Accreditation of the Clinical Laboratory

What is and what does the current INTE-ISO 15189 standard include?

ISO 15189 "Clinical laboratories - Particular requirements for quality and competence" sets out the specific quality requirements for clinical laboratories.

Unlike other standards, the Clinical Laboratory accredited to ISO 15189 demonstrates its competence to perform tests with emphasis on the reliability of results and patient safety, as well as in the pre-analytical phases (obligations to patients related to the preparation, identification and transport of samples) and post-analysis (obligations to the Laboratory professional staff in relation to validation, information, interpretation and advice to patients and physicians), demonstrating its quality in all processes, from the beginning of patient care to the delivery of a reliable result for clinical use.

How do patients and institutions benefit from the use of an ISO 15189 accredited laboratory?

• Increases confidence in results to establish a basis for accurate diagnostic decisions.
• Reduction of errors associated with decisions that could affect the protection of health and the environment.
• Cost reduction: less repetitions due to the reliability in the reports, avoids duplicity of functions.
• Quality assurance for the services provided.
• International recognition, through mutual recognition agreements between accreditation bodies in different countries.
• The Quality Management System of the Clinical Laboratory, the analyses included in the scope of accreditation and its service is periodically evaluated by an independent and competent body recognized by the state.
• Continuous improvement ensures that the Laboratory is always in the process of innovation, staff training and advancement of new techniques.