Requirements for infrastructure

Answer:

ISO 13485 allows exclusions of any requirements from clauses 6, 7 and 8, if they are not applicable to the type of business your organization is performing. Of course, as long as you can provide justification for the exclusion.

Requirements for infrastructure can hardly be excluded, because you still use some kind of equipment, and the entire point of this clause is to define and plan maintenance activities .

Work environment requirements, on the other hand are probably not entirely applicable to your type of business, so you can exclude requirements fo r cleanliness and clothing of personnel (clause 6.4.1) and contamination control (clause 6.4.2).

All the parts of the Procedure for Infrastructure and Work Environment that are not applicable to your type of business can be either edited or completely deleted.

For more information, see: 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/