ISO 22000

Food safety refers to all those hazards, whether chronic or , that may make food injurious to the health of the consumer.{{cite book |title=Assuring food safety and quality |publisher=FAO/WHO Publication |page=3 |url=http://www.fao.org/3/y8705e/y8705e.pdf |access-date=15 September 2021}}

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 [https://www.iso.org/the-iso-survey.html ISO Survey 2022]). The ISO 22000 family are international voluntary consensus standards which align to Good Standardization Practices (GSP){{cite book |title=Good Standardization Practices (GSP) |date=2019 |publisher=ISO |location=Geneva Switzerland |isbn=978-92-67-10986-2 |edition=1 |url=https://www.iso.org/publication/PUB100440.html}} and the World Trade Organization (WTO) Principles for the Development of International Standards.{{cite web |title=Principles for the Development of International Standards, Guides and Recommendations |url=https://www.wto.org/english/tratop_e/tbt_e/principles_standards_tbt_e.htm |website=wto.org |publisher=World Trade Organization |access-date=17 September 2021}} Defining the requirements for a Food Safety Management System (FSMS) and incorporating the following elements which as defined as FSMS principles:

• system management
• prerequisite programs
• HACCP principles

Critical reviews of the above elements have been conducted by many scientists.{{cite web

| last = Klaas Wenztel

| first = Richard Jackson of Zimbabwe.

| title = ISO 22000: Requirements for Food Safety Management Systems

| url = http://www.asq.org/qic/display-item/index.html?item=20317

| access-date = 28 February 2008

| archive-date = 25 July 2011

| archive-url = https://web.archive.org/web/20110725022021/http://asq.org/qic/display-item/index.html?item=20317

| url-status = dead

}}{{cite web

| last = Hiroshi

| first = Ogawa

| title = Sterilization and sanitation technologies in the latest food manufacture processes, Total food safety management by ISO 22000 "food safety management system"

| url = http://sciencelinks.jp/j-east/article/200705/000020070505A0463346.php

| access-date = 28 February 2008

| archive-date = 21 December 2010

| archive-url = https://web.archive.org/web/20101221224758/http://sciencelinks.jp/j-east/article/200705/000020070505A0463346.php

| url-status = dead

}}{{cite web

| last = Mijanović Markuš

| first = Marina

| title = ISOC 22000:2005 and HACCP

| work = Festival kvaliteta 2006.

| publisher = Asocijacija za kvalitet i standardizaciju Srbije

| date = May 2006

| url = http://www.cqm.rs/fq2006/pdf/A/52%20-%20Markus%20M%20M.pdf

| access-date = 17 October 2010

}}{{cite journal

| last = Prati

| first = R

|author2=Deborah A. McIntyre

| title = The new ISO 22000 (final proposal) norm on food safety management

| journal = Ingredienti Alimentari

| volume = 3

| issue = 4

| pages = 19–21

| publisher = Chiriotti Editori Spa

| year = 2004

}} 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 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{{cite web |title=General Principles of Food Hygiene, CXC 1-1969 |url=http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf |website=fao.org |publisher=Codex Alimentarius |access-date=15 September 2021}} 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 {{cite web |title=Guidelines for the validation of food safety control measures, CXG 69-2008 |url=http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B69-2008%252FCXG_069e.pdf |website=fao.org |publisher=Codex Alimentarius |access-date=15 September 2021}}

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.{{cite journal |last1=Lee |first1=Jocelyn C. |last2=Daraba |first2=Aura |last3=Voidarou |first3=Chrysa |last4=Rozos |first4=Georgios |last5=Hesham A. |first5=El Enshasy |last6=Varzakas |first6=Theodoros |title=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 |journal= Foods|date=13 September 2021 |volume=10 |issue=9 |page=2169 |doi=10.3390/foods10092169 |pmid=34574279 |pmc=8468768 |doi-access=free }} 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.{{cite journal |last1=Psomas |first1=Evangelos |last2=Kafetzopoulos |first2=Dimitrios |title=HACCP effectiveness between ISO 22000 certified and non-certified dairy companies |journal=Food Control |date=July 2015 |volume=53 |pages=134–139 |doi=10.1016/j.foodcont.2015.01.023 |url=https://www.sciencedirect.com/science/article/abs/pii/S0956713515000407 |access-date=23 June 2021|url-access=subscription }}

