Educational Program

ISO 22367

Risk Management in Medical Labs

Directors and executives of public and private clinical laboratories
Clinical laboratory operators
Technicians and technical quality managers
Internal auditors of clinical laboratories
Representatives of certification and control bodies
Consultants for quality management systems in clinical laboratories
Accreditation body assessors

Program Duration: 2 days

The seminar’s purpose is to provide comprehensive training to participants in the principles and practical application of risk management in clinical laboratories, in accordance with the European and international standard EN ISO 22367 Medical Laboratories – Application of Risk Management in Medical Laboratories.

The seminar aims to foster an understanding of the critical importance of risk management for the effective implementation of the EN ISO 15189 accreditation standard for clinical laboratories, as well as to develop practical skills for the identification, recording, evaluation, and monitoring of both operational risks and risks related to clinical processes, through practical examples and application exercises.

Instructor: Dimitrios Katsieris, Vice President of an American Accreditation Body, Program Director, Lead Assessor of accreditation schemes based on European and international standards (EN ISO 15189, ISO 17025, etc.)

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.

Introduction to risk management: basic concepts, definitions, and the significance of risk management within the framework of EN ISO 15189
Risk management within the management system: operational and financial risks
Key requirements of EN ISO 22367: presentation of the general risk management process, management responsibilities, planning, identification, analysis, evaluation, and risk control
Implementation and evaluation of risk control: control measures, verification, the role of standards and IVD medical devices, residual risk evaluation, and benefit-risk analysis
Review and monitoring of risk management: completeness of control, evaluation of overall residual risk, reporting, and risk monitoring, analysis, and control activities (internal – external information sources, immediate actions)
Review of informative annexes of EN ISO 22367: indicative examples of safety-related characteristics identification, hazards, foreseeable sequences of events, hazardous situations, risk analysis tools and techniques, assessment methods, and overall residual risk evaluation

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Ημερομηνία

Πρόγραμμα

Συμμετοχή

03-04/07/2025

ISO 22367 - Risk Management in Medical Labs

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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