harmonization (standards)
{{About|harmonization in standards|other uses|Harmonisation (disambiguation)}}
Harmonization is the process of minimizing redundant or conflicting standards which may have evolved independently.{{cite journal|year=1987|title=The New Approach to Technical Harmonization and Standardization|journal=JCMS: Journal of Common Market Studies|volume=25|issue=3|pages=249–269|doi=10.1111/j.1468-5965.1987.tb00294.x|last1=Pelkmans|first1=J.}}{{cite journal |doi= 10.1016/S1386-5056(97)00121-4 |title= HL7 Version 3–An object-oriented methodology for collaborative standards development (Presented at the International Medical Informatics Association Working Group 16 Conference on Standardisation in Medical Informatics–Towards International Consensus and Cooperation, Bermuda, 12 September 1997) |journal= International Journal of Medical Informatics |volume= 48 |pages= 151–61 |year= 1998 |last1= Beeler |first1= G. W.|issue= 1–3 |pmid= 9600415 }} The name is also an analogy to the process to harmonizing discordant music.
Harmonization is different from standardization. Harmonization involves a reduction in variation of standards, while standardization entails moving towards the eradication of any variation with the adoption of a single standard.{{cite journal |last1=Fuertes |first1=Iluminada |title=Towards Harmonization or Standardization in Governmental Accounting? |journal=The International Public Sector Accounting Standards Board Experience, Journal of Comparative Policy Analysis: Research and Practice |date=2008 |volume=10 |issue=4 |pages=327–345 |doi=10.1080/13876980802468766 |s2cid=155081167 |url=https://www.tandfonline.com/doi/abs/10.1080/13876980802468766|url-access=subscription }} The goal for standard harmonization is to find commonalities, identify critical requirements that need to be retained, and provide a common framework for standards setting organizations (SSO) to adopt. In some instances, businesses come together forming alliances or coalitions,{{cite web |title=Coalitions of Action |url=https://www.theconsumergoodsforum.com/what-we-do/join-our-coalitions-of-action/ |website=theconsumergoodsforum.com |publisher=The Consumer Goods Forum (CGF)}} also referred to multi-stakeholder initiatives (MSI) with a belief that harmonization could reduce compliance costs and simplify the process of meeting requirements. With potential to reduce complexity for those tasked with testing and auditing standards for compliance.
Harmonization in the Public Sector
A harmonised standard is a European standard developed by a recognised European Standards Organisation: European Committee for Standardization (CEN), European Committee for Electrotechnical Standardization (CENELEC), or European Telecommunications Standards Institute (ETSI).{{cite web |title=Harmonised Standards |url=https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en |website=single-market-economy.ec.europa.eu |publisher=European Union}} It is created following a request from the European Commission to one of these organisations. Harmonised standards must be published in the Official Journal of the European Union (OJEU).
In the information and communication technologies (ICT) sector, companies initially formed closed groups to develop private standards, for reasons which included competitive advantage. An example being the phrase "embrace, extend, and extinguish" used internally by Microsoft which led to legal action taken by United States Department of Justice.{{cite web |title=U.S. V. MICROSOFT: PROPOSED FINDINGS OF FACT |url=https://www.justice.gov/atr/us-v-microsoft-proposed-findings-fact-2 |website=justice.gov/ |date=14 August 2015 |publisher=US Department of Justice}} In response, governments and intergovernmental organizations (IGOs) recommended the use of international standards which resulted in standard harmonization. Examples include the Linux operating system, Adobe portable document format (PDF) and the OASIS open document format (ODF) being converted into ISO and IEC international standards. In 2022, EU legislation was passed for all mobile phones, tablets and cameras sold in the EU requiring a USB-C charging port by 2024.{{cite web |title=Long-awaited common charger for mobile devices will be a reality in 2024 |url=https://www.europarl.europa.eu/news/en/press-room/20220930IPR41928/long-awaited-common-charger-for-mobile-devices-will-be-a-reality-in-2024 |website=europarl.europa.eu/ |date=4 October 2022 |publisher=European Parliament}} The USB Type-C Specification is an IEC international standard, IEC 62680-1-3. This was reaffirmed at the G7 Hiroshima Summit 2023, where cooperating on international standards setting with a commitment to collectively support the development of open, voluntary and consensus-based standards that will shape the next generation of technology.{{cite web |title=G7 Leaders' Statement on Economic Resilience and Economic Security |url=https://bidenwhitehouse.archives.gov/briefing-room/statements-releases/2023/05/20/g7-leaders-statement-on-economic-resilience-and-economic-security/ |website=White House |publisher=The White House |date=May 2023}}
