Educational Program

ISO 15189:2022

Requirements for the Accreditation of Medical Laboratories

ISO 15189
  • Directors and executives of clinical laboratories in the public and private sector
  • Technical Officers and Quality Managers of Clinical Laboratories
  • Representatives of Certification Bodies and Audit Bodies
  • Clinical Laboratory Quality Management Systems Consultants
  • Evaluators of Accreditation Bodies etc.
Information

Course Duration: 2 days

The role of a clinical laboratory is very important for the diagnosis, prognosis, monitoring and treatment of patients and there is an indisputable need for laboratory results that are accurate and reliable.

Furthermore, a clinical laboratory need to prove the level of services of clinical laboratories vis-a-vis their partners e.g. doctors, public and private health services, insurance companies etc.

The implementation and accreditation based on the international accreditation standard of clinical laboratories ISO 15189: 2023, can meet this need, as laboratories will be able to prove their independence, reliability and technical adequacy, ensuring transparency and confidence in the results they issue.

The objective of the training program is to train all the participants in the requirements of ISO 15189:2023, to understand important concepts such as the quality and reliability of results, to understand the concept of accreditation and its importance, to understand concepts such as non-conformities, quality control, calibration, verification, uncertainty of measurements, etc. In addition, participants will gain knowledge with practical advice on the conditions for effective application of the standard.

Finally, the training course presents the organization, design and implementation of Internal audits and analyzes the methods of conducting an audit according to the requirements of ISO 19011. At the end of this training course, participants will have the opportunity to organize and carry out Internal Audits of Clinical Laboratory Management Systems both in their company as internal auditor or in other companies as external consultant.

To inquire about the cost of the courses contact us. BQC adjusts its pricing policy for the unemployed and for students. Every second participation from the same company will have a 10% discount.

Teaching methods used include lectures, practical training and group collaboration.

In this context, the participants are invited to carry out group and individual exercises and tasks, as well as Role playing exercises, aimed at developing their skills (time management, team spirit, cooperation).

At the end, an evaluation test and a satisfaction questionnaire are distributed to the participants in order to evaluate the results of their training and the achievement of its objectives.

  • A detailed description of the administrative and technical requirements of the ISO 15189: 2012 standard
  • The training in theoretical knowledge and practical skills for the design, development, implementation and inspection of Management Systems of Laboratories of testing and calibration according to ELOT EN ISO 15189: 2012
  • The provision of specialized knowledge in matters of validation / verification, internal and external quality control of laboratory testing and measurement methods
  • The analysis, interpretation and evaluation of the results of calibrations
  • Understanding the measurement uncertainty calculation
  • The provision of specialized knowledge on topics for the Pre-analytical, Analytical, Post-analytical stage, Publication of results
  • Information on specific issues such as: Protection of medical data. Confidentiality Statement – Laboratory Information System Security (LIS) – Code of Ethics in Laboratory Medicine
  • Conducting horizontal and vertical internal audits
  • Exercises and practical examples of application
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Ημερομηνία
Πρόγραμμα
Συμμετοχή
15-16/05/2025
ISO 15189:2022 - Requirements for the Accreditation of Medical Laboratories

Education Methodology

The teaching methods used include lectures, practical training and group work.

In this context, participants are invited to carry out group and individual exercises and tasks, as well as role playing exercises, aimed at developing their skills (time management, team spirit, cooperation).

At the end, an evaluation test and a satisfaction questionnaire are distributed to the participants in order to evaluate the results of their training and the achievement of its objectives.

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