Matrix for Requirements against Process/Department

For internal audit you can definitively use our Internal audit checklist from our ISO 13485:2016 Documentation toolkit. The Internal Audit Checklist is the list of questions required to ensure the management system is implemented and maintained. The listing includes more than 100 questions to ensure each requirement of the ISO 13485 standard is implemented and maintained within the Quality Management System and includes the ability for the company to add additional questions to suit individual needs. Of course within these 100 questions are questions regarding production, warehouse, quality control, and so on. Therefore, you can find questions applicable to your medical devices.

Here is the link for the Internal audit checklist: https://advisera.com/13485academy/documentation/internal-audit-checklist-iso-13485-2016/

For more information about conducting the internal audit, please see the following links:

• Five main steps in the ISO 13485:2016 internal audit https://advisera.com/13485academy/knowledgebase/five-main-steps-in-the-iso-134852016-internal-audit/
• How to create a checklist for an ISO 13485 internal audit for your QMS https://advisera.com/13485academy/knowledgebase/how-to-create-a-checklist-for-an-iso-13485-internal-audit-for-your-qms/

On following link you can see which documents and records our ISO 13485:2016 Internal audit toolkit has: https://advisera.com/13485academy/iso-13485-internal-audit-toolkit/