Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Will EN ISO 13485:2012 be revised when ISO 13485 is reviewed??

E

Elynn

#1
Hi all, very happy New Year...

I know the topic on BS EN ISO 13485:2012 has been clarified by many Gurus in elsmar. However, just wondering since ISO 13485 is also undergoing it's systematic review by ISO TC 210 WG1, will CEN revise their 2012 version once ISO has released the version? Otherwise manufacturers will have two versions to comply with...

Also, is there any guidelines for manufacturers from CEN or ISO on the standards?
 
#2
However, just wondering since ISO 13485 is also undergoing it's systematic review by ISO TC 210 WG1, will CEN revise their 2012 version once ISO has released the version? Otherwise manufacturers will have two versions to comply with...
Probably, that?s what usually happens.

Also, is there any guidelines for manufacturers from CEN or ISO on the standards?
You men something like ISO/TR 14969:2004 Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003?
 
Top Bottom