A Critical Update on the New ISO15189:2022 Edition

Thursday, 13th April 2023

14:00 BST | 15:00 CEST | 09:00 EST

LGC Clinical Diagnostics were proud to sponsor this educational webinar, delivered by Professor Folker Spitzenberger M.D.R.A.

Presented By

Professor Folker Spitzenberger
M.D.R.A.

Biography

Folker Spitzenberger is Professor for Regulatory Affairs for medical devices at the University of Applied Sciences in Lübeck, Germany. As Master of Drug Regulatory Affairs, he also holds a Diploma in chemistry and a PhD in molecular biology and is a biomedical laboratory specialist with more than 15 years of experiences as quality assessor for medical laboratories, testing laboratories, certification bodies and proficiency testing organisations in the field of IVD medical devices. Folker Spitzenberger is active in the field of international medical device standardization and is the convener of the German mirror committee of ISO TC 212 that most recently developed the revised version of the standard ISO 15189.

Abstract

Through this webinar the participant will learn about the latest developments in the standard ISO 15189:2022 “Medical laboratories - Requirements for quality and competence”. It has been developed with the objective of promoting the welfare of patients through confidence in the quality and competence of medical laboratories. Because the primary consideration is the welfare of patients and the satisfaction of users, the standard contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities in various aspects of the daily laboratory work. This is the basis for increasing the effectiveness of the management system, achieving improved laboratory results, and preventing negative effects which could result in harm to patients, laboratory personnel, the public and the environment.

The standard will facilitate cooperation between medical laboratories and other healthcare services, assist in the exchange of information, and in the harmonization of methods, procedures and laboratory results. Also, laboratories conforming to this standard might contribute to reduction of waste and minimize repeat testing.

Who Should Attend:

• Clinical, hospital, and reference laboratory stakeholders.
• Laboratory directors, laboratory managers, quality managers.
• Clinical laboratory scientists and technicians.