Audit checklist for "Design Controls" per ISO 13485 wanted

Coury Ferguson

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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.


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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!


  • blank ISO 13485-9001-21cfr820 Checklist.doc
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