As in many industrial sectors, the elaboration of standards and quality infrastructure is crucial for maintaining the highest quality of medical products and services. Failure to observe rules on metrology, calibration and standards for medical products can not only result in goods not making it to the market, but can also have negative implications for human health and safety.
The COVID-19 pandemic has highlighted the importance of quality infrastructures and standards in ensuring the availability of key medical devices, diagnostic tests and personal protective equipment. For example, it is very clear that laboratory services, by ensuring the quality and accuracy of laboratory-developed tests, will increasingly provide an essential contribution to the diagnostic reasoning, managed care and therapeutic monitoring, needed to combat the highly infectious COVID-19.
“The development of relevant and reliable standards, measurements and certifications touches many aspects of international trade and investment across a wide range of sectors,” says Bernardo Calzadilla-Sarmiento, Director of UNIDO’s Department of Trade, Industry and Innovation. “The coronavirus pandemic has shown us that in a globalized world, the agreement of technical standards can save lives, improve human health and keep essential value chains moving in times of strain. From the food we eat, to the goods we use, to ensuring occupational safety in the workplace, ensuring quality infrastructure is critical to keeping us safe and facilitating trade and investment.”
The COVID-19 crisis has brought the value of reliable and agreed standards into sharp focus. In Europe, there have been a number of reports of national medical authorities being unable to use newly delivered paraphernalia designed to battle the coronavirus, such as medical jumpsuits, masks and testing kits, owing to defects or simply because the products were not designed to comply with the certifications employed in that region. Such issues can easily further strain stressed medical budgets, waste valuable time and further endanger medical professionals and patients.
UNIDO’s Department of Trade, Industry and Innovation works extensively with partners in national standards’ bodies, accreditation institutes and metrology authorities, and multilateral partners such as the International Organization for Standardization, as well as with private sector companies, in order to develop relevant standards and to diffuse the latest knowledge on quality infrastructure across a range of industrial sectors. These efforts have several real-world applications, such as ensuring that medical tests to detect the virus are reliable; that quality control and testing for medical products is fit-for-purpose; and that laboratories support the development of new medicines and vaccines through verifiable scientific methods.
The development of reliable measurements and quality instruments can also help to mitigate some of the external outcomes of the COVID-19 pandemic. For instance, the unexpected surge in medical procedures globally is expected to lead to an increase in the disposal of medical waste, which may increase hazardous emissions from health facilities. Certified testing laboratories can help track these emissions and detect pollution levels accordingly.
Quality infrastructure is 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. It relies on metrology, standardization, accreditation, conformity assessment and market surveillance.
UNIDO’s approach to quality infrastructure development is systemic and holistic, from building awareness to helping initiate, develop and strengthen a fit-for-purpose quality infrastructure that runs efficiently and is cost-effective. UNIDO promotes good practice, capacity-building and training, and fosters global cooperation in the development of standards-setting, measurement and compliance along value chains.
Read the new publication: "Quality and Standards and their Role in Responding to COVID-19".