Two successful recertifications at Fleima-Plastic

The TÜV audit took place at the end of July and the certificates have now been presented. There was great praise for the quality management system: "The auditors particularly praised the very good anticipation and implementation of the new requirements," says Peter Bremer, Managing Director Operations Europe at the Masterflex Group. Both recertifications had become necessary because there was a new version with some changes for both ISO 9001 and ISO 13485
ISO 9001 defines the minimum requirements for a quality management system (QM system), which is the most widespread national and international standard in this area. ISO 13485 is a standard representing the requirements for a comprehensive management system specifically for the design and manufacture of medical devices.
Fleima-Plastic has more than 40 years of experience in the production of high-quality injection moulds and parts for high-tech industries such as medical and food technology.