Greetings everyone,
I am a newcomer to the forum, so I am learning the process. I have seen some interesting topics and think this will be very helpful.
I am the Corp Quality Systems Assessment Manager, for a medical company.
All of our divisions and corporate are registered to ISO 9000 and are registering to ISO 13485-2003. I am looking for an audit checklist that will cover all of the requirements. Any recommendations. (I saw one posted by the ISO Guy, but could not open it.)

Thanks in advance fro your help.

Rick

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

Hi Rick,

I have made up this check list to allow me compare additionally requirements to ISO9001;2000. This table needs to be used along side ISO9001;2000 as only the changes are noted here. I have also compared to ISO13485:1996. Hope it is of some use.


Cathy

Cathy - that looks like a useful tool to compare the standards. I'll be doing a 13485 audit in December, so I'll probably use this spreadsheet to look at the changes.

Thanks!

Hi Cathy

Your attached checklist is very useful for me to introduce the changes of new version of ISO 13485 to my students.

Dear ISOGUY
I too would most apprecaite a copy of your checklist. Going crazy converting.

Many thanks
Pete

Dear ISOGUY,

A very popular bit of information you have put together!

THANKS! :thanx:

I would be interested in a ISO 13485 checklist and aslo a gap analysis. Anyone help?
I am a consultant that deals woth ISO and AS, but new to the medical.

I am just wondering why do we have to bother with structured audit checklist? Is it that ISO 9001 & ISO 13485 have adopted the process approach and WHY do we need to develop a long list of checklist???

I am just wondering whether the CBs auditors for ISO 13485 would still look for structured checklist and would the internal auditors still be given a long checklist by their QMR?

I am just wondering ...... :biglaugh:

Checklists are just tools to help auditors. IMO there is no best checklist format - it all depends on what the auditor needs to help make the audit process go smoothly. In my case, the checklist reminds me what I need to look for and provides a place to record evidence. I rarely follow the sequence of the checklist, but always make sure that each requirement is addressed before I'm done.

When I audit for registrars I look for evidence that all requirements of the standard have been audited for effectiveness and conformity to requirements. There is no requirement for a checklist at all. But just because it's not required doesn't mean it's a bad idea to have one.

I'm attaching a generic ISO 13485:2003 checklist. It also contains the ISO 9001:2000 requirements for organizations that are interested in both. Black text is common to both standards, blue text is 13485 only, and red text is 9001 only. It has a blank sheet at the end to add company-specific requirements or any other additional questions determined in audit prep. It also has sample questions throughout that might be asked by the auditor to get the information needed (some of this isn't finished yet). If anyone would like to use this as-is or modify it to suit your needs, feel free.

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?

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.

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?

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.

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.

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 (jkderbyshire@aol.com)

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.

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?

It opens just fine for me...

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 (juliedavies246@hotmail.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.

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 (juliedavies246@hotmail.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.Try clearing your cookies and then sign on and try to download the file.

Can anyone email it to me?
I just emailed a copy to you...

Thank you very much for taking the time to email me the download. I really appreciate it.

Thanks very much for the simplified comparison. It was very helpful as a starting point.

I have seen a more detailed line by line comparison between ISO 13485 ans ISO 9001:2000 on the web a few years back but cannot find it . Anyone has one?

TX

Thanks very much for the simplified comparison. It was very helpful as a starting point.

I have seen a more detailed line by line comparison between ISO 13485 ans ISO 9001:2000 on the web a few years back but cannot find it . Anyone has one?

TX Here is one (http://elsmar.com/Forums/attachment.php?attachmentid=3831) of many in the Post Attachments List (see the green button in the headline at the top of every page in the forums.

Hi Al,

Thanks very much that is the one I was looking for. Your help is truly appreciated.

Another question for you. Why are reagents and cell culture media considered class II medical device ?

Regards,

MaryRose

Hi Al,

Thanks very much that is the one I was looking for. Your help is truly appreciated.

Another question for you. Why are reagents and cell culture media considered class II medical device ?

Regards,

MaryRoseSorry, I don't know the answer. Maybe someone else can answer that one.