There are three parallel ‘creation worlds’ that contribute to the formation of uniform standards in the broadest sense. The first world is the most trusted: primary and secondary legislative standards, directives, etc. This world, however, is not the usual way, especially when it comes to the standardisation of material goods.
Instead, the legislature has shifted its steering function back to society and business, thus creating a secondary level of regulation. Private standardisation institutes that are officially recognised by the state, such as the German Institute for Standardisation (DIN), develop technical standards in a complex process on request, including requests from the business world. Use of these standards by companies is (at first) voluntary. However, they remain the intellectual property of the standardisation institutes. There are fees for accessing this work and for purchasing standards.
At this point, it is important to explain the different paths that are taken when standardising goods as opposed to standardising services. As will be seen, these have consequences for the positions and demands of the German social insurance system. Whether a tangible ‘good’ meets a certain standard is determined by accredited bodies using the ‘conformity assessment procedure’; this is the case for most medical devices. In Germany, these are generally the TÜV inspection bodies. The focus here is on the result of the production process and less on the process itself. The situation is different for services. They cannot be observed in the same way as ‘tangible’ goods. In many cases, production and consumption occur at the same time, which is the case for healthcare services. The focus of quality control is then on inspecting the facility, its equipment, the qualifications of the people providing the service and internal processes. If these comply with the descriptions in a standard then the facility meets ‘certification’ requirements. However, these types of certificates cannot hide the fact that the ‘interchangeability’ of services is for consumers far more questionable than the interchangeability of goods.
The third path is only mentioned here to complete the picture. On a case-by-case basis, the business community and other interested parties can agree on specifications in the form of codes of conduct or good practices, without going through the formal standardisation institutes such as DIN or CEN. These are often referred to as ‘quality standards’, although the word ‘standard’ here is not used in its strict sense.
The globalisation of the flow of goods and services means that formal standardisation has shifted to a global level. In Europe, it is standardisation which prepares the foundation for the Single Market. The dualism of legal regulation and formal technical standardisation is also found here. It is generally well-known that the harmonised European legal framework does not leave any room for national rules to deviate. Less well-known is that European Standards from the European Committee for Standardisation (CEN), supersede conflicting national standards as far as these have been adopted by formal national standardisation institutes such as DIN. But compliance with these standards is voluntary. In addition, European Standards cannot displace national laws; these have precedence. However, it is already clear at this point that Europe not only legally ‘regulates’ its Single Market but also steers self-organisation of the market towards European level. The two creation worlds – legislative and technical – completely overlap or complement each other when the European Commission publishes a European Standard. This is also referred to as a mandate to create ‘harmonised European Standards’. These then displace national technical standards in the same area.
At first, the use of European Standards is voluntary; however, they can be made compulsory by means of contractual provisions or implementation into law. Within the framework of the European Single Market, pressure is being applied to use standardised goods in public procurement procedures. In addition, national regulatory bodies are also encouraged to inspect goods at a level which complies with formal European Standards.
Quality definition and assurance in Germany: responsibility lies with the system of self-governance
In Germany, the quality of medical care and rehabilitation is controlled and assured by secondary legislative regulations and guidelines on a contractual basis in close cooperation between service providers and social insurance institutions. This is achieved through a wide range of instruments that are coordinated with one another. The system of self-governance plays a special role in this. For example, in the Federal Joint Committee, representatives from health insurance funds, physicians and hospitals issue directives on medical care and quality assurance. In addition, evidence-based guidelines are developed by self-governing committees from the medical profession, professional associations and expert associations in the field of medical science. The same applies to the setting of quality standards for outpatient, inpatient and rehabilitative care of patients injured in the workplace. The medical and occupational rehabilitation services provided by the German statutory pension insurance scheme are also subject to a sophisticated quality assurance system both internally and externally.
As such, the German social insurance system has developed numerous instruments to ensure the highest possible level of quality care without needing to involve standardisation institutes.