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Kalms Operations Implemented ISO 13485:2016 Quality Management System

Kalms Operations is pleased to announce the implementation of their ISO13485:2016 based 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.

Gerald Schröder, Head of the strategic Business Unit at Kalms Operations, says, “We are all extremely excited about this great step forward. Plus, we are looking forward to a successful ISO audit in the months to come. We thank all of the helping hands and minds, who made this great success possible.”

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. They ship all around the world. Kalms Operations offers modular, flexible and tailor-made services; for start-ups, small and mid-sized companies.

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ISO 13485:2016

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.

Healthcare companies using their services can rely on Kalms Operations’ fulfilment and warehousing services, which follow all of 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.

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"We are all extremely excited about this great step forward. Plus, we are looking forward to a successful ISO audit in the months to come. We thank all of the helping hands and minds, who made this great success possible."

Gerald Schröder

Quality & Regulatory

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