ISO 22000

Last updated
Awarded ISO 22000 and Hazard analysis and critical control points's Guang Ying natural water. Awarded ISO 22000 and Hazard analysis and critical control points's Guang Ying natural water.png
Awarded ISO 22000 and Hazard analysis and critical control points's Guang Ying natural water.

ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, [1] providing requirements for any organization in the food industry with objective to help to improve overall performance in food safety. These standards are intended to ensure safety in the global food supply chain. The standards involve the overall guidelines for food safety management and also focuses on traceability in the feed and food chain.

Contents

Food safety

Food safety refers to all those hazards, whether chronic or acute, that may make food injurious to the health of the consumer. [2]

ISO 22000 standard

ISO 22000 is the most popular voluntary food safety international standard in the food industry with 51,535 total number of sites (as per the ISO Survey 2022). The ISO 22000 family are international voluntary consensus standards which align to Good Standardization Practices (GSP) [3] and the World Trade Organization (WTO) Principles for the Development of International Standards. [4] Defining the requirements for a Food Safety Management System (FSMS) and incorporating the following elements which as defined as FSMS principles:

Critical reviews of the above elements have been conducted by many scientists. [5] [6] [7] [8] 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 consumer.

ISO 22000 and HACCP

ISO 22000 has two Plan-Do-Check-Act (PDCA) cycles which operate one inside the other, the first covering the management system, the second the operations (described in ISO 22000:2018, Clause 8), which simultaneously cover the HACCP principles. ISO 22000 references the Codex Alimentarius General Principles of Food Hygiene, CXC 1-1969 [9] which includes HACCP principles and 12 HACCP application steps. The following table explains the relationship and alignment between ISO 22000 and the Codex Alimentarius General Principles of Food Hygiene, CXC 1-1969. The task, Validate the control measure(s) or combination(s) of control measures, also references Guidelines for the Validation of Food Safety Control Measures, CXG 69-2008 [10]

ISO 22000 and HACCP
TaskISO 22000:2018General Principles of Food Hygiene, CXC 1-1969
Establish the food safety teamSubclauses 5.3.1 c) and 5.3.2, and links to Subclauses 7.1.2 (people) and 7.2 (competence)HACCP step 1
Provide the information needed to conduct the hazard analysisSubclause 8.5.1 (from Subclauses 8.5.1.2 to 8.5.1.4)HACCP steps 2 and 3
Prepare the process flow diagramSubclause 8.5.1.5HACCP step 6 and principle 1
Identify the hazards associated with the foodSubclauses 8.5.2.1 and 8.5.2.2HACCP step 6 and principle 1
Conduct a hazard assessmentSubclause 8.5.2.3HACCP step 6 and principle 1
List and select control measure(s) or combination(s) of control measuresSubclause 8.5.2.4HACCP step 6 and principle 1
Categorize, manage, monitor and document the control measuresSubclauses 8.5.2.4 and 8.5.4 (from 8.5.4.1 to 8.5.4.3)HACCP principles 2 and 3, HACCP steps 6, 7, 8, 9 and 12)
Validate the control measure(s) or combination(s) of control measuresSubclause 8.5.3HACCP step 7 and principle 2, step 6 and principle 3, step 11 and principle 6
Establish and apply corrections and corrective actionsSubclauses 8.5.4.1, 8.5.4.4 and 8.9HACCP principle 5, HACCP steps 10 and 11
Control monitoring and measuring (operational processes)Subclause 8.7
Conduct a verification related to the PRPs and hazard control planSubclause 8.8
Update the preliminary informationSubclause 8.6HACCP steps 5 and 7

A study explains the importance of ISO 22000 Food Safety Management System (FSMS), Critical Control Points Hazard Analysis (HACCP) and the Prerequisite Programs (PRPs) as the foundation of HACCP, in preventing foodborne outbreaks. [11] In addition, another study for HACCP effectiveness between ISO 22000 certified and non-certified dairy companies identified that by implementing the HACCP Food Safety System (FSS) and by being ISO 22000 certified, the level of the achievement of the HACCP objectives is improved significantly. [12]

ISO 22000 family of standards

ISO published additional standards that are related to ISO 22000. These standards are 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 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, also referred to as a certification programme owner (CPO). The differences between ISO 22000 and schemes with GFSI recognition are explained in a paper from ISO, International standards and private standards. [13]

