An effective quality system forms the basis for the development of usable processes and suitable medicines. In this context, the crucial responsibilities of management, competent persons and quality assurance must be highlighted. By clarifying these roles, clear guidelines for action should be created for effective implementation. A particular focus is on the question of whether “Quality Oversight” will become mandatory in the EU. It is important to discuss a possible new approach that could significantly influence quality standards in the pharmaceutical industry. All of this is contained in Chapter 3 of Annex 1. But it is always overlooked or not interpreted correctly. But it is one of the most important chapters for understanding Annex 1 and its objectives.