance of food safety management systems in the Consumer Goods industry, while also offering information and support for the auditing and certification processes Additionally, the Scheme strives to create a positive impact by aligning its public goals with the UN Sustainable Development Goals.

The Foundation aims to achieve its goals by collaborating with strategic partners, ensuring governance and oversight through its Integrity Program, and offering ongoing support to licensed partners via training and knowledge management Additionally, it proactively addresses any incidents that may jeopardize its reputation, business continuity, certification, or brand integrity Furthermore, the Foundation supports other organizations with similar objectives to enhance collective efforts in achieving shared goals.

Nature of the Scheme

The Scheme offers an independent ISO-based framework for third-party auditing and certification, incorporating ISO standards alongside sector-specific technical specifications for PRPs and additional market-driven requirements It is recognized by the Global Food Safety Initiative and facilitates integration with various ISO-based management system standards, including those for quality, environmental, health, and safety Governed by a non-profit Foundation and managed by an independent Board of Stakeholders, the Scheme enhances transparency across the food supply chain through the publicly accessible "FSSC 22000 Register of certified organizations."

The Scheme aims to audit and certify organizations across specified food chain subcategories, as detailed in Table 1, and is in accordance with the classifications established in ISO 22003-1:2022.

Table 1 Overview of (Sub)Categories

Category Subcategory Description Example of included activities and products

A AI Farming of animals for meat/milk/ eggs/honey

Raising animals used for meat production, egg production, milk production or honey production (associated farm packing and storage)

ISO 22000: 2018 ISO/TS 22002-3, FSSC 22000 Additional requirements

Raising fish and seafood used for meat production (associated farm packing and storage)

ISO 22000: 2018 ISO/TS 22002-3, FSSC 22000 Additional requirements

B BIII Pre-process handling of plant products

Post-harvest activities on horticultural products and hydrophytes, which maintain the original whole form of the plants, encompass essential processes such as cleaning, washing, rinsing, sorting, grading, trimming, bundling, cooling, hydro-cooling, waxing, drenching, aeration, and preparation for storage or processing Additionally, these activities include packing, repacking, staging, storing, and loading, all crucial for ensuring the quality and longevity of food products.

ISO 22000:2018 ISO/TS 22002-1:2009 FSSC 22000 Additional requirements

The conversion of animal carcasses involves several key processes, including lairage, slaughter, evisceration, and bulk chilling Additionally, it encompasses bulk freezing and storage of animals, as well as game gutting and bulk freezing of fish Proper handling and storage are essential for maintaining the quality and safety of these products.

ISO 22000:2018, ISO/TS 22002-1:2009 FSSC 22000 Additional requirements

CI Processing of perishable animal products

Processing and packaging including fish, fish products, seafood, meat, eggs, and dairy requiring chilled or frozen temperature control

Processing pet food from animal products only

ISO 22000:2018, ISO/TS 22002-1:2009, FSSC 22000 Additional requirements

C CII Processing of perishable plant-based products

Processing and packaging including fruits and fresh juices, vegetables, grains, nuts, pulses, frozen water- based products, plant-based meat, and dairy substitutes

Processing pet food from plant products only

CIII Processing of perishable animal and plant products (mixed products)

Processing and packaging including pizza, lasagna, sandwiches, dumplings and ready-to-eat meals

Includes off-site catering kitchens

Includes products of industrial kitchens not offered for immediate consumption

Processing perishable pet food from mixed products

CIV Processing of ambient stable products

Processing and packaging of products stored and sold at ambient temperature including canned foods, biscuits, snacks, oil, drinking water, beverages, pasta, flour, sugar, and food-grade salt

Processing ambient stable pet food

D DI Processing of feed and animal food

Processing feed material intended for food and non-food producing animals not kept in households, e.g meal from grain, oilseeds, by- products of food production

Processing feed mixtures, with or without additives, intended for food- producing animals, e.g premixes, medicated feed, compound feeds

DIIa Production of pet food (only for dogs and cats)

Production of single or multiple products, whether processed, semi- processed or raw, which are intended to be fed to non-food producing animals being dogs and cats

Examples: Dry and wet pet food, treats, cooled, chilled, frozen, and ambient stable

DIIb Production of pet food (for other pets)

Production of single or multiple products, whether processed, semi- processed or raw, which are intended to be fed to non-food producing animals other than dogs and cats

Examples: Dry and wet pet food, treats, cooled, chilled, frozen, and ambient stable

Open exposed food activities such as cooking, mixing, and blending, preparation of components and products for on-site direct consumer consumption or take away

Examples include restaurants, hotels, food trucks, institutions, work places (school or factory cafeteria), including retail with on-site preparation (e.g rotisserie chicken)

Includes reheating of food, event catering, coffee shops and pubs

Storage and provision of finished products to customers and consumers (retail outlets, shops, wholesalers) Includes minor processing activities, e.g., slicing, portioning, reheating.

