1. What is ISO/CEI 17025?

ISO/CEI 17025 is a quality, administrative and technical management system standard applicable to any laboratory carrying out calibration and/or testing, regardless of its size or the scope of its calibration and/or testing activities.

The term "test" is to be understood in its broadest sense, and covers any type of experimental measurement, whether physical, chemical or biological. Since 2003, like ISO/CEI 17025, the ISO 15189 standard has covered specific requirements concerning the quality and competence of medical biology laboratories.

To consider ISO/IEC 17025 as a quality management system would be to run the risk of depriving it of a large part of its value, namely the opportunity to demonstrate a laboratory's technical competence.

In its two main chapters, the standard describes the general competence requirements...