ISO 13485:2003 Status: Published

[Jimmy Olson]

Just thought I would pass on that ISO 13485:2003 was published on July 3rd.

Let the fun begin.

[howste]

I guess it's time to get a copy and see how it compares with the final draft now...

[Aaron Lupo]

Originally Posted by howste

I guess it's time to get a copy and see how it compares with the final draft now...

I have a copy does not look much different. Some of the things I noticed that are different from the draft copy I have are:

Section 5.6.2 Review Input added H: New or Revised Regulatory Requirements
5.6.3 Review Output A: Now states Improvements needed to maintain the effectivness....
6.4 They reordered A-d no changes to wording
7.3.1 Design and Development Planning B; added Design Transfer Activities as well as added a note at the end.
7.3.2 Section A added safety and added section E Outputs of Risk Mgmt.

There are some other minor changes but for the most part it is very similar to the draft copy.

[Jimmy Olson]

Thanks for the info Aaron. Hopefully I'll get a copy soon, but in the meantime it's niceto know things haven't changed much and I can keep planning based on the draft version.

I'm surprised I haven't heard more about it being published. It seems like a lot of people and organizations were waiting for it and now that it's out everyone is quiet.

[Aaron Lupo]

Originally Posted by Richard Olson

Thanks for the info Aaron. Hopefully I'll get a copy soon, but in the meantime it's niceto know things haven't changed much and I can keep planning based on the draft version.

I'm surprised I haven't heard more about it being published. It seems like a lot of people and organizations were waiting for it and now that it's out everyone is quiet.

The actual date on the document is 07/15/03, so I am guessing that your will "officially" hear about it on 07/15/03.

[Aaron Lupo]

See this post http://Elsmar.com/Forums/showpost.php?p=58151 for a copy of checklist you can use it is set up as a process.

[Dawn Harris]

The final ISO 13485:2003 is suppose to be signed and released in September/October 2003. Some registrars are auditing to the 13485:2003 FDraft but unable to issue cert, of course, until the official release.

The QSR 820 may or may not be changed based on what the FDA is going to do with the cCMP requirements which are ISO 9000 based. I have not heard any chat on this subject.

[Aaron Lupo]

Originally Posted by Dawn Harris

The final ISO 13485:2003 is suppose to be signed and released in September/October 2003. Some registrars are auditing to the 13485:2003 FDraft but unable to issue cert, of course, until the official release.

The QSR 820 may or may not be changed based on what the FDA is going to do with the cCMP requirements which are ISO 9000 based. I have not heard any chat on this subject.

Dawn-

Where did you hear that. I have a copy of 13485:2003 in my grubby hands as I type. Second edition published 07/15/2003.