From: Suzanne Fiorino - cardiotech.com
Subject: RE: Medical Audit/Rothkopf/Fiorino
> I am doing some work with a small medical company that follows: ISO
> 9001, EN46001 and FDA's QS regulartions. The company already has ISO
> 9000, a CE mark and FDA approval on 3 of their products. I have
> remotely assisted them with internal audits in the past, but only on
> sections of the regulations. The company now wants an external audit
> of the entire system conducted by a third party (me) before the ISO and
> FDA guys show up again (in Sept.). I have conducted quality system ISO
> audits before but I have never done a GMP audit of a company. I know
> this is the wrong forum, but I couldn't find a GMP 'consultants' help
> group. Does anyone out there know of a group or have a generic
> checklist to build an Audit Plan.
>
> thanks,
>
> Dave
Since the group has a CE mark, they must have been audited by a Notified Body. Ask your client for their NB checklist which should have both ISO 9001 + EN 46001 + any EC directive items (i.e. MDD or AIMD). These are the EC equivalent to the FDA QSR if their product is classified as a med device.