Setting the right governance of the system of national standards, quality and assurance, often call national quality infrastructure (NQI) is crucial for building coherent, efficient, and trusted frameworks that support economic growth, public safety, and innovation. This chapter explores the key elements required to enable such governance, beginning with the development of a national policy on QI that establishes clear objectives, priorities, and institutional mandates. It then examines the importance of co-ordination between government bodies and QI institutions to ensure alignment and collaboration. Finally, the chapter discusses strategies for embedding QI into broader government policies, ensuring that quality, safety, and compliance considerations are integrated into national development agendas and sectoral strategies. By strengthening governance structures and promoting policy coherence, these efforts enhance the effectiveness and impact of both the QI system and regulatory frameworks.
Reinforcing Regulatory Frameworks through Standards, Measurements and Assurance
3. Enabling effective governance of the standards and quality assurance and regulatory systems
Copy link to 3. Enabling effective governance of the standards and quality assurance and regulatory systemsAbstract
Key Recommendations
Copy link to Key RecommendationsGovernments should optimise their national standards and quality assurance systems by setting an explicit high-level policy on the setup and utilisation of QI, and on the co-ordination mechanisms among governments, regulators and QI bodies for public policy delivery. This policy should consider what is the best institutional arrangement for the different QI bodies, including their location and resourcing mechanisms, and their capacity to implement policy for current and future policy challenges.
Governments should include assessments of anticipated needs of QI services to deliver their high-level sectoral strategies (e.g. on transport, environment, health, education). This helps QI services to plan and ready themselves for policy delivery, identifies existing QI tools of use to regulators, and helps governments plan policy implementation.
QI bodies should review their processes, including how they engage stakeholders, who they engage, to remain relevant in the future. This means becoming more agile, proactive and innovative to enable faster multi-stakeholder-led standards, measurement and assurance processes for tackling current challenges. This also means using the digital transformation and other innovations to enable this agility and be ready for future governance challenges.
Governments can utilise the practical checklist (Chapter 5) included in this report to consider who their national QI actors are, how they are currently interacting with each other and with regulators, and how to optimise QI-regulation interactions. QI bodies can use the checklist in their engagement with governments to highlight their critical role in policy implementation and enforcement, and to better understand where gaps and challenges lie in their remits and delivery mechanisms.
Survey of National QI setups
Copy link to Survey of National QI setupsThere is no universal model of a national QI system that encompasses the institutional setting of the QI bodies and how they interact with policymakers and regulators. QI bodies are sometimes part government or independent public and/or private bodies, depending on the national approaches to trade, risk and economic priorities (WTO Committee for Technical Barriers to Trade, 2024[1]). In this way, the objectives of national QI bodies may depend on location and their legal status as government, semi-private or private bodies. This means, the drivers of QI bodies inside and outside government may vary, dependent on the strength of their linkage to government priorities, organisational priorities, profit or by industry priorities. The objectives of these various QI pillars have also evolved over the years, from quality assurance of products to broader remits on public and environmental safety, sustainability, and economic development (Kellermann, 2019[2]).
Alongside these core pillars, as QI interacts with actors across the economy, from governments, regulators, consumers, and businesses. The ecosystem of QI is linked intrinsically to all aspects of a country’s governance, institutions, enterprises and citizens (Figure 3.1). Such a holistic approach to QI has been highlighted in literature (UNIDO, 2024[3])and visualises the whole system that helps stimulate industrial development, trade competitiveness, innovation and efficient use of resources, while ensuring food safety and protecting human health and the environment. This system is essential for our local markets to work well, and if other countries recognise and trust our institutions, it helps our products get accepted in their markets too. Overall, QI is a crucial part of making sure our economy grows, and it also contributes to the well-being of our environment and society.