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 – 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 Withdrawn).
• ISO/TS 22002- Prerequisite programmes on food safety—Part 1: Food manufacturing; Part 2: Catering; Part 3: Farming; Part 4: Food packaging manufacturing; Part 5: Transport and storage; Part 6: Feed and animal food production
• ISO/TS 22003 – Food safety — Part 1: Requirements for bodies providing audit and certification of food safety management systems; Part 2: Requirements for bodies providing evaluation and certification of products, processes and services, including an audit of the food safety system
• 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, 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.{{cite book |title=International standards and private standards |date=2010 |publisher=International Organization for Standardization |isbn=978-92-67-10518-5 |url=https://docplayer.net/23885374-International-standards-and-private-standards.html}}

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.{{cite journal |last1=Adams |first1=Catherine E |title=ISO 9000 and HACCP Systems |journal=Food and Drug Law Journal |date=1994 |volume=49 |issue=4 |pages=603–607 |jstor=26659453 |url=https://www.jstor.org/stable/26659453}}{{cite journal |last1=Harrigan |first1=W.F. |title=The ISO 9000 series and its implications for HACCP |journal=Food Control |date=1993 |volume=4 |issue=2 |pages=105–111 |doi=10.1016/0956-7135(93)90166-L |url=https://dx.doi.org/10.1016/0956-7135%2893%2990166-L|url-access=subscription }} With ISO 9001 and HACCP established and accepted, the food industry was working towards standardization and a single international standard, eventually, ISO 22000. This path was diverted when the British Retail Consortium published the BRC Food Technical Standard, in 1998.{{cite web |title=Brand owners |url=https://www.brcgs.com/brand-owners |website=BRCGS |access-date=2 February 2025}} The BRC decision to publish as a stand-alone standard, instead of publishing as an addendum and adding food safety requirements to support ISO 9001, led to the Global Food Safety Initiative creating a benchmarking model for harmonization of private standards. Harmonization was considered as an alternative to promoting standardization with an international standard. Food retailers, as members of the Consumer Goods Forum, changed their ‘due diligence’ defence from ISO 9001 and HACCP, to BRC and other private standards recognized by the Global Food Safety Initiative,{{cite book |last1=van der Meulen |first1=Bernd M.J |title=Private food law Governing food chains through contract law, self-regulation, private standards, audits and certification schemes |date=2011 |publisher=Wageningen Academic Publishers |isbn=978-90-8686-176-7 |page=97 |url=https://library.oapen.org/bitstream/id/cbb8b2b8-9ad6-4f36-a1c7-0090187c8262/396410.pdf |access-date=2 February 2025}} despite any evidence whether private standards are beneficial or detrimental for global food supply chains.{{cite journal |last1=Rao |first1=Madhura |last2=Bast |first2=Aalt |last3=de Boer |first3=Alie |title=European private food safety standards in global agri-food supply chains: a systematic review |journal=International Food and Agribusiness Management Review |date=2021 |volume=24 |issue=5 |page=750 |doi=10.22434/IFAMR2020.0146 |url=https://brill.com/view/journals/ifam/24/5/article-p739_1.xml |access-date=14 February 2025}}

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.{{cite web

| last = Surak

| first = John G.

| title = Comparison of ISO 9001 and ISO 22000

| url = http://foodsqm.files.wordpress.com/2007/11/comparison_of_iso_9001_and_iso_22000.pdf

| access-date = 28 February 2008

}}^, {{cite web

| last = Faergemand

| first = Jacob

|author2=Dorte Jespersen

| title = ISO 22000 to ensure integrity of food supply chain

| url = http://www.iso.org/iso/tool_5-04.pdf

| access-date = 28 February 2008

}}^, {{cite web

| last = Frost

| first = Roger

| title = ISO 22000 is first in family of food safety management system standards

| url = http://www.iso.org/iso/iso-22000_food_safety.pdf

| access-date = 28 February 2008

}}^,.{{cite web

| last = Goichiro

| first = Yukawa

| title = The points of ISO 22000

| url = http://sciencelinks.jp/j-east/article/200618/000020061806A0655370.php

| access-date = 28 February 2008

| archive-date = 12 November 2013

| archive-url = https://web.archive.org/web/20131112083321/http://sciencelinks.jp/j-east/article/200618/000020061806A0655370.php

