Medical laboratories can be accredited to ISO 15189 Medical laboratories - Particular requirements for quality and competence, to demonstrate the quality and reliability of their services. ISO 15189 was developed with the participation of the medical, scientific, and clinical community, and it contains requirements for diagnostic labs to demonstrate competence to deliver reliable timely, accurate, and reliable results.

ISO 15189 accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel qualifications and competence, equipment, reagents and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors. Qualified assessors conduct a thorough evaluation of all factors affecting the production of test data.