Figure 3.1. The standards and quality assurance, or quality infrastructure (QI), ecosystem
Copy link to Figure 3.1. The standards and quality assurance, or quality infrastructure (QI), ecosystemThe institutions, services and governance of QI, and its interactions with government, consumers and citizens
Regardless of their institutional arrangement, QI bodies need a supportive and efficient relationship with government agencies to make sure their services are effective and useful for positive policy outcomes. However, this variety of QI systems is crucial to understanding how objectives of QI and regulation can better support each other for effective public policy outcomes. An overview of QI systems in different regions
The OECD conducted a light-touch survey with seven countries to better understand QI-regulation interactions in national contexts. The survey displays the variety of institutional frameworks under which QI and government relationships are housed within these 7 countries - Indonesia, Myanmar, Thailand, Phillipines, Singapore, Sweden and Costa Rica. In particular, it demonstrates that the location of QI institutions in federal or national regulatory structures determines their objectives and their resources in delivering them, how they interact with and deliver against key policy priorities, and follow policy elaboration guidelines.
ASEAN countries
In the case of ASEAN countries (Indonesia, Myanmar, Thailand, Phillipines, Singapore) the survey finds that the placement of NQI institutions within specific ministries or departments plays a predominant role in shaping their operational dynamics. It reveals several important trends and patterns in how these NQI bodies are organised and interact with each other (Figure 3.2), such as:
Public institutional bodies acting on behalf of a specific ministry or government department are predominant across all QI pillars in ASEAN countries; often set up a division, office or government agency. In Market Surveillance, ministries or departments directly serve this role in some cases.
The National Standards Body (NSB) and National Accreditation Body (NAB) in all surveyed ASEAN countries fall under the same ministry or department, often the Ministry of (Trade and) Industry. However, the location of the National Metrology Institute (NMI) varies, with some countries housing it alongside their NSB and NAB. For instance, in Myanmar, the National Metrology Institute (NMI) is housed in the same department as the NSB and NAB, all three being under the Department of Research and Innovation under the Ministry of Sciences and Technologies. While in the case of Indonesia, the oversight role for the NSB and NAB are fulfilled by non-ministerial institutions, with the chair and some employees shared between the NSB and NAB. Additionally, Thailand’s Ministry of Industry oversees a part of Market Surveillance alongside overseeing the NSB and NAB, which is not commonly seen in the other surveyed countries.
The organisational structures of Conformity Assessment Bodies (CABs) are not explicitly defined and are managed mostly by private entities across all the surveyed countries, although public bodies play a role in Indonesia, Myanmar and Thailand. This is likely due to the prevalent participation of the private sector.
In Market Surveillance, responsibilities are typically co-ordinated by the Ministry of Trade with food and drug oversight sometimes being managed by a separate body such as the Food and Drug Administration (FDA) under the Ministry of Health, as in Thailand and Indonesia. Due to the nature of the function of Market Surveillance, private sector involvement is rarely observed in the surveyed countries, with the exception of Singapore.
Figure 3.2. An overview of NQI institutional setup in ASEAN countries
Copy link to Figure 3.2. An overview of NQI institutional setup in ASEAN countries
* Department of Agriculture.
** Ministry of Higher Education, Science, Research and Innovation.
n.s: Entities not specified.
Source: OECD Questionnaire on the interrelations between regulation and quality infrastructure Q2.
Sweden
On the other hand, the institutional set up in Sweden significantly varies from ASEAN countries (Figure 3.3). For standards, there are three independent bodies delivering standards services, while co-ordinating with each other– Svensk Elstandard (SEK) covering electrotechnology standards, the Swedish Institute for Standards (SIS), and the Swedish Information and Telecommunications Standardization (ITS). Conversely, the accreditation body is a public body under a government ministry and comes under oversight from the Market Surveillance Council, which also has oversight over 14 other agencies related to market surveillance. Metrology services are delivered via a non-minsterial institute, while conformity assessment is delivered via a mix of public and private bodies.
Figure 3.3. An overview of NQI institutional setup in Sweden
Copy link to Figure 3.3. An overview of NQI institutional setup in Sweden
Note: n.s. Entities not specified.
Source: OECD Questionnaire on the interrelations between regulation and quality infrastructure.
