A well-functioning standards and quality assurance system, often referred to as quality infrastructure or QI, and an effective regulatory policy cycle are essential for promoting economic development, safeguarding public welfare, and ensuring fair and efficient markets. The QI system provides the foundation for standardisation, metrology, accreditation, conformity assessment, and market surveillance — all of which help ensure that products, services, and processes meet established quality and safety standards. On the other hand, the regulatory policy cycle offers a structured approach to designing, implementing, and evaluating regulations, using tools such as regulatory impact assessments, stakeholder consultations, and ex post evaluations. This chapter introduces the key components of the standards and quality assurance (QI) system and the regulatory policy cycle. Together, these systems enhance transparency, accountability, and the effectiveness of regulatory frameworks, fostering trust and innovation in both public and private sectors.
Reinforcing Regulatory Frameworks through Standards, Measurements and Assurance
Abstract
The Quality Infrastructure (QI) system (in this report referred to as standards and quality assurance system) is a set of institutions, policies and frameworks that ensure that products and services meet a stated level of quality. The structure of the “QI system” varies across countries and comprises a host of public and sometimes private bodies that, together, deliver trust for consumers, and ensure compliance in the market, and form the backbone of a country's industrial, trade and consumer system. Throughout this report the terms “standards and quality assurance” or “QI” will be used to describe this quality infrastructure system.
The core pillars of the QI system include standardisation, metrology, accreditation, conformity assessment, and market surveillance. The institutions that deliver these services come in all shapes and sizes around the world, varying by their location with respect to government, independence, and remit. The International Network on Quality Infrastructure (INetQI), a network of international organisations, adopted the following definition of QI:
The system comprising the organizations (public and private) together with the policies, relevant legal and regulatory framework, and practices needed to support and enhance the quality, safety and environmental soundness of goods, services and processes.
The quality infrastructure is required for the effective operation of domestic markets, and its international recognition is important to enable access to foreign markets. It is a critical element in promoting and sustaining economic development, as well as environmental and social wellbeing.
It relies on: metrology, standardisation, accreditation, conformity assessment, and, market surveillance. (INETQI, 2024[1]).
This QI system of public and private sector collaboration underpins consumer safety, trust, trade and policy compliance around the world. Examples of this in action include harmonising requirements to make life for consumers easier, such as uniform-sized credit cards across the world to enable global use of bank cards, or recognition across national borders of food quality to enable food exports and imports. Figure 1 illustrates the interactions among these various components.
Note: This figure shows simplified interactions between the core pillars of QI to highlight the critical ways in which QI supports policy, businesses and consumers. For further detail on complexity of interactions among these QI pillars, please see https://www.worldbank.org/en/topic/competitiveness/brief/qi.
Source: Authors’ own elaboration.
The key pillars of standards and quality assurance (QI) are defined as:
Standardisation: In the context of QI, these refer to documents approved by a recognised body, that provides for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory, unless regulations require compliance with specific standards. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. Standards can have varied definitions, which can be found in the checklist in Chapter 5. Countries often have a national standards body, which represents national interests in international fora such as the International Organisation for Standardization (ISO) among others (For a list of standards organisations see INETQI (INETQI, 2024[1]))
Metrology: Metrology is the science of measurement and its application. Countries may have a National Metrology Institute (NMI), which represents national interests in international co-operation fora on metrology such as The Bureau International des Poids et des Mesures (BIPM) and International Organisation of Legal Metrology (OIML). There may also be other government recognised or designated institutes related to measurement complimenting the National Metrology Institute. Metrology can be divided into three subfields:
Scientific or fundamental metrology: Scientific or fundamental metrology concerns the establishment of measurement units, unit systems, the development of new measurement methods, realisation of measurement standards and the transfer of traceability from these standards to users in society.
Legal metrology: Legal metrology is the application of legal requirements to measurements and measuring instruments (Organisation International de Metrologie Legale (OIML), 2020[2]). Legal metrology activities include, for example, the legal control of measuring instruments, metrological supervision, type examination and approval, conformity with approved type, inspection, and verification.
Applied or industrial metrology: Industrial metrology refers to the measurements made in the industrial sector (World Bank and PTB, 2019[3]). For example, industrial metrology concerns the application of measurement science to manufacturing and other processes and their use in society, ensuring the suitability of measurement instruments, their calibration and quality control of measurements. This also includes concepts such as the metrological traceability of the measurement results as well as specific regulatory aspects.
