ISO 13485:2003 / Corrigendum 1:2009 has been published - Free!

[Marcelo]

Not sure if everyone is aware (interesting enough, i was reviewing the documentation for a meeting of the ISO TC 210 mirror in Brazil, which i chair, and "found" this has already been published!), but ISO 13485:2003/Cor 1:2009 has been published.

It´s a one-and-half page doc updating the standard after the release of ISO 9001:2008. It simply determine that ISO 13485 is "aligned" with ISO 9001:2000, not the new version.

It can be obtained, for free, from this link: https://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=54724&commid=54892

 

[Marc]

I got it. You do have to 'register' but it's kinda weird. You sorta go though a 'buying' process but the cost is 0.

Thanks for the heads up on this!

 

[Marcelo]

Yep, you DO buy...note that it´s watermarked. I think that´s because it´s a "technical" corringendum, instead of a normal corrigendum.

 

[Sidney Vianna]

I think you can download it, also for free and without registration/cart check out from ***DEAD LINK REMOVED***

or https://webstore.ansi.org/RecordDetail.aspx?sku=ISO+13485/Cor1:2009

 

[zhang126]

thanks a lot

 

[Ajit Basrur]

This corrigendum looks so basic; wonder whats in store for the new version of ISO 13485

 

[Marcelo]

This corrigendum looks so basic; wonder whats in store for the new version of ISO 13485

Well, i can give you some hints on that..basically, from what i understand, TC 210 is working in conjunction with TC 176 in the development of the new edition of ISO 9001.

There´s a SC in TC 176 (SC 2) which is researching a lot of new concepts and ideas which might be inlcuded or enhanced in the next revision of ISO 9001 (there are more than 30 research areas, including risk management, financial, standardized KPis, etc).

This new version of ISO 9001 will eventually prompt a revision of ISO 13485 (but this is expected only in 2015).

Also, an revision of ISO 14969 might be made before that.

 

[xcanals_tecno-med.es]

The corrigendum was published as standard by the CEN as:

EN ISO 13485:2003/AC:2009 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)


see the CEN website:

https://www.cen.eu/CENORM/Sectors/T...Standards.asp?param=581003&title=CEN/CLC/TC+3

as stated by the CEN not yet harmonized

Regards

Xavier

 

[ahmqutubuddin]

So if Corrigendum 1:2009 is not harmonised and if we are only medical device company and do not claim compliance to ISO 9001, can we keep on using EN ISO 13485:2003 in our Essential Requirement instead of EN ISO 13485:2003/AC 2009 ?

 

[Marcelo]

I don´t understand your question as AC 1:2009 is already harmonised in the EU.