ISO 15189:2012 Medical laboratories — Requirements for quality and competence
NBE offers an internationally recognized accreditation program for medical testing laboratories. Requirements for NBE’s Accreditation Program for medical testing laboratories are defined in ISO 15189:2012 Standard.
NBE’s Accreditation Program is internationally recognized and it's accreditation helps medical testing laboratories deliver services with confidence and attract new customers. NBE 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 NBE Accreditation for Medical Laboratories
Accredits third-party medical laboratories.
Assists medical laboratories develop a quality management system to ensure ISO 15189 and ISO 9001 requirements are met
Establishes inbuilt processes to educate laboratories to assess their own competence and personnel.
Assists in improving quality patient care, needs of patients and clinical personnel whom are responsible for the care of patients.
Increases health safety, confidentiality, ethical reporting practices and patient management.
The current NBE proposed scope available for applicant and accredited medical laboratories are as follows: Clinical Biochemistry (sub-scope: Toxicology), Clinical Microbiology, Clinical Pathology, Genetics (sub-scope: Cytogenetics), Haematology, Histopathology [sub-scopes: Cytopathology (Cytology) Hospital Autopsy], Immunology, Medical Imaging, Molecular Pathology, Nuclear Medicine, Point-of-care Testing (POCT), Pharmacology
The International Standard ISO 15189 delivers requirements for competence and quality of medical laboratories and Imaging Units. Accredited Units enhance credibility and competency of their testing services. It contains all of the requirements for a medical laboratory’s quality management system, as well as the technical requirements used as the basis for confirming a medical laboratory’s competence to perform specific medical tests. Accreditation also helps Laboratories to meet National regulatory requirements.