ISO 22000:2018, BSI/PAS 221:2013, FSSC 22000 Additional requirements

Buying and selling products on its own account without physical handling or as an agent for others of any item that enters the food chain

Storage facilities and distribution vehicles for perishable food and feed where temperature integrity shall be maintained

Storage facilities and distribution vehicles for ambient stable food and feed

Relabelling/repackaging excluding open exposed product materials

Storage facilities and distribution vehicles for food packaging material

GI Provision of transport and storage services for perishable food and feed

Transport and storage with cooling, chilling, or frozen temperatures

Additional activities such as re- packing of packed product, freezing and thawing

GII Provision of transport and storage services for ambient stable food, feed, and packaging materials

Transport and storage Additional activities such as re-packing of packed product

Production of packaging material in contact with food, feed, and animal food

May include packaging produced on- site for use in processing,

Production of food and feed processing aids, additives (e.g., flavorings, vitamins), gases and minerals

Production of bio-cultures and enzymes

Farming of Animals (Category A)

Food chain subcategory AI refers to farming of livestock animals on land for human consumption Activities such as hunting, or trapping are not included.

Handling of Plants (Category B)

Food chain subcategory BIII pertains to the handling of whole plants, such as those in fruit and vegetable packhouses, where minimal processing occurs without altering the product's original form This includes activities like washing, sorting, grading, trimming, waxing, and drenching However, any processing that changes the product's form, such as cutting and dicing, falls under subcategory CII and is not included in BIII.

Food Manufacturing (Category C)

Food chain category C encompasses various food processing activities essential for managing both animal and plant products It includes C0, which involves the conversion of animal carcasses through processes like slaughter and bulk storage CI focuses on the processing and packaging of perishable animal products, such as meat, dairy, and pet food, requiring temperature control CII pertains to the processing of perishable plant-based products, including fruits, vegetables, and plant-based substitutes, as well as pet food made from plant ingredients CIII covers mixed product processing, producing items like ready-to-eat meals and catering services, while CIV involves the production of ambient stable products, such as canned foods and snacks, that can be stored and sold at room temperature.

Foods designed for special dietary needs and those intended for specific medical purposes can be categorized under food chain category C, provided they are legally recognized as food in their country of manufacture However, products classified as pharmaceuticals or medical devices under relevant legislation fall outside the scope of FSSC 22000 certification.

Animal Feed Production (Category D)

Food chain category D encompasses the production of animal feed and pet food, including the processing of feed materials for food and non-food producing animals, such as grain meal and oilseed by-products It also involves the creation of feed mixtures, with or without additives, specifically designed for food-producing animals, including premixes and medicated feeds Additionally, this category covers the production of pet food, primarily for dogs and cats, as well as for other pets, utilizing either single or mixed food sources for non-food producing animals.

Catering (Category E)

Food chain category E applies when the catering service is delivered directly to consumers The food is prepared for on-site consumption or take away or at a satellite unit

• Units that serve food directly to the consumer or offer food for immediate consumption, e.g., restaurants, hotels, cafeterias and onboard passenger service;

• Catering sites handling foods at remote site with direct serving to consumers, e.g., canteens, coffee shops, food trucks and event catering.

Trading, Retail, Wholesale and E-commerce (Category F)

Food chain category FI applies to retail and wholesale activities, and related E-commerce activities

Retail involves the sale of goods directly to consumers in small quantities for personal use rather than for resale Retailers operate through physical establishments such as shops and warehouses to facilitate these transactions.

• Wholesale is defined as the buying of goods from manufacturers or other sellers and selling of goods to other businesses such as retailers, industries, and occasionally end consumers

E-commerce activities, such as internet sales or deliveries, are considered part of the retailer or wholesaler's operations only when they are connected to a physical location, rather than functioning as an independent activity.

• Wholesalers always take ownership of the products and activities may include food, feed and/or packaging products for food and feed

In both retail and wholesale settings, minor in-shop processing activities can enhance pre-prepared foods by adding a final touch, such as grilling meat, baking bread, reheating ready-to-eat meals, or cutting and portioning meat and fish.

