QP-004 Management Review Process

Subject Issue date: 00/00/2021
Management review Process Issue/Modification: 1/0

Modification date:
No.: QP-004 Page: 1 of 3
A. Purpose:
This procedure defines the process for the Annually evaluation by management of the effectiveness of the Quality
Management System.
Management reviews are conducted to assess the continuing suitability, adequacy, and effectiveness of the Quality
Management System (QMS).
These reviews are intended to facilitate the identification and correction of deficiencies.
B. SCOPE
This procedure applies to all activities on the implementation of management review activities in Titan Industries
C. Responsibility
Management Proposes/defines/approves company’s policy regarding to QMS.
• Defines/approves Quality Objectives.
• Participates management reviews meeting.
• Provide the information of key performance for the review inputs.
• Implement the review outputs.
Management • Reports on the overall performance of the QMS as a basis for improvement·
Representative • Monitors QMS implementation and improvement activities.
Each Function • Collects and monitor key objectives of performance.
Department • Reports the results to management for review·
D. Abbreviations & Definitions
Management a periodic review of the QMS performed by the top management to analyze and determine
Review the effectiveness of the established management system.
E. Forms and Enclosures
-
F. Process/ method:
 Management reviews are held a minimum of once per quarter and more often as deemed necessary by
the Management Review Team.
 Management reviews are held to ensure the process management system’s continuing suitability,
adequacy, and effectiveness. The reviews include assessing opportunities for improvement and the need
for changes to the integrated process management system, including the quality policy and district
objectives.
 The date and agenda for the meeting will be set. Relevant key personnel will be tasked with preparing their
own reports (complete with analysis and graphical presentation).
The input to management reviews shall include information on:

 follow-up actions from previous management reviews;
 results of internal audits
Modification date:
 customer feedback, as a result of customer complaints and/or customer surveys conducted, when required
 reporting to regulatory authorities
 monitoring and measurements of products
 monitoring and measurements of processes
 status of corrective and preventive actions;
 planned changes that could affect the integrated process management system
 applicable new or revised regulatory requirements
 recommendations for improvement.
- The minutes of the previous management review meeting will be read. It will serve as review of what were
discussed before
- DISCUSS ALL INPUTS Current situation, with respect to noted opportunities for improvements and results of
audits are reviewed and actions for improvement are discussed, including conclusion as to the status and
effectiveness of the QMS. The appointed Secretary takes minutes of the meeting using Minutes of the Meeting
Form (QF-004-002)
Review output—The output from the management review shall include any decisions and actions
related to:
 Business requirements
 Improving effectiveness of QMS
 Improvements of service related to customer requirements
 Changes needed to respond to applicable new or revised regulatory requirements
 Modification of procedures and other documents that affect the QMS
 Resource needs (funds and budgets included)
DOCUMENT AND MAINTAIN RECORDS OF THE REVIEW
The review of findings and plan of actions are fully documented and filed.
The Chief Regulator approves the minutes of the meeting.
COMMUNICATE RESULTS OF THE Disseminate
Management Review Report to all relevant personnel
IMPLEMENT ACTION PLANS AS AGREED
Follow-up actions to ensure effective implementation of committed actions.
The management review meeting minutes will include the items discussed in the agenda items, action items
assigned, and any miscellaneous items discussed.
A. References.
EN ISO 13485:2016
B. Change History.
Issue/modification date Issue/modification No. Description of modification
DD/MM/YY (1/0) First issue
Modification date:
C. Approvals
Name Position Signature / date
Prepared by
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Subject Issue date: 00/00/2021

Management review Process Issue/Modification: 1/0

No.: QP-004 Page: 1 of 3

The input to management reviews shall include information on:

No.: QP-004 Page: 2 of 3

No.: QP-004 Page: 3 of 3

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