ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Form

[yaozhigang]

ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Forms

who can offer this documents?

 

[Marc]

Re: ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures

No one here. You need to buy them. There are many of stores on the internet for these documents.

 

[Marc]

I mis-read the post and have split it off of the thread it was in.

Are you asking for a complete set of "finished" documents?

 

[yaozhigang]

I mis-read the post and have split it off of the thread it was in.

Are you asking for a complete set of "finished" documents?

yes,but i am now in China,and it's not very convenient to buy this book

 

[maaquilino]

If you're looking for finished documents for your company, such as a Quality Manual and the quality procedures under it, that comply with 13485 and 820, the only way you'll get finished ones is if you hire someone to write them for you or write them yourself. The Quality Manual and procedures need to reflect your company and what it does and how it does it, so they're not something that's just out there in a one size fits all form.

FDA has 820 online for free at http://www.fda.gov/ but all ISO standards must be purchased, http://www.iso.org/iso/home.html

There are a number of examples of documents and templates at the link below; just do a search for the type you're looking for, e.g. quality manual, document control, etc. These can give you a starting place.

http://elsmar.com/Forums/fileslist.php?mode=allfiles&sortby=filename&pageamt=1&criteria=

Also, check here for a comparison of ISO 13485 to CFR 820
http://elsmar.com/Forums/showpost.php?p=273379&postcount=2

 

[suzhou]

i think it a good choice to ask third party consultant to help writing these procedure.

 

[Ronen E]

i think it a good choice to ask third party consultant to help writing these procedure.

Are you looking to get the documentation in Chinese or in English?

 

[yaozhigang]

I think english or chinese edition are ok,dou you have ?

 

[Ronen E]

I think english or chinese edition are ok,dou you have ?

Hi,

As stated in post #5 above:

If you're looking for finished documents for your company, such as a Quality Manual and the quality procedures under it, that comply with 13485 and 820, the only way you'll get finished ones is if you hire someone to write them for you or write them yourself. The Quality Manual and procedures need to reflect your company and what it does and how it does it, so they're not something that's just out there in a one size fits all form.

There may be other ways, but IMO the above is the only effective way.

If you're interested, I can write them for you.

Cheers,
Ronen.