ISO 15189 Medical Laboratories

Course Overview

ISO 15189 is an international quality management system standard designed specifically for medical laboratories. It outlines the controls required to manage risks that may have an impact on the validity of examination results, and tools to help the laboratory to improve its operations and customer satisfaction.

ISO 15189's requirements are designed to apply to all types of human pathology testing and therefore often need to be interpreted with respect to the type of testing concerned, and the techniques involved. The requirements in the ISO 15189 standard covers management and technical requirements that will ensure an efficient and efficient laboratory producing reliable results. The requirements also cover staff, management, physical laboratory, quality of samples and analytical methods,

customers, process management, equipment quality, competence, complaint management, error prevention etc.

This training will help you understand the key concepts in ISO 15189 for implementing a quality management system, a prerequisite for clinical laboratory accreditation. The delegates will be able to understand and interpret the requirements of ISO 15189, including its Quality Management System (QMS). This course is delivered in such a way that delegates will be able to apply the concepts, methods and principles in their daily professional lines.

Who should attend?

1. Pathologists
2. Clinical Microbiologists
3. Clinical Biochemists and Technicians
4. Those Working in Medical Labs with A Need to Understand ISO 15189
5. Consultants
6. Laboratory Scientists
7. Internal Assessors
8. Companies Seeking ISO 15189 Accreditation
9. Certification / Registrar / Accreditation Body Auditors
10. Existing Internal Auditors Who Are Looking to Expand Their Skills in The Area of Laboratory Practices
11. Supplier Quality Auditors Who Need to Evaluate Clinical Laboratory Services

Covered topics

           History of ISO 15189

          What is ISO 15189:2022?

          Purpose and Scope of ISO 15189

          Contents of ISO 15189:2022

          Scope and Normative References

          Key terms and Definitions

          Requirements of ISO 15189:2022

          Benefits of ISO 15189 Accreditation

          Steps towards ISO certification

          Introduction to auditing

          Documentation for ISO 15189 certification

          Case study

          References

Study Materials

This training course is based on the mixed approach of the study materials including the standard and updated guidelines of ISO 15189:2022, ISO 17025:2017, many research articles and online study materials with case studies for the clear conceptual understanding. There are sample templates for the proper understanding of the documentation requirements in ISO 15189.

Learning outcomes

1. An understanding of the medical testing accreditation requirements.
2. Ability to apply the requirements of ISO 15189 standard
3. Identify the purpose and interaction of the management system and technical requirements.
4. Implement these requirements to ensure added service to customers and enhanced confidence in the facility's results.
5. An understanding of the internal audit process in laboratories
6. An understanding of the documentation requirement of the ISO 15189 with sample templates.

End of Course

 After completion of the course students must undertake the exam. Once the exam is passed, it is considered as end of the course.