ISO 13485:2015 Pre-Release News and Discussion

[Sidney Vianna]

Re: News on the ISO 13485 revision

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.

Realizing that, based on the latest ISO Survey, Europe and North America represent about 75% of the ISO 13485 certificates in the World, that is expected.

I have no idea how the TC 210 operates, but some other TC's go through the hassle of surveys just to totally disregard the feedback from the users in the end. After all what do the users of standards know?

 

[Marcelo]

Re: News on the ISO 13485 revision

Realizing that, based on the latest ISO Survey, Europe and North America represent about 75% of the ISO 13485 certificates in the World, that is expected.

Yeah, we did make this link, however WG 1 would still want to hear more perspectives.

I have no idea how the TC 210 operates, but some other TC's go through the hassle of surveys just to totally disregard the feedback from the users in the end. After all what do the users of standards know?

I've also seen this kind of behavior from some other TCs and was pleased when I discovered that ISO TC 210 WG 1 is really worried about the user input.

One member has already performed the herculean task of separating all comments in their respectives topics, and the small groups working in each topic will revise all comments related to that topic. Sure a lot of comments will be deleted because they add no value or something like that, but int the brief overview we performed on one of the topics, we did find a lot of interesting comments.

So, i'm pretty sure that these will at least be taken into account when drafting the revised standard.

But obviously we cannot please everyone

 

[Marcelo]

Re: News on the ISO 13485 revision

I have no idea how the TC 210 operates, but some other TC's go through the hassle of surveys just to totally disregard the feedback from the users in the end. After all what do the users of standards know?

One of the problems (I´ve been revising some of the comments in the last few days) is that a great part of the comments are not related to the standard, but are related to the implementation of the standard. Example - comments related to how auditors perform auditing of ISO 13485.

Another type (a lot) are like - included FDA or EU requirements - which cannot be included because ISO 13485 does not include regional/national regulations due to the objective of being an harmonized standard worldwide - also ,ISO 13485 is already aligned with those.

Anyway, a lot of the comments are interesting and will require action.

 

[Roland Cooke]

Re: News on the ISO 13485 revision - 2011 - 2012

Is the intent to bring out a revised version of ISO 14969 at around the same time, or is that a completely unrelated task?

 

[Marcelo]

Re: News on the ISO 13485 revision - 2011 - 2012

Is the intent to bring out a revised version of ISO 14969 at around the same time, or is that a completely unrelated task?

It´s a complete unrelated task (including formally, because there will be a need to issue a NWIP).

However, the group was tasked with identifying possible revisions to 14969. And come comments even mentioned the need to include a streamlined version of 14969 in 13485 (which in fact is not a crazy idea - it would surely help promoting in a better way the guidance).

 

[Roland Cooke]

Re: News on the ISO 13485 revision - 2011 - 2012

some comments even mentioned the need to include a streamlined version of 14969 in 13485 (which in fact is not a crazy idea - it would surely help promoting in a better way the guidance).

Interesting suggestion, so that would be in the form of some kind of non-binding guidance appendix?

 

[Marcelo]

Re: News on the ISO 13485 revision - 2011 - 2012

Interesting suggestion, so that would be in the form of some kind of non-binding guidance appendix?

This would be the way, an informative annex. However, I´m pretty sure that a lot of people will oppose this idea.

 

[Roland Cooke]

Re: News on the ISO 13485 revision - 2011 - 2012

Probably correctly, from the bureaucratic perspective, but I would then add the comment to the committee to address the fact that a significant minority of people/companies don't even know ISO14969 exists.....

 

[Marcelo]

Re: News on the ISO 13485 revision - 2011 - 2012

The commitee is pretty aware of that, in fact.

The real problem is that ISO 13485 is a very political document, being used or accepted in general in a lot reg systems. Any possible change to the standard will be met with resistance in principle. And one general opposition (from a lot of WG members and NCs) is that anything that is not a requirement does not fit into the document.

 

[Roland Cooke]

Re: News on the ISO 13485 revision - 2011 - 2012

Maybe instead have an informative annex that just includes links (or equivalent) to these guidance sources (ISO14969, FDA guidance, MEDDEVs, whatever). Then everyone will be equally happy/unhappy....