ISO 15189:2022 Implementation Training

Introduction

The ISO 15189:2022 standard, Requirements for quality and competence in medical laboratories, was designed to bring consistency in the development of quality management systems for Research and medical laboratories. Medical laboratories are required to develop their quality management system in the light of this very vital document. It is therefore imperative for a laboratory undergoing the accreditation process to understand the contents of the standard when it comes to the management and technical requirements, in order to develop a Laboratory system that is compliant to international standards and resistant to failure as much as possible.

Learning Objectives

• To understand ISO 15189:2022 requirements for medical laboratories
• To learn the required documentation for medical laboratories accredited to the standard
• To understand how the standard is used in assessing the competence of medical laboratories

Key Topics

• ISO 15189 management principles
• ISO 15189 technical requirements
• Overview and requirements of ISO 15189
• Additional requirements of ISO 15189
• Measurement uncertainty
• Quality and Quality Management concepts
• Commonly used quality management system standards
• Structure of documentation
• Sources of information and further development

Who Should Attend?

• Laboratory Quality/Technical Managers
• Laboratory Technicians/Supervisors
• Assessors of Laboratory Management Systems
• Personnel responsible for procurement and evaluation of Laboratory Services
• Users of clinical test services