ISO 22000 is a standard developed by the International Organization for Standardization dealing with food safety. It is a general derivative of ISO 9000.
The International Organization for Standardization is an international standard-setting body composed of representatives from various national standards organizations.
Food safety is a scientific discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illnesses resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry to market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods. In considering market to consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer.
The ISO 9000 family of quality management systems (QMS) standards is designed to help organisations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of quality management systems, including the seven quality management principles upon which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.
Food safety is linked to the presence of food-borne hazards in food at the point of consumption. Since food safety hazards can occur at any stage in the food chain it is essential that adequate control be in place. Therefore, a combined effort of all parties through the food chain is required.
The ISO 22000 international standard specifies the requirements for a food safety management system that involves the following elements:
Interactive communication is an exchange of ideas where both participants, whether human, machine or art form, are active and can have an effect on one another. It is a dynamic, two-way flow of information.
Critical reviews of the above elements have been conducted by many scientists.Communication along the food chain is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step within the food chain. This implies communication between organizations both upstream and downstream in the food chain. Communication with customers and suppliers about identified hazards and control measures will assist in clarifying customer and supplier requirements.
Recognition of the organization's role and position within the food chain is essential to ensure effective interactive communication throughout the chain in order to deliver safe food products to the final consumer.
The most effective food safety systems are established, operated and updated within the framework of a structured management system and incorporated into the overall management activities of the organization. This provides maximum benefit for the organization and interested parties. ISO 22000 has been aligned with ISO 9001 in order to enhance the compatibility of the two standards.
ISO 22000 can be applied independently of other management system standards or integrated with existing management system requirements.
ISO 22000 integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system and application steps developed by the Codex Alimentarius Commission. By means of auditable requirements, it combines the HACCP plan with prerequisite programmes. Hazard analysis is the key to an effective food safety management system, since conducting a hazard analysis assists in organizing the knowledge required to establish an effective combination of control measures. ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, are identified and assessed. Thus it provides the means to determine and document why certain identified hazards need to be controlled by a particular organization and why others need not.
The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety.
During hazard analysis, the organization determines the strategy to be used to ensure hazard control by combining the prerequisite programmes and the HACCP plan.
ISO is developing additional standards that are related to ISO 22000. These standards will be known as the ISO 22000 family of standards. At the present time, the following standards will make up the ISO 22000 family of standards:
ISO 22000 - Food safety management systems - Requirements for any organization in the food chain.
ISO 22001 - Guidelines on the application of ISO 9001:2000 for the food and drink industry (replaces: ISO 15161:2001).
ISO/TS 22002- Prerequisite programmes on food safety—Part 1: Food manufacturing; Part 2: Catering; Part 3: Farming; Part 4: Food packaging manufacturing; Part 6: Feed and animal food production
ISO TS 22003 - Food safety management systems for bodies providing audit and certification of food safety management systems.
ISO TS 22004 - Food safety management systems - Guidance on the application of ISO 22000:2005.
ISO 22005 - Traceability in the feed and food chain - General principles and basic requirements for system design and implementation.
ISO 22006 - Quality management systems - Guidance on the application of ISO 9002:2000 for crop production.
ISO 22000 is also used as a basis for the Food Safety Systems Certification (FSSC) Scheme FSSC 22000. FSSC 22000 is a Global Food Safety Initiative (GFSI) approved scheme.
In comparison with ISO 9001, the standard is a more procedural orientated guidance than a principle based one. Apart from that, ISO 22000 is an industrial-specific risk management system for any type of food processing and marketing, which can be closely incorporated with the quality management system of ISO 9001. The detailed similarities and differences of the two standards can be found elsewhere, , ,.
In 2004, the European Office of Crafts, Trades and Small and Medium sized Enterprises for Standardisation noted that the standard is only suitable for large sized companies and small food businesses will not be able to seek such a high standard due to the lack of resources to pursue the certification. The agency suggested creating an alternative for small food businesses to achieve the same objective.EFSA is now making their efforts on the food legislations that are adaptable for the SMEs in food supply chains. A few critics also proposed that organizations which seek the standard certification should also do the same to the ISO 14001 along with the ISO 9001, as they consider that large amounts of risks are mainly from the primary production in the supply chains rather than the later stages of food processing ,
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality is increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both, and deals with quality and sustainability and their integration.
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.
Quality Assurance International (QAI) is a U.S.-based international organic certification company that is authorized by the United States Department of Agriculture (USDA) as "a USDA-accredited certifying agent that operates globally to certify organic operations to National Organic Program standards." It is a for-profit corporation, established in 1989, and headquartered in San Diego, California. It is one of the world's largest certifiers, operating in the United States, Canada, Latin America, European Union, and Japan. It is owned by public health and environmental organization NSF International.
Quality management ensures that an organization, product or service is consistent. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. What a customer wants and is willing to pay for it determines quality. It is written or unwritten commitment to a known or unknown consumer in the market. Thus, quality can be defined as fitness for intended use or, in other words, how well the product performs its intended function
AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was released in October, 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries.
ISO/TS 16949 is an ISO technical specification aimed at the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain. It is based on the ISO 9001 standard and the first edition was published in June 1999 as ISO/TS 16949:1999.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002, the previously published ISO 13485, and ISO 13488. ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25 : 1993 + A1: 1999 safety of Electrocardiograms.
The ISO/TC 215 is the International Organization for Standardization's (ISO) Technical Committee (TC) on health informatics. TC 215 works on the standardization of Health Information and Communications Technology (ICT), to allow for compatibility and interoperability between independent systems.
BSI Group, also known as the British Standards Institution (BSI), is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services, and also supplies certification and standards-related services to businesses.
Hani Mansour M. Al-Mazeedi is a Kuwaiti scientist who specializes in Halal requirements, quality and Safety systems for food and Halal services for the Halal Industry.
Nigel Howard Croft was appointed as Chairman of ISO’s Technical Committee TC 176/SC 2 in February 2010, with overall responsibility for the ISO 9001 standard, used worldwide as a basis for certification of quality management systems, and the ISO 9004 guidelines standard aimed at improving organisational performance, among others. His third and final term as Chairman expired at the end of 2018. He has subsequently been appointed to lead the revision of "Annex SL" of the ISO Directives, that forms the basis for over 40 management system standards including those on environmental management, Occupational Health and Safety, Information Security, Anti-bribery, Food Safety and many more.
NSF International is an American product testing, inspection and certification organization based in Ann Arbor, Michigan.
DQS Holding GmbH based in Frankfurt am Main is the holding company of the worldwide DQS Group. The group provides assessments and certifications of management systems and processes of any type.
Safefood 360, Inc. is a food safety management software company founded in Dublin, Ireland, and now headquartered in Manhattan, New York, United States. The company operates globally on four continents, including Europe, North America, Australia, and Africa.
Indian Register Quality Systems (IRQS) is an Indian company that specializes in implementing quality management systems and training companies on these certifications. IRQS is department functioning under the parent organisation Indian register of shipping (IRS) which was formed as a public limited company.
Hazard analysis and risk-based preventive controls or HARPC is a successor to the Hazard analysis and critical control points (HACCP) food safety system, mandated in the United States by the FDA Food Safety Modernization Act (FSMA) of 2010.
The Annex SL is a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written. The aim of Annex SL is to enhance the consistency and alignment of MSS by providing a unifying and agreed upon high level structure, identical core text and common terms and core definitions. The aim being that all ISO Type A MSS are aligned and the compatibility of these standards is enhanced.