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ISO 13485

2016 Update


In September, 2017 GEHR USA made a large step in its Quality Management System by incorporating two new ISO standards, ISO 13485: Quality Management Systems for Medical Devices and ISO 14001: Environmental Management Systems, to its existing Quality Management System which was Certified to ISO 9001. During April, 2018, GEHR USA successfully completed its transition from ISO 13485: 2003 to ISO 13485: 2016. One of the key updates during this transition was the use of the risk management approach within its quality management system. This, along with other updates, allow GEHR to establish and maintain effective processes which consistently produce high quality products for its customers.




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