what is ISO 15189?
ISO 15189 is an international standard that defines quality and qualification requirements in clinical laboratories. It is designed to be used by clinical laboratories to develop their quality management systems and to assess their own competence. The standard was first published in 2003 and last revised in 2012.
why is ISO 15189 important?
Medical laboratories play an important role in the diagnosis, treatment and prevention of disease. They produce reliable results that are used to make decisions about patient care. The quality of laboratory results is therefore essential, and laboratories must be able to demonstrate their competence to gain the trust of patients, healthcare providers and regulators.
how can a medical laboratory get iSO 15189 certified?
A certification body (third-party)assessment is the basis requirements for the laboratories certification. Certification bodies are organizations recognized by an authority to provide certification services. The evaluation process includes a review of the laboratory’s quality management system and demonstration of technical competence. After the satisfaction of laboratories requirement,certificate will issue.
what are the benefits of ISO 15189 certification?
- Demonstrate your ability and commitment to quality.
- Win new business and tenders.
- Increase efficiency and reduce costs.
- Enhance their reputation