Internal Audit Plan- ISO 13485

ISO 13485: 2016 +A11 2021 

QMS.8.2.4.2 - QR - Internal Audit Plan & Checklist 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 Internal Audit Plan & Checklist help my organisation?

• The purpose of the Internal Audit Plan is to help your organisation set a day plan when performing internal quality audits.
• You will also set the objective(s) for the audit and reference the relevant section(s) of regulation that you will be assessing your QMS against.

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 plans an audit program.
• This program should take into consideration the associated risk and importance of the processes being audited, as well as the outcomes of previous audits if any.

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.