Food chain category FII applies to Food brokering, trading, and E-commerce activities

Food brokering and trading involves the buying and selling of food products without the physical handling of items, either for one's own account or as an agent for others within the food supply chain.

• Food E-commerce is the buying and selling of food products over an electronic network (internet) without physical handling.

Transport and Storage (Category G)

Food chain category G encompasses third-party logistics service providers involved in the physical storage and transportation of food, feed, or packaging materials, irrespective of legal ownership This category may also cover supplementary activities like re-packing, relabeling, freezing, and thawing of products.

Manufacturers, caterers, and retailers or wholesalers that solely store or transport their own products, without offering services to others, will be audited based on their production activities.

Manufacturers, caterers, and retailers or wholesalers that offer storage and transport services to external organizations must obtain category G in addition to their relevant manufacturing category This requirement also applies to subsidiaries and sister companies.

Production of Food Packaging and Packaging Materials (Category I)

Category I of the food chain encompasses various packaging materials, including plastic, carton, paper, metal, glass, and wood, specifically related to food and feed packaging This includes materials that come into direct contact with food, such as surfaces and labels, as well as those that may indirectly contact food, like labels on primary packaging Additionally, closing materials like tape and disposable tableware are included only if they are proven to be applied to food packaging or sold with food products Certification for disposable tableware is limited to items sold with food, while napkins are certified only for food service use Packaging materials intended for food preparation within the food industry, such as aluminum foil and plastic wrap, are eligible for certification, but those meant for domestic use are excluded Activities such as inline unfolding or printing are not classified as food packaging activities, while the production of primary packaging, like blowing bottles from preforms, falls under the packaging scope Lastly, packaging for personal care or pharmaceutical products is not included in this certification scheme.

Production of Biochemicals (Category K)

Food chain category K encompasses the production of chemical and biochemical products, focusing on food and feed additives, vitamins, minerals, bio-cultures, flavorings, enzymes, gases, and processing aids.

Food supplements are categorized under food chain category K if they are legally classified as food in their country of manufacture However, if a product is classified as a pharmaceutical or medical product by legislation, it falls outside the scope of FSSC 22000 certification.

FSSC 22000 - Quality

FSSC 22000-Quality certification is an optional enhancement to the existing FSSC 22000 certification, integrating the standards of ISO 9001:2015 for Quality Management Systems This combination leads to the issuance of a FSSC 22000 certificate specifically for the FSSC 22000-Quality category.

The requirements for the development, implementation and maintenance of a quality management system are laid down in the standard ISO 9001:2015 “Quality Management Systems

This section outlines the Scheme requirements that licensed Certification Bodies must use to audit an organization's Food Safety Management System (FSMS) or its FSMS and Quality Management System (QMS) to obtain or uphold certification for FSSC 22000 or FSSC 22000-Quality.

General

Organizations shall develop, implement, and maintain all the requirements outlined below and shall be audited by a licensed Certification Body in order to receive a valid FSSC 22000 certificate

The audit requirements for FSSC 22000 certification consist of:

1) ISO 22000:2018 Food Safety Management System requirements;

2) Sector specific prerequisite program (PRPs) requirements (ISO/TS 22002-x series or other specified PRP standard) and;

The audit requirements for FSSC 22000-Quality certification consist of:

1) ISO 22000:2018 food safety management system requirements;

2) ISO 9001:2015 quality management system requirements;

3) Sector specific prerequisite program (PRPs) requirements (ISO/TS 22002-x series or other specified PRP standard) and;

Scheme Changes and Interpretation

The Board of Stakeholders (BoS) Decision List is a crucial document outlining decisions related to the FSSC 22000 Scheme These decisions clarify or modify existing scheme rules and must be implemented within a specified transition period Additionally, the decision list is dynamic, allowing the BoS to make adjustments as necessary.

The Foundation issues interpretation articles that clarify Scheme requirements and their implementation Certification bodies and Certified Organizations must comply with these articles It is the responsibility of the FSSC 22000 contact person to stay informed about these interpretations and communicate relevant updates to the appropriate parties within the Certification Body or Certified Organizations.

ISO 22000

The ISO 22000:2018 standard outlines the essential requirements for the development, implementation, and maintenance of a Food Safety Management System (FSMS) applicable to all organizations within the food chain.

For FSSC 22000-Quality certification, the requirements for the development, implementation, and maintenance of the Quality Management System (QMS) are laid down in the standard ISO 9001:2015 “Quality management system - Requirements”.

