Audit checklist for "Design Controls" per ISO 13485 wanted

[SGquality]

Does any one have an audit checklist on "Design Controls" for ISO 13485 ?

Thank you

 

[Coury Ferguson]

My suggestion is to look at it as the entire process. No need for the checklist in my opinion. Audit the process "Design Controls."

Follow it through the Preliminary review, Critical review, Customer review (if required) Final review, Release, and so on, following the organization's procedures. Take good notes and document any findings.

Just my opinion.

 

[somashekar]

Please see this thread ISO 13485 Practical Internal Audit Checklist - Standard vs. Process Based and the attachments in posts.....

THANKS

 

[QAengineer13]

Does any one have an audit checklist on "Design Controls" for ISO 13485 ?

Thank you

Hi SG,

Please refer to attached checklist but its still the older version of ISO, I am in the process of updating it but you can use this as a reference material. Hope this helps!