Practical implementation of a quality management system in a radiological department

This article describes the architecture of a project aiming to implement a DIN EN ISO 9001 quality management system in a radiological department. It is intended to be a practical guide to demonstrate each step of the project leading to certification of the system. In a planning phase resources for the implementation of the project have to be identified and a quality management (QM) group as core team has to be formed. In the first project phase all available documents have to be checked and compiled in the QM manual. Moreover all relevant processes of the department have to be described in so-called process descriptions. In a second step responsibilities for the project are identified. Customer and employee surveys have to be carried out and a nonconformity management system has to be implemented. In this phase internal audits are also needed to check the new QM system, which is finally tested in the external certification audit with reference to its conformity with the standards. (orig.)