Are Job Descriptions and Organizational Charts Controlled Documents?

A

auclairdiana

#11
Thanks to everyone for your advice and help. Both the org. chart and job descriptions will be controlled by HR with Exe. Management oversight.:applause:
 
Elsmar Forum Sponsor
#12
Org charts are required by FDA (21CFR 820.20) but 'establishing and maintaing an orgazational structure' doesn't appear in 13485 that I can see.

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Can you quote exactly where org charts are required? "Establishing and maintaining an organizational structure" is not a requirement for an org chart. An org chart MAY graphically depict the structure, but it is not the structure. You can easily have a structure without using an org chart to graphically depict it.
 

gholland

Involved In Discussions
#14
db

You are correct, they are not specifically mandated... my mistake to be so concrete to say that org charts specifically are mandated... but the structure is mandated and org charts are the simplest, most effective way of demonstrating it to an investigator/auditor.
 
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