EN 15224

Orderly, transparent and sound management inspires confidence in the general public. We have developed a range of services for healthcare organisations aimed at improving quality in healthcare.

With the SIQ Management Systems Certificate, you can increase your business efficiency and our renowned lecturers offer you expert support in continuous quality improvement. We also carry out a range of measurements and inspection procedures, check the condition of medical equipment and verify the level of electromagnetic radiation.

About the Standard

A growing number of health care institutions worldwide are becoming aware of the benefits of the introduction of an ISO 9001 standard in the operations of a health care institution:

• Increased trust in the institution;
• Lower risk of the occurrence of errors;
• Enhanced satisfaction of patients;
• Improved competitive position;
• Defined and optimized processes;
• Efficiency criteria and continuous improvement;
• Involvement of all employees;
• Improved communication;
• Reduced costs and well managed documentation.

The ISO 9001 standard cannot replace other procedures, methods or systems that are being introduced in health care. It can only support them and facilitate their smoother and faster establishment.

EN 15224:2012 Health Care Services – Quality Management Systems

The EN 15224:2012 standard is a sector specific quality management system standard for health care organisations. It is intended to provide patient safety and risk management in health care organisation and brings added value to quality management system in health care services.

It is a stand-alone standard and can be used for certification in health care

The requirements in the EN 15224 standard incorporate those from ISO 9001 with additional interpretations and specification for health care. The standard emphasizes clinical processes and risk management through planning, operation and control of processes.

The standard addresses the most basic requirements for quality in health care services. It specifies the following 11 characteristics:

SIQ – comprehensive solutions in health care:

• Assessment of the status of a management system – we ascertain the gap between the established quality management system in accordance with requirements of ISO 9001 standard and requirements of the EN 15224 standard. With this assessment you receive clear directions on what needs to be done to fully meet the requirements of the EN 15224 standard.
• Certification of quality management systems in health care organisations.
• Training, seminars, courses – The EN 15224:2016 Standard – Requirements and Opportunities.
• Testing and certification of medical devices
• Inspection of medical devices
• Identification of electromagnetic radiation and electromagnetic compatibility of devices