Quality

The INSION credo: Quality at its best.

The core of our product philosophy is to integrate maximum functionality into a moldable microchip – and to pay close attention to all details. Using precisely controlled batch processing, our products are unique with regard to their robustness, stability and inter-instrument agreement.

To ensure highest product quality throughout all project phases, our procedures include methods such as FMEA, SPC and lean 6 sigma. All development and production processes of INSION’s products have been established and optimized according to the rules and regulations of ISO 9001 and ISO 13485. The INSION quality management system continues to use these established processes and rules as our standard.

 

Path to ISO-certification

Status 2011: ISO 13485 conform system established at the time of the MBO (foundation of INSION)

Oct. `11 – Dec. `12: Process transfer to INSION + qualification in the new environment

  • Adaptation of established processes + documentation & forms to the new needs of INSION GmbH
  • Customer audits (according to ISO 13485 and ISO 9001)


2013 - 2016:

  • Optimization of processes
  • Audit preparation

2017: ISO 13485 audit on target