ISO 9001 vs ISO 22000

In the early 1990s, the application of ISO 9000:1987 series of standards were embraced by the food industry in the European Union (EU). At the same time, the USDA recognized HACCP systems to demonstrate food safety in the US. This led to these two systems being combined, where ISO 9001 was certified along with HACCP as a single management tool in organizations. In Europe, ISO 9001 and HACCP were used by companies as a "due diligence" defense against prosecution under the 1990 Food Safety Act. [14] [15]

In comparison with a Quality Management System ISO 9001, the Food Safety Management System, initially a standard (ISO 22000:2005 version) that was a more procedural-orientated guidance than a principle based one. The 2018 revision (ISO 22000:2018) addressed this by including the ISO general management principles, in addition to the FSMS principles, which are also referred to as the Quality Management Principles:

ISO general management principles

Apart from that, ISO 22000 is an industrial-specific risk management system for any type of food safety which includes farming, processing, manufacturing, catering, storage and distribution. ISO 22000 is designed using the ISO high level structure (HLS), also referred to as Annex SL, to be integrated with other ISO Management System Standards (MSS) including the Quality Management System of ISO 9001. For conformity assessment and auditing, both ISO 9001 and ISO 22000 refer to ISO 17021 Conformity assessment, Requirements for bodies providing audit and certification of management systems and ISO 19011 Guidelines for auditing management systems. The detailed similarities, differences and combined effects of the two standards (ISO 9001, ISO 22000) can be found elsewhere. [16] , [17] , [18] ,. [19] , [20] [21]

Potential justification

ISO Management System Standards (MSS) are designed to be integrated for any sector or industry and size, this is further explained in ISO and Small & Medium Enterprises. 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. [22] EFSA is now making their efforts on the food legislations that are adaptable for the SMEs in food supply chains. [23] In addition, ISO and United Nations Industrial Development Organization (UNIDO) jointly published ISO 22000 a practical guide which provides guidance to assist all organizations (including small and medium-sized) that recognize the potential benefits of implementing a FSMS in accordance with ISO 22000.

Food organizations which seek the standard certification are evolving towards integrated management systems, typically integrating Environmental (ISO 14001) and Occupational Health & Safety (ISO 45001) along with Quality (ISO 9001). This takes a process approach and risk-based thinking into consideration where risks are addressed at both organizational and operational levels which include food safety, worker safety and environmental and are from the primary production in the supply chains and the later stages of food processing. [24] , [25]

ISO 22000 is well positioned for future growth due to the ISO 2030 Strategy around inclusiveness [26] and the World Health Organization food safety strategy which explains governments should use international standards and guidelines to the greatest extent. [27] This is supported by the World Trade Organization and Food and Agriculture Organization joint publication which explains the WTO Agreements strongly encourage governments to harmonize their requirements on the basis of international standards. [28]

History

yearDescription
2005ISO 22000 (1st Edition)
2018ISO 22000 (2nd Edition)

See also

Related Research Articles

The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) which help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. The ISO refers to the set of standards as a "family", bringing together the standard for quality management systems and a set of "supporting standards", and their presentation as a family facilitates their integrated application within an organisation. ISO 9000 deals with the fundamentals and vocabulary of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. ISO/TS 9002 offers guidelines for the application of ISO 9001. ISO 9004 gives guidance on achieving sustained organizational success.

The ISO 14000 family of standards by the International Organization for Standardization (ISO) relate to environmental management that exists to help organizations (a) minimize how their operations negatively affect the environment ; (b) comply with applicable laws, regulations, and other environmentally oriented requirements; and (c) continually improve in the above.

A management system is a set of policies, processes and procedures used by an organization to ensure that it can fulfill the tasks required to achieve its objectives. These objectives cover many aspects of the organization's operations. For instance, an environmental management system enables organizations to improve their environmental performance, and an occupational safety and health management system enables an organization to control its occupational health and safety risks.

<span class="mw-page-title-main">Hazard analysis and critical control points</span> Systematic preventive approach to food safety

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.

<span class="mw-page-title-main">Codex Alimentarius</span> Collection of internationally recognized standards

The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations published by the Food and Agriculture Organization of the United Nations relating to food, food production, food labeling, and food safety.

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.

Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control, and quality improvement. Quality management is focused both on product and service quality and the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market. Quality can be defined as how well the product performs its intended function.

ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.

