Congratulations to our team at Hoffmann + Krippner GmbH who was able to complete this year’s certification according to ISO 9001, 14001 and 13485 with very good results! The auditors examined our processes both on site and online and found no deviations.
During the audit, the processes in management, purchasing, warehouse and in production were examined in detail. This was followed by the HR department, sales, design and development, including software validation and test equipment monitoring.
You can find our certificates here.
Extended requirements for ISO 13485
For many years we have been supplying medical technology customers with custom solutions such as membrane switches, touch systems and sensors. We offer support from the initial phase of development.
Hoffmann + Krippner GmbH has been ISO 13485 certified since 2010. In 2018 the switch was made to EN ISO 13485:2016. Compared to ISO 9001, EN ISO 13485 primarily requires extended risk management and extended documentation.
Through close communication with the customer during the proposal phase, we determine the customer-specific requirements and implement them systematically in the project phase. This ensures smooth implementation and transition from samples to series production.
For our customers, certification according to EN ISO 13485:2016 ensures that the basic understanding, the necessary tools, methods and standardized processes are established within the company. We speak the same language because the terms and requirements are not new territory for us.
This can create significant added value for our customers.
A big thank you goes to our amazing team at Hoffmann + Krippner GmbH to show such good results in all audits.
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