In Part Two of 'Equivalences between Standards and Regulatory Rules' the compliance of DIN EN ISO 9001 with GMP, EN 45001, and GLP was examined. For this purpose the concept of 'classes of regulatory circuits', a term that characterizes certain types of regulatory circuits, was introduced. These 20 classes of regulatory circuits were classified according to the 20 quality assurance elements of DIN EN ISO 9001, with the consequence that many equivalences between the different documents stated in our title were found. Therefore, the following question was raised: how many standards, directives, or regulatory rules are necessary for medical or blood banking institutions whenever they do not limit their activities to local blood component preparation and patient care, but try to cooperate with commercial companies to secure their established position and. at the same time, guarantee for a permanent high level of quality assurance? A proposition is offered for consideration.
