ISO 13485 Revision Questions - November 2013

F

faragafifi

#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.
thanks mr :marcelo
i have question about iso 13485 update
if i can obtain the update version
thanks
farag
 
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Marcelo

Inactive Registered Visitor
#3
Re: ISO 13485:2015 Pre-Release News and Discussion

thanks mr :marcelo
i have question about iso 13485 update
if i can obtain the update version
thanks
farag
Hello Farag and welcome to the Cove!

The revision is not yet finished, and will be finished only in 2015. The drafts are copyrighted and cannot be shared. The only way to obtain them is to try and get them from the ISO National Committee of your country.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: ISO 13485:2015 Pre-Release News and Discussion

I never understood this.

I thought it's in everybody's interest (maybe except the ISO CFO) that such drafts would be available to the general public free of charge. What commercial use could anyone make of an unfinalized draft? They wouldn't be able to get certified against it, and would anyway need to buy the official release, when it becomes available. On the other hand, if it's available to more people, there would be a better chance that useful feedback would find its way to the authors, and that companies would be better prepared when the final version is issued.

BTW, getting such drafts from local (country) committees can be very difficult (if not impossible) in some countries!... Seems like less and less people around the world acknowledge the possibility of people just wanting to make a contribution for the general public's good. :(

Ronen.
 

Valli

Involved In Discussions
#5
Re: ISO 13485:2015 Pre-Release News and Discussion

I agree with you , It is impossible to get draft from local( country ) Committees
 

Marcelo

Inactive Registered Visitor
#6
Re: ISO 13485:2015 Pre-Release News and Discussion

What commercial use could anyone make of an unfinalized draft?
There?s always been several reports of manufacturers using a draft version of the standard, and when someone was assessing it, they told they they used this wrong version and were told they it would not be accepted. There was even a case in Brazil in the past where one manufacturer that was somewhat a "leader" in the field convinced several others to use a draft version which ended up being heavily modified, and this created a lot of trouble for the involved.

I thought it's in everybody's interest (maybe except the ISO CFO) that such drafts would be available to the general public free of charge....On the other hand, if it's available to more people, there would be a better chance that useful feedback would find its way to the authors, and that companies would be better prepared when the final version is issued.
In principle yes, but this is not how International Standardization works. National Committees (which are the formal members of ISO and IEC) must appoint experts which represents the country to deal with this. It?s impossible to tackle the comments from everyone involved. In fact nothing works like that, so I don?t understand why standards should.


BTW, getting such drafts from local (country) committees can be very difficult (if not impossible) in some countries!... Seems like less and less people around the world acknowledge the possibility of people just wanting to make a contribution for the general public's good
They are usually easy to get if you participate in standards activities on the related NC. If you never participate and simply goes there asking for a document, they will probably not give it to you, which I also think is fine.
 

Marcelo

Inactive Registered Visitor
#7
Re: ISO 13485:2015 Pre-Release News and Discussion

I agree with you , It is impossible to get draft from local( country ) Committees
Well, India (thru the Bureau of Indian Standards) is a participating country on ISO TC 210. They probably have a mirror committee there (if not, you would have the opportunity to create one :p). So they have access to the documents. I don?t understand why they would not give the document for members of this committee to comment, because that?s exactly what they do.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Re: ISO 13485:2015 Pre-Release News and Discussion

In fact nothing works like that.
Not correct, haven't you heard of Wikipedia?...

They are usually easy to get if you participate in standards activities on the related NC.
That's really nice, the thing is that in some countries it's very difficult to even get to participate. It may be a very exclusive club.
 

Marcelo

Inactive Registered Visitor
#9
Re: ISO 13485:2015 Pre-Release News and Discussion

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

In fact nothing works like that.
Not correct, haven't you heard of Wikipedia?...
I meant, reliable stuff?...:note:
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Re: ISO 13485:2015 Pre-Release News and Discussion

I meant, reliable stuff?...:note:
Call it anyway you want, it was just an example. There are many other examples in the Open Source world, where people contribute not for a material reward.

I think that the involvement of many promotes advancement much more than the internal workings of a small group of mutually-appointed "experts" (mind you, some of the "crowd" are rightfully experts themselves). If the number of participants is big enough, this population will automatically moderate and weed out the invalid content; this is pretty much what's happening on WikiPedia (albeit not 100%). The central ISO committee can be the final moderator anyway, so it's not like complete nonsense could get into a standard this way.

If the problem is too many comments, just randomly draw the amount that you can handle... :lol: Seriously, in some countries this is definitely not the problem.

Last, wide dissemination is important not only for getting comments, but also for promoting the planned changes and helping stakeholders brace for impact.

Nobody is trying to steal your precious golden egg. :)

Cheers,
Ronen.
 
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