ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist

[Buirl - 2008]

Hello Everyone

I am new to the forum and would like to know if anyone of you have started your transition over to ISO 13485:2003? Are there any specifics guidelines or checklist that was used or would be helpful during the transition from ISO 13485:1996 to ISO 13485:2003?

 

[Grant M.]

Yes, I've just been through it - audit next Tuesday.

Did you check out the checklist in the post just above yours? I haven't checked it myself, but if it is no use to you, I have some information that will help.There are a couple of useful aids around.

Cheers,

Grant.

 

[Buirl - 2008]

Thanks

Thanks for respondingto my post. I've reviewed the checklist it does provide some useful information for me. The additional aid you mention, are they website that offers this information?

 

[Grant M.]

Sorry i haven't responded - been caught up with the 13485 audit, with the final wash-up meeting in a few minutes....

I will dig out what i was referring to and send you the details (atatchment or link) tomorrow.

Cheers,

grant.

 

[travlinman]

Thanks for the Checklist !

I am new here. I found your site by Googling for ISO 13485-2003 Audit Checklist. After a quick review of the PDF, it appears as if this a pretty good tool for doing one's pre-audit for ISO 13485-2003.

I'll be back from time to time. Hopefully, I can contribute something and help someone else out at some point in the future. Thanks a bunch.

 

[Jeanne]

Checklist

If you let me know your e-mail address I would be more than happy to e-mail it to you.

Hi,

Please email me same copy of ISO 13485:2003 checklist. Thanks, Jeanne

jkderbyshire(at)aol(dot)com

 

[welshery]

Why can I not download this checklist to my pc. I can download other files from this site, but not this one and it looks oh so useful? Thanks.

 

[Al Rosen]

Why can I not download this checklist to my pc. I can download other files from this site, but not this one and it looks oh so useful? Thanks.

What happens when you try to download it?

 

[howste]

It opens just fine for me...

 

[welshery]

Hi and thanks for getting back to me. When I click on the link, it takes me to a page and states two options for why I cannot download the file. One states that I may not be registered and I cannot remember option 2. I have tried to close the site down and then re-enter via internet explorer but it still takes me to the option page. I can however open up and download other files but just not this one. Can anyone email it to me? juliedavies246(at)hotmail(dot)com I would be most grateful. By the way, this site is the most helpful of sites that I have ever been on. It is just great to see the way in which other people tackle these standards and the comments that I have read thus far, have been really helpful to me, so thank you to all those who have commented on iso13485. Long may it continue. Thanks.