ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.

ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

Definition of Medical  laboratory – Laboratory for the biological, microbiological, immunological, chemical, immunohaematological, hematological, biophysical, cytological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of the health of, human beings, and which may provide a consultant advisory service covering all aspects of laboratory investigations including interpretations of results and advice on further appropriate investigations.

The following are the basic requirements for ISO 15189 certification/accreditation:

  • A well documented procedure analysis by the laboratories.
  • Training manual provided by the laboratories.
  • ISO 15189 requires an effective detailed analysis of medical laboratory procedures in a bid to make sure that all weaknesses have been identified.
  • Detailed evaluation reports of the existing quality management system as well as other monitoring and evaluation reports.
  • A detail audit of management reviews.

The ISO 15189 certification has a set of unique benefits and the main objective of certification is quality assurance.

The benefits are listed here below:

  • An ISO 15189 certification promotes development of an international reputable image for your organization through Quality Assurance and Management Systems.
  • Promotes a strong degree of consistency in compliance to medical laboratory laws and legislation both from an international and national perspective.
  • Fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery.
  • The certification program also has been very critical in promoting modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs.
  • Ultimately, promote the growth of customer satisfaction in organizations involved in medical laboratory testing.
  • Accreditation ensures technical competence of the laboratory.
  • Insurance, corporate customer, clinician and patient get confidence on the test results issued by the Accreditation Body.

Medical Laboratory accreditation (ISO 15189)

Accreditation Body provides accreditation to the internationally recognised standard ISO 15189:2012 Medical Laboratories – requirements for quality and competence. 

Accreditation covers the following disciplines: 

  • Clinical Biochemistry – Toxicology – Endocrinology
  • Haematology – Blood Transfusion
  • Microbiology – Virology – Parasitology – Serology – Mycology
  • Histopathology – Cytology – Mortuaries/ Anatomic pathology
  • Immunology
  • Genetics/Molecular biology
  • Andrology
  • Clinical pathology

Who can provide Accreditation:

List of Accreditation Body can be checked from ILAC Website www.ilac.org