Harmonization of regulatory standards is seen by economists as a key component in reducing trade costs and increasing interstate trade.{{Cite journal |last1=Schmidt |first1=Julia |last2=Steingress |first2=Walter |date=2022 |title=No double standards: Quantifying the impact of standard harmonization on trade |url=https://www.sciencedirect.com/science/article/pii/S0022199622000514 |journal=Journal of International Economics |volume=137 |page=103619 |language=en |doi=10.1016/j.jinteco.2022.103619 |issn=0022-1996|hdl=10419/210776 |hdl-access=free }} Where importing-market standards are harmonized with international standards, such as those from ISO or IEC, the negative effect on developing-country
exporters is substantially lessened, or even reversed.{{cite book |last1=Shepherd |first1=Ben |title=International Standards and Trade - What does the research say? |date=March 2020 |publisher=International Organization for Standardization |location=Switzerland |isbn=978-92-67-11094-3 |url=https://www.iso.org/publication/PUB100448.html}} The US Government Office of Management and Budget published CircularA-119{{cite web |title=CIRCULAR NO. A-119 Revised |url=https://bidenwhitehouse.archives.gov/wp-content/uploads/2017/11/Circular-119-1.pdf |website=White House |publisher=The White House}} instructing its agencies to adopt voluntary consensus standards before relying upon private standards. The circular mandates standard harmonization by eliminating or reducing US agency use of private standards and government standards. The priority for governments to adopt voluntary consensus standards is supported by international standards such as ISO supporting public policy initiatives.{{cite web |title=Using and referencing ISO and IEC standards to support public policy |url=https://policy.iso.org/home.html |website=iso.org |publisher=International Organization for Standardization}} An example is regulators creating the International Medical Devices Regulatory Forum (IMDRF){{cite web |title=International Medical Device Regulatory Forum (IMDRF) |url=https://www.imdrf.org/ |website=mdrf.org/ |publisher=IMDRF}} and promoting the Medical Devices Single Audit Program (MDSAP). This uses an international standard, ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes. World Bank Group explain that private standards cannot be used in technical regulation and have to be moved into the public standardization system before they can be used as the basis for technical regulations.{{cite book |last1=Kellermann |first1=Martin |title=Ensuring Quality to Gain Access to Global Markets |date=2019 |publisher=International Bank for Reconstruction and Development / The World Bank and Physikalisch-Technische Bundesanstalt (PTB) |location=Washington, DC |isbn=978-1-4648-1372-6 |page=76 |url=https://thedocs.worldbank.org/en/doc/249621553265195570-0090022019/original/FullQIToolkitReport.pdf}}
Harmonization in the Private Sector
In comparison to the public sector, where governments, IGOs and regulators work towards a harmonised standard, there are instances where private sector promote harmonization of multiple standards. An example is the private organization ISEAL Alliance accepting multiple schemes as community members{{cite web |title=ISEAL Community Members |url=https://www.isealalliance.org/iseal-community-members |website=isealalliance.org |publisher=ISEAL Alliance}} using private standards who commit to their code of good practice.{{cite web |title=ISEAL Codes of Good Practice |url=https://www.isealalliance.org/defining-credible-practice/iseal-codes-good-practice |website=isealalliance.org |publisher=ISEAL Alliance}} Another example is the Global Food Safety Initiative which is a private organization that promotes harmonization using a benchmarking process{{cite web |title=Harmonisation |url=https://mygfsi.com/what-we-do/harmonisation/ |website=mygfsi.com |publisher=Global Food Safety Initiative (GFSI)}} that results in recognition{{cite web |title=GFSI-Recognised Certification Programme Owners |url=https://mygfsi.com/how-to-implement/recognition/certification-programme-owners |website=mygfsi.com |publisher=Global Food Safety Initiative}} of multiple scheme owners using private standards. The harmonization approach for multiple private standards has led to criticism from various organizations including the Institute for Multi-Stakeholder Initiative Integrity{{cite web |title=Not Fit-for-Purpose The Grand Experiment of Multi-Stakeholder Initiatives in Corporate Accountability, Human Rights and Global Governance |url=https://www.msi-integrity.org/not-fit-for-purpose/ |website=msi-integrity.org |publisher=Institute for Multi-Stakeholder Initiative Integrity}} and The International Food and Agribusiness Management Review.{{cite journal |last1=Roa |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=6 |pages=739–754 |doi=10.22434/IFAMR2020.0146 |doi-access=free }}
