The International Standard ISO 15189: 2012 specifies the requirements for the competence and quality that are particular to medical laboratories.
The implementation of this international standard by medical laboratories provides confidence in the results of examinations performed by these laboratories.
The International Standard is applicable to all laboratories regardless of the number of personnel or the extent of the scope of medical testing
The international standard ISO 15189: 2012 is used by the accreditation bodies in confirming and recognizing the competence of medical laboratories in the way to allow the acceptance of their results between different parties.
The standard includes the management and technical requirements that are related to the competence of medical laboratories and essential to patient care.
The GCC accreditation center (GAC) has organized this training course in the framework of its role in laboratories accreditation and in dissemination of the requirements and importance of accreditation.
The training course is carried out proffer including presentations by the trainer, group discussions and case studies with participation of all delegates.
The training material will be available to all participants during the course. Certificates will be delivered by GAC reprehensive at the end of the training course.
The course aims to:
•Gain the knowledge of the international system for laboratories accreditation
•Gain an understanding of the requirements for the technical competence of medical laboratories
•Learn how a laboratory quality management system is designed and operated and learn all elements of the standard and the important concepts
•Increase the confidence in the performance of staff who implement the requirements.
•Have the opportunity to exchange experience and take benefits from the case studies and the group discussions
Introduction on the international system of laboratories accreditation and ISO 15189 requirements
Management requirements of the standard
•Organization and management responsibilities
•Quality management system
•Examination by referral laboratories
•External services and supplies
•Resolution of complaints
•Identification and control of nonconformities
•Control of records
•Evaluation and audits
Technical requirements of the Standard
•Accommodation and environmental conditions
•Laboratory equipment, reagents and consumables.
•Ensuring quality of examination results
•Post examination processes
•Reporting of results
•Release of results
•Laboratory information management
Technical and management staff in medical laboratories