| url-status = dead

}}^, {{cite journal

|author1=Dimitrios Kafetzopoulos

|author2=Katerina Gotzamani

|author3=Evangelos Psomas

|title=Quality systems and competitive performance of food companies

|url=https://www.emerald.com/insight/content/doi/10.1108/BIJ-08-2011-0065/full/html

|journal=Benchmarking

|year=2013

|volume=20

|issue=4

|pages=463–483

|doi=10.1108/BIJ-08-2011-0065

|access-date=23 June 2021|url-access=subscription}}{{cite journal |last1=SILVA |first1=Maria Manuela |last2=FONSECA |first2=Luis Miguel |last3=SOUSA |first3=Sérgio Dinis |title=The Impact of ISO 9001:2015 on ISO 22000 and Food Safety Management Systems (FSMS) |journal=QUALITY Access to Success |date=2016 |volume=17 |issue=152 |pages=81–85}}

ISO Management System Standards (MSS) are designed to be integrated for any sector or industry and size, this is further explained in [https://www.iso.org/iso-and-smes.html 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.{{cite web

| last = European Office of Crafts, Trades and Small and Medium-sized Enterprises for Standardisation

| title = Normapme Food Group Position on TC 34 draft standard ISO 22000

| year = 2004

| url = http://www.normapme.com/docs/positions/2004/iso22000%20position%20of%20NORMAPME.pdf

| access-date = 28 February 2008

}}

EFSA is now making their efforts on the food legislations that are adaptable for the SMEs in food supply chains.{{cite web

| last = NORMAPME

| title = Promoting craft and SMEs in the area of European standardisation

| year = 2007

| url = http://ec.europa.eu/enterprise/entrepreneurship/craft/craft-priorities/doc_stand/normapme_report_2007.pdf

| access-date = 28 February 2008

}} In addition, ISO and United Nations Industrial Development Organization (UNIDO) jointly published [https://www.iso.org/publication/PUB100454.html 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.{{cite web

| last = Dias Report

| title = Life Cycle Assessment in the Agri-food sector

| year = 2003

| url = http://www.lcafood.dk/lca_conf/DJFrapport_paper_2_poster.pdf

| access-date = 29 February 2008

}}^, {{cite web

| last = URS/PK Project Report

| title = Training Courses on International Standards and Regulations for the Food Industry

| year = 2007

| url = http://www.safefood.org.pk/training/Final%20Report.pdf

| access-date = 29 February 2008

| archive-url = https://web.archive.org/web/20111003124027/http://www.safefood.org.pk/training/Final%20Report.pdf

| archive-date = 3 October 2011

| url-status = dead

}}

The ISO 22000 standard is managed and revised by ISO/TC 34/SC 17 with subject matter feedback from experts proposed by national standards bodies.

ISO 22000 was first published in 2005 as the first international standard for Food Safety Management Systems (FSMS), harmonizing global food safety practices. It integrated Hazard Analysis and Critical Control Points (HACCP) principles with prerequisite programs (PRPs) to create a unified framework for food safety. The initial release established core requirements for FSMS, emphasizing risk management, supply chain communication, and continuous improvement.{{cite web |title=ISO 22000:2005 |url=https://www.iso.org/standard/35466.html |publisher=International Organization for Standardization}} Initially this version was a more procedural-orientated than a principle based management system.

A major revision aligned ISO 22000 with Annex SL, the high-level structure for ISO management system standards. Key changes included:

• Stronger emphasis on risk-based thinking (beyond HACCP).
• Clarification of PRPs vs. operational controls.
• Enhanced leadership and compliance requirements.{{cite web |title=ISO 22000:2018 |url=https://www.iso.org/standard/65464.html |publisher=International Organization for Standardization}}

The 2018 revision addressed procedural-orientated rather than a principle-based by including the ISO general management principles, in addition to the FSMS principles, which are also referred to as the [https://www.iso.org/publication/PUB100080.html Quality Management Principles].