<span class="mw-page-title-main">Food safety</span> Scientific discipline

Food safety is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. The occurrence of two or more cases of a similar illness 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. Food safety, nutrition and food security are closely related. Unhealthy food creates a cycle of disease and malnutrition that affects infants and adults as well.

<span class="mw-page-title-main">BSI Group</span> British standards development organization

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.

A technical standard is an established norm or requirement for a repeatable technical task which is applied to a common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, and related management systems practices. A technical standard includes definition of terms; classification of components; delineation of procedures; specification of dimensions, materials, performance, designs, or operations; measurement of quality and quantity in describing materials, processes, products, systems, services, or practices; test methods and sampling procedures; or descriptions of fit and measurements of size or strength.

<span class="mw-page-title-main">Standardization Administration of China</span> Peoples Republic of China national standardization body; represented in the ISO and IEC

The Standardization Administration of China is an external name of the State Administration for Market Regulation. Prior to 2018, it was an administrative office under the State Council to exercise administrative responsibilities by undertaking unified management, supervision and overall coordination of standardization work in China.

<span class="mw-page-title-main">Bureau of Indian Standards</span> Indian organization for developing standards

The Bureau of Indian Standards (BIS) is the National Standards Body of India under Department of Consumer affairs,Ministry of Consumer Affairs, Food & Public Distribution, Government of India. It is established by the Bureau of Indian Standards Act, 2016 which came into effect on 12 October 2017.< The Minister in charge of the Ministry or Department having administrative control of the BIS is the ex-officio President of the BIS. BIS has 500 plus scientific officers working as Certification Officers, Member secretaries of technical committees and lab OIC's.

ISO 31000 is a family of international standards relating to risk management codified by the International Organization for Standardization. The standard is intended to provide a consistent vocabulary and methodology for assessing and managing risk, resolving the historic ambiguities and differences in the ways risk are described.

The Global Food Safety Initiative (GFSI) is a private organization that works as a "coalition of action" from the Consumer Goods Forum (CGF) and brings together retailers and brand owners (manufacturers) from across the CGF membership. The GFSI operates under multi-stakeholder governance, with the objective to create "an extended food safety community to oversee food safety standards for businesses and help provide access to safe food for people everywhere". GFSI's work in benchmarking and harmonization aims to foster mutual acceptance of GFSI-recognized certification programs across the industry, with the ambition to enable a "once certified, accepted everywhere" approach.

Nigel Howard Croft is a globally recognized authority on quality management and conformity assessment. He retired as Chairman of the ISO Joint Technical Coordination Group for Management System Standards in December 2023 after serving a three-year term, having been appointed by ISO's Technical Management Board in December 2020. During his tenure, he coordinated the deployment of the ISO London Declaration on Climate Action into all ISO Management System Standards, requiring organizations that implement these standards to determine the extent to which climate change can affect their results and the ways in which their activities can have a impact on climate change. This can then lead to the implementation of risk-based adaptation and mitigation strategies. Dr Croft was previously Chair of the ISO Technical Committee TC 176/SC 2 from February 2010 until December 2018, 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. In 2019 and 2020 he led 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, Artificial Intelligence and many more.

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.

Harmonization is the process of minimizing redundant or conflicting standards which may have evolved independently. The name is also an analogy to the process to harmonizing discordant music.

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.

