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

[duff999]

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,

 

[yodon]

I, personally do not break those out, I include design verification and design validation in my D&D SOP.

 

[duff999]

Perfect, thanks

 

[mihzago]

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.

 

[James]

I, personally do not break those out, I include design verification and design validation in my D&D SOP.

Same for me, all covered in the same procedure.

 

[yogeshshetty2000]

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,

I have seen the list of SOPs as below
SOP for Risk Assessment
SOP for Design Input and Design Output
SOP for Design and Development Planning, Traceability Matrix, and Design Review
SOP Design Verification and Validation
SOP for Design Transfer
SOP for Design History File

 

[James]

I have seen the list of SOPs as below
SOP for Risk Assessment
SOP for Design Input and Design Output
SOP for Design and Development Planning, Traceability Matrix, and Design Review
SOP Design Verification and Validation
SOP for Design Transfer
SOP for Design History File

I have one Procedure for design and development. We make fairly straightforward class 1 devices though