Medical laboratories

Accredited activity

Blood tests, laboratory tests, POCT

Description of the activity

The medical laboratory, in accordance with clinical and healthcare needs, performs tests on samples of human origin, typically fluids or tissues, for health promotion, prevention, diagnosis, prognosis, monitoring, and treatment surveillance.

It can also perform specific management and control activities for tests performed in healthcare departments, outpatient clinics, and community services (so-called Point-of-Care Testing, or POCT), ensuring the accuracy and reliability of results.

Accreditation standards

ISO 15189
Medical laboratories — Requirements for quality and competence

Document issued

General Regulations for accreditation

RG-02
Regulation for the accreditation of Testing and Medical Laboratories
RG-02-01
Regulation for the accreditation of multisite Testing Laboratories, Medical Laboratories and Proficiency Testing Providers
RG-09
Regulation for the use of the ACCREDIA logo and mark

Other Regulations for accreditation

RT-26
Requirements for the accreditation of flexible scope – Testing Laboratories, Medical Laboratories, Calibration Laboratories, Proficiency Testing Providers
RT-35
Requirements for the accreditation of medical laboratories – UNI EN ISO 15189:2024
RT-39
Requirements for participation in proficiency testing (PT) and/or interlaboratory comparisons (ILC)

Complete list of standards and reference documents for accreditation

LS-04
List of reference standards and documents for the accreditation of Testing Laboratories, Medical Laboratories and Proficiency Testings Providers

Application for accreditation

DA-00
Application for Accreditation
DA-08
Application for Accreditation of Medical Laboratories
DA-08 All.1
List of Examinations to be Accredited (*) of Diagnostic Systems and Equipment
DA-08 All.2
List of collection points, type of analyses to be accredited (*) and related information
DA-08 All.3
List of POCT and decentralized analysis centers to be accredited (*)