Costa Rica
In Costa Rica, QI encompasses a diverse range of institutions (Figure 3.4), from a non-profit association to direct ministry operations, with mandates defined by national laws. Similar to Sweden, the NSB is managed by a private non-profit institution, Instituto de Normas Técnica de Costa Rica (INTECO) (run by a private sector organisation), as designated under the condition mentioned in Law No. 10473 (National Quality System). The law requires government bodies to use exclusively accredited conformity assessment services, which has strengthened the outreach and competence of Costa Rica’s NAB. This law also outlines the roles of other QI bodies, where non-ministerial public entities in NAB and CABs play leading roles in the system. A government office operates as the NMI, which is an independent agency under the Ministry of Economy, Industry and Commerce (MEIC). This means that while it receives administrative support from the ministry, it maintains technical independence, allowing it to fulfil its mandate autonomously. Market Surveillance is conducted by various ministries within their respective legal competencies. For instance, the Market Verification Department of the Quality Directorate (DVM) under MEIC is tasked with verifying that products comply with mandatory technical regulations and addressing non-compliance to safeguard consumer rights and interests. MEIC also has strong co-operation with the Ministry of Foreign Trade.
Costa Rica fosters systematic collaboration via the establishment of the National Quality Council (CONAC) and the National Quality System (SNC). All relevant institutions, whether public or private sectors, are part of the SNC with their directors participating in the technical committee of CONAC. This mechanism facilitates technical co-ordination and the development of joint initiatives addressing quality issues across multiple sectors.
Figure 3.4. An overview of NQI institutional setup in Costa Rica
Copy link to Figure 3.4. An overview of NQI institutional setup in Costa Rica
Note: * Market Verification Department of the Quality Directorate; n.s: entities not specified.
Source: OECD Questionnaire on the interrelations between regulation and quality infrastructure.
A national policy on the standards, measurement, assurance and market surveillance (QI) system
Copy link to A national policy on the standards, measurement, assurance and market surveillance (QI) systemThe governance and institutional location of QI bodies should be decided strategically to best deliver on government policy priorities, drawing on national specificities. QI governance is very diverse, dependent on different country and historical contexts. As shown by the survey conducted by the OECD of the 7 countries, the location of QI institutions in federal or national regulatory structures determines their remits, the independence in delivering their remits, and how they interact with and deliver against key policy priorities and guidelines. This diversity can add complexity for regulators when considering QI in regulatory processes, if knowledge about the different QI actors and their setup is limited. Similarly, if QI bodies do not have sufficient visibility and influence, regulators may lack incentives to consider them for regulatory design and delivery.
Developing an overarching policy on QI can be a mechanism to co-ordinate the implementation of QI services aligned to national priorities. Such a policy is termed “Quality Policy” (PAQI, 2021[4]), (UNIDO, 2016[5]) which identifies the governance required, and by extension, how QI services and their expertise can be leveraged to deliver accountability against key national priorities. Such a strategy can be developed by governments in consultation with their QI bodies, and national stakeholders more widely. Box 3.1 presents an example of how Chile set up a better QI system to react to the COVID-19 pandemic. A Quality Policy also encompasses broader concerns from businesses and consumers such as environmental impact, social responsibility, and corporate governance to complement existing national policy priorities (UNIDO, 2016[5]).
Box 3.1. Health regulations and QI in Chile: Reforms following Covid-19 pandemic
Copy link to Box 3.1. Health regulations and QI in Chile: Reforms following Covid-19 pandemicLegislation, regulation, and good practices are the main tools of national healthcare systems. The elaboration and implementation of these instruments are typically done by a nation’s Ministry of Health, with the support of international organisations such as the World Health Organization (WHO) and regional organisations such as the Pan American Health Organization (PAHO). These organisations are complemented by a national QI system (NQI) that oversees the following key issues: traceability of the measurements; international standards for the conformity assessment of pharmaceutical products, personal protective equipment (PPE) and medical devices; evidence of the technical competencies of the testing laboratories (ISO/IEC 17025) and clinical laboratories (ISO/IEC 15189); assuring the confidence and comparability of the measurements of the testing and clinical labs by periodical proficiency tests (on the base of ISO/IEC 17043); the production and the use of reliable reference materials (ISO 17034); Good Manufacturing Practice (GMP) for quality assurance and Good Laboratory Practice (GLP) in testing and clinical laboratories.
