ISO 13485:2015 Pre-Release News and Discussion

xcanals_tecno-med.es

Involved In Discussions
Only a comment

The ISO DIS2 standard is approved with 82% (required for approval 66% - 27 members vote yes of 33 members)

but unfortunately the CEN was disapproved the draft with 70.57% (required for approval 71% - 15 members vote yes and 4 members vote no)

So ISO 13485:2015 will not be also an european standard
as EN ISO 13485:2015 at the moment
:frust:

Any comments? :mg:

Xavier
 
G

gramaley

I'm told by someone near CEN that there are provisions to examine the voting results, and determine if they reflect properly those that are voting members, and that at least one member of CEN that had voted favorably before, neglected to vote in this last round, and that one vote would have allowed it to pass at CEN.

There is a provision under the Vienna Agreement (agreements between ISO and CEN for producing common standards) that indicates as follows:

5.7.2 After a positive result of vote in one organization and a negative result in the other one, a consultation between ISO/CS and CCMC takes place involving committee officers.

When taking decisions on how to proceed based on voting results and comments, committee leaders and secretariats have to take into account the decisions of the respective committees. If it seems likely that the negative votes which resulted in the text being disapproved can be resolved, a second parallel vote may be carried out. If the consultation shows that there is no immediate possibility for reconciling the comments that resulted in disapproval of the document, each organization proceeds in accordance with its own rules.


This information was provided to me by someone I trust, but I cannot confirm from my own experience the full details here provided to me.

So it would seem that there could be reason for another vote to be undertaken, to allow those that did not vote (by some accidental neglect perhaps? I hope). Or perhaps it is not such as difficult stretch to use the common instrument of the EN Annex Z, to resolve a detail of concern that must be met by the regulations that follow 93/42/EEC Annex II and V.
 

Marcelo

Inactive Registered Visitor
I'm told by someone near CEN that there are provisions to examine the voting results, and determine if they reflect properly those that are voting members, and that at least one member of CEN that had voted favorably before, neglected to vote in this last round, and that one vote would have allowed it to pass at CEN.

There is a provision under the Vienna Agreement (agreements between ISO and CEN for producing common standards) that indicates as follows:

5.7.2 After a positive result of vote in one organization and a negative result in the other one, a consultation between ISO/CS and CCMC takes place involving committee officers.

When taking decisions on how to proceed based on voting results and comments, committee leaders and secretariats have to take into account the decisions of the respective committees. If it seems likely that the negative votes which resulted in the text being disapproved can be resolved, a second parallel vote may be carried out. If the consultation shows that there is no immediate possibility for reconciling the comments that resulted in disapproval of the document, each organization proceeds in accordance with its own rules.

This information was provided to me by someone I trust, but I cannot confirm from my own experience the full details here provided to me.

So it would seem that there could be reason for another vote to be undertaken, to allow those that did not vote (by some accidental neglect perhaps? I hope).

There?s some conditional negative votes from some European countries on DIS2, so probably this could be resolved this way.

Or perhaps it is not such as difficult stretch to use the common instrument of the EN Annex Z, to resolve a detail of concern that must be met by the regulations that follow 93/42/EEC Annex II and V.

This is a little different, because Annex Z is created for a published standard, and in this case, if the votes were really negative, the standard would not proceed for publication, the project would have been halted (and, in the case of ISO, due to timeframes, the project would need to begin again anew).


Just as an additional information, the Vienna Agreement can be found here: AGREEMENT ON TECHNICAL CO-OPERATION BETWEEN ISO AND CEN (Vienna Agreement)

and the guidelines (where the mentioned text can be found): VA Guidelines
 

Marcelo

Inactive Registered Visitor
ISO TC 210 WG 1 will meet in Denver-CO, USA, next week (June 08-11) to discuss the votes and comments on ISO 13485:201(5) DIS 2.

The 800+ comments were pre-analyzed by a small group of volunteers and a draft response for each was created, as a way to speed up the process (we have been doing this on the last draft due to the volume of comments). Those will be presented and discussed during the meeting.

One specific topic that will be addressed is the persistent (albeit in low numbers) comments about the need for ISO 13485 to use the High Level Structure that is now required for Management Systems standards. A draft paper was circulated discussing this topic and why it´s important that this revision does not use this structure. Hopefully this will settle things down.
 

Marcelo

Inactive Registered Visitor
ISO TC 210 WG 1 met June 8-11 in Denver to continue the revision of ISO 13485. The 800 comments for the DIS2 were analyzed and dealt with. There has been several changes to the standards due to the comments, in particular the ones which have been pointed out as reasons for negative votes for the DIS2.

The revised text will be distributed to final analysis by the WG members at the end of June. An extraordinary face-to-face meeting has been scheduled at the end of August to discuss any necessary changes after the analysis. The expectation is that after this meeting, and FDIS will be circulated.
 
C

CBAL08

Can anyone let me know what impact will it have when ISO 9001:2015 is released and the organization also has ISO 13485:2003?
 

Marcelo

Inactive Registered Visitor
Can anyone let me know what impact will it have when ISO 9001:2015 is released and the organization also has ISO 13485:2003?

The organization will need more a lot more work to comply with both, as they will be very different.
 
C

CBAL08

Well more hard work and struggle to keep all documentation for both standards. Or choose to drop ISO 9001 as being a Medical Device industry it hardly is required for any registration. Any idea of when will the New ISO 13485 will
be publised? Any plans for making it similar to the New ISO 9001:2015?
 
Top Bottom