Quality & Compliance Services
At Intelesens, we conduct periodic reviews of our quality management system and monitor the implementation and effectiveness of quality plans. We implement and maintain a risk management approach in the processes of the Quality System and in the life cycle of products. Our pursuit of our quality standards and operational procedures are clearly defined in the Quality Manual, and strictly enforced throughout the company and the production of the full range of Intelesens products.
These procedures are in accordance with the requirements of ISO 13485 and are the minimum standard adopted by Intelesens. All Quality System procedures are mandatory and unauthorised deviations from these standards are not allowed. Procedures other than those defined, or otherwise required by the customer, may apply only after their effectiveness has been demonstrated and agreed by management.