International standards are adjusting the characteristics of a product, process or a production cycle as to make them consistent and in line with the rules regarding what is proper and acceptable. Standard is a document that specifies such established set of criteria. International Standards covering almost all aspects of human activity, including healthcare.
For healthcare organizations, standards are a harmonizing
force that helps increase the effectiveness of medical care across countries. And for manufacturers, standards make it easier to develop safe and reliable products.
The healthcare and medical sector is vital to the world economy. Covering a diverse range of industries and activities, the sector includes medical and healthcare services, healthcare products, laboratory services and medical devices.
Standards cover a broad range of topics and are applicable to commissioners of health, specialists in primary care, public health staff, and social care providers as well as the local authorities and service users. Health products, ranging from medical devices and health informatics to traditional medicines and unconventional healing tools are all in the focus of standards application. Standards are designed to establish patterns of quality and performance including the measures to protect and improve the safety of patients, to promote a culture of continual improvement, support efficient exchange of information and data protection while benefiting the environment. Depending on the scope of responsibilities and areas of activity every organization is able to voluntarily choose among the standards it wishes to implement. ISO has created about 1200 health standards that are grouped in families. Some of them, such as Quality Management System ISO 9001, Environmental Management ISO 14000, Occupational Health and Safety Management System ISO 45001, Guidance on social responsibility ISO 26000, Environmental management 14000 are featured as widely applicable to public health and healthcare. ISO 13485:2016 – Medical devices, is also a useful standard. It is designed to define the requirements of Quality Management System with the aim of demonstrating a company’s ability to provide medical devices and related services that meet the clients’ and regulatory requirements. Together with EN 15224:2012 – Certification of quality management systems in healthcare, with its emphasis on the hospital process and risk management, both standards become strong indicators of quality level of care provided at an institution.
Twenty-first century and the globalization bring new challenges to the organizations exposed to the global market. With a drastic number of competitors, growing demands of consumers and legislators, quality requirements of goods and services together with a lack of resources are constantly increasing. Assessments ensure that tested products, methods, services or systems are reliable with regard to their quality and safety, that they correspond to the technical criteria and conform with the characteristics, guidelines, and laws.
ISO standard is a step-by-step process that requires commitment and cooperation of all parties. It may flow both in the bottom-up and in the top-down directions. The key element of this evolutionary process is the end-user of services – the patient, in whose best interest the described changes should be made. The patient, service provider, health insurance officer, public health institution, legislative body – all of them form an integral network of relationships and responsibility. Therefore, awareness regarding the benefits of the standardization process and full understanding of its stages, by those included, are key factors in the overall success of its implementation. Quality management systems based on the international standards should be a strategic decision of the national public health institutions in an attempt to meet long-term strategic goals. If an organization wishes to use one of the worldwide-recognized norms it has to ensure its adherence to best practices in everything it is involved in. It also includes the mapping processes, setting performance targets and making sure that it continually improves and meets the goals of shareholders, clients, and patients. Regular audit processes and subsequent annual assessments meet the needs of health service providers, patients, in this way guaranteeing the quality of services and achieving maximum results. In this way, the standardization creates powerful tools in order to fine-tune the performance and manage the risks while operating in more efficient ways that allow time and capacity for innovation and creativity, finally leading to an overall success. As a result, public health and healthcare sectors may become sustainable and reliable social partners with a high level of responsibility, encouraging committed and motivated employees and satisfied patients.
