Internal Audit Report Template - ISO 13485

ISO 13485:2016 +A11 2021

QMS.8.2.4.3 - QR - Internal Audit Report Template

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements.

What is an Audit?

• An audit is an independent examination of your Quality Management System (QMS) to ensure that it meets the requirements of ISO 13485.
• The assigned auditor will review your QMS documents, records and procedures and check your system for compliance with the standard.
• Your organisation will have to schedule regular assessments by both internal and external auditors.

How will having an Audit Findings Report help my organisation?

• The purpose of the Audit Findings Report is to help your organisation record the findings of your internal quality audits.
• You will also record any non-conformances found and corrective actions planned.

What does the standard say about Internal Audits?

• The standard requires that your organisation perform regular internal audits at planned intervals.
• You must use these audits to ensure that the Quality Management System conforms to:
  • planned and documented arrangements,
  • requirements of ISO 13485,
  • any applicable requirements established by the organisation,
  • any applicable regulatory requirements.
• The standard also requires that your organisation records your audits and their results and conclusions.
• Your organisation must ensure that you make any necessary corrections and take corrective actions where appropriate.

If you would like further information on our wide range of templates or have any suggestions for improvements that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

Quality Management Support:

If you are looking for support with your QMS then Patient Guards consultancy services could be a cost effective solution for your organisation.