For food safety, a single international standard, ISO 22000, was proposed in 2007{{cite web |title=Joint UNCTAD/WTO informal information session on private standards |url=https://www.wto.org/english/tratop_e/sps_e/private_standards_june07_e/private_standards_june07_e.htm |website=wto.org |publisher=World Trade Organization (WTO)}} and 2020{{cite web |title=One Standard for the Food Industry |url=https://mygfsi.com/news_updates/one-standard-for-the-food-industry-ask-gfsi/ |website=mygfsi.com/ |date=13 August 2020 |publisher=Global Food Safety Initiative}} as a harmonized standard approach used by the public sector. On both occasions, the Global Food Safety Initiative rejected the proposal because promoting ISO 22000 would mean reducing the power of global retailers in terms of control over standards.{{cite journal |last1=Soon |first1=Jan Mei |last2=Baines |first2=Richard N. |title=Public and Private Food Safety Standards: Facilitating or Frustrating Fresh Produce Growers? |journal=Laws |date=2013 |volume=2 |issue=Global Food Safety Law and Policy |pages=1–19 |doi=10.3390/laws2010001 |doi-access=free }}
Private corporations are not allowed to be members or have voting rights over international standards, because they are consensus-based. Whereas it is possible to have a controlling interest and exert influence if they promote private standards because they are non-consensus. In the environmental sector for “net zero”, corporations continue to promote private standards over international standards. This allows the creation of new terms that are non-consensus and do not follow terms which are defined in international standards such as ISO 14050 Environmental management Vocabulary. An example is the term “insetting” that has been introduced by the private sector, despite it not being part of IWA 42 Net Zero Guidelines.{{cite web |title=Net Zero Guidelines |url=https://www.iso.org/netzero |website=iso.org |publisher=International Organization for Standardization}} This approach is an obstacle to standard harmonization and received criticism from the New Climate Institute (NCI), where companies are successfully lobbying the standards setting organizations (SSOs) who use private standards to rubber-stamp the inclusion of insetting claims within their net zero pledges.{{cite web |title=Corporate Climate Responsibility Monitor 2023 |url=https://newclimate.org/resources/publications/corporate-climate-responsibility-monitor-2023 |website=newclimate.org |publisher=The New Climate Institute}} Another example of corporate lobbying of a standards setter relates to the Science Based Targets initiative (SBTi). One of their funders, the Bezos Earth Fund exerted influence on SBTi to relax their position on carbon offsets. This resulted in an open letter from SBTi staff to the Board of Trustees disagreeing with the decision. Standards setting organizations who do not follow a consensus model or the WTO principles for international standards development are vulnerable to corporate lobbying, especially when they are receiving funding from the private sector.{{cite web |last1=Suppan |first1=Steve |title=Science Based Targets Initiative board undermines integrity of its corporate climate standard |url=https://www.iatp.org/SBTi-board-undermines-integrity-corporate-climate |website=iatp.org |publisher=The Institute for Agriculture and Trade Policy (IATP) |access-date=18 April 2024}}
In the sustainability sector, the ITC created a Standard Map{{cite web |title=ITC Standards Map |url=https://www.standardsmap.org/en/home |website=standardsmap.org |publisher=International Trade Centre (ITC)}} as an informational tool in an attempt to harmonize and group together voluntary sustainability standards (VSS). With over 300 sustainability standards mapped, and financial opportunities with fees that are associated to private standards, this may have led to a perverse incentive. The unintended consequence being a proliferation of private standards, some of which could be primarily seeking monetary gain and may have sabotaged sustainability standards and certification.{{cite book |last1=Baue |first1=Bill |title=The Lost Decade: Sustainability Standards Sabotage Sustainability |date=August 2023 |publisher=r3.0 (Redesign for Resilience & Regeneration) |location=Papelallee 78-79 10437 Berlin, Germany |url=https://www.r3-0.org/the-lost-decade/}}
Harmonization vs Standardization
To avoid harmonization failures like plugs and sockets, video cassettes and keyboard layouts,{{cite web |last1=Horlock |first1=David |title=Why governments need to adopt standards for procurement |url=https://www.hinrichfoundation.com/research/article/tech/why-governments-need-to-adopt-standards-for-procurement/ |website=hinrichfoundation.com |publisher=Hinrich Foundation |access-date=16 March 2025}} the ambition is to achieve a single international standard as outlined by the European Union,{{cite web |title=Standards in Europe |url=https://europa.eu/youreurope/business/product-requirements/standards/standards-in-europe/ |website=europa.eu |publisher=European Union |access-date=16 March 2025}} supported by regional or regulatory addendums where necessary. Not multiple harmonized private standards, all competing against each other, trying to achieve the same goal.
