The healthcare sector faces major challenges—from demographic change to shortages of skilled workers, limited resources, pandemics, and advancing digitalization. With the publication of ISO 7101:2023, an international standard for quality management systems in healthcare was established for the first time, marking a significant milestone for the industry. The standard helps healthcare organizations systematically improve quality, patient safety, and efficiency. It focuses on high-quality, patient-centered care, the involvement of patients and their families, and the well-being of employees. In this way, ISO 7101:2023 makes an important contribution to sustainable and future-proof healthcare.
Patient-centered care and patient safety are the focus
Employees: Safe working conditions and the active involvement of employees support a high quality of care.
Culture of Quality and Safety: Quality, patient safety, and an open approach to errors are actively promoted.
Risk management and improvement: Risks are systematically managed, and processes are continuously improved.
Standardization and evaluation: Clear standards, along with regular monitoring and evaluation of services, ensure effective and high-quality care.
ISO 7101:2023 applies to all healthcare organizations, including hospitals, clinics, rehabilitation and long-term care facilities, medical practices, group practices, pharmacies, and other health and social care facilities.
4.1. Organizational Context
The organization identifies and evaluates relevant internal and external factors, as well as the requirements of key stakeholders, such as patients, family members, and employees. In doing so, it takes into account legal, social, technological, and organizational conditions, as well as the potential impacts of climate change. In addition, the scope and boundaries of the quality management system are defined.
5. Leadership
A culture of quality and safety that is actively practiced promotes the achievement of quality objectives. Top management serves as a role model. Employees are actively involved and supported in understanding and implementing their contributions to the quality management system. Furthermore, the well-being and safety of employees are promoted, and awareness-raising measures are ensured.
6. Planning
The organization takes risks and opportunities into account to continuously improve the quality and safety of healthcare. Risk management is documented and accessible to employees. Regular training and awareness-raising measures strengthen awareness of risks, quality, and safety.
7. Support
The organization provides the necessary human, financial, and organizational resources for an effective quality management system. Employees are aware of their duties and responsibilities. In addition, effective internal and external communication, the protection of personal data, secure clinical communication, and the management and documentation of relevant information are ensured.
8. Operations
The operation of healthcare facilities involves the safe management of infrastructure, resources, and services. This includes emergency management, medication safety, infection prevention, the responsible use of new technologies, and patient-centered care.
9. Performance Evaluation
The performance of the healthcare facility is assessed through regular monitoring, measurement, analysis, and evaluation of relevant indicators. This includes internal audits, management reviews, feedback from patients and their families, as well as input from other stakeholders. Aspects of occupational safety and employee well-being are also taken into account to evaluate the effectiveness of processes and identify opportunities for improvement.
10. Improvement
The effectiveness of the quality management system is continuously reviewed and improved. Findings from analyses, evaluations, audits, and management reviews are used to implement improvements. Nonconformities are documented and corrected through appropriate corrective actions to sustainably strengthen the quality and safety of healthcare.
Quality Austria Certification GmbH is accredited by Akkreditierung Austria to perform certification in accordance with ISO 7101.
ISO 9001, ISO 14001, ISO 45001, ÖNORM EN 15224