Prerequisite Programs

The Scheme mandates the application of technical specifications for prerequisite programs (PRPs) as outlined in clause 8.2 of ISO 22000:2018, excluding sub-category FII These PRP requirements are detailed in the ISO/TS 22002-x series and the BSI/PAS 221 standards For more information, refer to Part 1, Table 1 of the Scheme.

FSSC 22000 Additional Requirements

2.5.1 MANAGEMENT OF SERVICES AND PURCHASED MATERIALS (ALL

In compliance with ISO 22000:2018, organizations must ensure that laboratory analyses for food safety verification are conducted by competent laboratories capable of delivering precise and repeatable results through validated methods For food chain categories C, D, I, FII, G, and K, organizations are required to have documented emergency procurement procedures to evaluate suppliers and ensure product conformity Additionally, for categories C0, CI, CIII, and CIV, a policy must be in place for the procurement of animals, fish, and seafood, controlling prohibited substances Organizations in categories C, D, I, FII, G, and K must also implement a review process for raw material and finished product specifications to maintain compliance with food safety and quality standards Furthermore, for category I, criteria related to the use of recycled packaging as a raw material must be established to meet legal and customer requirements.

2.5.2 PRODUCT LABELING AND PRINTED MATERIALS (ALL FOOD CHAIN

Organizations must comply with clause 8.5.1.3 of ISO 22000:2018 by ensuring that finished products are labeled according to all relevant statutory and regulatory requirements in the intended sales country, including allergen and customer-specific needs For unlabeled products, essential product information must be accessible to guarantee safe consumer use If any claims are made on product labels or packaging, the organization is required to maintain validation evidence and implement verification systems, including traceability and mass balance, to uphold product integrity In food chain category I, it is crucial to establish and enforce artwork management and print control procedures to ensure compliance with customer and legal standards These procedures should include the approval of artwork standards, management of changes and obsolete materials, verification of print runs against agreed standards, detection of printing errors, segregation of different print variants, and accounting for any unused printed products.

2.5.3 FOOD DEFENSE (ALL FOOD CHAIN CATEGORIES)

The organization must establish a documented procedure to carry out and record a food defense threat assessment using a defined methodology This assessment aims to identify and evaluate potential threats associated with the organization's processes and products Additionally, the organization is required to develop and implement effective mitigation measures for any significant threats identified.

The organization must develop a documented food defense plan that includes a threat assessment, detailing mitigation measures and verification procedures This plan should be integrated with the organization's Food Safety Management System (FSMS) and adhere to relevant legislation, encompassing all processes and products within its scope while remaining current Additionally, for food chain category FII, the organization is required to ensure that its suppliers also possess a food defense plan.

2.5.4 FOOD FRAUD MITIGATION (ALL FOOD CHAIN CATEGORIES)

The organization must establish a documented procedure to conduct a food fraud vulnerability assessment using a defined methodology to identify and evaluate potential vulnerabilities Additionally, it is essential to develop and implement effective mitigation measures for any significant vulnerabilities identified This assessment should encompass all relevant processes and products within the organization's scope.

The organization must establish a documented food fraud mitigation plan informed by a vulnerability assessment, detailing specific mitigation measures and verification procedures This plan should be integrated into the organization's Food Safety Management System (FSMS) and adhere to relevant legislation, encompassing all processes and products within the organization's scope while remaining current Additionally, for food chain category FII, the organization is required to ensure that its suppliers also have a food fraud mitigation plan in effect.

2.5.5 LOGO USE (ALL FOOD CHAIN CATEGORIES) a) Certified organizations, Certification Bodies and Training Organizations shall use the FSSC

The FSSC logo, intended exclusively for marketing activities including printed materials, websites, and promotional items, must be utilized by certified organizations To use the logo, these organizations are required to obtain the most recent version from their Certification Body and adhere to specified guidelines.

The FSSC 22000 logo may be used in black and white only when all accompanying text and images are also in black and white Certified organizations are prohibited from using the FSSC 22000 logo or referencing their certified status on products, labels, packaging (including primary and secondary), certificates of analysis or conformance, or in any way that suggests FSSC 22000 endorses a product, process, or service, particularly where certification scope exclusions exist.

