ISO 15189 Medical Laboratory Competence and Calibration

ISO 15189 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.

This standard is based on ISO 17025, which covers general requirements for the competence of testing laboratories and calibration activities. However, it specifies additional requirements that help 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 was originally published in 2003, but revised in 2007 to reflect ISO 17025 to a greater extent. It went through a further round of changes in 2012 to include a new section on laboratory information management, and has since remained the same.

The standard was developed by a Technical Committee of the International Organisation for Standardisation. The committee assigned a working group to draw up advice to medical professionals working in laboratories, covering specific aspects of collecting samples from patients; interpreting results; completing tasks within acceptable turnaround times; testing provision during a medical emergency; and acknowledging the lab owner’s role in healthcare employees’ training and education.

How ISO can add dramatic outcomes to your scientific procedures

ISO 15189 is relevant to businesses in the medical field that rely on taking measurements, conduct regular experiments and assess scientific outcomes relating to their own or other organisations’ operations. It’s also worth considering whether your company is involved in designing, making or selling products to medical firms, as the standard demonstrates reliability in a highly regulated industry.

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 accredictation and our expert team of Qualitators is waiting to help you achieve this standard for your business.