Management Review Meeting Minutes Templates - ISO 13485

ISO 13485: 2016 +A11 2021  

QMS.5.6.0.2 – QR –Management Review Meeting Minuets 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.

Why will I need to take minutes of my Management Review Meetings?

• Each Management Review Meeting (MRM) must be documented by formal minutes of the meeting. This will help to show compliance with ISO 13485 clause 4.5 (control of records).
• This document will provide you with a standard minuets template to use in you MRMs that is compliant with ISO 13485.

What should go into my MRM Minuets?

• Your MRM Minuets should include details of your meeting, as well as an abridged version of what was discussed. Examples of some fields to include are:
  • Attendance – attendance is taken to assure a representative from the responsible departments is present and documented on the record
  • Follow up actions – these should be from the prior MRM (unless this is the first)
  • Items listed in your agenda – as well as what was discussed regarding them
  • Inputs and outputs – Information, reports, products relating to meeting agenda items
  • A summary of actions required
• Meeting minutes should be reviewed with those Management Team members not present and their signature(s) obtained to show that this review was performed.

If you would like further information on our wide range of templates or have any suggestions for improvement 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.