2.5.6 MANAGEMENT OF ALLERGENS (ALL FOOD CHAIN CATEGORIES)

An effective allergen management plan must be documented and include a comprehensive list of allergens present in raw materials and finished products, alongside a thorough risk assessment of potential cross-contamination sources Control measures should be identified and implemented based on this assessment, with validation and verification maintained as documented evidence In production areas with multiple products having different allergen profiles, verification testing must occur at a risk-based frequency, such as surface testing or product testing Precautionary labels should only be utilized when risk assessments indicate a potential allergen cross-contamination risk, and organizations remain responsible for enforcing control measures and conducting verification testing All personnel must undergo training in allergen awareness and specific control measures relevant to their roles The allergen management plan should be reviewed annually and after significant changes affecting food safety, ensuring an evaluation of existing control measures and the potential need for new ones Verification data must be analyzed to inform these reviews For Food Chain Category D, if no allergen-related legislation exists for animal feed in the country of sale, this requirement may be marked as 'Not Applicable' unless an allergen status claim is made.

2.5.7 ENVIRONMENTAL MONITORING (FOOD CHAIN CATEGORIES BIII, C,

The organization must implement a risk-based environmental monitoring program targeting relevant pathogens, spoilage, and indicator organisms This includes a documented procedure to evaluate the effectiveness of contamination controls in the manufacturing environment, ensuring compliance with legal and customer requirements Regular data collection and trend analysis of environmental monitoring activities are essential The program should be reviewed annually for effectiveness and suitability, or more frequently when significant changes occur in products, processes, or legislation, when there are extended periods without positive testing results, when there is a trend of out-of-specification microbiological results, upon repeat detection of pathogens, or in response to alerts, recalls, or withdrawals of affected products.

2.5.8 FOOD SAFETY AND QUALITY CULTURE (ALL FOOD CHAIN

In alignment with clause 5.1 of ISO 22000:2018, organizations must demonstrate a commitment to fostering a positive food safety and quality culture Senior management is responsible for establishing, implementing, and maintaining specific objectives related to food safety and quality culture within the management system, ensuring that essential elements are thoroughly addressed.

• Employee feedback and engagement, and

Effective performance measurement of activities across all organizational sections is crucial for ensuring food safety and quality To achieve this, objectives must be backed by a documented food safety and quality culture plan that outlines specific targets and timelines This plan should be integrated into the management review and continuous improvement processes of the management system, fostering a culture of accountability and enhancement.

To ensure effective quality control across all food chain categories, organizations must establish and maintain a quality policy and objectives in alignment with ISO 22000:2018 This includes defining quality parameters that meet finished product specifications and implementing robust quality control and testing protocols Regular analysis of these quality control results should be integrated into management reviews, while quality elements must be included in internal audits Additionally, organizations should implement quantity control procedures to comply with customer and legal requirements, alongside a calibration program for relevant equipment Furthermore, line start-up and change-over procedures are essential to guarantee that products, packaging, and labeling meet all applicable standards, ensuring the removal of previous run materials from the production line.

2.5.10 TRANSPORT, STORAGE AND WAREHOUSING (ALL FOOD CHAIN

Organizations must establish and maintain a stock rotation system that incorporates both FEFO and FIFO principles For food chain category C0, they need to define specific post-slaughter time and temperature requirements for chilling or freezing products, in accordance with ISO/TS 22002-1:2009 clause 16.2 In food chain category FI, compliance with BSI/PAS 221:2013 clause 9.3 necessitates that products are transported and delivered in conditions that reduce contamination risks Additionally, when using transport tankers, organizations must implement a documented risk-based cleaning plan that addresses potential cross-contamination sources and includes cleaning validation It is essential to assess the cleanliness of tankers upon their arrival before loading, and supplier agreements for raw materials transported in tankers should mandate cleaning validation, usage restrictions, and relevant control measures to ensure product safety and prevent cross-contamination.

2.5.11 HAZARD CONTROL AND MEASURES FOR PREVENTING CROSS-

For food chain categories BIII, C, and I, ISO 22000:2018 clause 8.5.1.3 mandates that organizations implement specific requirements for packaging that affects food functionality, such as shelf-life extension In food chain category C0 CI, organizations must establish inspection processes at lairage or evisceration to ensure animals are suitable for human consumption, as per ISO/TS 22002-1:2009 clause 10.1 For category D, organizations need to manage ingredients and additives that may negatively impact animal health, in accordance with ISO/TS 22002-6:2016 clause 4.7 Additionally, all food chain categories, excluding FII, must adhere to foreign matter management requirements beyond clause 8.2.4 (h) of ISO 22000:2018, including conducting risk assessments to identify necessary foreign body detection equipment, maintaining documented justification if no equipment is used, having documented procedures for the selected equipment, and implementing controls for managing potential physical contamination from breakages.

