Hi..Our company is producing examination gloves and next week TUV is coming for a surveillance audit.Since i'm a new kids on da block,appreciate some advice or tips on how to handle this people.Especially for Internal Quality Audit department that i'm handling.What items that i should be concerned of...Thank you in advance...

Maybe a medical device person will reply as well, but in my opinion there is no special way to 'handle' auditors other than to make sure you know as much, or more, about the standard you are being audited to (in this case ISO 13485 - Medical Devices I assume), and to make sure you're ready to explain how you comply with each statement in the ISO 13485 standard.

As for internal audits and that specific department, as long as you are fulfilling standard internal audit requirements (established schedule, audits being performed, corrective action requests being acted on and closed out (or followed up with an escalation when they're not) you should be set.

In a surveillance audit if everyone has been doing what they should there shouldn't be any issues.

Hi, Farina

as a matter of fact i also working in a exam.gloves manufacturing company, and we ve just being audited by TUV for CE Marking . From my experience i think you should prepared the internal quality audit schedule and check list .


chicha

Depending on which TUV auditors whether it was from TUV Product Services, TUV Nord or TUV Rhineland.

good day everyone,

firstly, i would like to thank u all for replying on my thread...
fyi,tuv already came to audit us and guess what,we only got some minor ncr's...it was less than what we have expected so hoorah for us in here..
the most important thing is no findings were made for internal quality audit.
just a few comments from the auditors.

i would like to share with u all on his comments..
his said that i have to mentioned in my sop about impartiality of my auditors.i agreed with that because i missed that part where as in iso clearly stated about it.

another comments from the auditor was that i have to clearly defined in what circumstances i should re-audit,based on what criteria etc..i already mentioned it in my sop but he said that the criteria were not sufficient enough.well,i have to get a look at it again soon...

so,u guys thanx..and if u guys have anything interesting comments to share,please feel free to do so..looking forward to hear from all of you..

off me goes...

Hi, Folks

Our company has TUV surveillance audit last Dec. 2005.
And our company has good results officially (No NCR, major even minor).

But I'm still dissatisfying my effort of current QMS. Our registration was made Dec.2004 and our company is 'still young' medical device manufacturer.

I worked 7 years this medical fields, (I knew what we have to do, .. but I couldn't sustain for surrounding circumstances of situation, EWB [Extended Work Bench] from mother company) but current company does not cover or handle properly 'Risk Management' well. That is TUV lead auditors comment to me, similar to personally (like a food for thought).

I would recommend all of medical device manufacturers & quality folks in that field as following.
Clever and wise speculating on What ISO 13485;2003 title says,
Quality Management System Particulated in Medical Device Requirement for Regulatory Purpose
it means, manufacturer demonstrate his products 1.Safety 2.Stability 3.Functionality at least.
For do that, Process/Product should be verified or validated .. must be choose one from two. (if you are interesting on this, please visit FDA web-site, and seek 'Warning Letter', lots of sample for validation fail,...)

Another significant subject is 'Risk' concept. Recall what ISO 13485 title says. We are facing to Government Agency (FDA, KFDA, ...) or equivalent authority (ex. MDD) for product Safety, Stability and Functionality.

Risk concept is similar concept for PL (Product Liability) law. PL preparation should cover following 3 big basical errors, 1. Manufacturing Error / 2. Design Error / 3. Labeling Error

and most QMS should worry about and try to (especially, medical device fileds)
1. Prevent recurrence of improper (Bad) output (already happened and cared as CAPA)
2. Reduce 'Risk'. (PLwise - Safety) (Risk is base on 'Probability' (=Frequency) and 'Severity', those compounding could be measured as RPN-Risk Priority Number and should be Reduced before launching product into market))

That's it. Any comment..? Feel free..