Accreditation: Accreditation is a third-party attestation that a conformity assessment body is competent to carry out a specific conformity assessment activity (adapted from ISO/IEC 17000). Countries often have a national accreditation body, which represents that country at regional and international accreditation forums such as the International Accreditation Forum (for list of accreditation bodies see IAF (International Accreditation Forum, 2025[4]) and INETQI (INETQI, 2025[5]).
Conformity assessment: Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled (ISO and UNIDO, 2009[6]). It helps to ensure that products and services deliver on their promises. Conformity assessment techniques include, inter alia, testing, inspection, validation, verification, evaluation, certification, examination, and audit, accreditation, as well as their combination. Conformity assessment activities can also be categorised into first, second and third party, with first party being performed by the provider of the product or service, second party by entities with user interests in those products and services, and third party performed by a body independent to the provider with no user interest A range of primarily private and some public organisations provide conformity assessment services, and there are associations of such organisations such as those convened by the Independent International Organisation for Assurance (IIOA).
Market surveillance: comprises the measures that authorities take to ensure that products comply with the legislation’s operational requirements and comply with high levels of protection and fair competition. Market surveillance can be delivered through a range of national regulators, government and non-government departments.
Standards can be understood in different ways in the market and in literature. Key definition sources used in literature are from the WTO, ISO, IEC, among others, but the meaning of standards may vary according to different stakeholders.
Some of the common definitions used for such standards are:
ISO/IEC Guide 2: Document established by consensus and approved by a recognised body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.
World Trade Organisation Technical Barriers to Trade Agreement: Document approved by a recognised body, that provides, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.
To help understand how standards may arise, they can be thought of under two broad categories of standards – Public and Private, dependent on the stakeholders that are involved in their development and their recognition from government.
Public standards: Standards developed by government-recognised actors or in government-recognised forums
These standards are developed via government recognised standardisation bodies at national level, or co-ordination of such bodies via regional or international level standardisation fora. For example, at national level, standards can be developed by government recognised national standard bodies or directly by government bodies themselves. However, different National QI models may allow for different forms of government recognition, including providing government recognition for private bodies.
Private or industry-led standards: Standards developed outside of systems of formal recognition from governments
Alongside the above, there are also standards that are developed by non-government bodies, such as industry co-ordination bodies, civil society actors, and multi-stakeholder initiatives. There are a number of ways in which such standards can be defined, for purposes of this report, two definitions will be used, defined below:
Private standards: Standards developed by non-governmental bodies of economic and/or social actors that are neither recognised as national standards bodies (NSBs) nor composed of representatives from NSBs or their nominees. This includes for example, standards set by industry and civil society actors or multistakeholder initiatives.
Voluntary Sustainability Standards (VSS): Private standards that require products to meet specific economic, social and environmental sustainability metrics. The requirements can refer to product quality or attributes, but also to production and processing methods, as well as transportation. VSS are mostly designed and marketed by non-governmental organisations (NGOs) or private firms and they are adopted by actors up- and down-stream of the value chain, from farmers to retailers. Certifications and labels are used to signal the successful implementation of VSS.
International Standards
Many international organisations develop international standards, however, there is no universally recognised definition of international standards across organisations. International standards setters may follow different models for the development of voluntary consensus standards, such as:
A multilateral model where national delegate-based representations develop standards at international level (e.g. International Standards produced by International Organisation for Standardization – ISO).
A direct membership model that allows any interested stakeholder — regardless of geography or affiliation — to participate (e.g. ASTM International).
Source: WTO TBT Agreement – Annex 1, https://www.wto.org/english/res_e/publications_e/ai17_e/tbt_ann1_jur.pdf; Lang and Messenger 2024 the-standards-regulation-nexus_mapping-the-ecosystem-of-standardisation_fv.pdf (bsigroup.com);UNCTAD VSS Voluntary Sustainability Standards | UNCTAD.; OECD 2021 *The Case of ASTM International.
Regulations are typically developed to address a public policy issue, identified at the parliamentary level or one of the various levels of the executive such as regional governments, municipalities, or national government (OECD, 2021[7]). For instance, rules and regulations could be designed to manage evolving political and social situations, to roll out new technologies, for supporting innovation or to facilitate economic growth. Additionally, regulations may be developed to fulfil international commitments where governments have agreed together on shared priorities, such as those related to free trade, environmental protection, and food safety.
