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23. August 2018

KUMAVISION honored for best quality management

The Healthcare division of KUMAVISION has successfully completed the annual audit of the DIN ISO 9001: 2015 standard and again received the "Best Quality Management" award. In this way, the ERP specialist documents practiced quality management in his own company, from the development of his industry-specific healthcare solution to the introduction of the software and support. Thanks to the proven ISO certification, medical and health care customers benefit in many ways: Transparent processes support the implementation of laws and regulations, and the use of KUMAVISION's certified ERP solution simplifies its own validation.

Wolfgang Renner, Head of Quality Management (BdOL) at KUMAVISION, accepted the prize for "Best Quality Management" on behalf of the entire healthcare sector in Stuttgart. The trophy and the certificate were handed over by the accredited certification body H + S GmbH. "This award particularly pleases us. Because the audit has proven successfully that all our internal processes, documentation and guidelines meet the requirements of effective quality management, "stresses Renner.

Certified processes

The Quality Management Manual (QM) documents all processes and work instructions that relate to the development and operation of KUMAVISION ERP software for the healthcare sector. In addition, the processes in the areas of consulting, introduction, support and support are regulated. For each topic procedural instructions, test instructions and structural and procedural rules are deposited. In addition to the audit of the QM manual, the audit also includes a visit by the auditor on site to examine whether the requirements of the QM manual are being implemented in everyday working life. KUMAVISION mastered both stages of the examination without any objections.

Highest quality

The regular, successfully completed audit shows that KUMAVISION makes no compromise on quality assurance and is constantly evolving in this area. "With the changed market and customer expectations, our products, services and processes must change continuously. The successful certification of our company proves that we conscientiously fulfill this task, "says Renner. However, customers not only benefit from the proven processes at KUMAVISION, because they can rely on high quality standards. You can also refer to the software service provider's certificate in your own validation process and thus simplify your audit. Numerous processes documented in the QM manual serve as the basis for the validation of internal processes. Companies save time and can reduce the cost of their own ISO certification.

Comprehensive support

With the Best Quality Management award, KUMAVISION is well-prepared for upcoming validation procedures for computerized systems that are mandatory for medical and pharmaceutical companies in accordance with ISO 13485: 2016 and FDA Device Regulation. "Negative effects on patient safety, product quality and data integrity should therefore be ruled out," explains Ulrike Schanbacher, quality management representative at KUMAVISION. KUMAVISION offers its customers comprehensive support for validation: First, the current state of process validation is worked out in a kick-off, followed by documentation of the general and ERP-specific processes. KUMAVISION is supported by well-known consulting companies specializing in customers from the pharmaceutical and chemical industries as well as medical technology. "Together with our partners, we offer our customers in-depth know-how for processes and processes in the regulated environment as well as for the underlying functions in the software," explains Schanbacher, who oversees the cooperation. Customers from the medical technology and pharmaceutical industries benefit in several ways: With KUMAVISION, you have a partner at your side who bundles the required ERP know-how and can also access the comprehensive expertise of consulting companies that have many years of experience in quality management and the validation of computerized systems.

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