The description of the key terms is used for the purpose of the report only and are without prejudice to the meaning of these terms in individual international organisations, as well as in their respective members.
Accreditation: Accreditation is defined as an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity.
Conformity assessment: Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled (ISO and UNIDO, 2009[1]). It helps to ensure that products and services deliver on their promises. Conformity assessment procedures include, inter alia, procedures for sampling, testing and inspection; evaluation, verification and assurance of conformity; registration, accreditation and approval as well as their combinations. Conformity assessment activities can 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, and third party performed by a body independent to the provider with no user interest.
International regulatory co-operation encompasses any agreement or organisational arrangement, formal or informal, between countries to promote some form of co-operation in the design, monitoring, enforcement, or ex-port management of regulation.
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.
Metrology: Metrology is the science of measurement and its application. Metrology can be divided into three subfields:
Applied or industrial metrology: Industrial metrology refers to the measurements made in the industrial sector. 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.
Legal metrology: Legal metrology is the application of legal requirements to measurements and measuring instruments. 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.
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.
Quality assurance: in this report quality assurance is understood as the process to ensure products and services meet the expected compliance and outcomes. It encompasses metrology, accreditation, conformity assessment, and market surveillance. The report uses the concept “standards and quality assurance’ interchangeably with “quality infrastructure” (see below).
Quality Infrastructure is the set of institutions and processes that develop standards, ensure consistent measurements (metrology), independently and competently assess conformity with the standards (accreditation and conformity assessment), and keep an eye on the market (market surveillance). It is referred to as standards and quality assurance systems and institutions throughout this report.
Regulation is the instrument by which governments set requirements on enterprises and citizens. Regulation is expected to be mandatory and includes all laws, formal and informal orders, subordinate rules, administrative formalities, and rules issued by non-governmental or self-regulatory bodies to whom governments have delegated regulatory power (OECD/WTO, 2019[2]).
Regulatory policy comprises the set of rules, procedures and tools introduced by government to improve the design, delivery and ex post assessment of regulations.
Regulatory impact assessments (RIAs): a systemic approach to critically assessing the positive and negative effects of proposed and existing regulations and non-regulatory alternatives.
Technical regulations are documents which outline “product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is 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.
Technical standards: 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. 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. This report also refers to measurement standards, that are physical artefacts or instruments agreed for use in metrology as references.