What Is ISO 15189?

I. Introduction to ISO 15189

Medical testing is an essential part of diagnosis and patient care. ISO 15189 provides internationally recognized requirements for the quality and competence of medical laboratories, helping hospitals and laboratories build effective management systems and strengthen confidence in test results.

The original article referred to ISO 15189:2007 and its Vietnamese adoption, TCVN 7782:2008. That edition drew on ISO/IEC 17025 and ISO 9001, with additional requirements specific to medical laboratory quality. Current implementation should use ISO 15189:2022.

Medical laboratories can use ISO 15189 to improve quality and competence and prepare for accreditation, such as under the VILAS Med programme. ISO 9001 may be integrated where useful, but separate ISO 9001 certification is not a prerequisite for ISO 15189 accreditation.

The original article described an earlier structure with 15 management and eight technical requirements. Those counts should not be treated as the structure of ISO 15189:2022. Relevant technical subjects include laboratory personnel competence and skills;

• Environmental conditions;
• Laboratory equipment;
• Pre-examination activities; and
• Control of examination processes.

Effective implementation supports reliable results and provides a basis for cooperation and appropriate acceptance of results between healthcare organizations; it does not automatically require every institution to accept every result.

ISO 15189:2022

II. Who can use the standard?

• Medical laboratories and laboratory facilities within hospitals.
• Regulatory authorities assessing medical laboratory competence.
• Accreditation bodies assessing and recognizing medical laboratory competence.

III. Benefits

• Improve the accuracy and reliability of examination results used in diagnosis and care.
• Strengthen medical laboratory quality management capabilities.
• Help hospitals and other healthcare providers assess whether results from other laboratories can be used.
• Provide reliable laboratory evidence for health assessments and, where within the laboratory’s competence and scope, forensic activities.
• Support recognition and cooperation with other laboratories and professional development of medical and technical personnel.

Related article

• Steps for Implementing ISO 15189