ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department

Detif

Registered
#1
Hi all,
I hope you all are doing well and staying safe,

This is my first time auditing accounting and I am not quite sure how to relate the requirements from ISO 13485 and 21 CFR 820 to the accounting department.

Thank you!
 
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William55401

Involved In Discussions
#2
What do your QMS procedures state regarding the role of Accounting? In my experience, Accounting gets involved in the QMS when there is a need for ERP supplier data maintenance / set up when adding suppliers or changing supplier data. If Accounting is not named in a procedure, it would be hard (impossible?) to audit them.
 

sagai

Quite Involved in Discussions
#3
One word ...

Do not do that !

Find something more useful like delivering groceries for elderly people to their doorstep.
Or cut their grass or anything that makes a real value in these days.
 
Last edited:

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
One word ...

Do not do that !
Hey....these are 4 words.

On a serious note, chances are the accounting processes have no issues related to 13485 and FDA. If it were 9001, though, things could be different as incorrect billing is a TYPICAL source of customer dissatisfaction, issue discussed numerous times here. Technically whomever scheduled the OP to audit accounting should be responsible for identifying what processes there are connected to the QMS.
 

LUFAN

Starting to get Involved
#5
My old company accounting was leaned on heavily to track SN devices to certain accounts and pull up records. I did have to audit certain functions related to that.
 
#6
Accounting may be audited as it related to Returns (RMAs) to ensure costing and customer requirements are still met. TYpically accounting isnt audited in QMS unless your QMS directly calls them out..
 
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