EN 15224 - QUALITY MANAGEMENT SYSTEMS FOR HEALTHCARE

Where can I find the official name of the standard EN 15224 and the valid version of the standard?

• You can always find the current edition of the standard, amendments or corrections to the standard on the website of the Lithuanian Department of Standardization.
• EN 15224 Quality management systems ISO 9001:2015 for healthcare EN 15224:2016.

Overview of EN 15224 standard

EN 15224 is a European standard for quality management systems in the healthcare sector. This standard covers: patient safety, service quality, risk management, efficiency of service delivery processes and continuous improvement. The EN 15224 standard is an important tool for healthcare institutions aiming to ensure high quality and efficiency of services, as well as promoting transparency and trust between patients and healthcare providers.

• Competitive advantage;
• Increased patient confidence;
• Planning, execution, control and improvement of operational processes is ensured;
• The quality of processes and services improves;
• Responsibilities and powers are clearly defined;
• A risk assessment is carried out.

Benefits of certification for the client

Our certification services guarantee that the companies you cooperate with comply with the requirements of the EN 15224 standard. It means:

• Confidence in the service provider is increased;
• Compliance with legal requirements is ensured;
• Quality services and patient safety;
• Protection of personal data is ensured;
• Transparency and traceability.

Is it possible to integrate EN 15224 with other standards?

The EN 15224 standard can be integrated into one efficiently managed system together with the following standards:

• ISO 13485 - standard for quality management systems for medical devices. Integration with EN 15224 is important for manufacturers and suppliers of medical devices to ensure that their products and services meet high healthcare quality standards.

• ISO 45001 - standard for occupational safety and health management systems. Together with EN 15224, this standard helps healthcare facilities to create a safe and healthy work environment, reducing the risk of occupational diseases and injuries.

• ISO/IEC 27001 - standard for information security management systems. In the healthcare sector, the integration of this standard with EN 15224 is particularly important due to the large amount of sensitive patient information that needs to be protected.

• ISO 14001 - environmental management systems standard. Integrating this standard helps healthcare facilities operate in an environmentally responsible manner, reducing negative environmental impacts and promoting sustainability.

• ISO 22000 - food safety management system standard. In healthcare facilities that provide catering services, the integration of this standard with EN 15224 can help ensure a high level of food safety and quality.