In 2024, the standard was under review for potential updates, including blockchain traceability and AI-driven hazard analysis.{{cite journal |last=Smith |first=J. |title=Emerging Technologies in Food Safety |journal=Food Control |year=2024 |doi=10.1016/j.foodcont.2024.110123}} ISO 22000 is well positioned for growth due to the ISO 2030 Strategy around inclusiveness{{cite web |title=ISO STRATEGY 2030 |url=https://www.iso.org/publication/PUB100364.html |website=iso.org |publisher=International Organization for Standardization}} and the World Health Organization food safety strategy which explains governments should use international standards and guidelines to the greatest extent.{{cite web |title=Draft WHO Global Strategy for Food Safety 2022-2030 |url=https://www.who.int/publications/m/item/draft-who-global-strategy-for-food-safety-2022-2030 |website=who.int |publisher=World Health Organization}} 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.{{cite book |title=Trade and Food Standards |date=2017 |publisher=FAO and WTO |isbn=978-92-5-109793-9 |url=https://www.wto.org/english/res_e/publications_e/tradefoodfao17_e.htm}}

The European Union and U.S. FDA recognize ISO 22000 as a voluntary compliance tool for food safety regulations e.g., EU Regulation 852/2004{{cite web |title=EU Food Hygiene Regulations |url=https://eur-lex.europa.eu/eli/reg/2004/852 |publisher=European Commission}} and FSMA Final Rule for Preventive Controls for Human Food.{{cite web |title=Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food |url=https://www.federalregister.gov/documents/2015/09/17/2015-21920/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-human |website=federalregister.gov |publisher=Food and Drug Administration (FDA) |access-date=19 May 2025}}

Developing economies e.g., India, Brazil increasingly adopt ISO 22000 to access global markets.{{cite news |title=ISO 22000 Gains Traction in Emerging Markets |newspaper=Food Safety News |date=2022-05-15 |url=https://www.foodsafetynews.com}} For public sector organisations, there are case studies and research papers explaining the benefits of using accredited conformity assessment for ISO 22000.{{cite web |title=Case studies, Research and Supporting Materials tagged as ISO 22000 |url=//publicsectorassurance.org/standard/iso-22000/ |website=publicsectorassurance.org |publisher=INetQI |access-date=6 May 2025}} The Codex Alimentarius Committee on Methods of Analysis and Sampling endorses analytical and test methods from various standards writing bodies, including ISO, following recommendations from the relevant Codex Commodity Committee.{{cite web |title=Policy - Food products |url=https://policy.iso.org/food-products.html |website=policy.iso.org |publisher=International Organization for Standardization (ISO) |access-date=19 May 2025}}

• Annex SL
• Codex Alimentarius
• Foodborne illness
• Food engineering
• Food packaging
• Food safety
• Food system
• Global Food Safety Initiative
• Harmonization (standards)
• International Organization for Standardization
• International Standard
• ISO 9000
• List of ISO standards
• Management system
• PDCA
• Process manufacturing
• Standardization
• Technical standard

{{Reflist}}

• Surak, John G. "A Recipe for Safe Food: ISO 22000 and HACCP". Quality Progress. October 2007. pp. 21–27.
• McKinley, Kevin;Chambers, Albert [https://www.wto.org/english/tratop_e/sps_e/private_standards_june07_e/private_standards_june07_e.htm Overview of the ISO 22000 Family of Standards], Joint UNCTAD/WTO Informal Information Session, 25 June 2007
• Ghizzoni, L; Surak, J; [https://www.intracen.org/uploadedFiles/intracenorg/Content/Exporters/Exporting_Better/Quality_Management/Redesign/EQB85_An%20Introduction%20to%20ISO%2022000_10%20Oct%2008.pdf An introduction to ISO 22000 - food safety management systems], International Trade Centre, BULLETIN No. 85/2008

• [https://www.ifc.org/wps/wcm/connect/industry_ext_content/ifc_external_corporate_site/agribusiness/resources/food+safety+handbook Food Safety Handbook A Practical Guide for Building a Robust Food Safety Management System – International Finance Corporation]
• [https://www.iso.org/standard/65464.html ISO 22000 Food safety management systems — Requirements for any organization in the food chain]
• [https://www.iso.org/publication/PUB100412.html ISO and Agriculture]
• [https://www.iso.org/publication/PUB100297.html ISO and Food]
• [https://policy.iso.org/food-products.html ISO Policy - Examples by Sector - Food Products]

{{ISO standards}}

{{Public health}}

#22000

Category:Food safety