2.5.12 PRP VERIFICATION (FOOD CHAIN CATEGORIES BIII, C, D, G, I & K)

The following additional requirement applies to ISO 22000:2018 clause 8.8.1:

IAF Membership

Accreditation Bodies (ABs) granting certification to Certification Bodies (CBs) for FSSC 22000 and FSSC 22000-Quality must be current members of the International Accreditation Forum (IAF) They should be signatories to the IAF Multilateral Recognition Arrangement (MLA) for Food Safety Management Systems (FSMS) to provide FSSC 22000 accreditation services, and also signatories to the IAF MLA for FSSC 22000 once it becomes available Additionally, they must be signatories to the IAF MLA for Quality Management Systems (QMS) to offer FSSC 22000-Quality accreditation services.

License Agreement

1) As a prerequisite for the license application, the CB shall hold a valid ISO/IEC 17021-1:2015 and ISO/TS 22003:2013 ISO 22003-1:2022 accreditation for ISO 22000

2) For the Scheme Requirements, the FSSC 22000 accreditation shall cover the applicable food chain categories and sub-categories in which it supplies its FSSC 22000 certification services

3) The CB shall provide the Foundation with information and documentation related to its accreditation to the Scheme when requested

4) The Foundation is entitled to request information from the Accreditation Body related to the CB accreditation

5) The CB may hold more than one accreditation for FSSC 22000 for the main location which shall be covered by a single FSSC license

If a Certification Body (CB) has multiple locations with individual FSSC 22000 accreditations, it must inform the Foundation about these additional accreditations during the initial application and whenever changes occur These accredited locations will be integrated into the main license and included in the IP Assessment Program of the licensed CB Any costs related to these additional IP activities will be the responsibility of the CB.

7) Alternatively, the CB may opt to have a separate FSSC license with the Foundation for each accredited location, which will be subject to its own IP activities and costs

Certification Bodies (CBs) must apply for a license from the Foundation to conduct recognized FSSC 22000 Scheme certification activities Licenses are granted for specific CB office locations indicated in the application form, and any outsourcing of certification-related tasks must be detailed in the application.

2) A license may cover multiple Food Chain Categories for FSSC 22000 and/or FSSC 22000- Quality, and related Addendums where applicable

3) By signing the License Agreement, the CB commits to the implementation of all Scheme requirements and any other obligations outlined in the license agreement

The Certification Body (CB) must submit an application to the Foundation detailing the specific food chain categories and sub-categories for which they seek certification services, as outlined in Part 1, Table 1 of the Scheme Additionally, the application should include all necessary documentation required by the Integrity Program during the onboarding process.

After reviewing the submitted information and successfully completing the necessary stages of the Foundation’s Integrity Program, the Certification Body (CB) will receive a provisional license and will be listed as provisionally approved on the FSSC 22000 CB list available on the FSSC website.

The Certification Body (CB) must extend its ISO/IEC 17021-1 accreditation to encompass FSSC 22000, utilizing an Accreditation Body (AB) recognized by the Foundation Additionally, the CB is required to submit a written confirmation of the application acceptance to the Foundation promptly.

The provisional status permits a Certification Body (CB) to utilize the Scheme for unaccredited certification upon receiving authorization from the Foundation, in line with the Integrity Program onboarding process Unaccredited certificates must be registered on the Assurance Platform, and once accreditation is achieved, these unaccredited certificates can be replaced with accredited ones either immediately or after the next certification audit, adhering to the specific requirements of the Accreditation Body (AB).

The provisional license is valid for twelve months from the date of signature by the Foundation During this period, the Certification Body (CB) must achieve accreditation from an accepted Accreditation Body (AB) for FSSC 22000 in the relevant categories and sub-categories Failure to obtain accreditation within this timeframe will result in the termination of the provisional license and the withdrawal of any issued certificates Additionally, the CB must register at least five certified or audited organizations on the Assurance Platform and successfully complete the necessary stages of the Integrity Program onboarding process For more details on the FSSC 22000 accreditation requirements, refer to Part 5 of the Scheme.

Once the criteria outlined in section 2.1.2.1 are fulfilled, the Certification Body (CB) must provide the Foundation with a copy of its accreditation certificate for ISO/IEC 17021-1 and ISO 22003-1 related to FSSC 22000, which should include the relevant categories and sub-categories specified in the license agreement, along with its assessment reports from the Accreditation Body (AB), including both office and witness assessments.

