IAS: ISO 15189:2012 - Medical Laboratories Accreditation
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Medical Laboratories

ISO 15189:2012

IAS accredits medical laboratories to ISO 15189:2012 and industry specific standards. This accreditation demonstrates to the marketplace and to regulators that the medical laboratories have met the IAS accreditation requirements and are periodically monitored for compliance.

IAS 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 IAS 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


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ISO 15189 Webinar Series

Module 1 – ISO 15189 – Resource and infrastructure requirement for competence in a medical / clinical laboratory

Module 2 – ISO 15189 – Method and Process requirements

Module 3 – ISO 15189 – Process Management – Outcomes – Technical Requirements

Module 4 – ISO 15189 – System Management Policies – What is required?

Module 5 – ISO 15189 – Requirements and Procedures for Records

Module 6 – ISO 15189 – QA and QC in the Clinical Lab

Module 7 – ISO 15189 – Auditing Clinical Lab Processes

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