ISO 13485, how to ?
- From: "rover8898" <rover8898@xxxxxxxxxxx>
- Date: 10 Feb 2006 14:51:33 -0800
Good day to all,
Can someone offer any advice concerning what documents are required for
an ISO 13485:2003 certification.
I already talked to a company that is responsible for the certification
of ISO 13485:2003.
I already downloaded the ISO 13485:2003 standard.
And I am still confused to as what an ISO 13485:2003 certification's
requires.
What documents does it require?
What has to be done to get ready for the ISO 13485 certification?
If anyone can forward me a link to a completed ISO 13485 documentation,
be it very BAD documentation and be it a first a draft, it will be much
appreciated.
Basically, I want to a gander to what a finalized doumentaion of an ISO
13485 documentaion looks like. I know, I am asking for much.
The point is that I want to avoid any consulting fees. The company
which I work for is small (4 employees, and the scope of the
certification is only 1 product) so I think the ISO 13485 certification
can avoid consultant fees. The company is not ISO 9001 certified
either.
In order to some better insigth, the company is comprised mainly of
engineers more focused on gettings things working than documenting the
steps they took to a given procedure. We have just developped a product
that requires an ISO 13485 certification. So how do I start?
I already got quotes for the certification process, but I can't very
well sit down with the certification inspector without having any idea
of what is it that he requires of me. That is why I wanted to look at
an already finished ISO 13485 documentation; I want to know what is I
must be able to supply in order to get the ball rolling.
Perphaps someone can tell me the first step I should do (aside from
talking to a pro :-) ).
Regards,
Roger
.
- Follow-Ups:
- Re: ISO 13485, how to ?
- From: Paul E. Bennett
- Re: ISO 13485, how to ?
- From: billb
- Re: ISO 13485, how to ?
- Prev by Date: Re: European Standards Nuance
- Next by Date: Re: ISO 13485, how to ?
- Previous by thread: European Standards Nuance
- Next by thread: Re: ISO 13485, how to ?
- Index(es):
Relevant Pages
|
Loading