ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories.
[1] This working group included provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab's role in the education and training of health care staff.
[1] A third edition of the standard was published in 2012, which revised the layout again and added a section on laboratory information management.
[3] Starting in 2010, it took four years for the Kenya National HIV Reference Laboratory to gain ISO 15189 accreditation.
[6] In 2021 it became apparent that the International Health Regulations was a driver for ISO 15189 accreditation when the UKHSA provided training to EPHI staff.