ISO/IEC 15189 Implementation in Microbiology Laboratory - General Concepts

Microbiology laboratory is a type of medical laboratory and should be safe and efficient environment. Even it is not a mandatory for the accreditation in most of the countries, ISO/IEC 15189 remains the most common reference for quality of work in medical laboratories. It is mostly based on good laboratory practices and is oriented to support accurate clinical decisions. ISO/IEC 15189 has potential to become very effective instrument for development and improvement of medical laboratories. Results from laboratory should guide the majority of clinical decisions and help in providing adequate patient care. This article provides a simple approach to meet the minimum requirements set. To achieve intended goal and strictly follow the requirements proposed in the standard, the trained and well-motivated laboratory staff is necessary to implement the system. The objective of this article is for it to be used as a guideline for evaluation and implementation of the ISO 15189.