ISO 15189 – ISO 17025

Engineering and development of management systems for Clinical Laboratories and Testing and Calibration Laboratories (ISO 15189 / ISO 17025)

Purpose

Control and reduce errors that may occur in the results of analysis and testing by taking appropriate measures to avoid them.
The accreditation of laboratories carrying out analysis and testing is a one-way course, since most laboratories on the market are accredited and in most cases are legally required.

Framework

Its planning is based on the principles of a quality system, but the standard has additional technical requirements which have to do with the measurements of the laboratory. All the processes of the system are part of the “process – approach” principle. The activities which are crucial for the management of the quality system include technical activities that contribute to the increase of the credibility of the measurements carried out in the laboratory. Usually, specific procedures are develop and are adopted for these activities.

Our services

Having as a main objective the total customer satisfaction, we develop, maintain, improve upgrade and audit systems and structures in clinical laboratories and / or testing, calibration laboratories that already have or do not have organized departments and management systems for ISO 15189 / ISO 17025.

The system (ISO 15189) (ISO 17025)

In the context of continuous improvement and constant performance, laboratories must be oriented to:
The proper use of contemporary techniques for the implementation of the analysis / testing.
The strict implementation of internal and external quality proficiency testing.
The automation, in the greatest degree possible, through the implementation of specific laboratory programs and through the usage of contemporary laboratory analysts / equipment which eventually leads to:
the proper management of the samples
the reduction of the possibility of laboratory error,
the systematic training of the staff.

The laboratories participate in external quality testing programs (both Greek and international), so that the published results are reliable and match with the results of other laboratories.
Contact us for further information for any questions you may have or any clarifications you may need.