In Chile, the Ministry of Health is responsible for instructing, co-ordinating, and controlling the national healthcare system. It also elaborates and edits laws and regulations. The Ministry co-ordinates with its subsidiaries such as the Superintendency of Health, the regional delegates of the Ministry, and the Institute of Public Health. These ministries are supported by a national standards and quality assurance system that includes the Division of Standardization, the Division of Accreditation, and the Division of Metrology.
The Covid-19 pandemic underlined weaknesses in the NQI system and its support for public health objectives. Chile needed to establish an efficient and reliable system for the development and application of PCR tests, the production and importation of PPE, and elaborate its sanitarian protocols. To overcome these weaknesses, the Chilean Government made several reforms, including the creation of the Subdepartment of Registration of Pesticides and Disinfectants and the National Agency for Medical Appliances, Innovation and Development (ANDID). The former is responsible for the registration of sanitary and domestic disinfectants and the latter is now fully responsible for assuring the security and performance of all medical devices applied in the country. Importantly the government established co-operation between the Departamento Laboratorio Biomédico Nacional y de Referencia and the Departamento Agencia Nacional de Medicamentos in the field of metrology and proficiency tests.
Source: this box was prepared by the Instituto de Salud Pública de Chile.
Currently, governments can set their policies on their national standards and quality assurance system via legislative and policy guidance pathways, including specific acts related to standards and quality assurance components (e.g. a Standards act), or through policy guidance (E.g. approach to conformity assessments) (UNIDO, 2016[5]). There are some common best practices on setting up components of a QI system such as those provided by WTO (WTO Committee for Technical Barriers to Trade, 2024[1]) on conformity assessment procedures, which encourages governments to think about the level of risk acceptance, and aligning the procedures according – such as choosing first, second or third party verification, and the impartiality and independence of the organisations performing conformity assessment. Similarly, ISO and IEC’s standards on conformity assessment and accreditation set out best practices (ISO, 2024[6]), including the need to independently verify processes or products. However, the WTO notes that the risk accepted may be different in different countries, and hence the approaches to QI may vary (WTO Committee for Technical Barriers to Trade, 2024[1]), leading to differences in objectives of QI bodies between countries (Box 3.2).
As separate legislative acts may exist to cover metrology, standardisation, market surveillance and accreditation activities, and vary in their setup between countries, the interactions between QI and regulation are variable around the world (UNIDO, 2025[7]). If some QI bodies (e.g., standardisation and metrology) are under the same ministry, there may also in cases be a single law covering these different QI components and operation of these institutes. However, as shown by our survey, there are also examples of QI bodies having the same sponsor government department, while having different contractual agreements with government.
One of the commonalities of the QI system around the world is that they can provide evidenced based advice to policymakers, and conduct their processes on standards, measurement and assurance in an impartial, and where required, independent manner. Ensuring the impartiality and integrity of the QI system is critical to preventing capture of processes on standards and assurance by specific interests, and ensuring standards and assurance provide the best support for all interested stakeholders across business, policy and citizens. Governments should consider how within their national policy on QI, they can establish processes and support to ensure national QI systems remain impartial, and build capacity in QI systems to increase inclusivity across diverse stakeholders. This in particular can help ensure the QI system supports development of tools and services through a diversity of voices, including those with lower resources or capacities to engage.
Box 3.2. Examples of objectives of different national and regional QI bodies
Copy link to Box 3.2. Examples of objectives of different national and regional QI bodiesNational co-ordination of standards and quality assurance bodies
The Australian Technical Infrastructure Alliance (ATIA) is a lean co-ordination body of the Australian standards and quality assurance system, providing a single point of access to the combined capability, expertise and resources of the four core QI bodies. Its objectives include facilitating local and international trade, community health and safety, economic productivity and growth, industrial effectiveness and consumer protection.
