ISO 13485:2015 Pre-Release News and Discussion

[Ajit Basrur]

wow ... I can see the light now

 

[Reg Morrison]

A quick update - the DIS of the revision of ISO 13485 will be distributed to NCs on late February and comments need to be sent by July.

Thanks Marcelo.

For those who CAN'T wait to see how ISO 13485 is shaping up, the DIS is available for purchase from ISO, for CHF 38.00.

 

[Marc]

Discussion of ISO selling Draft standards cut off and moved to: ISO is Selling Draft Standards at http://Elsmar.com/Forums/showthread.php?t=62495

 

[stevenking]

Hello all

Just some quick news, ISO 13485 is going to be revised, a decision was made on the meeting of ISO TC 210 WG 1 this week. There's at least some 17 topics which are going to be revised or enhanced. A new work proposal will be circulated within the next month or so, along with a user survey on other possible changes.

Dear Marcelo:
Hello!
How about the clinical comments in ISO 13485:2015 drafting? In China, all class II/III Medical Devices are needed to undergo clinical trial for the initial registration. it is more rigorous than other coutries'.
Thanks a lot!

 

[Marcelo]

Dear Marcelo:
Hello!
How about the clinical comments in ISO 13485:2015 drafting? In China, all class II/III Medical Devices are needed to undergo clinical trial for the initial registration. it is more rigorous than other coutries'.
Thanks a lot!

Hello, ale welcome to the Cove.

The clinical requirements as about the same in the draft: if required by the target regulatory system, they have to be performed. But it?s only a general remark, because the standards is not related to any particular system.

 

[stevenking]

Hello, ale welcome to the Cove.

The clinical requirements as about the same in the draft: if required by the target regulatory system, they have to be performed. But it?s only a general remark, because the standards is not related to any particular system.

Great! Thanks,
Would you please tell me when the FDIS will be issued, and where we can get the comment discussion materials?

 

[Marcelo]

Would you please tell me when the FDIS will be issued

Probably in the end of the year or in the beginning of 2015. if everything goes as planned.

where we can get the comment discussion materials

They are only available to members of ISO TC 210 WG 1 but can be get thru NCs too.

 

[stevenking]

Probably in the end of the year or in the beginning of 2015. if everything goes as planned.



They are only available to members of ISO TC 210 WG 1 but can be get thru NCs too.

Thanks,
The current format of ISO 13485 might not be acceptable given that the next edition of ISO 9001 is due for publishing in 2015 and this follows the Annex SL format – High Level specification for Management Systems Standards. It is expected that all Management System Standards would follow this format.
Right?

 

[Marcelo]

The current format of ISO 13485 might not be acceptable given that the next edition of ISO 9001 is due for publishing in 2015 and this follows the Annex SL format ? High Level specification for Management Systems Standards. It is expected that all Management System Standards would follow this format.
Right?

Even if mandatory, there?s no requirement that documents already in process of being revised use this structure. But the next revision will have to use it (if the high level structure is maintained in the future).

 

[stevenking]

thanks for your response