Preparing site for first-time ISO 13485 audit

This depends on the type of your medical device. It is expected that, if the medical device is sterile, those necessary premises are properly clean. Also, there should be no cross-contamination between warehouse and production, that pathways for raw material and final goods are not crossed over each other. It is also expected that everything will be properly labeled. For example, cabinets, tables, drawers if they can be used for different purposes (eg clean/unclean) that it is so marked; if there is a defined place to dispose of something then that too should be properly marked; in the warehouse to see exactly where the non-compliant products are disposed of, and to see the paths of forklifts and people. If separate work clothes are required, then the place from which one can only move in it should be marked.

Following article regarding infrastructure can be helpful:

• Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/