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Management Review Procedure - ISO 9001

Management Review Procedure - ISO 9001

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ISO 9001:2015 - QMS.9.3.1 - QP - 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? Why do I need it in my Quality Management System (QMS)?

  • Management Review is an essential part of an ISO 9001 Quality Management System, it is essential that the top management of the organisation are involved with the Quality Management System in order for it to work effectively and promote a quality culture within the organisation. 
  • The management review procedure details how top management review the quality management system at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of
    the organization.
  • This is by setting quality policy, objectives, these are the objectives the quality management system is set up to monitor and provide data on. Management then review the data being generated by the QMS to ensure that it is working effectively and allowing the organisation to meet its objectives inline with policy. 

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.

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