EN ISO 13485:2016 Standard should be used as base for the establishment of the Quality Management System (KYS) for medical device producers. Accordingly;

  • At first every process that are applied/ will be applied should be determined in detail with the consideration of the extent of the operation, which involves the planned or completed production of medical devices by the company.
  • All resource needs such as people, who will apply the process in process specification, process representatives, machine or equipment that are needed, should be identified and the resource needs that are specified by the executives should be provided.
  • The interaction between all processes from specified design to purchasing, production to quality control, storage/delivery to sales should be formed within the content of the ISO 13485 Standard and the operation of the company. This interaction should preserve the integrity and the continuity of the Quality Management System.
  • Specified processes along with their details from how the processes will be conducted to how they will be recorded should be documented in accordance with the ISO 13485 Standard.

We advise to base the “identify what you have done, apply what you have identified and record what you have applied” consciousness.