(16) Transfuzijske ustanove morajo uvesti in vzdrževati sisteme kakovosti, ki vključujejo vse dejavnosti, ki opredeljujejo cilje politike kakovosti in odgovornosti, in jih izvajati v smislu načrtovanja kakovosti, nadzora kakovosti, zagotavljanja kakovosti ter izboljševanja kavosti znotraj sistema kakovosti, ob upoštevanju načel dobre proizvodne prakse, kot tudi sistema ES za ugotavljanje skladnosti.
(16) Blood establishments should establish and maintain quality systems involving all activities that determine the quality policy objectives and responsibilities and implement them by such means as quality planning, quality control, quality assurance, and quality improvement within the quality system, taking into account the principles of good manufacturing practice as well as the EC conformity assessment system.