How to use the ISO 13485:2016 Internal Audit Toolkit

You can always customize any document and use it for just one department. In the audit plan, you will then state that the audit criterion is only one requirement that applies specifically to that department. For example, if you only want to audit the sterilization department, then you will specify requirement 7.5.5 Particular requirements for sterile medical devices and 7.5.7 Particular requirements for validation of the process for sterilization and sterile barrier systems as the audit criteria. If you want to audit only Installation Processes, then your auditing criteria will be requirement 7.5.3 Installation activities. 

If you look at the audit checklist, you can apply the same principle here, so that you fulfill the audit results only in those requirements in which you performed the audit.

How these documents look like in our ISO 13485:2016 Documentation toolkit you can see on the following link:

• Internal audit checklist https://advisera.com/13485academy/documentation/internal-audit-checklist-iso-13485-2016/
• Internal audit plan https://advisera.com/13485academy/documentation/internal-audit-plan-iso-13485-2016/

The following articles can be useful:

• 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/