EBME

Procedure for Management Review Meetings

Purpose: The purpose of this procedure is to define the methods used to review the Quality System that is in operation.

Scope: This procedure applies to all Management Review Meetings, including their associated documentation.

Definition Management Review: A structured meeting that must take place at regular intervals to discuss the functioning of the quality system of the EBME Department and to take action to correct it when necessary.

Responsibilities It is the responsibility of the Facilities Manager or the EBME Manager to conduct regular Management Review Meetings. It is the responsibility of the Quality Assurance Manager to ensure that this procedure is carried out.

 

Management Review

Management Review Meetings are designed to ensure that all quality related functions are reviewed at the highest possible level and so that all levels of management affecting quality are made aware of changes, updates, revisions, verification activities and policies.  The Management Review will take the form of a formal, recorded meeting under the Chairmanship of the Facilities Manager or EBME Manager.  The Quality Assurance Manager, the Chief Biomedical Technician and any other staff designated by senior Management will attend.

 

Objectives of mangement review meetings The objectives of the Management Review are:-

  • To establish that the Quality Assurance System is achieving the expected results, continuing to conform to the standard, and functioning in accordance with the established Operating Procedures.
  • To expose irregularities or defects in the System, identify weaknesses and make recommendations for continual improvement.
  • To review the effectiveness of previous corrective actions including those related to subcontractor and supplier performance.
  • To review the adequacy and suitability of the Quality Assurance System for current and future operations.
  • To review any complaints received, identify the cause and recommend corrective action if required including customer feedback.
  • To review the finding of internal / external audits and identify any areas of recurring problems.
  • To review the reports of non-conformities and evaluate trend information.
  • To review training requirements. Analyse all the above for trends and make appropriate improvements

 

Model Review Meeting Agenda

  1. Apologies for Absence.
  2. Minutes of Previous Meeting.
  3. Review of Corrective Actions from Previous meeting.
  4. Review of General Actions from Previous Meeting.
  5. Changes to the Quality Assurance Standard, Quality Assessment Schedule or Certification Requirements.
  6. Review Input Results of audits Customer Feedback Service Performance Status of preventive and corrective action Review Output Improvement of the effectiveness of the system Improvements of the service related to customer requirements Resources needed. Update in objectives
  7. Proposed Quality Assurance System Improvements/Modifications.             (Including objectives and policy)
  8. Scheduled Internal Audit Programme.
  9. Subcontractor/suppliers performance.
  10. Staff training needs review.
  11. Review of infrastructure and work environment
  12. Any other business.
  13. Date and Time of Next Meeting. The Quality Assurance Manager will produce documentation (including analyses, reviews, proposals, etc.) for circulation to participants. The content of the meetings will be formally documented and recorded by the Quality Assurance Manager. These records will be made available to External Assessors.

 

Internal Communication Meetings

In addition to formal management review meetings, the EBME Manager will hold regular staff meetings at appropriate intervals to review processes, inform staff of the effectiveness of the Quality System, review Customer feedback, carry out preventive action (risk analysis) communicate the organisations commitment to meeting customers' needs and ensure staff are familiar with the Department's Legal and Regulatory obligations.

Department objectives will be verified, and the continued suitability, adequacy and effectiveness of the department will be discussed.

These meetings will be appropriately documented.

 

 

References: ISO 9001-2000 Management Responsibilities