EN 15224 – Quality Management System in Health Care Services

EN 15224 Certification

EN 15224:2012

Compliance with the Quality Management System EN 15224 provides to a company the ability to commit to its long-term goal of providing better health care services. By complying with the certification requirements, the company will increase the organizational efficiency and quality of its services, while minimizing waste, thus increasing its overall productivity.

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 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.

EN 15224
Quality Management System
in Health Care Services

Certification Process / Required documents

Organizations interested in getting certified to EN 15224 standard requirements, should contact ISC Control 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 ISC Control as Your Certification Body?

Global Recognition

Selecting the right organization or certification body that offers qualitative and credible training and certification services can be a challenge. However, by choosing an accredited certification body, such as ISC Control, proves that you follow best practices, up to speed, and trustworthy.

Professionals who pursue a ISC Control con certification credential will benefit from the recognition in domestic and overseas markets. Being accredited by some of the strictest and most reputable accreditation bodies in the world gives us global recognition.