EN 15224:2016

The standard EN 15224 has been developed as a Sector Specific Quality Management System Standard in Healthcare, in order to combine the advantages of ISO 9001 with the particular quality requirements in health services.

EN 15224 was published in 2012 and was revised in 2016 to follow the new version of EN ISO 9001:2015.

As described in the forward of EN 15224, there are several potential benefits:

“The potential benefits to a healthcare organization of implementing a quality management system based on this standard are:

1. the ability to consistently provide healthcare products and services that meet customer and applicable statutory and regulatory requirements;
2. facilitating opportunities to enhance customer satisfaction;
3. addressing risks and opportunities associated with its context and objectives;
4. the ability to demonstrate conformity to specified quality management system requirements.”

The World Health Organization (WHO), has defined Health as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity" and has also identified as important for Health, the “five health components; body function, body structure, activity, participation and environmental factors”

The above are the basis and background for the concept of Health throughout the Standard.

Consequently, there are 11 quality characteristics described in this standard, which must be related to the quality requirements for each specific Healthcare Organization, either for Clinical Processes, or Resources, Support, Management and Administrative processes.

These 11 characteristics are:

1. Appropriate, correct care
2. Availability
3. Continuity of the care
4. Effectiveness
5. Efficiency
6. Equity
7. Evidence /knowledge based care
8. Patient centred care including consistency
9. Patient involvement
10. Patient safety
11. Timeliness/ accessibility

The requirements of this Standard can be applied to all healthcare organizations (healthcare services, hospitals, clinics, rehabilitation services, chronic diseases management, healthcare centers, diagnostic laboratories, private practices, dental practices, pharmacies, nursing homes, provision of services for people with special needs, any support process subcontractors etc.)

• Improvement of health services delivered to the patients and other clients,
• Demonstrate compliance Legal /Regulatory requirements,
• Improvement of communication between departments,
• Reduction of resources needed for risk assessment, 
• Data Management System,
• Efficient use of material and human resources,
• Reduction of the patients’ complaints and increased satisfaction,
• Improvement of the positive attitude of personnel towards quality issues,

TÜV HELLAS (TUV NORD) SA offers accredited certification services according to ΕΝ 15224, having extensive experience in Quality Systems Certifications of healthcare organizations, both of the public and private sector.

Our experts include highly experienced Healthcare professionals, delivering added-value assessments and audits.

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