Egypt has established a National Quality Infrastructure Project which is the institutional framework that establishes and implements all the pillars of QI for improved trade, public, environmental and food safety, etc.
The Indian Bureau of Standards (BIS) has objectives which focus on consumer and industry interest and perform a number of activities under this mandate. Activities include standards formulation, product certification, laboratory recognition, promotional activities etc. The Quality Council of India, which is responsible for accreditation through its five independent boards states its objectives as leading nationwide quality movement for greater adherence to quality standards for promoting and protecting national and citizen interests.
In Kenya, the Kenya Bureau of Standards, which started as an institution for developing standards and quality control, now has an expanded remit and is tasked with several QI functions: Metrology, Conformity Assessment such as certification and training. Its stated objective is to provide standards-based solutions for trade and sustainable development. It also provides market surveillance related activities wherein it supports the regulator with ensuring product safety.
The Singapore Accreditation Council has a mission of providing a robust accreditation system to support industry and national needs. Its Standards Body- Singapore Standards Council has a main focus of developing quality standards to facilitate international trade, enhance competitiveness, and support health, environment and safety initiatives.
The Swedish Standards Body (Sveriges Standardiseringsförbund) is tasked with promoting interest in standardisation and the employment of standards to benefit industry and commerce, public administration and society at large.
Regional co-ordination of QI
The ASEAN consultative Committee on Standards and Quality (ACCSQ) aims to remove technical barriers to trade within ASEAN by harmonising national standards with international ones and implementing mutual recognition arrangements (MRAs). The ACCSQ works through various working groups and sectoral committees to develop regulatory regimes, standards harmonisation, and conformity assessment processes, ultimately supporting the ASEAN Free Trade Area (AFTA) and promoting regional and global trade.
Pan-Africa Quality Infrastructure Networks (PAQI) objectives are to enhance African policies on standards and accreditation, support trade, represent Africa globally in these areas, and secure funding for capacity development in collaboration with international partners.
Quality Infrastructure Council of the Americas (QICA) comprises three independent regional organisations involved in QI: Pan American Standards Commission (COPANT), Inter-American Metrology System (SIM), and the Inter-American Accreditation Cooperation (IAAC). It has the objective of developing joint projects, information sharing, and capacity-building.
Source: Author’s own elaboration based on interviews and the organisations’ websites.
Co-ordination in the regulatory and standards and quality assurance system
Copy link to Co-ordination in the regulatory and standards and quality assurance systemTo tackle specific policy challenges, government often prepare high-level policy strategies defining specific goals that signal policy vision to the market. Such sectoral policy strategies enable strategic planning, investment and alignment with wider policies already in place. These strategies tend to focus on the need for reforming legislation, public investment or earmarking public funding for a targeted sector. Broad policy goals allow government and regulators to anticipate the need of their services and to reflect on the need to update their mandate, budget, and organisational structure.
Standards and quality assurance services are essential in delivering the vision set out in such high-level policy strategies. When drafting high-level sectoral strategies such as on health, transport or development policies, governments should anticipate the need of QI services like standards development, assurance such as certification, or measurement and surveillance. This would allow QI bodies to prepare, allocate resources, and for governments to develop capacities where needed. For instance, developing an overarching “Quality Policy” can help align national QI services to national policy priorities and anticipate the governance required for policy implementation, and by extension, help government to strategically utilise QI bodies to best serve policy priorities. Such a “Quality Policy” can also raise awareness of QI services and what they offer, reducing duplicative efforts, such as reinvention of governance levers by private or public actors to provide QI-like services, streamlining policy design and simplifying what is required of businesses to show compliance. Some options that policymakers have at hand to strengthen the relationship between government policy goals and QI bodies (UNIDO, 2017[8]) (ISO, 2023[9]) (WTO Committee for Technical Barriers to Trade, 2024[1]) (OECD, 2021[10]) include:
Funding for QI system across institutions and services;
Cross-pollination between policy objectives, standardisation needs, metrology research and business needs;
Fostering increased participation of policymakers and regulators into standards development processes, and where appropriate, in development of other QI tools and services;
Fostering improvement or expansion of accredited conformity assessment in specific sectors to streamline compliance processes;
Regular improvements to whole QI system aligned to changing policy governance needs.
