The objective of this Standard is to promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories. This standard contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement.
The requirements for risk management are aligned with the principles of ISO22367:2020 – Application of Risk Management to Medical Laboratories
The requirements for laboratory safety are aligned with the principles of ISO15190:2020 Medical Laboratories-Requirements for safety.
The requirements for sample collection and transportation are aligned with ISO20658: Requirements for the collection and transportation of samples for medical laboratories.
Course Content
- ISO 15189:2022 Overview
- Introduction - Quality Management Concepts and Key Success Factors
- General Requirements:
- Structural and Governance Requirements
- Resource Requirements
- Process Requirements
- Management Requirements
- Application of Risk Management in Medical Laboratory
- Introduction to Auditing
Who Should Attend?
- Laboratory personnel in Medical Laboratories
- Laboratory Directors
- Quality Managers
- Technical Managers
- Quality Officers
- Top Management of medical laboratories
- ISO 15189 consultants and experts
