Hekuma Is now ISO 13485: 2012 Certified
On August 26, 2015, the system manufacturer Hekuma GmbH, Eching, Germany, had its market-specific performance level in designing and implementing medical systems certified according to the "ISO 13485:2012 standard". The objective of the certification process was not only to be able to demonstrate and document the company's normative quality and performance standards to its existing customers and those to be newly acquired. Another major objective was to expand among its employees an understanding of the specific requirements in the extremely demanding medical technology industry in order to be able to optimize the internal processes accordingly.
At the end of the preparation and implementation phases for the certification, which took a total of two years to complete, the company boasts "even more clearly optimized services for the customer", says Jakob Kammerloher, Technical Director and Quality Management Officer of hekuma: "I believe that as a result we can sharpen the understanding of the specific relationships within the industry. Customers will certainly be able to benefit from this in the future."
An additional service advantage for the customer can be found in the expanded options available for the qualification and validation processes. Especially during conducting the system qualification process, there is now an option to have high-performance automation systems be evaluated in house over several project phases and, if necessary, to carry out systematic process improvements. An integrated qualification on site makes it much easier for customers to transition to the validation process that subsequently takes place under real production conditions. This way, in the future Hekuma customers can save time and money, which would otherwise be incurred for having technicians on site to carry out the process.
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