We help you achieve ISO 15189

The purpose of UNE-EN ISO 15189 is to demonstrate how committed a clinical laboratory is to technical competence and quality. Accordingly, it ensures proper operation by controlling the procedures carried out on a daily basis and by meeting the necessary technical requirements to guarantee high-quality clinical results.

UNE-EN ISO 15189 is divided into a management section, which deals with the administrative aspects of the Quality System and sets the requirements for accreditation, and a technical section, which focuses on personnel, facilities, equipment, procedures (pre-analytical, analytical, and post-analytical), quality assurance of results, and reporting.

UNE-EN ISO 15189 provides significant benefits to clinical laboratories because it not only demonstrates their proper management system and high technical competence, but also brings important advantages for their growth as a business:

• More satisfied clients: the results provided are technically valid.
• Cost reduction: it decreases the need for complete retesting, leading to savings in time, reagents, and other resources, as errors can be detected in preliminary stages before analytical reports are issued.
• Enhanced competence: achieving accreditation provides a key competitive advantage over other clinical laboratories.
• A public administration requirement: clinical laboratories with this accreditation are highly valued by authorities.