LST EN 15224 audit, certification, maintenance

How to certify LST EN 15224 Quality Management System

Where can I find the official name of the standard LST EN 15224 and the valid version of the standard?

You can always find the current edition of the standard, amendments or corrections to the standard on the website of the Lithuanian Department of Standardization.

LST EN 15224 Quality management systems EN ISO 9001:2015 for healthcare EN 15224:2016.

Briefly about LST EN 15224

This is a specific quality management system standard for healthcare organizations. This standard includes the requirements of ISO 9001:2015. It is a stand-alone standard and can be used to certify healthcare organizations. This standard presents the requirements of ISO 9001:2015, additionally interpreting them in the context of healthcare and supplementing them with healthcare-related requirements. The requirements have been supplemented and clarified taking into account the specific context of healthcare. The standard also contains requirements related to clinical risk management throughout the planning, execution and control processes.

Objective of LST EN 15224

The requirements and standardization of operational processes are set for the services of the health care institution in order to implement them effectively and efficiently. This European standard focuses on the requirements of clinical processes. Organizations that also carry out research and/or training processes could apply the requirements of this European Standard in their quality management system, where appropriate. This European standard also focuses on clinical processes and their risk management to promote good quality healthcare.

LST EN 15224 value

The advantages of an organization that implements a quality management system in accordance with the requirements of international standards:
  • systematic planning, execution, control, improvement of the organization's operational processes is taking place;
  • the quality of processes and services improves;
  • responsibilities and powers are clearly defined, they are known, understood and willing and able to be carried out within the organization's team; employees perform their functions better;
  • risk assessment is carried out.
After implementing the management system in accordance with the requirements of the above-mentioned standard and certifying it, health care institutions declare to their clients (patients) that the services they provide are based on high obligations.

Advantages of a certified management system according to the LST EN 15224 standard:

  • confidence in the manufacturer or service provider is increased;
  • the reputation and image of the organization improves;
  • compliance with legal requirements;
  • competitive advantage when offering or supplying products to the European Union or other countries and participating in public tenders.

Integrated management system

Requirements related to environmental management are not included in this quality management system. Therefore, it is advisable that organizations applying a management system also carry out environmental protection management (according to the requirements of the ISO 14001 standard). This standard is a quality management system standard and can be applied in conjunction with other standards, e.g. LST EN ISO 27799:2016 Health informatics. Information security management in the field of healthcare, applying ISO/IEC 27002 (ISO 27799:2016).

You can learn more about the LST EN 15224 standard here:
More about UAB "Sertika" management system certification process is presented in the document "Management system certification (conformity assessment) regulations" (here) and section „FAQ“ (here).

Where to start the certification process?

In order for us to submit an offer, please fill out the application and send it by e-mail:;

Link to download the application

Do you have additional questions about management system certification?

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