Regulations have the objective of managing public concerns, reflecting public values and should be created through public deliberation. Typically, regulations are crafted to achieve key objectives such as ensuring public health and safety, environmental protection, competitiveness, and economic growth, among others. Well-designed regulations provide public authorities with the tools necessary to pursue these goals, and regulatory policy seeks to ensure regulation achieves these goals. Overall, when properly created and implemented, regulations provide the fundamental basis to ensure safety while promoting economic activity.
The OECD Recommendation for Regulatory Policy and Governance and related best practice principles on regulatory policy list several tools for the effective creation of regulations and for the governance of regulators to ensure high functioning regulatory outcomes (OECD, 2014[8]). These tools are part of the regulatory policy cycle, a process encompassing the development, implementation, and evaluation of regulations (see Figure 2). This ensures that regulations are evidence-based, adaptable and responsive to evolving conditions.
Source: Authors’ own elaboration.
To ensure regulations are efficient and effective, governments adopt regulatory policy tools such as regulatory impact assessments, which include a risk and an ex ante cost-benefit analysis. These tools are employed throughout the regulatory policy cycle: regulatory design, regulatory delivery (implementation, monitoring, enforcement), and ex post assessment of regulations. The OECD has adopted several recommendations and best practice principles to provide guidance for governments to implement regulatory quality tools.
The first stage is the identification of a public policy issue: This initial stage involves the recognition of specific problems or opportunities that require regulations. These issues can be identified based on societal needs by various stakeholders such as government officials, regulators, or public interest groups.
Policy design: Before implementing new regulations to address a public policy issue, policymakers should conduct an ex ante RIA to assess the potential impacts of the proposed regulations. The OECD Best Practice Principles on RIA provides policymakers, civil servants and other public sector practitioners with a practical instrument for better designing and implementing RIA systems and strategies (OECD, 2020[9]). They emphasise that every process of regulatory impact assessments should include a problem definition, an objective, a description of the regulatory proposal, identification of alternatives, an analysis of benefits and costs, an identification of the preferred solution and should set out the monitoring and evaluation framework. The policy goals should be clearly identified to determine whether the regulation is necessary and how it can be most effective and efficient in achieving these goals.
Implementation and enforcement: This stage involves the rollout of the proposed regulation, and ensuring it is properly enforced. Governments often employ licensing and permitting systems to facilitate the implementation and enforcement of regulations, ensuring that only qualified entities can operate within regulated sectors. The upcoming OECD Best Practice Principles on Licensing and Permitting (OECD, 2024[10]), discuss how licensing and permitting differ from other regulatory interventions by providing governments with a structured regime that focuses on risk prevention at the outset, rather than regulating ongoing operations or addressing issues after they arise. The OECD Regulatory Enforcement and Inspections Toolkit provides a checklist of twelve criteria that governments should incorporate into their inspection and enforcement activities (OECD, 2018[11]). It highlights that a good inspection and enforcement system should aim at delivering the best possible outcomes in terms of risk prevention/mitigation and promoting economic prosperity, without exceedingly increasing costs for the state and burden for regulated subjects. Co-ordination between different levels and departments of government, which may be responsible for different aspects of enforcement, is essential to guarantee trust and satisfaction from various stakeholders whose perspectives are often conflicting.
Monitoring and performance evaluation: Once a regulation has been implemented, continuous monitoring is essential to ensure the compliance and effectiveness of the regulation. Market surveillance plays a vital role in tracking the behaviour of market participants and identifying any potential violations or inefficiencies. Performance evaluations are then conducted to determine whether the desired outcomes of the regulation are being achieved and how the regulations are functioning in practice.
Ex post evaluations of regulations ensure that they stay relevant and effective over time. Without such assessments, regulations may become outdated, leading to increased complexity and costs. These evaluations help assess the actual impacts, identify areas for improvement, and reduce administrative burdens. However, systematic approaches are not yet widely adopted across OECD countries, highlighting the need for improved oversight, standard methodologies, and broader adoption to ensure regulatory effectiveness and efficiency (OECD, 2017[12]).
Periodic evaluation can make regulatory intervention proportionate to changes in technology and innovation. It can allow for other non-regulatory options if the costs and benefits justify it. For instance, ex post evaluations could be of benefit in strictly regulated sectors such as health technology. As safety data improves, regulatory control can be eased in favour of proportionate policy tools such as employing standards to continue protecting consumers.
The regulatory policy cycle creates a feedback loop, where insights from monitoring, evaluation, and ex post review can inform future policy identification and design, thereby continually improving the framework. This approach enables regulators to adapt and refine policies effectively over time, enhancing the governance process.
References
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