ISO 13485:2015 Pre-Release News and Discussion

Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

It is sad to hear that the reference to 'generally acknowledged state of the art" was taken out. I find that the MDD approach is far superior to ISO 14971, and it would have been nice to have gradual shift in that direction.

The paragraphs on software were IMHO poorly written, and I'm glad to see them go.

I'm more puzzled by the omission of "reasonably foreseeable misuse". From where would this already be required?

Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

perim said:

It is sad to hear that the reference to 'generally acknowledged state of the art" was taken out.

Click to expand...

IMO it's not so sad. We had numerous discussions on the Cove about why wall-to-wall pursuit of compliance with current / re-issued published standards is not always / automatically in the best interest of patients, health professionals and progress in general.

perim said:

I'm more puzzled by the omission of "reasonably foreseeable misuse". From where would this already be required?

Click to expand...

Why should it be spelled out? ISO 13485 is not a risk management / usability standard, it's a QMS standard. I think general references (requirements) concerning risk management (perhaps even usability) are appropriate, but specifics should be detailed in more dedicated standards such as 14971 (a good standard IMO, minus the 2012 mess) and 62366.

Cheers,
Ronen.

Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

It is sad to hear that the reference to 'generally acknowledged state of the art" was taken out. I find that the MDD approach is far superior to ISO 14971, and it would have been nice to have gradual shift in that direction.

The paragraphs on software were IMHO poorly written, and I'm glad to see them go.

I'm more puzzled by the omission of "reasonably foreseeable misuse". From where would this already be required?

Click to expand...

My answers would be like what Ronen said . We removed the policy and any more detailed requirement related to product from the standard because it?s a system standard. And yes, there?s even a nod to usability requirements and IEC 62366, but that?s it. No need to go beyond that.

Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

ISO TC 210 WG 1 will meet next week in France to deal with the comments to CD 1 of the revision to ISO 13485.

There's more than 500 comments to address in the 4-day meeting. Hopefully we can come out with the DIS at the end

Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Thanks for the update Marcelo!

Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014? 2015 in fact!)

ISO TC 210 WG 1 met in Lyon on 30 Sep-03 Oct 2013 to continue the revision of ISO 13485. We were almost able to finish the reviewing of the 500+ comments sent for the CD. The last comments and revision will continue online for one more month, more or less, and then a DIS will be issued. The comments on the DIS will be evaluated at the next meeting of ISO TC 210 WG 1 in Sweden, September 2014 (together with the ISO TC 210 plenary).

We've had a lot of discussion and a lot of changes to the CD - some, in my opinion, not correct. I think that we will have a LOT of comments on the DIS, let's see.

Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014? 2015 in fact!)

Thanks Marcelo

Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Marcelo Antunes said:

End of 2014 / beginning of 2015.

It?s recorded as 2015 in the ISO project database, anyway.

Click to expand...

Marcelo, many thanks for the updates. I find interesting that the current version of ISO 13485 dates back to 2003. So, if the next revision comes in 2015, it will be almost 12 years between revisions.

As ISO has a policy of triggering a review process for standards every 5 years, it seems to me that the TC 210 profoundly deviated from the ISO process for standards maintenance. Adding to the fact that, as disclosed by you, in this thread, the future version of the ISO 13485 document will not follow the mandatory high level structure that the ISO technical management board has decided on for all management system standards, I wonder if the ISO 9001 certification that ISO has is at risk. We all know that ISO is certified to ISO 9001 by SQS. I wonder if the SQS auditor is asking ISO some probing questions....

Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014? 2015 in fact!)

As ISO has a policy of triggering a review process for standards every 5 years, it seems to me that the TC 210 profoundly deviated from the ISO process for standards maintenance.

Click to expand...

Nope, there was a systematic review in 2007 (which was a reconfirmation). Then again in 2011 (which began the revision process).

Adding to the fact that, as disclosed by you, in this thread, the future version of the ISO 13485 document will not follow the mandatory high level structure that the ISO technical management board has decided on for all management system standards, I wonder if the ISO 9001 certification that ISO has is at risk.

Click to expand...

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 maintaineed in the future).

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.