Preparing site for first-time audit

Site preparation depends on the type of production you have for your medical device. If that is a sterile medical device, then a lot of attention needs to be on the cleanliness of the premises. It means for example: the separate entrance of the raw material and exit of the finished product, special rules for clothing and behavior in the facility (protective clothing and other equipment, not allowed to eat or drink in the production area).

If you produce a non-sterile device, then also there must be special attention to the work environment which is applicable for that kind of device. 

If you produce software, rules for the work environment are less important, although it is important for the server room to have proper temperature and humidity. 

In the warehouse, you need to have a properly labeled place for non-conforming products. 

Other elements that cover site preparation mean that you need to have everything properly labeled, eg. shelves, lockers, locations in the premises.

For more information on this topic, please see the following articles:

• Managing cleanliness of a product and contamination control according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/07/04/managing-cleanliness-of-a-product-and-contamination-control-according-to-iso-134852016/
• 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/