ISO 13485:2015 Pre-Release News and Discussion

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#1
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.
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#3
Re: News on the ISO 13485 revision

Ajit

Sure it is, the meeting ended yesterday, I only know because i was there :)

Anyway, i just made this quick comment so our Cove members could begin to collect their comments on possible modifications. Maybe we could open a thread on this so people can freely comment. I'm sure the members of the Cove could greatly help giving their views of problems and solutions.
 
M

manju.ado

Guest
#4
Re: News on the ISO 13485 revision

Thank you Marcelo for the news.:)

Its good idea to have a thread, gives right platform to discuss and provide comments.

Thanks again.

Regards,

Manju
 

GPjeri

Inactive Registered Visitor
#5
Re: News on the ISO 13485 revision

Wow, THANKS !!!! Just listened to a webinar the other day where this was mentioned but on a very high level also talked about de-harmonizing some standards and potentially revising ISO 14971.
 

MIREGMGR

Inactive Registered Visitor
#6
Re: News on the ISO 13485 revision

Does this encompass Sweden's issues with ISO 13485 in regard to its compability with the various Directives?
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#7
Re: News on the ISO 13485 revision

Does this encompass Sweden's issues with ISO 13485 in regard to its compability with the various Directives?
Yes, their issues were discussed and some where taken into account, but others deemed a problem of the directives and not of the standard (and some too euro-centric too, also related to the directives).

The person responsible for the Sweden issues is a member of TC 210 and was there, so there seems to be, in principle, a solved issue regarding the standard (but there might still be problem in the EU).
 

MIREGMGR

Inactive Registered Visitor
#8
Re: News on the ISO 13485 revision

I've been under the impression that the argument being made by some EU parties was that the Directives are law while the Standards (ISO 13485, ISO 14971, etc.) are adopted documents, therefore both practically and theoretically the Standards would have to change to conform to the Directives.

It's an odd issue to arise, given ISO 13485's history.

Was US FDA represented in the discussions? I'm very curious as to whether this will affect US FDA's movement toward VARSP acceptance of NB-certified ISO 13485 conformance in place of QSIT1 inspection exposure.
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#9
Re: News on the ISO 13485 revision

I've been under the impression that the argument being made by some EU parties was that the Directives are law while the Standards (ISO 13485, ISO 14971, etc.) are adopted documents, therefore both practically and theoretically the Standards would have to change to conform to the Directives.

It's an odd issue to arise, given ISO 13485's history.
The problem is really more weird, and, as i've said somewhere else before, even the EU is not really sure of their own arguments (I was with the guy responsible for the formal Eu answer to this problem and he even he wasn't aware what was really happening :))

One example - in New Approach directives, directives have essential (less detailed) requirements, and harmonized standards details that essentials requirements and therefore gives 'presumption of conformity' with the essential requirements they are linked with (annex zx). However, this presumption of conformity is only related to the essential requirements which are given in annex I of the directives. Quality system requirements are not in Annex I, they are only required in the "route" annexes (particularly the annex II route - full quality assurance). So, one of the problems is that ISO 13485 cannot really give presumption of conformity.

Was US FDA represented in the discussions? I'm very curious as to whether this will affect US FDA's movement toward VARSP acceptance of NB-certified ISO 13485 conformance in place of QSIT1 inspection exposure.
Yes, Kim Trautman is a WG 1 member and represents the FDA. From the standpoint of the standard, she didn't seem to have any problems (she mentioned the VARSP program but only to remember that she would prefer the standard to stick to requirements which were already on the regulations) but nothing regarding the EU. As i said, the focus of the discussion obviously was the standard, not the regulations that use them, because it was deemed that a lot of the comments were really problems of the regulations, not the standard.

Update: Just to make things clear here, i didn't imply i know Kim's or FDA's position, what i said is only what I felt during the meeting.
 
Last edited:

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#10
Re: News on the ISO 13485 revision

Another update on the ISO 13485 revision - ISO TC 210 WG 1 met last week and reviewed some issues, including the results of the user survey. The survey had a lot os responses, however one major problem is that almost 90 % of the respondents wer from the US or Europe. We are going to reopen the survey to see if we can find more comments from other parts of the world.

The 14 original topics for revision (not 17 as i mentioned before) were expanded to 24 due to the answers from the survey.

We have already separated 24 groups to deal with each topic, and everyone can now begin working on specific topics.

Next meeting will be in March 2012.
 
Top