Auditing Design and Development in ISO 9001 (Internal Audit)



I had a 9001 audit two weeks ago and a 14001 audit last week and did a great job with management review with those of you that assisted me...thanks so much! One stumbling block i have with 9001 is the Design and Development clause....not familiar with D&D and while i try to following the questioning sequence i guess i don't have it right yet. once i can meet this requirement i can be qualified to do my own audits with pay. Any assistance anybody can give me? I'm auditing 9001 tuesday-friday this week in MN and hope to be able to ace it this time!


Sidney Vianna

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Auditing a process that you are totally unfamiliar with is a big challenge, and you should have shadowed (observed) an experienced lead auditor perform an assessment of such process, before you are expected to audit product D&D on your own.

Depending on the product criticality and complexity, the product D&D process can be quite demanding with multiple levels of reviews, verification and validations.

Notwithstanding the concerns, the ISO APG also provides a paper on auditing the product D&D against ISO 9001:2015. That document might assist you.

Good luck.
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