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Infrastructure: Equipment, Work Environment and Contamination Control

QMS for Medical Device Companies
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Y

yodon

Staff member
Super Moderator
#2
#2
Why do you think a procedure is needed? The requirement is:

The organization shall document the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product.

(emphasis added)

I just document them as part of the management review minutes (that's easiest for me but may not work well everywhere).

There are certainly elements within those requirements that typically drive procedures (especially when you get into the maintenance activities).
 
D

duff999

Involved In Discussions
#3
#3
Thank you for the feedback, appreciate it. i was given a project to create for Infrastructure: Equipment, Work Environment and Contamination control, I thought I was in good shape but struggling with the contamination control portion.
 
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