References

  1. ↑ Expected Outcomes for Certification to ISO 22000, a Food Safety Management System (FSMS) (1 ed.). International Organization for Standardization. 2022. ISBN   978-92-67-11250-3.
  2. ↑ Assuring food safety and quality (PDF). FAO/WHO Publication. p. 3. Retrieved 15 September 2021.
  3. ↑ Good Standardization Practices (GSP) (1 ed.). Geneva Switzerland: ISO. 2019. ISBN   978-92-67-10986-2.
  4. ↑ "Principles for the Development of International Standards, Guides and Recommendations". wto.org. World Trade Organization. Retrieved 17 September 2021.
  5. ↑ Klaas Wenztel, Richard Jackson of Zimbabwe. "ISO 22000: Requirements for Food Safety Management Systems". Archived from the original on 25 July 2011. Retrieved 28 February 2008.
  6. ↑ Hiroshi, Ogawa. "Sterilization and sanitation technologies in the latest food manufacture processes, Total food safety management by ISO 22000 "food safety management system"". Archived from the original on 21 December 2010. Retrieved 28 February 2008.
  7. ↑ Mijanović Markuš, Marina (May 2006). "ISOC 22000:2005 and HACCP" (PDF). Festival kvaliteta 2006. Asocijacija za kvalitet i standardizaciju Srbije. Retrieved 17 October 2010.
  8. ↑ Prati, R; Deborah A. McIntyre (2004). "The new ISO 22000 (final proposal) norm on food safety management". Ingredienti Alimentari. 3 (4). Chiriotti Editori Spa: 19–21.
  9. ↑ "General Principles of Food Hygiene, CXC 1-1969" (PDF). fao.org. Codex Alimentarius. Retrieved 15 September 2021.
  10. ↑ "Guidelines for the validation of food safety control measures, CXG 69-2008" (PDF). fao.org. Codex Alimentarius. Retrieved 15 September 2021.
  11. ↑ Lee, Jocelyn C.; Daraba, Aura; Voidarou, Chrysa; Rozos, Georgios; Hesham A., El Enshasy; Varzakas, Theodoros (13 September 2021). "Implementation of Food Safety Management Systems along with Other Management Tools (HAZOP, FMEA, Ishikawa, Pareto). The Case Study of Listeria monocytogenes and Correlation with Microbiological Criteria". Foods. 10 (9): 2169. doi: 10.3390/foods10092169 . PMC   8468768 . PMID   34574279.
  12. ↑ Psomas, Evangelos; Kafetzopoulos, Dimitrios (July 2015). "HACCP effectiveness between ISO 22000 certified and non-certified dairy companies". Food Control. 53: 134–139. doi:10.1016/j.foodcont.2015.01.023 . Retrieved 23 June 2021.
  13. ↑ International standards and private standards. International Organization for Standardization. 2010. ISBN   978-92-67-10518-5.
  14. ↑ Adams, Catherine E (1994). "ISO 9000 and HACCP Systems". Food and Drug Law Journal. 49 (4): 603–607. JSTOR   26659453.
  15. ↑ Harrigan, W.F. (1993). "The ISO 9000 series and its implications for HACCP". Food Control. 4 (2): 105–111. doi:10.1016/0956-7135(93)90166-L.
  16. ↑ Surak, John G. "Comparison of ISO 9001 and ISO 22000" (PDF). Retrieved 28 February 2008.
  17. ↑ Faergemand, Jacob; Dorte Jespersen. "ISO 22000 to ensure integrity of food supply chain" (PDF). Retrieved 28 February 2008.
  18. ↑ Frost, Roger. "ISO 22000 is first in family of food safety management system standards" (PDF). Retrieved 28 February 2008.
  19. ↑ Goichiro, Yukawa. "The points of ISO 22000". Archived from the original on 12 November 2013. Retrieved 28 February 2008.
  20. ↑ Dimitrios Kafetzopoulos; Katerina Gotzamani; Evangelos Psomas (2013). "Quality systems and competitive performance of food companies". Benchmarking. 20 (4): 463–483. doi:10.1108/BIJ-08-2011-0065 . Retrieved 23 June 2021.
  21. ↑ SILVA, Maria Manuela; FONSECA, Luis Miguel; SOUSA, Sérgio Dinis (2016). "The Impact of ISO 9001:2015 on ISO 22000 and Food Safety Management Systems (FSMS)". QUALITY Access to Success. 17 (152): 81–85.
  22. ↑ European Office of Crafts, Trades and Small and Medium-sized Enterprises for Standardisation (2004). "Normapme Food Group Position on TC 34 draft standard ISO 22000" (PDF). Retrieved 28 February 2008.
  23. ↑ NORMAPME (2007). "Promoting craft and SMEs in the area of European standardisation" (PDF). Retrieved 28 February 2008.
  24. ↑ Dias Report (2003). "Life Cycle Assessment in the Agri-food sector" (PDF). Retrieved 29 February 2008.
  25. ↑ URS/PK Project Report (2007). "Training Courses on International Standards and Regulations for the Food Industry" (PDF). Archived from the original (PDF) on 3 October 2011. Retrieved 29 February 2008.
  26. ↑ "ISO STRATEGY 2030". iso.org. International Organization for Standardization.
  27. ↑ "Draft WHO Global Strategy for Food Safety 2022-2030". who.int. World Health Organization.
  28. ↑ Trade and Food Standards. FAO and WTO. 2017. ISBN   978-92-5-109793-9.

Further reading

This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.