DIN EN 15224 - Quality Management System for Healthcare

DIN EN 15224 - Quality Management System for Healthcare

TÜV PROFiCERT DIN EN 15224

Passed in October 2012, DIN EN 15224 is the first uniform European standard for medicine and healthcare services. Nearly 30 years ago, the WHO called for comparable quality and an internationally-recognized and uniform set of rules in healthcare. With its well-known TÜV PROFiCERT brand, TÜV Hessen is one of the first certification companies to offer certification of your quality management system in accordance with DIN EN 15224.

 

What are the requirements of the standard?

The principles and structure of the standard are based on the proven DIN EN ISO 9001. Compared to the
"mother of standards", DIN EN 15224 speaks of patients and clinical processes and specifies the requirements for healthcare services. The standard includes the International Classification of Functioning, Disability and Health (ICF), takes specific statutory framework conditions into consideration and defines eleven clear quality features on which the normative requirements for the organization are oriented. One focus of the standard is on the comprehensive requirements for risk management, which are handled in every chapter in the standard. The requirements are tested and evaluated in the course of the certification procedure, which consists of the document inspection in advance and the subsequent on-site company audit.

Who is the standard aimed at?

Your benefits

Beyond the quality assurance aspect, quality management is organization and process oriented and includes systematic monitoring and control of clinical processes as well as minimizing avoidable clinical risks. Quality management is becoming increasingly important against the background of reducing liability and risk and protecting against organizational fault. Lower liability risks are of financial relevance and are thus an economic factor in and decisive influence on the quality of services.

How does certification take place?

The requirements are tested and evaluated in the course of the certification procedure, which consists of the document inspection in advance and the subsequent on-site company audit. The TÜV PROFiCERT certificate DIN EN 15224 is awarded upon successful completion of the certification process. It is valid for three years and must be confirmed every year by a monitoring audit.

You want to know more?
Contact us by eMail or Phone: +49 6151 600-331

back to TÜV PROFiCERT table of contents

You want to know more?

Get more Information:
Our Procedure Directive / Prices / GTC (PDF)
Contant us by:
Phone: +49 6151 600-331
eMail Contact

Product Information

Get the Product-Information-Sheet as