Information on the latest Standard And Regulatory Updates

[jfloyd]

I have been trying to locate a site where I can get the information on the latest updates to Standards (for me Specifically ISO 9001, 13485, and 14971) as well as country specific regulations (Health Canada, 93/42/EEC, FDA, etc.). Does such a site exist where you can find updates or have them sent to you?

I entered Quality in late 2007 and just had some issues with the 2007/47/EC admendment - I am trying to avoid the same issues in the future and ANY help would be Greatly appreciated!!!!

 

[Duke Okes]

Re: HELP - Standard And Regulatory Updates

Have you googled ISO and other organizations which issue the relevant standards?

 

[Ronen E]

Re: HELP - Standard And Regulatory Updates

I have been trying to locate a site where I can get the information on the latest updates to Standards (for me Specifically ISO 9001, 13485, and 14971) as well as country specific regulations (Health Canada, 93/42/EEC, FDA, etc.). Does such a site exist where you can find updates or have them sent to you?

I entered Quality in late 2007 and just had some issues with the 2007/47/EC admendment - I am trying to avoid the same issues in the future and ANY help would be Greatly appreciated!!!!

Hi,

I am not aware of any such single website. However, the updates are usually easy to find in the relevant websites:

- Updates to ISO standards can easily be found on the official ISO website. Just run a search on the standard number you are interested in.
- Updates regarding the MDD are published on the EU enterprize website. Additionally, if you are already working with a notified body, they will most likely update you with any relevant updates (otherwise I recommend you consider changing your NB ).
- Updates regarding FDA policy are published on the official FDA website.
- etc.

Cheers,
Ronen.

 

[Marc]

There are some related existing discussions here you might want to read through, for example: Standards & Standard Maintenance - Knowing what the latest revisions are

 

[MIREGMGR]

Read the post titles here daily. No new standard or regulation of substantial importance will ever get by you.

And, this is the community for discussions of what they'll mean, well before they take effect.

This site is much more effective at keeping us informed than would be the hypothetical announcements-only site you are describing.

 

[Marcelo]

Although i totally agree with MIREGMGR, you seems to be looking for what is called a regulatory intelligence service or database.

Clinivation and Tarius, among others, offers this kind of service (but i cannot give an opinion on them because i´ve never used them).

 

[Beth KL]

I have been trying to locate a site where I can get the information on the latest updates to Standards (for me Specifically ISO 9001, 13485, and 14971) as well as country specific regulations (Health Canada, 93/42/EEC, FDA, etc.). Does such a site exist where you can find updates or have them sent to you?

I entered Quality in late 2007 and just had some issues with the 2007/47/EC admendment - I am trying to avoid the same issues in the future and ANY help would be Greatly appreciated!!!!

Hello JFloyd - I am new to using this site so if this is not permitted, I apologize. There are some RIM software company's out there but I happen to work for one that does in fact track and notify you when standards get revised, withdrawn or made obsolete. If you are interested further, please respond and we can talk outside this forum.

 

[Sidney Vianna]

Hello JFloyd - I am new to using this site so if this is not permitted, I apologize. There are some RIM software company's out there but I happen to work for one that does in fact track and notify you when standards get revised, withdrawn or made obsolete. If you are interested further, please respond and we can talk outside this forum.

The post your replied to is over 10 years old and the poster is inactive at The Cove.

 

[Beth KL]

The post your replied to is over 10 years old and the poster is inactive at The Cove.

Hi Sidney - I did realize that but you never know if someone is still following it? I couldn't tell that it was inactive. Thanks for the information.