Is the next revision of ISO 15378 following the High Level Structure?

paulag

Involved In Discussions
#1
Sorry, wrong thread, I know... but I just can't figure out how to start a new one. Button missing?!

But, the question I actually wanted to ask is - does anyone know whether ISO 15378 is going to change to ISO 9001's high level structure during next revision, or will it stuck to the good old 8 chapter style, like ISO 13485 did?

Thanks, and have a great day!
 
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Ronen E

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#2
Re: ISO 15378 high level structure

Hi,

I've spun off your post into a new thread, I hope you like the title I chose... To start a new thread you can go to the forum of your choice, then look for the green "New Thread" button at the top left hand area of the page.

Sorry, I don't know the answer to your Q.

Cheers,
Ronen.
 
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Sidney Vianna

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#3
Re: ISO 15378 high level structure

But, the question I actually wanted to ask is - does anyone know whether ISO 15378 is going to change to ISO 9001's high level structure during next revision, or will it stuck to the good old 8 chapter style, like ISO 13485 did
According to the ISO website, ISO 15378 was last revised in 2015 and you can preview the standard here.

The last revision did not follow the High Level Structure.

But, wait. There is more. The standard is undergoing another round of revision and the DIS of the next revision is also available for preview. The next revision does follow the HLS.
 

paulag

Involved In Discussions
#5
Thanks to everyone!

So I should better wait with implementing ISO 15378... Standards should have a minimum durability!!! Two revisions in two years are too much, when you also have the new ISO 13485 and EU Medical Device Regulation to cope with...

But it keeps us busy :rolleyes:
 

zac2944

Involved In Discussions
#6
Looks like the new version of this standard with the new high level structure is still in draft. Anyone know when this new version is expected to be released?
 
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