There are many different requirements with which in vitro diagnostic manufacturers must comply in order to place the product on the market. At the core of most of these requirements is a fundamental need to have a good quality management system (QMS) in place. This is certainly not a new requirement for companies. Philip B. Crosby said ‘Quality Management is a systematic way of guaranteeing that organized activities happen the way that they are planned Quality management is needed because nothing is simple anymore if indeed it ever was’. Although this quote is now nearly 40 years old, it is as true today as it was then.