Maximum Safety – Quality Management at WOM
WOM represents the highest level of product quality in medical technology. To ensure this, our company uses precisely tailored, integrated quality management to constantly and consistently improve all work and production processes and to define new standards.
Quality right from the Get-Go
We define intensive verification and validation processes as soon as the go-ahead has been given for development. We carefully consider requirements of a specification at an early stage of development, so that a product meets the desired characteristics later on. For example, we define early on the extensive testing required to ensure the exact pressure conditions in the body cavity using our Insufflators, even in the event of pressure loss through leakages. Verification and validation are important building blocks, so that we can fulfill our promise of quality. We follow the principle: Error prevention saves troubleshooting.
Workshops for ongoing Optimization
To continuously improve our products and their performance, we organize regular workshops, which can be initiated by our employees as well as by supervisors. The focus is particularly on our organization processes. This includes a review of the respective tests to which we subject our devices – beyond existing norms and standards – before we bring them to market. We also carry out extensive testing in our cleanroom facility before and after the actual production process.
Strict Criteria for Suppliers
The careful selection of our suppliers according to strict criteria is another quality feature. All suppliers are certified and regularly audited by us and by our major customers. Only after extensive testing of their suitability through certifications are purchases from new suppliers approved.
Important Certifications and Registrations
As a manufacturer of medical devices, WOM satisfies all relevant national and international regulations, including the requirements and guidelines of the MPG (Medical Devices Act). Our quality management is certified according to ISO 9001 (Quality Management – Requirements) as well as EN ISO 13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes). Our environmental management system also meets the requirements of ISO 14001. In addition, we are registered with the U.S. FDA (Food and Drug Administration). We gladly provide you with further information.