Co-ordination within the QI system: Connecting standards, measurement, assurance and market surveillance effectively
Co-ordination within the QI system is also critical to ensure domestic co-ordination of QI bodies across the public and private sector, operating as a holistic system to deliver against policy objectives. This co-ordination can be fostered by governments in their oversight and capacity building activities of QI bodies, and also by QI bodies, like national standards, metrology or accreditation bodies, themselves.
Examples of the benefits of such co-ordination include:
Increased joint preparation across the QI system when developing QI services, aligned to emerging policy and market needs, will be critical for success of globally aligned goals such as on nature, health and development. Mobilising all parts of the QI system together to upskill and be ready for new standards, assessments and regulation can enable smooth transitions into new and reformed policy areas. For instance, as a standard is developed, Conformity Assessment Bodies and Accreditation bodies can mobilise during the development to gather market interest in the standard, upskill workforce, and ready their processes to deliver certification, inspection and testing against the new standard requirements.
Increased information availability in a digital age, where data sharing between QI systems, public and private sector bodies, could enable faster processes, and ultimately increased efficiency in the delivery of governance. Information sharing between QI services, regulators could create increased transparency of data where possible, and help build increased trust in verification of products and services, further protecting consumers.
Alongside, it is important for QI bodies to identify areas of strengths and areas of improvement to enable them to meet market and policy needs faster and more flexible. The QI system should look to understand how it can reform to become more agile, innovative, inclusive and fit for a digital future. In particular, the strengths of the QI system, such as management of risk and conflicts, and consensus building, can be time consuming processes, and there are barriers to participation particularly from Low to Middle Income Countries. In particular, QI systems in their national contexts should also look to better understand the existing governance landscapes of sectors of economic importance, and utilise their consensus building to achieve buy in across public and private actors, to enable better collaboration and co-ordination across businesses, QI bodies and governments. This would enable reduction in duplicative standards and norms, bringing together processes to simplify compliance mechanisms, and creating guidance or assurance that is applicable across the economy more effectively.
Similarly, at the international level, International QI forums already have well established capacity building networks, and it will be critical to consider how these networks can be leveraged more effectively to increase participation of stakeholders from across the world to create inclusive and truly global governance tools. Currently, low to middle income countries can face barriers when participating in international QI processes to develop tools such as standards and assurance, due to their reduced capacity or resources. It is essential to increase their participation to ensure QI systems produce truly inclusive governance tools. QI bodies can utilise the Practical Checklist to better understand their interrelations with government, their international co-operation processes, and discuss where their skills and expertise can help scale governance of current policy challenges, and where reform of processes is required to be fit for the future. Co-ordination between policymakers and the QI system.
Whether situated within government, a public body outside of government ministries, or an entirely private body, the relationship with government is important to ensure that QI bodies and services underpin public good and deliver against national priorities. The relationship between QI bodies and regulators, their co-ordination and co-operation mechanisms and a shared vision of public policy outcomes can ensure effective and efficient functioning of both systems. On the contrary, and in the absence of an enabling relationship, serious impacts can occur, such as increased fragmentation and duplication as governments, businesses and QI bodies attempt to develop solutions separately.
Co-ordination between QI and regulatory bodies
Co-ordination between regulatory and QI bodies is also an important aspect of achieving policy outcomes whether public or private. For co-ordination to be successful, regulatory systems can benefit from a legal, organisational and cultural framework for co-ordination and co-operation (PTB and UNIDO, 2024[11]).
