Harmonization (standards)

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Harmonization is the process of minimizing redundant or conflicting standards which may have evolved independently. [1] [2] The name is also an analogy to the process to harmonizing discordant music.

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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. [3] 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, [4] 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). [5] 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. [6] 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. [7] 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. [8]

Harmonization of regulatory standards is seen by economists as a key component in reducing trade costs and increasing interstate trade. [9] 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. [10] The US Government Office of Management and Budget published CircularA-119 [11] 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. [12] An example is regulators creating the International Medical Devices Regulatory Forum (IMDRF) [13] 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. [14]

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 [15] using private standards who commit to their code of good practice. [16] Another example is the Global Food Safety Initiative which is a private organization that promotes harmonization using a benchmarking process [17] that results in recognition [18] 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 [19] and The International Food and Agribusiness Management Review. [20]

For food safety, a single international standard, ISO 22000, was proposed in 2007 [21] and 2020 [22] 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. [23]

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. [24] 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. [25] 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. [26]

In the sustainability sector, the ITC created a Standard Map [27] 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. [28]

Harmonization vs Standardization

International standards organizations express that standardization plays a crucial role for the realization of the UN SDGs in their strategies and activities for sustainability. [29] [30] 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, [31] the International Trade Centre, [32] UNIDO, [33] the World Trade Organization and the Food and Agriculture Organization. [34] 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, the private sector can avoid fragmentation and accusations of undue influence and lobbying in the standards setting and multistakeholder governance process. [35] [36]

See also

Related Research Articles

<span class="mw-page-title-main">International Organization for Standardization</span> International standards development organization

The International Organization for Standardization is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes.

An international standard is a technical standard developed by one or more international standards organizations. International standards are available for consideration and use worldwide. The most prominent such organization is the International Organization for Standardization (ISO). Other prominent international standards organizations including the International Telecommunication Union (ITU) and the International Electrotechnical Commission (IEC). Together, these three organizations have formed the World Standards Cooperation alliance.

Standardization or standardisation is the process of implementing and developing technical standards based on the consensus of different parties that include firms, users, interest groups, standards organizations and governments. Standardization can help maximize compatibility, interoperability, safety, repeatability, or quality. It can also facilitate a normalization of formerly custom processes.

A standards organization, standards body, standards developing organization (SDO), or standards setting organization (SSO) is an organization whose primary function is developing, coordinating, promulgating, revising, amending, reissuing, interpreting, or otherwise contributing to the usefulness of technical standards to those who employ them. Such an organization works to create uniformity across producers, consumers, government agencies, and other relevant parties regarding terminology, product specifications, protocols, and more. Its goals could include ensuring that Company A's external hard drive works on Company B's computer, an individual's blood pressure measures the same with Company C's sphygmomanometer as it does with Company D's, or that all shirts that should not be ironed have the same icon on the label.

<span class="mw-page-title-main">Ecolabel</span> Labeling systems for food and consumer products

Ecolabels and Green Stickers are labeling systems for food and consumer products. The use of ecolabels is voluntary, whereas green stickers are mandated by law; for example, in North America major appliances and automobiles use Energy Star. They are a form of sustainability measurement directed at consumers, intended to make it easy to take environmental concerns into account when shopping. Some labels quantify pollution or energy consumption by way of index scores or units of measurement, while others assert compliance with a set of practices or minimum requirements for sustainability or reduction of harm to the environment. Many ecolabels are focused on minimising the negative ecological impacts of primary production or resource extraction in a given sector or commodity through a set of good practices that are captured in a sustainability standard. Through a verification process, usually referred to as "certification", a farm, forest, fishery, or mine can show that it complies with a standard and earn the right to sell its products as certified through the supply chain, often resulting in a consumer-facing ecolabel.

Accreditation is the independent, third-party evaluation of a conformity assessment body against recognised standards, conveying formal demonstration of its impartiality and competence to carry out specific conformity assessment tasks.

European Standards, sometimes called Euronorm, are technical standards which have been ratified by one of the three European Standards Organizations (ESO): European Committee for Standardization (CEN), European Committee for Electrotechnical Standardization (CENELEC), or European Telecommunications Standards Institute (ETSI). All ENs are designed and created by all standards organizations and interested parties through a transparent, open, and consensual process.

<span class="mw-page-title-main">Certification</span> Formal attestation of certain characteristics of an object, person, or organization

Certification is part of testing, inspection and certification and the provision by an independent body of written assurance that the product, service or system in question meets specific requirements. It is the formal attestation or confirmation of certain characteristics of an object, person, or organization. This confirmation is often, but not always, provided by some form of external review, education, assessment, or audit. Accreditation is a specific organization's process of certification. According to the U.S. National Council on Measurement in Education, a certification test is a credentialing test used to determine whether individuals are knowledgeable enough in a given occupational area to be labeled "competent to practice" in that area.

<span class="mw-page-title-main">Global Reporting Initiative</span> International standards organization

The Global Reporting Initiative is an international independent standards organization that helps businesses, governments, and other organizations understand and communicate their impacts on issues such as climate change, human rights, and corruption.

<span class="mw-page-title-main">ISO 22000</span> Food safety standard

ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, 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.

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">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.

An environmental audit is a type of evaluation intended to identify environmental compliance and management system implementation gaps, along with related corrective actions. In this way they perform an analogous (similar) function to financial audits. There are generally two different types of environmental audits: compliance audits and management systems audits. Compliance audits tend to be the primary type in the US or within US-based multinationals.

