ISO 15224

ISO 15224 was developed by the International Organization for Standardization (ISO) and is an international standard specifying the general requirements for the development, implementation, and continuous improvement of a Quality Management System in healthcare services. It is based on the principles of ISO 9001 but incorporates specialized requirements aimed at providing safe and high-quality healthcare services, with an emphasis on clinical risk management.

ISO 15224 can be applied by any organization operating in the healthcare and medical services sector. It is targeted at hospitals, clinics, medical centers, diagnostic laboratories, healthcare providers, and any organization offering health-related services, seeking to improve the quality and safety of those services.

Developing a Quality Management System in healthcare according to ISO 15224 involves the following steps:

• Identifying legal, regulatory, and clinical requirements for the healthcare services provided
• Analyzing and managing clinical risks to ensure patient safety and quality of care
• Developing and implementing procedures for the continuous improvement of healthcare service quality
• Training personnel on quality requirements, safety, and risk management
• Continuously evaluating, reviewing, and improving the system through audits and incident reports

The difficulty of implementing ISO 15224 depends on the size and nature of the healthcare facility, as well as its existing quality management processes. Organizations that have already implemented ISO 9001 or other quality management standards can more easily adapt to the requirements of ISO 15224. Working with specialized consultants can facilitate the process and ensure smooth integration into the organization’s operations.

There are several certification bodies in Greece, accredited by the Hellenic Accreditation System (ESYD) or other equivalent bodies, that can issue the relevant certificates depending on the company’s area of activity. The certification process involves evaluating the organization’s compliance with its healthcare quality management processes, assessing the Quality Management System against the standard’s requirements, and evaluating its practical implementation.

Upon successful completion of the assessment, the Certification Body issues a Certificate of Conformity valid for three years. If there are significant deviations, corrective actions must be completed by the organization before the certificate is issued. Minor deviations must be resolved before the next assessment.

The certificate remains valid as long as scheduled periodic assessments are conducted by the Certification Body, at least annually, confirming continued compliance with the specified requirements.

Organizations adopting ISO 15224 can enjoy multiple benefits, such as:

• Improving the quality of provided healthcare services, ensuring high standards of care
• Effectively managing clinical risks, reducing errors and enhancing patient safety
• Complying with regulatory and legislative requirements related to healthcare
• Increasing patient and partner trust through a commitment to quality and safety
• Improving internal organization and efficiency with standardized processes and clear operating guidelines

The time required to develop and certify a Quality Management System in healthcare varies based on the organization’s level of preparedness, size, existing risk management processes, and staff involvement. For small healthcare facilities, it typically ranges from 2 to 5 months, while larger organizations may need a longer preparation period.