Accreditation for Medical Testing Laboratories

Accreditation Programs

Accreditation for Medical Testing Laboratories

EAF offers an internationally recognized accreditation program for medical testing laboratories. Requirements for EAF’s Accreditation Program for medical testing laboratories are defined in ISO 15189:2012 Medical laboratories — Requirements for quality and competence.

Accreditation for Medical Testing Laboratories

EAF’s Accreditation Program is internationally recognized and it's accreditation helps medical testing laboratories deliver services with confidence and attract new customers. EAF accreditation proves a medical testing laboratory’s ability to manage and perform activities defined by its specific program scope of accreditation.

Medical laboratories are laboratories that focus specifically on the healthcare sector. If, for example, a doctor or specialist requires information about the blood, urine or tissue of a patient in order for a diagnosis to be made on the basis of this information or to check the effectiveness of a treatment, he or she engages the services of a medical laboratory.

These laboratories are mainly found in hospitals, however, there are also independent medical laboratories. A medical laboratory employs specialists who are able to interpret the test results and advise the client accordingly. Like test laboratories medical laboratories also use calibrated equipment.

ISO 15189:2012 delivers the specific requirements for quality and competence that are specific to medical imaging Units. The standard encourages global harmonization of medical practices. It safeguards the health and safety of patients and healthcare providers.

The Imaging Units are the key associates in health safety. Imaging results influence 75% of medical diagnoses. Quality of imaging service is the main issue which directly affects the quality of health care. The clinical Imaging as a whole has to provide the best patient care encouraging excellence.

Advantages of EAF Accreditation for Medical Laboratories

  • Helps medical laboratories develop a quality management system to meet ISO 15189 requirements,
  • Improving health safety, privacy, ethical reporting practices and patient management.
  • Helps to train laboratories to assess their competencies and personnels,
  • Helps to develop the needs of clinical personnel responsible for caring for patients.
  • The scope proposed by the current EAF for applicant and accredited medical laboratories is as follows: Medical Imaging, Haematology, Immunology, Point-of-care Testing, Clinical Microbiology, Genetics, Clinical Pathology, Clinical Biochemistry

ISO 15189 specifies requirements for quality and competence in medical laboratories. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.