Auditing design and development

Answer:

The design and development process is audited in a same way as any other process. You need to identify first all requirements of the standard, you can also create a checklist just to make sure you don't miss anything. For more information, see: Writing an Audit Checklist for ISO 9001 Processes https://advisera.com/9001academy/blog/2014/11/25/writing-audit-checklist-iso-9001-processes/

Once you determine all requirements of the standard, you need to examine your design and development process and determine whether it is compliant with the standard or not. For more information, see: The ISO 9001 Design Process Explained https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/

For more information about internal audit process, see:
- How to create a check list for an ISO 9001 internal audit for your QMS https://advisera.com/9001academy/blog/2016/07/12/how-to-create-a-check-list-for-an-iso-9001-internal-audit-for-your-qms/
- Five Main Steps in ISO 9001 Internal Audit https://advisera.com/9001academy/knowledgebase/five-main-steps-in-iso-9001-internal-audit/

And we also have free ISO 9001:2015 Internal Auditor online course available here https://advisera.com/training/iso-9001-internal-auditor-course/