ISO 7101:2023 – the First Quality Management Standard in Healthcare
A look at the current state of the healthcare industry around the world reveals a number of problems, including workforce shortages, rising costs in face of declining financial resources, a general increase in the number of people in need of healthcare services, especially the elderly due to an ageing population, rising rates of chronic diseases, and shortages or inadequacy of medical equipment and drugs. The COVID-19 pandemic has also brought a number of issues to the fore.
The purpose of ISO 7101 is to provide organisations with requirements for the delivery of high quality healthcare and to define requirements for quality management systems in healthcare organisations. Implementation of the standard will help organisations focus their efforts on providing timely, safe and person-cantered care, while highlighting the urgent need to adapt due to technological advances and the advent of digital technologies. The quality management systems of healthcare organisations should include the following according to the standard:
- creating a culture of quality, starting with senior management;
- creating a healthcare system based on caring for people, respect, compassion, people using health and care services, carers and communities working together in equal partnership, equity and dignity;
- identifying and managing risks;
- ensuring the safety and well-being of patients and staff;
- monitoring service delivery through documented processes and documented information;
- monitoring and evaluating of clinical and non-clinical performance; and
- continuous improvement of processes and outcomes.
ISO 7101:2023 does not override the organisations responsibilities related to regulatory and sub-regulatory requirements. It is designed to improve patient safety, reduce costs, increase efficiency, and enhance reputation and market share.
Implementation of management standards
CONSEJO Ltd. is a consulting company with over 20 years of practical experience in the development, implementation and maintenance of management systems in accordance with international standards and regulatory requirements. The company provides consulting services in the areas of quality management, environmental management, occupational health and safety, food safety, information security, cybersecurity, risk management and sustainable development. Our expertise covers standards and schemes such as ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO/IEC 27001, IFS Food, BRCGS and HACCP, as well as consulting services related to NIS2, DORA, GDPR and EcoVadis.
The CONSEJO team has been involved in over 1,500 projects for organizations across various sectors of the economy, including manufacturing, construction, energy, information technology, transport, trade, the food industry and services. Our approach focuses on developing management systems that work effectively in practice, tailored to the specific characteristics and needs of each organization. We work closely with our clients, providing consulting support, staff training and assistance during implementation. We strive to deliver high-quality services within the agreed deadlines and solutions that support successful certification and create long-term value for businesses.
