Update of SOPs for ISO 13485:2016 / MDSAP

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Wolf.K

Quite Involved in Discussions
#12
Hi,

I need one, too. But as this is a new item for 13485:2016, I think nobody currently has such a SOP. So, how about writing one together here on Elsmar? I'll start collecting data/information soon and then I will post a draft SOP here, and hopefully will get a lot of good feedback!

W.
 

Ajit Basrur

Staff member
Admin
#14
https://www.iso.org/standard/60044.html

ISO/PRF TR 80002-2
Medical device software -- Part 2: Validation of software for medical device quality systems

is still in the approval status - does someone have a draft version?
This standard is under the PRF stage which means "Proof of a new International Standard" and the next stage is release of the international standard.

Please note that ISO standards are copyright documents and we do not share copyright materials in the Cove.
 

Wolf.K

Quite Involved in Discussions
#15
Yes, I know. And I was not asking for a copy - I just wonder if someone KNOWS what is written in the draft and can share some of the knowledge with us? Anyway, ISO is kind of non-democratic. I think the users (we!) should be part of the discussions! But there is not even the draft of the table of contents available yet!
 

Marcelo

Inactive Registered Visitor
#16
Yes, I know. And I was not asking for a copy - I just wonder if someone KNOWS what is written in the draft and can share some of the knowledge with us?
Yes, there's some people here that participate in standards development that knows the draft. In fact, I was the task leader for this project. We used AAMI TIR36, Validation of Software for Regulated Processes as a basis, and changed several stuff to have it become and international standard and also to include some better correlation with risk management and ISO 14971. The standards details a series of tools (the toolbox) that needs to be defined for each software. Some of the tools ara mandatory, most need to be chosen based on risk.

Anyway, ISO is kind of non-democratic. I think the users (we!) should be part of the discussions! But there is not even the draft of the table of contents available yet!
Anyone can have access to the documents if they participate in the process. The usual problem (and I'm not saying is your case) is that people want access only to the finished/near finished product, but they are not willing to participate in the development of the standard.
 

Wolf.K

Quite Involved in Discussions
#17
Thank you very much for this information!

Do you know how long (approximately) the approval process will be? Is there a possibility that we can buy the standard before the end of the year?
 

Mark Meer

Trusted Information Resource
#19
Anyone can have access to the documents if they participate in the process. The usual problem (and I'm not saying is your case) is that people want access only to the finished/near finished product, but they are not willing to participate in the development of the standard.
Hi Marcelo,

To clarify, when you say "anyone", there are many qualifiers, no?

First, you have to go through a national member organization, and these, in turn, dictate the "technical committees" that are involved with development of specific standards. Do I have this correct?

The bottom-line is that, it seems (correct me if I'm wrong), to be involved in the development of a specific standard that you're interested in is not a simple matter for the vast majority of small-to-medium sized manufacturers.

---
Unrelated, looking at the ISO members list, it is interesting to see the distribution of TC participation. Does this participation necessarily translate into influence on standards' development (i.e. do certain countries with high participation exercise disproportionate influence on the decision making process)?
 

Ronen E

Problem Solver
Staff member
Moderator
#20
The bottom-line is that, it seems (correct me if I'm wrong), to be involved in the development of a specific standard that you're interested in is not a simple matter for the vast majority of small-to-medium sized manufacturers.
From my personal experience, this is spot on.

It seems that it has a lot to do with local mentality / culture. In some countries it's fairly easy to join in and contribute but in others it's practically impossible for the common person.
 
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