International standards organizations express that standardization plays a crucial role for the realization of the UN SDGs in their strategies and activities for sustainability.{{cite journal |last1=Algan |first1=F. M. |title=Global Standardization for a Sustainable Future |journal=Curr Res Soc Sci |date=2023 |volume=9 |issue=1 |pages=30–40 |doi=10.30613/curesosc.1173926 |url=https://dergipark.org.tr/tr/download/article-file/2644875|doi-access=free }} {{cite book |last1=Birkbeck |first1=Carolyn Deere |last2=Sugathan |first2=Mahesh |last3=Boinnard |first3=Sophie |last4=Grekova |first4=Valeriia |last5=Cleeland |first5=Belinda |title=Standards and Related Initiatives in International Cooperation to End Plastic Pollution: Mapping and State of Play |date=September 2023 |publisher=Forum on Trade, Environment, & the SDGs (TESS) |location=Geneva, Switzerland |pages=https://tessforum.org/latest/standards-and-related-initiatives-in-international-cooperation-to-end-plastic-pollution-mapping-and-state-of-play}} Similar to reducing and preventing the proliferation of private standards in the information and communication technologies (ICT) sector, governments and IGOs recommend international standards in the food sector. This includes the World Health Organization,{{cite web |title=WHO Global Strategy for Food Safety 2022-2030 |url=https://www.who.int/publications/i/item/9789240057685 |website=who.int |publisher=World Health Organization}} the International Trade Centre,{{cite web |last1=Wozniak |first1=Joseph |title=How to Shape the Future of Trade Together |url=https://www.theauditoronline.com/how-to-shape-the-future-of-trade-together/ |website=theauditoronline.com |date=21 January 2023 |publisher=Exemplar Global |access-date=14 April 2023}} UNIDO,{{cite web |title=Making standards work for SMEs |url=https://hub.unido.org/news/making-standards-work-smes |website=hub.unido.org |publisher=United Nations Industrial Development Organization (UNIDO)}}
the World Trade Organization and the Food and Agriculture Organization.{{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}}
With the public sector recommending standardization over private sector attempts for harmonization, IGOs are encouraging corporation led coalitions to surrender the control they have over private standards. By promoting international standards and standardization instead of harmonization,{{cite web |title=Harmonisation |url=https://mygfsi.com/what-we-do/harmonisation/ |website=mygfsi.com |publisher=Global Food Safety Initiative |access-date=24 March 2025}} the private sector can avoid fragmentation and accusations of undue influence and lobbying in the standards setting and multistakeholder governance process.{{cite web |title=Multistakeholderism: a critical look |url=https://www.tni.org/en/publication/multistakeholderism-a-critical-look |website=tni.org |date=8 February 2024 |publisher=Transnational Institute}} {{cite web |title=Who's Tipping the Scales? |url=http://www.ipes-food.org/pages/tippingthescales |website=ipes-food.org |publisher=IPES-Food}}
See also
- De facto standard
- European Committee for Electrotechnical Standardization
- European Committee for Standardization
- European Telecommunications Standards Institute
- Harmonisation of law
- International Organization for Standardization
- International Standard
- Multistakeholder governance
- Standardization
- Standards organization
- Tax harmonization
- Technical Standard
- World Standards Cooperation
References
{{Reflist}}
External links
- [https://wiki.hl7.org/index.php?title=Vocabulary_and_RIM_Harmonization_Process Vocabulary and RIM Harmonization Process] from Health Level 7 (HL7)
- [https://ulstandards.ul.com/about/harmonizing-standards/ Harmonizing Standards from UL]
- [https://www.w3.org/WAI/standards-guidelines/harmonization/ Why Standards Harmonization is Essential to Web Accessibility], W3C
- [https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/ Harmonised Standards], OJEU
- [https://www.astm.org/SNEWS/MARCH_2005/plaintalk_mar05.html Harmonization], James A. Thomas, ASTM Standards News, March 2005