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Management Review Procedure ISO 13485

Management Review Procedure ISO 13485

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ISO 13485:2016 +A11 2021

QMS.5.6.0  – Management Review Procedure

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 a Management Review Procedure?

  • The Management Review Procedure should identify the requirements for Management Review.
  • The Management Review should be in the form of a formal meeting and must be held according to the requirements identified in the Management Review Procedure.
  • The Management Review Meetings (MRMs) should involve appointed members of your organisation’s top leadership team.
  • This template will help you set your organisation’s Management Review Procedure and plan your MRMs.

Who is responsible for setting up the Management Review?

  • Top Management shall appoint a Management Representative (MR) who must be a member of the management team. If they wish, the MR can appoint a delegate within the quality team who can take responsibility with the MR’s oversight.
  • Irrespective of other responsibilities, the MR or their delegate has responsibility and authority that includes documenting and maintaining the Management Review Procedure.
  • Each section or topic reviewed shall also include any recommendations for improvement that have been identified by the MR, department manager or other source.
  • Top Management and MR may adjust frequency of when Management Reviews Meetings are held, and meetings should be recorded (see template form 5.6-0-2 ).

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