ISO13485 Cl. 7.1 Process Flow (Product Realization & Risk Management requirements)?

L

LNeJame

Does anyone have an example of a standard process flow used for the standard ISO13485 7.1? inparticular identifying product realization risk management requirements?

Thanks in advance!
 

bio_subbu

Super Moderator
Re: ISO13485 Cl. 7.1 Process Flow (product realization & risk management requirements

Does anyone have an example of a standard process flow used for the standard ISO13485 7.1? inparticular identifying product realization risk management requirements?

Thanks in advance!

Attached is risk management process flow chart, prepared in accordance with clause 7.1 of ISO 13485:2003 and FDA QSR 21 CFR 820.30. Hope you will find and useful.

Regards
S. Subramaniam
 

Attachments

  • Risk management Process Map.doc
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Q

qremsg26

Re: ISO13485 Cl. 7.1 Process Flow (product realization & risk management requirements

Thanks Subramaniam. It's very detailed and useful.
 
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