Covid-19 analysis and ISO 15189 accreditation of medical laboratories

The Covid pandemic made analysis laboratories (medical and testing laboratories) a fundamental reference to introduce new solutions aimed at identifying, diagnosing and proposing solutions to combat the SARS-CoV-2 virus (Covid-19).

In this scenario, it is essential that the requirements for the competences of a laboratory are increasingly becoming of central importance in scientific and analytical dynamics. The criteria for quality and competences proposed by internationally recognized standards, which provide indications for an adequate management of instrumental equipment, validation of analytical methods, environmental conditions, staff skills and management of quality controls, play a key role in allowing laboratories in achieving reliable and acceptable results.

The standard for quality management applicable to this wide and delicate sector is the ISO 15189 standard. It is addressed specifically to medical laboratories and provides requirements aimed at guaranteeing their quality and competence and assuring the reliability of the results expressed in the report.

The ISO 15189 standard includes management and technical requirements that allow to design an adequate quality management system aimed at guaranteeing the reliability and precision of analytical results. In this way, it is possible to accredit laboratory analysis.

A controlled and effective management of pre-analytical, analytical and post-analytical processes to guarantee the quality of the analytical results issued, especially with the purpose of handling a global health crisis such as the current one, it is a fundamental if not essential factor!

For further details, please consult the article “The accreditation of an Analysis Laboratory according to the UNI EN ISO 15189 standard – The importance of an adequate and recognized management system in dealing with a health emergency” (Fedele A., Cavallaro A., Scipioni A. Rivista Qualità, n°6/2020). https://www.spinquality.it/wp-content/uploads/2021/08/Articolo-Accreditamento-ISO15189_Fedele-Cavallaro-Scipioni.pdf

Our service to support public and private medical laboratories in the design and implementation of a quality management system aimed at the effectiveness and efficiency of the actions taken to protect public health: