|Another milestone on the path is reached - We are ISO 13485 certified now!
We are pround to inform you, that we fulfil completely the high requirements of the ISO 13485:2003 and are now certified.
The management system comprises the development, manufacture and distribution of ultrasonic welding machines and ultrasonic components for special purpose machines as well as the applications advisory, development and manufacture of customized tools.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. Please note, that our Ultrasonic Welding Machine Dynamic 3000 is already certified by Class ISO 6 and is therefore in accordance with clean room requirements.
However, RINCO ULTRASONICS AG does not rest on its laurels. In the interest of continuous improvement the processes are constantly improved in order to provide our customer also in future with highest quality.