ISO 13485 Clause 6.3 - System to determine and provide infrastructure

F

farina

#1
hi guys..
happy new year and best wishes...........
our company just being audited by tuv last week and to our dismay we received 7 MNC.well,thats already history.but now i'm having a problem to answer CA for one particular finding.hope ur guys can toss up some ideas for me to come up with a proper CA.
here it is...
'the system to determine and provide infrastructure could not be established at the time of the audit.'
He nailed it down with clause 6.3
so :thanx: in advance
 
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Al Rosen

Staff member
Super Moderator
#2
With the information you have provided, I don't know what the issue is. If you have proper manufacturing facilities, ample space and equipment along with maintenance procedures and records, there shouldn't be a nonconformance. What's missing?
 
F

farina

#4
hi,thanx for da reply :D

well,as for my understanding the auditor said that our system is not in a close loop.everything is here and there.do i need a sop to cover all the infrastucture elements because for the time being our company only have one sop for facility maintenance.
 

Al Rosen

Staff member
Super Moderator
#5
farina said:
hi,thanx for da reply :D

well,as for my understanding the auditor said that our system is not in a close loop.everything is here and there.do i need a sop to cover all the infrastucture elements because for the time being our company only have one sop for facility maintenance.
I don't think you would need another SOP. You should be able to work with what you have. What does your SOP state? Was the auditor referimg to your whole system or just maintenance? Can you describe or post your maintenance procedure? Maybe we can suggest how to improve what you have.
 
R

Robert Soares

#6
Infrastructure

In my experience, typically an auditor is looking for a place where some type of evidence is available that infrastructure needs are periodically reviewed and addressed as needed. With that in mind there are a couple of ways to handle it.

1) You could have a it asked each time you do a new product (on some type of design review worksheet etc.)
2) You can include it as a standard item on the Management Review agenda as a periodic question and make sure it shows up in the Management Review output on the minutes.

I think that should do it (unless you are already doing something similar, in which case I would have no idea where the auditor was coming from)!:agree1:

Hope that helps!

Soarsy
 
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