18. September 2019

KUMAVISION receives award for best quality management

Within the framework of the annual audit for the standard DIN ISO 9001: 2015, the Healthcare Solutions division of KUMAVISION won the "Best implementation" award, as it did last year. The award documents the lived quality management of the ERP specialist, which covers all processes from development to implementation to the support of the ERP industry solution for healthcare and medical technology. This benefits the customers who, for example, can rely on the certified and documented processes of KUMAVISION for their own validation.

Wolfgang Renner, who is responsible for Quality Management at KUMAVISION as Head of Healthcare Solutions, accepted the award for the "Best Implementation" at the beginning of this week in Stuttgart from the accredited certification body H + S GmbH, representing the entire healthcare sector. "The award confirms the successful implementation of the highest quality standards in all processes, documentation and guidelines," enthuses Renner.

Certified processes

All processes and work instructions that play a role in the development of the ERP software are documented in the quality management manual. Process instructions, test instructions as well as structure and process rules are stored there for each individual topic. In addition to this, the QM manual also regulates the processes for the areas of consulting, introduction, care and support, which, like software development or release management, are elementary components of the portfolio. In addition to checking the normative requirements, the audit also includes visits by the auditors directly to the KUMAVISION locations. During this appointment, it is checked whether employees are adhering to the quality requirements and whether the specifications specified in the QM manual are also implemented in practice.

Proven Quality

The fact that KUMAVISION once again secured first place is demonstrated by the continuous commitment of the business software provider. "The regulated environment is very dynamic: It is not just changing market and customer requirements that constantly confront us and our customers with new challenges, but also the introduction of new laws and regulations. According to these requirements, we continue to develop our products, services and processes - as evidenced by the successful certification of our company ", says Renner. High quality standards are one advantage, simplified processes are another: Companies can rely on the support of KUMAVISION in their validation process in their own validation process. The certified and documented processes serve as a basis and save both time and costs.

Validation as an opportunity

KUMAVISION is also well-equipped for validating software and IT systems involved in development and production processes. These are mandatory for medical device manufacturers, the medical device trade and technical service companies according to the Medical Device Regulation as of 26.05.2020 or the DIN EN ISO 13485: 2016. "In the validation of computer-based systems, we see a great opportunity to further digitize processes and make companies from the regulated environment fit for the future," explains Renner. The ERP industry software for medical technology and healthcare brings with it the required functions.

More information about the topic Validation and ERP software for medical technology


 +49 800 5862876