ISO 15189:2012 Medical laboratories Course Overview

To ensure that you are well-prepared and can derive maximum benefit from the ISO 15189:2012 Medical laboratories course, the following are the minimum required prerequisites:

• Basic understanding of laboratory operations and processes.
• Familiarity with quality control and assurance concepts in a laboratory setting.
• Knowledge of general requirements for competence and quality in medical laboratories.
• Awareness of the importance of documentation and records management in a clinical laboratory environment.
• An interest in learning about the ISO 15189:2012 standard and its application in medical laboratory settings.
• Willingness to engage with the material and apply it to real-world laboratory scenarios for quality improvement.

No specific professional background or certification is necessary to enroll in this course. However, it is beneficial if participants have some experience working in or with medical laboratory environments. This foundational knowledge will help contextualize the ISO 15189:2012 standards within the practical operations of a medical laboratory.

Target Audience for ISO 15189:2012 Medical laboratories

The ISO 15189:2012 Medical laboratories course is designed for professionals involved in clinical laboratory processes and quality management.

• Laboratory Managers
• Quality Managers and Coordinators
• Medical Laboratory Technologists
• Pathologists
• Clinical Biochemists
• Microbiologists
• Laboratory Analysts
• Quality Assurance/Quality Control Personnel
• Medical Laboratory Assistants
• Laboratory Equipment Suppliers
• Healthcare Quality Professionals
• Regulatory Affairs Professionals
• Laboratory Accreditation Specialists
• Compliance Officers in Medical Laboratories
• Internal and External Auditors for Medical Laboratories
• Medical Laboratory Educators and Trainers
• Laboratory Information System Administrators
• Risk Management Professionals in Healthcare
• Management Representatives for Laboratory Quality
• Laboratory Consultants
• Healthcare Administrators with Laboratory Oversight Responsibilities
• Research Scientists involved with clinical trials requiring laboratory services
• Professionals aiming to implement ISO 15189 standards in laboratories
• Technical Supervisors in Medical Laboratories
• Professionals preparing laboratories for accreditation and certification processes

Learning Objectives - What you will Learn in this ISO 15189:2012 Medical laboratories?

Introduction to the ISO 15189:2012 Medical Laboratories Course Learning Outcomes:

Gain comprehensive knowledge on the ISO 15189:2012 standards for medical laboratories, focusing on quality management systems, laboratory operations, and the accreditation process.

Learning Objectives and Outcomes:

• Understand the requirements of the ISO 15189:2012 standard and its application in medical laboratory settings.
• Develop skills necessary to implement and maintain a Quality Management System in compliance with ISO 15189.
• Learn to effectively manage laboratory personnel, ensuring their competence and ability to produce reliable test results.
• Acquire knowledge on the proper selection, maintenance, and operation of laboratory equipment to meet ISO 15189 standards.
• Gain insights into the process control measures required for accurate and reliable laboratory testing and calibration.
• Master the processes for validation and verification of test methods and equipment to ensure high-quality laboratory services.
• Understand the importance of proficiency testing and internal quality control in the continuous improvement of laboratory quality.
• Learn how to prepare and manage documentation and records in adherence to ISO 15189 requirements.
• Identify and apply risk management principles to enhance the safety and efficacy of laboratory operations.
• Equip yourself with the knowledge to successfully prepare for and achieve ISO 15189:2012 accreditation for medical laboratories.