gms | German Medical Science

Introduction: The term quality management (QM) refers to organisational measures aimed at improving process orientation and process optimisation. A crucial aspect is the application of goal-oriented and goal-directed management techniques that include staff and promote commitment in order to achieve a positive impact on end products. University ENT departments play an integral role in the German health care system and provide services in health care, research and teaching. There is an increasing tendency to obtain certification in order to prove compliance with requirements to introduce quality-assurance measures and to implement an internal quality management as set down in paragraph 135a of Volume V of the German Social Insurance Code (SGB V). In view of this, the necessity of achieving this accreditation in a university ENT department was investigated.

Material and methods: This project was defined as the implementation and development of a quality- management system with the aim of attaining patient-oriented process optimisation and achieving certification to prove that all requirements of the DIN EN ISO 9001:2008 standard are met. After a project plan had been drawn up, the measures necessary to fulfil these stipulations were carried out by a quality-management core team, which included employees from four areas: health care, research, nursing and teaching.

Results: The project and necessary measures carried out resulted in the achievement of DIN EN ISO 9001:2008 certification, covering health care, research and teaching activities, within a university hospital department. This accomplishment shows that the QM system enabled process orientation to be attained in all relevant work areas.

Discussion: DIN EN ISO 9001:2008 certification verifies that all process quality standards have been met. When a university hospital department achieves this accreditation, the distinctive aspect involved is that not only health care but also teaching and research have to be included in order to attain an integrated certification process, which is required for the interaction of the various disciplines and groups. It is, however, often not possible to directly and demonstrably show that the effects of certification influence the quality of outcomes. Nevertheless, a causal relationship of this kind can be achieved by greater trust built on the basis of increased process quality or optimisation of documentation structure. This may potentially also have a positive impact on financial statements. A basic prerequisite is a high penetration rate in order to bring about implementation of the culture-changing elements of certification.