Quality management is a top priority in industries such as pharmaceuticals and medical technology. The ISO 9001 standard in particular ensures uniform standards and generates trust. Since the beginning of June, COSMO CONSULT LS GmbH, which specializes in life sciences, has had ISO 9001:2015 certification. This certification confirms the software and consulting company's process competence and customer orientation, bolsters its own competitiveness and simplifies cooperation with life sciences companies.
Pharmaceuticals and medical technology are among the industries that are highly regulated. Because especially in this field uneven quality can have serious consequences, law-makers have established high requirements. Companies must do more that ensure that their own processes are valid and run smoothly. They are also responsible for ensuring that their suppliers operate at a similarly high level in terms of safety and quality. After all, processes can rarely be confined within one company. The ISO 9001 standard has established itself as a sensible foundation for taking care of this. By obtaining certification, partners demonstrate that they work with a quality management system that is compliant.
Since the beginning of June COSMO CONSULT LS GmbH has been among the number of ISO 9001:2015 certified solution providers in this field. The company, which is part of the COSMO CONSULT Group, is specialized in software and consulting projects in the life sciences sector. "The ISO 9001 certification highlights our attention to quality and lays the foundation for a positive qualification of suppliers by our customers. A certificate from an independent third party establishes the necessary trust with existing and potential customers", says Oliver Benecke, Director Sales for Life Science Manager at the COSMO CONSULT Group.
The certification was carried out by DEKRA e. V., which reviewed the processes in all areas. This includes resource planning and responsibilities, as well as, customer satisfaction, quality policy and also complaints and document management. "We worked through all requirements step by step and developed new systems for areas in which solutions were not yet available" explains Christoph John, Senior Consultant, Quality Management and Computer System Validation at COSMO CONSULT LS GmbH. To ensure that the organization of future operations is flexible and decentralized, all processes are digital and can also be controlled from on the road or when working from home.
For COSMO CONSULT LS GmbH, improved competitiveness and easier market access represent only two of the advantages of the ISO 9001 certification. The progress made in terms of processes is equally important. "Some of the requirements required us to do some hard thinking, and then we found solutions that not only meet the specifications, but also allow us to work more efficiently and transparently. Today, there are fewer misunderstandings and our processes are optimized to avoid extra work," says John. The certification therefore also has a high additional value inside the company. "For us, it was almost an act of liberation. It was something we really wanted to do. Now we have a tangible document attesting our ability to work at a high level of quality," says Benecke. He sees the successful ISO 9001 certification as a blueprint for other companies in the COSMO CONSULT Group to make advances with quality management, customer satisfaction and customer loyalty.