Comprehensive quality management has always been a part of Invisio Clinical Studies Consulting’s DNA. In August 2021, the Mannheim-based clinical research organization went one step further and became certified according to the DIN ISO 9001:2015 Quality Management Standard. The initiative to achieve this accomplishment came from Managing Director Florian Schnabel. In explaining his motivation to become certified, he said: “One goal was to further professionalize internal and external processes. We were also looking for a way to demonstrate to our business partners that we meet internationally comparable quality standards. With this certification, potential clients now immediately know whether our way of working and operating meets their requirements. This reduces their workload and saves them time.” Dr. Christina Gehbauer, Clinical Project Manager, internally supervised the process, and Alina Varaksin, Management Assistant, supported her throughout the entire process. Moreover, Invisio brought in an external consultant in order to be as well prepared as possible for the audit. The external consultant examined existing processes and documents, identified potential for improvement, and prepared the team for the Dekra’s official audit by submitting the team to a trial audit.
Invisio is implementing a comprehensive set of measures
In regard to the certification process, Christina Gehbauer said: “We were able to build upon our existing quality management system. It was very helpful that we were already working with controlled documents and a predefined folder structure, and that we documented all the duties and responsibilities for the trials in a comprehensible way.” Gehbauer explained that the ISO certification has revealed potential to Invisio that it now wants to exploit by taking various measures. These included, among others, writing an Invisio quality management manual, creating clearer and more precise project-specific documents, and establishing centralized evaluation systems. “In order to be in the position to evaluate customer feedback in an even more targeted manner after completing a project, we are now documenting feedback from our customers via a standardized online questionnaire,” the project manager explained. In addition to the aforementioned improvements, an annual management review has also been implemented. “In combination with evaluations and risk analyses, this regular review makes it clear what went well and where we must take action. By doing so, we can continuously improve, further develop our offering, and be able to respond to potential challenges in time,” emphasized Florian Schnabel. Another plus point for him is that the management review reveals strategic perspectives and enables business decisions to be based on transparent processes and to be made in a reflective manner.
Schnabel and Gehbauer agree: Good quality management systems help them meet their responsibility to their customers and keep their promises. They explained that “for this reason, we would also like to become recertified when the time comes. In 2022 and 2023, there will be surveillance audits for which we will have to prove that we have achieved our goals and are constantly developing and improving. In 2024, the reaudit will follow.”