In Denmark, Sweden and Singapore, trust has been built through routine communication, co-operation and effective frameworks to support trust- building between the two systems, QI system and regulatory system. Stakeholder discussions from Denmark, Singapore and Australia revealed that co-ordination and co‑operation is better managed when the legal framework supports this. While in Denmark and Singapore co-operating with other ministries and public officials is seen as more cultural, Australia has created an organisational framework for closer co-operation between the different stakeholders. For example, in some countries co-ordination is mandated by law or through an institutional framework, as show in Box 3.3.
Box 3.3. Creating a co-ordination framework between regulators and QI bodies
Copy link to Box 3.3. Creating a co-ordination framework between regulators and QI bodiesAustralia: The Australian QI-system is characterised by close co-operation between private and public institutions. The Commonwealth Department of Industry, Science, Energy and Resources has a co-ordinating and supporting role. National Measurement Institute (NMI) is placed within the Department of Industry, Science, Energy and Resources. The other core institutions such as Standards Australia, the National Association of Testing Authorities (NATA), and the Joint Accreditation System of Australia and New Zealand (JAS-ANZ) are independent. Their integration into the National Quality System is regulated by individual Memorandum of Understanding (MoU) with the Australian Government. All institutions of the Australian standards and quality assurance system have to generate most of their financial resources themselves. The four key QI organisations formed a co-ordination body of Australian standards and quality assurance, known as ATIA in 2010, which includes representation from Australia Standards, NMI, NATA and JAS-ANZ. These bodies come together contribute their resources, knowledge and ideas and represent common interests within this forum, which acts as a focal point for external stakeholders. The collaboration promotes synergy within the standards and quality assurance system in Australia, and with its combined authority and experience, provides comprehensive advice to all sectors that depend on standards and compliance infrastructure.
Kenya: The strategic plan of the Kenya Bureau of Standards (KEBS) emphasises the importance of co-ordination with the government to align standardisation and regulatory efforts with national development goals. KEBS collaborates with various government agencies to ensure that standards support policy implementation, enhance industry competitiveness, and protect consumers. This co‑operation, also mandated by the Standards Act, Chapter 4, is crucial for the effective enforcement of standards, compliance with regulations, and fostering a conducive environment for trade and economic growth.
Source: https://www.kebs.org/strategic-plan/.
With an established framework and a mutual recognition of each other’s objectives, QI bodies can better support regulatory policy, including enabling regulators to make alternative choices to regulation by utilising QI. QI bodies can also provide timely and necessary technical advice to a regulator. For instance, a QI body can bring industry perspective gathered from their own services to the market and from their stakeholders to the decision-making process and enable regulators to better understand technical requirements (Box 3.4, Box 2.3).
Frameworks enabling co-ordination between QI and regulators to contribute in a systemic way to regulatory policy is also critical to building trust between QI bodies and regulators. Specifically, co-ordination and co-operation frameworks can help avoid silos, and enable a whole of government approach for effective policy results, avoiding situations where individual institutions are only working towards their individual mandate or objective, without aligning with key priorities of national interest, and with international policy targets.
Box 3.4. Inter-ministerial collaboration in Mexico
Copy link to Box 3.4. Inter-ministerial collaboration in MexicoMexico has multiple co-ordination mechanisms to support the development and implementation of technical regulations. These mechanisms involve multiple public and private entities, and while some co-ordination is mandated by law, they also occur on an ad-hoc basis. The Ministry of Economy, through the General Bureau of Standards (DGN), plays a central co-ordinating role. It is responsible for the National Standardisation Program, oversees the adoption of international standards, and ensures that other governmental entities comply with the Federal Law on Metrology and Standardisation (LFMN). The DGN recognises three private accreditation bodies: Entidad Mexicana de Acreditación (EMA), Mexicana de Acreditación (MAAC), Sociedad International de Acreditación (SIAAC)
Furthermore, the LFMN mandates sectoral regulators to co-ordinate with other agencies to ensure compliance with the Official Mexican Standards (NOMs). In 2020, the OECD found that that co-ordination has some challenges, with multiple regulators conducting oversight in a fragmented manner, and with multiple agencies having overlapping responsibilities. In response to these challenges, Mexico has developed digital tools like the System for Norms and Conformity Assessment (SINEC) to integrate, monitor, and evaluate technical regulation activities across the system.