After completing the relevant stages of the Integrity Program, the Foundation will issue a new license agreement or update the existing license agreement status for the Certification Body (CB) listed on the FSSC website and Assurance Platform.

To maintain its license, the Certification Body (CB) must register at least fifty certificates on the Assurance Platform, ensuring at least one certificate for each licensed food chain category New CBs are required to achieve this within 36 months of obtaining their full license, with specific milestones of fifteen certificates within 12 months, thirty-five within 24 months, and fifty within 36 months Additionally, the CB must comply with all requirements of the FSSC 22000 certification scheme and fulfill financial obligations to the Foundation.

The CB must submit an application to the Foundation detailing the specific food chain sub-categories, or the main category if no subcategories exist, for which an extension of the current license is being requested.

The Certification Body (CB) will receive provisional status for the new sub-category, or category if no sub-category exists, after a successful review This status will be recorded in the Assurance Platform and listed on the approved FSSC 22000 Certification Body list available on the FSSC website.

The Certification Body (CB) can only request accreditation from the Accreditation Body (AB) once the Foundation has granted a provisional license for the extension of scope Additionally, the CB must provide the Foundation with a written confirmation from the AB indicating their acceptance to initiate the accreditation process.

The provisional status enables a Certification Body (CB) to issue unaccredited certifications for new subcategories or categories These unaccredited certificates must be registered on the Assurance Platform Once accreditation is obtained, these certificates can be exchanged for accredited ones, provided they meet the specific requirements set by the Accreditation Body (AB).

The provisional license granted by the Foundation remains valid for 12 months from the date of signing During this timeframe, the Certification Body (CB) is required to obtain accreditation.

AB accepted by the Foundation for the (sub)-categories linked to the scope extension For FSSC 22000-Quality the accreditation shall cover ISO 9001

6) At least one certificate shall be listed in the Assurance Platform for the new category within the timelines defined

The Foundation has the right to suspend, terminate or limit the scope of a CB’s license agreement Reasons include, but are not limited to:

1) Accreditation not achieved within 12 months from the date of the provisional license being granted;

3) Not meeting the minimum number of certificates specified by the Foundation;

5) Non-payment of the fee to the Foundation;

6) Repetitive noncompliance with the Scheme requirements;

7) Noncompliance with the Integrity Program or components there-of;

8) Situations where the Foundation might be brought into disrepute and/or the integrity of the certification might be at risk;

1) The conditions applicable to suspensions are defined in the Foundation’s Integrity Program Sanction Policy

Integrity Program

The Certification Body (CB) is required to engage in the Integrity Program, which is the Foundation's system for continuous monitoring of its licensed CBs This program ensures adherence to all Scheme requirements across various activities The CB must submit any requested documentation to the Foundation for the Integrity Program promptly and within specified timelines.

Monitoring activities encompass a range of procedures, including desk reviews of audit documentation and auditor competence, assessments and registrations of auditors in the Assurance Platform, and evaluations of certification bodies' management systems to ensure compliance with Scheme requirements Additionally, witnessed audits are conducted, performance is measured against key performance indicators, and compliance breaches are addressed effectively The process also involves handling complaints and serious events to maintain the integrity of the program.

3) The frequency, duration and scope of the Integrity Program monitoring activities can be increased based on risk and performance trends

Further information on sanctions, the escalation protocol, as well as conditions for suspensions and terminations can be found in the Integrity Program Sanction Policy

1) The Foundation’s Integrity Program defines a “nonconformity” as any breach of Scheme, Integrity Program and/or The Foundation’s requirements

Nonconformities (NCs) necessitating a response from the Certification Body (CB) will be identified by the Foundation based on various sources, including discrepancies highlighted by the Integrity Program, user feedback from the Scheme, insights from certified organizations, input from Accreditation Bodies, comments from governmental authorities, media feedback, and any other credible feedback received.

Upon receiving a nonconformity, the Certification Body (CB) must record and manage it within their internal system They are required to respond within a specified timeframe and take actions to restore conformity, which includes implementing corrections and providing evidence of these actions Additionally, the CB should investigate to identify the root causes, conduct an impact analysis, and prepare a documented Corrective Action Plan (CAP) This CAP must detail the nonconformity, grading, root cause analysis, corrections made, impact analysis results, planned corrective actions, responsible individuals, due dates, effectiveness measures, and the date of closure.

