Accreditation for Medical Testing Laboratories

Accreditation for medical testing laboratories refers to the process of evaluating and certifying that a laboratory is competent to perform specific types of medical testing services. Medical testing laboratories are responsible for the analysis of samples taken from patients in order to diagnose, monitor, or treat medical conditions.

Accreditation for Medical Testing Laboratories

Medical testing laboratories may be accredited by a variety of organizations, including regulatory bodies, professional associations, and certification bodies. The specific accreditation standards that a laboratory must meet will depend on the types of medical testing services it offers, as well as the country or region in which it operates.

One common standard for medical testing laboratories is ISO 15189, which is an international standard for the competence of medical laboratories. To obtain ISO 15189 accreditation, a laboratory must demonstrate that it has the necessary equipment, facilities, and personnel to perform the specific types of medical testing services for which it seeks accreditation. It must also have a quality management system in place that meets the requirements of the standard.

Obtaining accreditation for medical testing laboratories is important for several reasons. It can help to ensure the accuracy and reliability of the test results, which can have significant impacts on patient care and treatment decisions. Accreditation can also demonstrate the laboratory's competence and credibility to customers and regulators, and may be required in order to perform certain types of medical testing services.

Accreditation is an effective way to demonstrate competence of the laboratory, a tool to recognize laboratories world-wide, is linked to periodical audits, to stimulate the maintenance and improvement of the quality, which leads to high standard of services for clients (patients, health care providers, etc.).

United States Accreditation Inc. offers an internationally recognized accreditation program for medical testing laboratories. Requirements for United States Accreditation, INC.'s Accreditation Program for medical testing laboratories are defined in ISO 15189:2012 Medical laboratories Requirements for quality and competence.

United States Accreditation Inc.'s Accreditation Program is internationally recognized and it's accreditation helps medical testing laboratories deliver services with confidence and attract new customers. United States Accreditation Inc. 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 United States Accreditation Inc. 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 United States Accreditation Inc. 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.

Accreditation is not about who the best is, but who has a system of standard procedures with aim to improve the quality and patient safety. Quality system is about people, with people and for people.

Get Accredited

Accreditation by U.S. Accreditation will boost the profile of your business and demonstrate its commitment to being a quality education provider, respected worldwide.