Omnitron Griese GmbH is certified according to DIN EN ISO 9001 and DIN EN ISO 13485 for batteries, rechargeable batteries and pack production.
Our quality management system is certified according to the DIN EN ISO 9001 standard. This worldwide standard is recognised in over 130 countries and formulates the general requirements for quality management systems. The scope covers design, development, packaging and distribution of mobile power supplies.
DIN EN ISO 9001 is process-oriented and supports the smooth execution of projects. The standard describes in detail the actual state of our company and makes processes transparent for business partners.
Our quality management system is additionally certified according to the DIN EN ISO 13485 standard for medical devices. This standard supplements the ISO-9001 quality management system with special requirements for the manufacture of medical devices.
An important element of ISO 13485 is the integrated risk management. It serves the early recognition of hazards which may emanate from the medical device or the processes used and their elimination already in the development process and in the later product life phases.