World Standards Cooperation (WSC) is an alliance of the IEC, ISO and ITU international standardization organizations with the objective to advance the voluntary consensus-based International Standards system. It was formed in 2001.

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.

ISO 14971Medical devices — Application of risk management to medical devices is a voluntary consensus standard, published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.

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.

Sustainability standards and certifications are voluntary guidelines used by producers, manufacturers, traders, retailers, and service providers to demonstrate their commitment to good environmental, social, ethical, and food safety practices. There are over 400 such standards across the world.

Multistakeholder governance is a practice of governance that employs bringing multiple stakeholders together to participate in dialogue, decision making, and implementation of responses to jointly perceived problems. The principle behind such a structure is that if enough input is provided by multiple types of actors involved in a question, the eventual consensual decision gains more legitimacy, and can be more effectively implemented than a traditional state-based response. While the evolution of multistakeholder governance is occurring principally at the international level, public-private partnerships (PPPs) are domestic analogues.

Ente Nazionale Italiano di Unificazione is a private non-profit association that performs regulatory activities in Italy across industrial, commercial, and service sectors, with the exception of electrical engineering and electronic competence of CEI.

References

  1. ↑ Pelkmans, J. (1987). "The New Approach to Technical Harmonization and Standardization". JCMS: Journal of Common Market Studies. 25 (3): 249–269. doi:10.1111/j.1468-5965.1987.tb00294.x.
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  3. ↑ Fuertes, Iluminada (2008). "Towards Harmonization or Standardization in Governmental Accounting?". The International Public Sector Accounting Standards Board Experience, Journal of Comparative Policy Analysis: Research and Practice. 10 (4): 327–345. doi:10.1080/13876980802468766. S2CID   155081167.
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  5. ↑ "Harmonised Standards". single-market-economy.ec.europa.eu. European Union.
  6. ↑ "U.S. V. MICROSOFT: PROPOSED FINDINGS OF FACT". justice.gov/. US Department of Justice. 14 August 2015.
  7. ↑ "Long-awaited common charger for mobile devices will be a reality in 2024". europarl.europa.eu/. European Parliament. 4 October 2022.
  8. ↑ "G7 Leaders' Statement on Economic Resilience and Economic Security". whitehouse.gov. The White House. May 2023.
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  11. ↑ "CIRCULAR NO. A-119 Revised" (PDF). whitehouse.gov. The White House.
  12. ↑ "Using and referencing ISO and IEC standards to support public policy". iso.org. International Organization for Standardization.
  13. ↑ "International Medical Device Regulatory Forum (IMDRF)". mdrf.org/. IMDRF.
  14. ↑ Kellermann, Martin (2019). Ensuring Quality to Gain Access to Global Markets (PDF). Washington, DC: International Bank for Reconstruction and Development / The World Bank and Physikalisch-Technische Bundesanstalt (PTB). p. 76. ISBN   978-1-4648-1372-6.
  15. ↑ "ISEAL Community Members". isealalliance.org. ISEAL Alliance.
  16. ↑ "ISEAL Codes of Good Practice". isealalliance.org. ISEAL Alliance.
  17. ↑ "Harmonisation". mygfsi.com. Global Food Safety Initiative (GFSI).
  18. ↑ "GFSI-Recognised Certification Programme Owners". mygfsi.com. Global Food Safety Initiative.
  19. ↑ "Not Fit-for-Purpose The Grand Experiment of Multi-Stakeholder Initiatives in Corporate Accountability, Human Rights and Global Governance". msi-integrity.org. Institute for Multi-Stakeholder Initiative Integrity.
  20. ↑ Roa, Madhura; Bast, Aalt; de Boer, Alie (2021). "European private food safety standards in global agri-food supply chains: a systematic review". International Food and Agribusiness Management Review. 24 (6): 739–754. doi: 10.22434/IFAMR2020.0146 .
  21. ↑ "Joint UNCTAD/WTO informal information session on private standards". wto.org. World Trade Organization (WTO).
  22. ↑ "One Standard for the Food Industry". mygfsi.com/. Global Food Safety Initiative. 13 August 2020.
  23. ↑ Soon, Jan Mei; Baines, Richard N. (2013). "Public and Private Food Safety Standards: Facilitating or Frustrating Fresh Produce Growers?". Laws. 2 (Global Food Safety Law and Policy): 1–19. doi: 10.3390/laws2010001 .
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  25. ↑ "Corporate Climate Responsibility Monitor 2023". newclimate.org. The New Climate Institute.
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  27. ↑ "ITC Standards Map". standardsmap.org. International Trade Centre (ITC).
  28. ↑ Baue, Bill (August 2023). The Lost Decade: Sustainability Standards Sabotage Sustainability. Papelallee 78-79 10437 Berlin, Germany: r3.0 (Redesign for Resilience & Regeneration).{{cite book}}: CS1 maint: location (link)
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  31. ↑ "WHO Global Strategy for Food Safety 2022-2030". who.int. World Health Organization.
  32. ↑ Wozniak, Joseph (21 January 2023). "How to Shape the Future of Trade Together". theauditoronline.com. Exemplar Global. Retrieved 14 April 2023.
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  34. ↑ Trade and Food Standards. FAO and WTO. 2017. ISBN   978-92-5-109793-9.
  35. ↑ "Multistakeholderism: a critical look". tni.org. Transnational Institute. 8 February 2024.
  36. ↑ "Who's Tipping the Scales?". ipes-food.org. IPES-Food.
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