Our facility is currently certified to ISO 9001:2000. By the end of 2009 I am planning on having the facility certified to both ISO 9001:2008 and ISO 13485:2003.
Recently, I had a "potential" consultant that I was considering to assist me in this endevor take a look at some of the QMS documentation. He commented that my Process Interaction Diagram would not pass ISO 13485:2003. What?
This is the same diagram I have been using since 2002, and as far as I can tell the ISO 13485:2003 standard has no impact on this area...
I have included the diagram for review. Comments greatly appreciated...
Recently, I had a "potential" consultant that I was considering to assist me in this endevor take a look at some of the QMS documentation. He commented that my Process Interaction Diagram would not pass ISO 13485:2003. What?
This is the same diagram I have been using since 2002, and as far as I can tell the ISO 13485:2003 standard has no impact on this area...
I have included the diagram for review. Comments greatly appreciated...
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