ISO 13485 and cleaning process

Cleaning is covered in the ISO 13485 in the following requirements: 6.4.1 Work environment and 6.4.2 Contamination control. There is no instruction how cleaning should be performed, there is even criteria which would be the required level of cleanliness for a particular product.  It is manufacturer responsibility  to define the requirements for health, cleanliness, clothing of personnel, contamination control.

For more information on this topic, please see following article:

• 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/

You can see in our ISO 13485:2016 Documentation toolkit how this procedure looks like:

• Procedure for Infrastructure and Work Environment https://advisera.com/13485academy/documentation/procedure-for-infrastructure-and-work-environment-iso-13485-2016/