Quality management system according to the latest standards in software development

The worldwide increasing of standardization activities in laboratory routines also comes along with higher requirements for companies in the field of certification. Data analyses should be-come more comparable, of higher quality and reproducible. In order to meet these require-ments, Kapelan Bio-Imaging has been working on the implementation of a quality manage-ment system according to ISO 13485 (Medical Devices Directive) since the beginning of 2021. Although the previous processes were already valid, transparent, and predominantly met the requirements of ISO 13485, as a customer from the regulated market of pharmaceutical pro-duction also noted in the course of a supplier audit, the target markets are constantly demand-ing more evidence about processes and products and, thus, the quality of products. With the new QM system, Kapelan Bio-Imaging is therefore focusing on implementing and streamlin-ing its own processes and improving documentation with the aim of exploring new markets. The focus of the new digital QM system is on increasing the quality of the products from software development to testing and release to maintenance. A certification audit for the new QM system is planned by the end of the current year.