5.2 Analysis and validation

The hospital's services, in particular the medical and nursing (medical) core services, should comply with the professional rules (of doctors, nurses and other professional groups) and take into account the current state of scientific knowledge. For the individual services, it should be proven that they are suitable to fulfill the expectations placed in them (validation of the services with regard to the essential quality characteristics) and that the services are reliably provided by the hospital in the planned manner (verification). Combinations of therapeutic procedures must be examined separately.

The evaluation must be carried out using scientific and technical rules and test theory. It must always be demonstrated whether and to what extent the specified and assumed quality requirements are met. The evaluation should describe the degree of fulfillment and the reliability of the statements with statistical data. Own studies, expert opinions, literature documentation or guidelines from authorized institutions (standards) can serve as evidence for the statements on performance. Several professional groups will always be involved in the evaluation process. The tools of process planning and review should be used. It should be stipulated that research and development activities for new treatment procedures are assigned to qualified personnel who are equipped with appropriate resources.