For the supplier of optical components and systems, this is confirmation of the successful implementation of the quality management system for medical device manufacturers. The Swiss Association for Quality and Management Systems (SQS) audited, amongst other things, strategic processes, core development and production processes as well as supporting processes. This also comprised SAP validation, as it is here that quality data is stored, production processes are controlled and traceability ensured within the Business Unit. Production processes such as adhesion processes were also validated, whereby the family company from Berlin obtained new know-how in quality assurance.
As of now, Berliner Glas will undergo an annual verification of the certification guidelines as well as compliance with the provisions of the Medical Devices Act and EC Directive 93/42/EEC (European Directive about Medical Devices).
The successful certification once again shows that Berliner Glas sees a strong future in the growing market of medical technology and life sciences. Sven Knuth, Head of the Medical Applications Business Unit, had the following to say about this: "For us the certification is a clear commitment to the medical technology market and underlines our strategic orientation to further expand our range of optical systems for OEM manufacturers in medical technology. In addition we offer our customers even more safety when it comes to our quality standards. The ISO 13485 certification is essential for us and we are delighted with it.“