Audit Report Template (ISO 13485, Medical Device)

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This downloadable audit report template will provide auditors with a starting point for creating the audit report for 1st of 2nd party audits.

Description

Why it is useful

This template contains a lot of the information that can be found in the audit plan. The audit report template ensures that the areas that should be addressed in the audit report are included and presented in a logical order.

How to use it

1. Use the audit plan to prepare for conducting the audit activities and communicating with the auditee.
2. Fill in as many fields as possible before conducting the audit activities to reduce the amount of time spent on administrative things during and after conducting the audit activities.
3. Make notes in the audit report while conducting the audit activities.
4. Complete the audit report as soon as possible after conducting the audit activities.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.
All texts that are not blue are example texts that can and should be edited by you.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customised to work with the current project.

Support

If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible on this link when you are logged into your Medical Device HQ account.

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