Hello there!
I am new to medical devices (formally involved/educated QS-9000) and I found a thread which contained a GHTF site which is supposed to contain guidance for 'maintaining compliance to 820 and 13485 in a single QMS'. However, I was unable to access this particular information and I was wondering if anyone knows where it can be found or has a copy of it. I would appreciate it immensely!

By the way, I just wanted to let everyone know how great this forum is...it is certainly helping me make some amount of sense of this puzzle.

Thanks!
Tracey

Tracey-

Welcome! What thread were you looking at? Were you looking for the QSIT manual?

:) Hi there thanks for replying.

I cannot seem to find the thread at the moment but I did print a portion of the page and it was written by Jerome Council, ASQCQA, CQA-Biomedical Auditing. Is it possible to track it by name?

Thanks so much :bigwave:

Tracey-

I looked around and couldn't find anything. If you can tell me a little more about what you are looking for I (or someone else here) might have the information you are looking for.

Thanks for looking around for me.
I am specifically looking for information regarding a way to structure and word my QMS so that it satisfies both 820 and 13485. If that is in fact possible...
I will attempt to locate the original thread in order to better explain myself.
Tracey

Thanks for looking around for me.
I am specifically looking for information regarding a way to structure and word my QMS so that it satisfies both 820 and 13485. If that is in fact possible...
I will attempt to locate the original thread in order to better explain myself.
Tracey

Ok now that I know what you are looking for that is pretty easy. Couple of questions, are you ISO certified now and I am guessing you will be looking for Certification to ISO 13485:2003? Do you have a current Quality manual I could take a look at, I can also pass along a sanatized copy of a QM that is compliant with ISO and FDA if you would like to see it.

I found the thread. July 4th 2002 by user counj3fl
I found it by looking him up and then browsing all of his posts.

We are currently FDA compliant. Not yet ISO I am working on ISO 13485. I have written the QM and just want to figure out how to make life easier.... :vfunny:

Yup - I think it's http://Elsmar.com/Forums/showthread.php?t=6697

Hello there!
I am new to medical devices (formally involved/educated QS-9000) and I found a thread which contained a GHTF site which is supposed to contain guidance for 'maintaining compliance to 820 and 13485 in a single QMS'. However, I was unable to access this particular information and I was wondering if anyone knows where it can be found or has a copy of it. I would appreciate it immensely!

By the way, I just wanted to let everyone know how great this forum is...it is certainly helping me make some amount of sense of this puzzle.

Thanks!
TraceyI found this old document. It's aligned with the old version of 13485.