To effectively manage identified causal factors, it is crucial to implement corrective actions that minimize recurrence risks to an acceptable level, supported by objective evidence of these measures Additionally, this process should include an investigation into potential similar nonconformities that could arise elsewhere Finally, taking preventive actions is essential to address these causal factors, ensuring that the risks associated with occurrences are also reduced to an acceptable level.

3) Failure to meet the deadlines for nonconformities will result in the Integrity Program Sanction Policy being initiated

The Foundation will investigate any Certification Bodies (CBs) that consistently fail to meet the Scheme's requirements, jeopardizing its integrity or damaging the Foundation's reputation, in accordance with the Integrity Program Sanction Policy.

Sanctions for non-compliant Certification Bodies (CBs) may involve the suspension of their certification issuance license until all discrepancies are resolved, or even the termination of their license to issue certifications under the Scheme.

The CB shall respond to the sanctions as indicated in the sanction notification Details are provided in the Integrity Program Sanction Policy

The Certification Body (CB) must adhere to the specifications outlined in Annex C of ISO/TS 22003 ISO 22003-1:2022, which detail the necessary competencies for performing application reviews, calculating audit durations, selecting audit teams, planning audits, conducting technical reviews, and making certification decisions.

2) There shall be a documented process for initial and ongoing competency review of all these functions Records of training and competency reviews shall be maintained

3.2 TECHNICAL REVIEWER AND CERTIFICATION DECISION

The technical reviewer must fulfill the same criteria as the certification decision maker, except for the specific requirement outlined in 3.2.2 – 1c, and is not mandated to possess food safety management system auditing experience The roles of technical review and certification decision can either be distinct or performed by a single individual, provided that the necessary competency standards are met.

To make informed decisions regarding the issuance, maintenance, extension, reduction, suspension, or withdrawal of a certificate for registration in the FSSC 22000 Register, individuals must demonstrate specific competencies These include meeting the requirements outlined in Annex C of ISO/TS 22003:2013 and ISO 22003-1:2022, possessing a thorough understanding of the FSSC 22000 Scheme requirements, and having the knowledge and skills to effectively assess food safety management systems.

2) In case of FSSC 22000-Quality the certification decision maker shall have knowledge of ISO

1) When deemed necessary a technical expert can be assigned to the audit team to cover competency at (sub)category level

The Certification Body (CB) must establish a procedure for approving technical experts with proven experience relevant to the audit's (sub)category These technical experts will work under the guidance of a qualified FSSC 22000 auditor, and their time will not be included in the overall audit duration.

When a technical expert is involved, the CB must confirm that the expert is registered on the Assurance Platform as a member of the audit team in the role of technical expert Additionally, the technical expert must fulfill the minimum requirements for subcategory approval as outlined in section 3.5.3.

4) Where a technical expert is used, the CB shall ensure that at least one auditor in the team has a qualification in the category

5) For the (sub)categories BIII, D, E, F, G and K, where the requirements of 3.3 (4) above cannot be met, at least one auditor in the audit team shall have a qualification in category C

6) In all instances, the CB shall ensure that the audit team meets the qualification requirements linked to the scope of the (certified) organization

The witnessed audit must be performed by an auditor qualified in FSSC 22000 or a GFSI recognized certification program, demonstrating competence in the FSSC 22000 Scheme requirements Alternatively, it can be conducted by a technical certification professional from a CB FSSC 22000, possessing equivalent experience and expertise, such as an FSSC 22000 Technical Reviewer.

2) Witnessors shall be assessed and qualified by the CB as suitable to undertake witness audits

3) The witnessor shall have received training in witness audit techniques

4) The witnessor shall play no active part in the audit

Witnessors must possess at least the same level of competency as the function being evaluated, in accordance with ISO/TS 22003:2013 and ISO 22003-1:2022 Annex C If necessary, a witnessor can be assisted by a technical expert; however, the expert is not permitted to take part in the audit process.

A witness audit conducted by a Certification Body (CB) can only be replaced by a witnessed audit from an Accreditation Body (AB) if it is the initial witness audit under a provisional license This applies to provisional licenses in cases where the CB seeks an extension of scope for FSSC 22000.

Tiêu đề	Fssc 22000 Scheme Version 6.0
Trường học	Foundation Fssc
Chuyên ngành	Food Safety Management System
Thể loại	publication
Năm xuất bản	2023
Thành phố	Gorinchem

Định dạng
Số trang	83
Dung lượng	0,92 MB
File đính kèm	FSSC-22000-Scheme-Version-6-.rar (3 MB)