Quality management system ISO 13485
Our first and the most important aim is to deliver quality to our customers. This is how we started our research and development process and this is also our main decision making tool. After the research process at the Faculty of electrical engineering was finished, we started development process as a start-up company MESI. As we realized the importance of quality management system in early stages of the development we immediately established the quality management system under international standards ISO 9001 and ISO 13485. I would like to share with you what in particular quality management system brings to our customers and why it makes our company more reliable partner.
We are certified under two ISO standards. Fundamental quality standard is EN ISO 9001:2008 titled Quality management system – Requirements and additional standard which covers medical devices manufacturers EN ISO 13485:2012 titled Medical devices – Quality management systems – Requirements for regulatory purposes. All requirement from EN ISO 9001:2008 are also included in EN ISO 13485:2012, therefore I will focus on EN ISO 13485:2012 importance of which is even higher as it includes requirements from EU medical directive 93/42/EEC.
Let me tell you now what in particular is beneficial for you. Firstly, each sub-part of medical device is fully tested by several different institutions before notified body Slovenian Institute of Quality and Metrology performs inside control of a medical device as a whole. After product is released to production, each production step and each quality control checkpoint is regulated. All components and sub-products are traceable from our sub-manufacturer to us and to end customer. This is how we catch all weaknesses before our ABPI MD is delivered to you. We perform all activities within the methodology Plan – Do – Check – Act and in our opinion this makes us a reliable healthcare partner.
Please see our certificates EN ISO 9001:2008 and EN ISO 13485:2012.