Quality policy

We attach great importance to your satisfaction

We do not compromise on quality. The most important criteria are compliance with specifications, laws, standards and environmental considerations. With our quality management, we ensure that there is complete traceability.

Our management system is ISO 9001 and ISO 13485 certified. With the successful ISO 13485 certification, we have proven that we apply a comprehensive quality management system for the manufacture of medical devices. ISO 13485 contains detailed requirements on topics relating to the manufacture and marketing of medical devices. This standard, which is groundbreaking in the healthcare sector, takes into account the high requirements for devices and systems used in the diagnosis and treatment of patients.

We require a customer and process-oriented management system from our producers in accordance with EN ISO 9001:2015. The services and deliveries provided by our suppliers must conform to our purchasing requirements and are continuously monitored by us. Every product is subject to our reception inspection in accordance with the specifications.

All processes of Antrimon Group AG are consistently documented and map all relevant main and sub-processes. All documents are digitally recorded and are available to our employees on an internal platform. Our employees use this quality system daily as an infodesk. Work-relevant templates and tools are directly attached here. The processes are regularly checked with internal and external audits and adjusted if necessary.

All our measuring equipment is recorded and periodically calibrated according to specifications. Customer requirements that go beyond our strict internal quality specifications are defined and implemented in so-called quality assurance agreements.

Certificates