Auditing documentation requirements for ISO 9001 and ISO 13485

Answer:

If your Quality Management System is compliant with both ISO 9001 and ISO 13485, during the internal audit you need to check compliance with both standards. When it comes to common requirements or requirements related to the same elements of the system, you need to audit against requirements of both standards. Whichever standard has stricter requirements, those requirements should be applied and auditing should be done against those requirements.

Another option is to conduct separate audits for ISO 9001 and ISo 13485 but this would just mean that you will double the work.

For more information, see: How to create a checklist for an ISO 13485 internal audit fo r your QMS https://advisera.com/13485academy/knowledgebase/how-to-create-a-checklist-for-an-iso-13485-internal-audit-for-your-qms/