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Audit Plan Template (ISO 13485, Medical Device)

49,00 €

This downloadable template will help auditors remember crucial areas and present information in a logical order when preparing the audit plan. It provides auditors with a starting point for creating the audit plan for 1st of 2nd party audits.

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Description

Why it is useful

There are several, more or less, mandatory aspects that should be planned while preparing an audit. The audit plan template helps the auditor remember these areas and presents the information in a logical order.

How to use it

1. Use the audit program as input when preparing the audit plan.
2. Fill in the fields of the audit plan template while reviewing quality documents from the auditee and preparing for the audit.
3. Ensure that the auditee confirms the audit plan before 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.

Need internal auditor training and a course certificate?

Take a look at our online course: ISO 13485 Internal Auditor Training. Develop the necessary skills to conduct internal audits, use remote auditing methods, and interpret ISO 13485 requirements. Created by industry experts. Certification on successful completion of course.

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