21/30386856 DC

This standard 21/30386856 DC BS EN ISO 15189. Medical laboratories. Requirements for quality and competence is classified in these ICS categories:

• 03.120.10 Quality management and quality assurance
• 11.100.01 Laboratory medicine in general

This document specifies requirements for quality and competence in medical laboratories.

This document can be used by medical laboratories in developing their management systems and assessing their competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

This document includes requirements for Point of Care Testing (POCT).