Please Review my Design and Development Plan

[pearson114]

One division of the company I work for are ISO9001 approved, and they are looking to extend their scope of approval to include 7.3.

Personally, anywhere I have ever been involved with the QMS has excluded 7.3 so in all honesty I'm pretty much a novice on the clause.

I've put together a bit of a plan, which I have attached. The idea is for the design engineers/authorities to use this to document in order to ensure all required aspects of the design have been considered, and to provide of record of this.

Can anyone with experience in this please let me know if I'm on the right tracks with this?

Thank you.

 

[pearson114]

Re: Design and Development Plan

Attachment here .......................................

 

[WEHTTAM]

Re: Design and Development Plan

Try the link below , its medical device orientated, but could suit you, particularly page 9 to 13.

http://www.fda.gov/downloads/MedicalDevices/.../ucm070642.pdf

Also a plan usually records responsible persons and timelines, perhaps using MS Project

Hope this helps