In some sectors, special laws establish alternative regimes that require additional co-ordination. For example, in the energy sector, the Energy Regulatory Group (ERG) was created as a forum for collaboration among various energy regulators. This group facilitates joint work and information sharing, aiming to improve the regulatory process and enforcement across the energy sector. These sector-specific co-ordination mechanisms reflect Mexico's broader strategy to improve the efficiency and effectiveness of its technical regulation and standards and quality assurance system through more structured and consistent co-operation between different regulatory and QI bodies.
QI bodies are often decentralised and varied in their location within government, with variable remit and mandate, and split between functions delivered through private and public sector bodies. Without proactive collaboration between regulators, ministries and QI, whether situated within or outside government, QI bodies can become siloed in their approaches to both the market and interactions with regulations.
Ultimately, taking a proactive approach to co-ordination will be critical to link the QI and regulatory ecosystem coherently and effectively, particularly to address governance needs of global challenges such as technological innovation (AI) or natural disasters. Governments will need to take a whole-of-government approach and foster collaboration between public sector bodies and the QI system, proactively as well as tapping into the international co-ordination forums operating within the global QI ecosystem. The benefits of such co-ordination and collaboration include:
Reducing conflicting regulations through effective inter-ministerial co-ordination fostering a holistic approach to policy development, where regulations across different sectors are harmonised and coherent, and aligned to global best practice codified in national and international standards. This reduces the likelihood of conflicting regulations, or duplicative effort, that could create barriers to trade, hinder innovation, or impose unnecessary burdens on businesses. A co-ordinated effort among ministries also ensures that regulatory policies are aligned with broader national objectives, such as economic growth, public health, and environmental protection. By working together, ministries can develop policy and regulations that are not only technically robust but also coherent aligned with the rest of government, such as aligned to socially and economically beneficial priorities, contributing to a more efficient and resilient national regulatory framework.
Utilising the expertise and resources of QI bodies during policy design to fully leverage the QI system’s expertise in developing consensus-based guidance and delivering independent assessments. For instance, when developing technical regulations, ministries responsible for areas such as health, agriculture, or industry can benefit from the technical expertise of QI agencies in developing and implementing robust verification processes to protect consumers. This collaboration enables the integration of precise metrological data, standardised testing procedures, and reliable accredited conformity assessment mechanisms into policy and regulations, ensuring that they are scientifically sound, verifiable and internationally recognised. Such an approach not only enhances the credibility and acceptance of the regulations but also facilitates smoother implementation and compliance across sectors and enhances consumer protection.
During strategic planning for emerging policy areas, or reviews of policies, governments should consider the capacity needed in QI services, to deliver against policy implementation goals, monitoring and verification. Aligning early on policy needs and QI needs will reduce duplicative efforts, enable trade, increase consumer protection and smooth operating of policies in the market, leading to economic growth.
Ensuring aligned approaches to reduce burden on businesses, as such co-ordination between policymakers and QI bodies is also critical to ensure that policy frameworks are connecting to business needs, as both parties engage with businesses. Connecting up such expertise and knowledge can help build more practical policy implementation pathways, and reduce duplications.
There is a need for governments to consider how they are effectively using their QI systems, and also the capabilities of the QI system, and consider ways in which to support reform and innovation to enable QI bodies to operate in an agile manner to meet global challenges across the market. The Practical checklist can support governments to better understand their QI systems, and consider the gaps and challenges within the system and how they can be resolved.
References
[6] ISO (2024), ISO CASCO Toolbox, https://casco.iso.org/toolbox.html.
[9] ISO (2023), Standards and public policy: A toolkit for national standards bodies.
[2] Kellermann, M. (2019), The Quality Infrastructure, https://doi.org/10.1596/978-1-4648-1372-6.
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