ISO 15189 Medical Laboratory Competence and Calibration standard was devised to uphold standards in medical laboratory environments, reflecting the importance of high-quality provision of scientific services as part of the treatment of patients.

The ISO 15189 standard is based on ISO 17025 Laboratory Competence and Calibration, which covers general requirements for the competence of testing laboratories and calibration activities. However, it specifies additional requirements that help medical labs achieve first-class levels of competence. It is relevant to businesses that operate in diverse areas of healthcare, from toxicology to haematology and genetics to pathology, as well as many other branches of the medical profession.

ISO 15189

ISO 15189 is the standard required by Covid testing facilities and hence has seen a surge in uptake over the last few years for this reason. As a result of the pressure this put on UKAS (the accreditation body) during this period, the normal accreditation process was altered. It is expected that once things return to more normal levels of activity, that UKAS will revert to the normal practices that took place before Covid. This may mean a change to how existing Covid facilities find the ISO 152189 processes take place. Please speak to our Consultants to get the latest on this.

To achieve ISO 15189 accreditation, organisations must prove:

• Laboratory processes are recorded, controlled and checked for errors
• A regular process audit is in place
• The audit feeds into management reviews.

The UK Accreditation Service (UKAS) provides ISO 15189 accreditation and our expert team of Consultants is waiting to help you achieve this standard for your business.