In the first post of this blog, we explained the term Quality Infrastructure. We referred to the definition by INetQI, which is agreed upon by the international associations for accreditation, metrology, standardisation and supporting international organisations. INetQI defined Quality Infrastructure as follows:
“… the system comprising the organisations (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 essential 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 (in regulated areas) “.
This definition implicitly refers to a dual function of the Quality Infrastructure. On the one hand, the Quality Infrastructure promotes competition, the functioning of markets and improves trade. On, and on the other hand, the Quality Infrastructure is a government tool to protect consumers, public health and the environment. Within the Quality Infrastructure, there is an inherent tension between public and private interests.
The ISO Committee on conformity assessment (CASCO) illustrates this duality (Figure 1). In their understanding, the Quality Infrastructure rests on three pillars: standardisation, metrology and conformity assessment. Accreditation is seen here as part of conformity assessment. The Quality Infrastructure responds to both societal and business demands. The figure shows the tension between the two concerns.
Figure 1: The role of the Quality Infrastructure
Source: ISO/ UNIDO 2004
The societal concerns are related to health, safety, environmental and consumer protection. These concerns justify legal measures and state regulations which, as legitimate objectives, are consistent with the rules of the World Trade Organization (WTO). The business concerns address the interests of companies and a functioning market. Here, the Quality Infrastructure contributes to a continuous upgrading process and ensuring the profitability of companies.
In the figure, the social concerns are at the top and the business concerns at the bottom. The figure implies a priority or sequence of the two concerns. In another publication, ISO and UNIDO emphasise:
“As a first priority, governments in all countries need to put in place and maintain the basic infrastructure to assure the security, health and wellbeing of their citizens – adequate and safe supplies of food and drinking water, access to healthcare and education, societal security, transportation and communications systems, etc. Once these are in place, even at a rudimentary level, the need to establish an efficient trading system becomes paramount. Economies cannot survive in the absence of trade, and it is therefore essential that the building blocks be put in place to facilitate access of goods and services to markets, both internal and external. Market access and the creation of an efficient trading system are the goals; metrology, standardisation and conformity assessment are some of the main building blocks. ” (ISO and UNIDO, 2008, 20)
Figure 2 also originates from ISO CASCO and shows the dual functionality of the system (ISO, 2010). The conformity assessment is in the centre of the system. It shows as a market which brings together supply and customer. There are two entry points to the system: the voluntary sector, which articulates customer requirements; and the regulated sector, in which Government acts as legislator and regulator of technical regulations. Both sectors participate in standardisation and influence conformity assessment. Metrology and accreditation are further supporting functions.
Figure 2: Example of a conformity assessment model
Source: ISO CASCO
The simultaneous influence of business and Government implies a risk for standardisation. In principle, standards should “…always be written in such a way that they facilitate and do not retard the development of technology. Usually, this is accomplished by specifying performance requirements rather than product design requirements” (ISO, 2010, 16). However, if the Government considers standards a direct instrument of regulation, this principle is violated. In this respect, technical regulation must be independent of standardisation. At the same time, it is good practice for technical regulations to refer to standards.
However, the view of conformity assessment as the centre of the quality infrastructure is controversial. In a conversation with Dr.-Ing. Clemens Sanetra, a leading Quality Infrastructure consultant for International Cooperation of the German Metrology Institute (PTB), he emphasised that the “services of the Quality Infrastructure go far beyond conformity assessment”. Sanetra refers to “the long way from the idea to a competitive and permanently updated product requires many Quality Infrastructure services”. Even before conformity testing, companies use test and measurement technology that gives feedback on development steps or trends. Quality Infrastructure services are essential also in R&D, plant monitoring, prototype development, damage and product life cycle analysis. The development and validation of new measurement methods and testing procedures, comparative measurements, development of reference material, training, consulting, coaching, development of measurement or testing technology applications, monitoring and alert and emergency and metrological monitoring systems are other examples. In short, we note that conformity assessment is only at the end of the process, whereas the other Quality Infrastructure services are needed earlier.
In Figure 3, Sanetra offers a different diagram of the two sides of the Quality Infrastructure. The image is resembling the shape of a butterfly. The head is the quality policy, the torso consists of the institutions of the National Technical Quality Infrastructure (National Standards, Metrology Institutes, Testing and Calibration Laboratories, Certification and Inspection Bodies and Accreditation Body) and they refer to the state-regulated or market-driven area.
Figure 3: Quality Infrastructure support to Quality Improvement & Protection
Quelle: Sanetra (2018) Published with the consent of the author.
The Quality Infrastructure itself covers only standardisation, metrology, conformity assessment (including accreditation). Conformity assessment refers here to the services which should be accredited. On both wings, the Quality Infrastructure has different strategic partners and customers, who can be users, promotors and facilitators of the system:
- The left, red wing refers to the regulated area and follows a top-down logic of enforcement. These include the ministries as competent authorities for border control (customs), type approval, labelling, market surveillance and consumer protection.
- The right, blue wing represents the application of the Quality Infrastructure in the market-driven area and follows a bottom-up logic of incentives. Strategic partners of the quality infrastructure are companies, business association, business support organisations and universities, who collaborate in the definition of the requirements for products and services. Here, the Quality Infrastructure services refer to product and process innovations and contribute to the creation of value.
It is striking that conformity assessment is mentioned both in the torso of the National Technical Quality Infrastructure and on both wings. Conformity assessment is overlapping. On the left-wing, conformity assessment again, a regulation serves, mandatory compliance whereas, on the right-wing, conformity assessment against buyer’s requirements serves to meet the expectations of the contractual partner and consumers.
For the overall system to function, all parties involved must accept it. The criteria for acceptance are technical competence, independence and impartiality. These criteria are written in ISO/IEC 17000:2004 and guide the work of the accreditation bodies. In this context, accreditation is a service that intends to guarantee the credibility of the overall system.
However, in developing and emerging countries, the problem is that the two wings of the system are usually developed very differently. The wing of regulation is strong, the market wing weak. The work of the National Standards Institute focuses on inputs for technical regulations; metrology is mainly active in verification and type approval; conformity assessment is used primarily by regulatory authorities. Companies then often perceive the Quality Infrastructure as part of government control, ignoring its potential benefits for continuous improvement and ignoring innovation. This perception, in turn, means that Quality Infrastructure in developing and emerging countries often lacks real contribution to increasing competitiveness and development.
The challenge for the promotion of Quality Infrastructure is to make it equally useful for strategic partners in the regulated and market sectors. A problem arises when the Quality Infrastructure is taken over or at least dominated by regulation. Then the private sector loses interest in using the system or limits itself to a lobbying function. For this reason, it makes sense to continue debating about the appropriate definition of the Quality Infrastructure so that the private sector can identify with it. It would be good if technical regulations and market surveillance become users only, but not constitutive elements of a competent, independent and impartial Quality Infrastructure.