ISO 15189

Medical Laboratory Accreditation

Providing confidence that medical laboratories deliver quality levels of performance and competence.

Laboratories are responsible for delivering an average of 300,000 tests every working day in support of the nation’s health services. From blood tests to biopsies covering diagnosis or the ability to monitor treatment progress, medical labs provide the vital test results that inform treatment decisions and health outcomes.

ISO 15189 accreditation underpins confidence in the quality of medical laboratories through a process that verifies their integrity, impartiality and competence. Assessments under UKAS accreditation ensure labs meet the relevant requirements including the operation of a quality management system and the ability to demonstrate that specific activities are performed within the criteria set out in the relevant standard.

ISO 15189 accreditation covers the following disciplines:

Clinical Biochemistry – Toxicology – Endocrinology
Haematology – Blood Transfusion
Microbiology – Virology – Parasitology – Serology – Mycology
Histopathology – Cytology – Mortuaries
Immunology
Genetics
Andrology
Histocompatibility & Immunogenetics

UKAS Training Academy

To support our accreditation work, the UKAS Training Academy offers a range of public and on-site training courses. Our portfolio of courses provide UK & overseas delegates with knowledge and best practice of accreditation practices and conformity assessment systems.

To find out more about courses specific to this standard, click here.

Readiness Assessment Tool

We appreciate the journey to accreditation can be daunting, with this in mind we’ve created a Readiness Assessment Tool. Start your self-assessment against the expectations of ISO 15189 and find out how ready you are to apply by clicking here.

How to apply

Complete the application form relevant to your application – this will include details of what to submit, including key policy and procedure documents and proof of legal status, to ensure swift processing.

Please download and complete the relevant application form(s) to apply for accreditation here.

Accreditation for healthcare professionals

Quality Standard for Imaging (QSI)

UKAS accreditation of imaging services is a patient-focused assessment that is designed to help diagnostic imaging services ensure that their patients consistently receive high quality services, delivered by competent staff working in safe environments.
Improving Quality in Physiological Services (IQIPS)

UKAS supports the delivery of quality physiological services based on a formal and impartial assurance process designed to deliver clearly defined and professionally led standards.
Medical Physics & Clinical Engineering (MPACE) to BS 70000

Accreditation underpins the delivery of safe, accurate and expert procedures and practices relating to medical physics and clinical engineering. It also provides assurance that equipment is managed, maintained and operated to recognised quality standards
Point of Care Testing (POCT) to ISO 22870

Applied in conjunction with ISO 15189, this accreditation is an important element in establishing and maintaining confidence in a point of care testing service.
External Quality Assurance Provider (EQA) to ISO/IEC 17043

Accreditation for Proficiency Testing (PT) scheme providers to demonstrate their competence to plan and implement proficiency testing programs.