ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP?

duff999

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#1
Hi All,

We are establishing our QMS and have questions regarding design verification and validation. Do most folks create a separate SOP regarding section 7.3.6 Design and Development Verification or is it part of the the Design and Development SOP capturing the entire process. I broke out a separate document regarding process validation but wasn't sure how to handle design V&V.

Thanks,
 
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mihzago

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#4
It depends how detailed and long your procedures are and general preference. I keep my procedures light and prefer to keep the number to minimum so I usually write a single procedure for D&D. I've worked for companies that had more than 20 procedures and work instructions for the D&D process alone.
There are no requirements or expectation as to the number of procedures, as long as it works for you.
 
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