EN 15224 - Quality Management System in Health Care Services
EN 15224 - Quality Management System in Health Care Services

EN 15224 aims to adjust and specify the requirements, as well as the “product” concept and customer perspectives in EN ISO 9001:2008 to the specific conditions for health care where products are mainly services and customers are mainly patients. The focus of this is the clinical processes and their risk management in order to promote good quality health care.

Target Group

With the new legislative framework for the Medically Assisted Reproduction Units (M.I.Y.A.) (Government Gazette issue A / 20 / 18-2-2016), the M.I.Y.A. are required to be certified according to the ISO 9001 standard for the health sector (EA 38) or a corresponding standard within one year after its issuance. On the next few years, the certification will be based on the standard EN 15224.

The benefits

The EN 15224 standard combines the advantages of the ISO 9001 standard with the quality requirements of healthcare services. It defines the issues that include the efficiency, the adequacy, the safety and reliability of healthcare processes.

Certification Process / Required documents

Organizations interested in getting certified to EN 15224 standard requirements, should contact BQC and fill in the certification application.

An initial audit is conducted and if successful, a certificate of compliance is issued that is valid for 3 years, provided that the organization undergoes annual audits.

Why choose BQC

BQC is accredited by the Hellenic Accreditation System (ESYD), issues internationally recognized Certificates, and cooperates with experienced inspectors and experts from all over the world, ensuring the most updated and professional knowledge in any business sector.