Purpose: The ISO 9000 family of standards is the most noted standard concerning quality management and its realisation. Over one million organisations are certified according to the requirements of ISO 9001 worldwide. Especially in Europe, this standard has an outstanding status. An ISO certification creates trust between customers, partners and suppliers. In addition, it drives the companies to improve continuously in order to get a recertification. For September 2015, a revision of the ISO 9001:2008 was published. It shows many differences compared to the version of 2008. These changes mean various challenges to companies, which want to get a recertification. A main modification is the risk-based approach, which requires that the companies plan and realise measures to treat risks and chances. Particularly in Europe, the ISO 9001 revision is one of the main topics of discussion in quality management. To investigate the current status how companies in Germany fulfil the additional requirements, and especially the challenge of risk consideration, the division for quality management of the Fraunhofer IPK conducted a study with 1175 participants. The paper will firstly address the changes mentioned and the associated challenges to give a good overview and show that the new ISO 9001:2015 offers the chance to improve for organisations. The main focus of the paper will be to present the results of the study and thereby to show the status of preparation for the new ISO 9001 of German companies of all sizes. Design/methodology/approach: After an introduction to the ISO 9001:2015 and its changes and challenges, the paper follows the same structure as the survey itself. It gives an overview of the demography and results of the study and ends with a conclusion. Findings: Most German companies neither consider themselves well prepared nor do they claim to possess sufficient knowledge about the new requirements included in the revised ISO 9001 standard. The need for action is especially great regarding the new requirements subsumed under the classification of risk-based thinking. The aforementioned applies to small and medium-sized enterprises as well as to large companies. Most organisations define risk as the effect of uncertainty with solely negative effects. Therefore, only a minority evaluates both risks and chances instead of only risks. Furthermore, enterprises mostly neglect planning of actions to address identified risks. Only in a few cases, companies do implement trainings to improve their employees' capabilities regarding risk management. The afore-cited applies even though companies consider a lack of experience the main challenge related to the analysis and assessment of risks. Additionally, other newly established requirements of the ISO 9001:2015 are also only fulfilled by a minority of participants. These new requirements include the need for measures to determine the expectations of interested parties and the necessity that modi operandi are implemented which ensure that knowledge is maintained and made available to the extent necessary. Originality/value: The paper considers the study results from different angles and shows the changes and challenges of the ISO 9001:2015.