Successfully certified pursuant to DIN EN ISO 15378

Riegler complements quality management by standard for primary packaging material

Within the framework of the DIN EN ISO 13485 and 9001 recertification, Riegler GmbH & Co. KG was successfully certified pursuant to DIN EN ISO 15378 with effect from 2019-10-31 for the first time. The DIN EN ISO 15378 certification combines the requirements of DIN EN ISO 9001 with those of Good Manufacturing Practice (GMP) specifically for primary packaging material. Thus, the quality management system ensures the high international standard requirements for pharmaceutical and medical primary packaging material.

“For our company this means another decisive step into the future. The extension of the certification demonstrates Riegler’s high product quality and successful quality development “, says André Neubauer, head of quality management of Riegler GmbH & Co. KG. Based on a certified and lived management system the medical technology expert Riegler meets customer requirements, regulatory requirements for cleanroom processes and requirements for a sustainable and resource-friendly production. “The positive certification is another result of continued and sustainable quality orientation by our workforce“, says Dr. Thomas Jakob, head of the medical technology business unit.