Guidance for Understanding ISO 13485

[wrodnigg]

I've decided to stay away from 13485. With a supporting document like 14969, I know I will get it confused with 16949. I can just see me asking for a PPAP on a pap...oh never mind! :mg:

...may I support your confusion a little bit more by pointing at EN 13485:2002 "Thermometers for measuring the air and product temperature for the transport, storage and distribution of chilled, frozen, deep-frozen/quick-frozen food and ice cream - Test, performance, suitability; English version of DIN EN 13485" ?

 

[Vincnet]

OK but this document is not free ...
Any other sources ?

As far as I remember while it is in a draft phase it is free for you if you are a member of your national standards association.

But I can tell you that between the 13485:2003 and the 14969 you'd better buy the latter. It's cheaper and much more helpful.

 

[Vincnet]

...may I support your confusion a little bit more by pointing at EN 13485:2002 ?

Well this one is day-light robbery. I found a book on streching more helpful to set a QMS as at least it helped me relaxing.

Vincent

 

[km214]

Iso Tr 14969

km214
Hello everyone,
As of 9-15-2004 this document is avail at AAMI.org for a price...cheaper if you are a member. $90 if you are not. As a Guidance document if you have the ISO 13485 and are familiar with applying standards to industries, you shouldn't need this. If you are already familiar with the CFR's associated with Medical devices this new ISO 13485:2003 (to me anyhow) is just meshing ISO with federal regulations regarding Medical Devices. None of these ISO 13485 clauses is new to me.
I am opting to not get the ISO / TR 14969...
Just my
Katherine

 

[PAMELAGR]

Go to the

 

[PAMELAGR]

Go to the BSI Americas web site, there is a free guide there.

 

[pbojsen]

Purchasing Standards

AAMI may not be the cheapest place to buy an ISO standard.

There are several Standards houses to choose from. If you want an ISO standard, be sure to get the ISO XXXX, not the ISO DIN XXXX, or the ISO EN XXXX, etc. The ISO standards are adopted by countries that republish them under their own national standard, and the cost is double the "plain ordinary" ISO version. An ISO TR is a Technical Report, which may be something you need.

I use Global Engineering Services at www.global.ihs.com. You can get standards from all over the world there.

ISO TR 14969:2004 has the main body of ISO 13485:2003 contained in it, as well as being a guideline for using the standard.

 

[solutions]

Harmonization efforts

I have been searching the FDA and Global Harmonization sites to determine the current status of FDA/QSR harmonization with the ISO Standards. I may be obtuse, but I can't determine if any thing has been finalized in this arena. Can someone please tell me where things stand and/or how to find this info?

 

[Sidney Vianna]

Would this http://www.fda.gov/cdrh/devadvice/ISO9001.pdf help?

 

[Quality Queen]

We're (finally) proceeding with the transition to the new ISO13485 standard and I'm compiling a list of the documents we need to purchase. I have a copy of the ISO14969-WD2 and I'm wondering if someone could tell me whether there are many differences between this and the released version? Is it really worth purchasing?

Thanks for any input you can provide me with!