ISO $9001$:$2015$ Management review meetings. $-$

PLease check below for grammer

$$

Management Review

A structured Management Review meeting will generally take place on a $6$ monthly basis or more frequently should the need arise. The Review will discuss the functioning of the Medical Engineering Departments quality system, in order to make improvements and take corrective action when necessary.

$$

RESPONSIBILITIES

$$

It is the responsibility of the Trust Medical Engineering 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.$$ To enable all levels of management affecting quality to be made aware of changes updates revisions, verification activities and policies.

$$

The Management Review will take the form of a formal, minuted meeting under the Chairmanship of the Trust Medical Engineering Manager.

$$

The Quality Assurance Manager, Office Manager, Systems Manager and Team Managers plus any other staff designated by Senior Management will attend.

$$

$$

$$

$$

$$

$$

$$

$$

$$

$$

$$

OBJECTIVES OF MANAGEMENT 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 international standard, and functioning in accordance with the established Operating Procedures and Processes.

$$

$$ To review that the Quality Policy meets the needs of the organisation.

$$

$$ To expose irregularities or defects in the System, identify weaknesses or risks or opportunities and make recommendations for continual improvement.

$$

$$ To review the effectiveness of previous corrective actions including those related to external providers performance.

$$

$$ To review the adequacy, effectiveness and suitability of the Quality Assurance System for current and future operations.

$$

$$ To review any interested parties complaints received, identify the cause and recommend corrective action if required including customer feedback.

$$

$$ To review the findings of internal $/$ external audits and identify any opportunities for improvements.

$$

$$ To review the reports of non$-$conformities and evaluate trend information.

$$

$$ To review the adequacy of current or future resource requirements.

$$

$$ Analyse all the above for trends and make appropriate improvements

$$

$$

$$

$$

$$

$$

$$

$$

$$

$$

$$

$$

$$

$$

$$

MODEL REVIEW MEETING AGENDA

$$

Apologies for Absence.

$$

Minutes of Previous Meeting.

$$

Review Inputs

$$ Actions Arising from Previous Meeting

$$ External and Internal Issue changes

$$ Customer Satisfaction and Feedback

$$ Quality Objectives Performance

$$ Status of Nonconformities and Corrective action

$$ Monitoring and Measurement Results

$$ Audit Results

$$ Performance of External Providers

$$ Adequacy of Resources

$$ Effectiveness of Actions to Address Risks and Opportunities

$$ Opportunities for Improvements

$$

Review Outputs

$$ Opportunities for Improvements

$$ Improvements to the Quality Management System

$$ Resource Requirements

$$

AOB

$$

Date 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 Trust Medical Engineering Manager will hold regular staff meetings at appropriate intervals. The object, to review processes, inform staff of the effectiveness of the Quality System, review Customer feedback, 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 communication meetings will be appropriately documented.