Implementation of ISO 13485:2016 QMS

After a successful ISO audit, we are proud to announce that Kalms Operations has successfully implemented the ISO 13485:2016 Quality Management System!

This important milestone opens a great opportunity for a reliable logistical distribution, fulfillment and multi-language customer service in the European life science market. We are proud to have earned this QMS that recognizes that quality standards that are an integral to the first-class service we constantly strive to provide our customers.

Gerald Schröder, Head of the strategic Business Unit at Kalms Operations, says, “We are all extremely excited about this great step forward. We look forward to the opportunities that our successful ISO audit will bring us. We thank all of the helping hands and minds, who made this great success possible.”

“We are all extremely excited about this great step forward. ”

Gerald Schröder,

Head of the Strategic Business Unit

The ISO 13485:2016 standard proves that a company following this standard, has a fully developed quality management system in place. It describes internal company procedures as standard operational procedures; with a strong focus on product preservation and customer satisfaction. This Quality Management System establishes that Kalms Operations reliably meets customer and regulatory requirements.

Kalms Operations, the operational brand of Kalms Consulting, is based in Berlin. They offer professional healthcare logistics, warehousing, customer service, fulfillment, marketing and trade-show support. Additionally, they ship all around the world. Kalms Operations offers modular, flexible and tailor-made services; for start-ups, small and mid-sized companies.

Healthcare companies using their services can rely on Kalms Operations’ fulfilment and warehousing services, which follow all the necessary regulations concerning product and patient safety. Manufacturers can trust their procedures on product preservation and traceability. They will also appreciate the excellent and committed customer service. If you are looking for a solution with a lean organizational structure in Europe or even without a legal entity there, Kalms Operations will support your business success in Europe.