Management Review Meeting Agenda Template - ISO 13485

ISO 13485: 2016 + A11 2021

QMS.5.6.0.1 – QR – Management Review Meetings Agenda 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 do I need to set an agenda?

• An effective agenda sets clear expectations for what needs to occur before and during your Management Review Meetings (MRMs).
• It will help the Top Management Team to prepare and allocate time
• Agendas quickly gets everyone on the same topic and identifies when the discussion is complete along with any post-meeting follow up actions.

How should I use this template?

• The Management Review Meetings Agenda Template helps you set agenda topics in advance of your MRM, as well as inputs/outputs and actions during/after the meeting.
• The template includes all agenda topics that are set out in the ISO 13485 standard. You must address all of these points at a minimum, and are able to include your own if desired.
• The Management Representative (MR) or their designee sends the Management Review Meeting Agenda to the management team members indicating the information being discussed and the scheduled date of the meeting.
• The agenda must be reviewed in entirety at each Management Review Meeting; additional items can be added, as needed.

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.

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