Management Review Meeting

process (PR365)
Rev:V1.1
17-Jan-2023
 Management Review Meeting Process Rev. V1.1

Revision History

Date Rev. No. Description By

15-Dec-2021 V1.0 First release Mithilesh Kumar
17-Jan-2023 V1.1 Procedure update by adding MRM Mithilesh Kumar
Agenda

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 Management Review Meeting Process Rev. V1.1

Table of Contents
1 Overview .................................................................................................................. 4

1.1 Intended Audience ........................................................................................... 4

1.2 Acronyms and Definitions ............................................................................... 4
1.3 Responsibility .................................................................................................. 4
1.4 References........................................................................................................ 5
2 Procedure ................................................................................................................. 6

2.1 Entry Criteria ................................................................................................... 6

2.2 Tasks ................................................................................................................ 6
2.2.1 Management reviews conducted ............................................................... 6
2.2.2 The agenda for review meeting. ................................................................ 6
2.2.3 Provide details .......................................................................................... 7
2.2.4 Compile details ......................................................................................... 7
2.2.5 Present the status ...................................................................................... 7
2.2.6 Review the status & take decision ............................................................. 7
2.2.7 Prepare MOM ........................................................................................... 8
2.2.8 Take actions .............................................................................................. 8
2.2.9 Verify the effectiveness .............................................................................. 8
2.2.10 Inform to top management. ....................................................................... 8
2.3 Verification & validation ................................................................................. 8
2.4 Exit criteria ...................................................................................................... 8
3 Process Flow Chart ................................................................................................. 9

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 Management Review Meeting Process Rev. V1.1

1 Overview
To establish system for management review at defined intervals and to ensure the
continuing suitability and effectiveness of the IATF 16949:2016, ISO 9100: Rev.-D &
ISO 13485:2016.

1.1 Intended Audience

This document is intended for use by:

 QMS Team (Leads, Engineers)

 Concerned Team (Leads, Engineers)

1.2 Acronyms and Definitions

Acronym Description
QMS Quality Management System
MDQMS Medical Device Quality Management System
MRM Management Review Meeting
MOM Minutes of Meeting

1.3 Responsibility

Sr. No. Activity Responsibility

1 Organize meeting QMS Team
2 Send agenda QMS Team
3 Provide details Concerned Head
4 Compile details QMS Team
5 Present the status Concerned Head
6 Review the status & take decision QMS Team
7 Prepare MOM QMS Team
8 Take actions Concerned Head
9 Verify the effectiveness QMS Team
10 Inform to top management QMS Team

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1.4 References
Reference ID Description
TP450 MRM Minutes of meeting
TP447 Internal Audit Plan

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2 Procedure
2.1 Entry Criteria
Management review meeting will be start when review and evaluate the effectiveness
while addressing the possible need for changes to quality policy, objective, targets &
other elements of our management system and to ensure its continuity suitability and
adequacy.

2.2 Tasks
QMS & other concern team shall be involved in following activities:

 Organize meeting
 Send details
 Prepare MRM MOM
 Take actions
 Verify the effectiveness

2.2.1 Management reviews MRM and KPI

Management reviews are conducted by management twice in a year as per MRM Plan
(TP447).
Key Performance Indictor (KPI) are reviewed by management once in every month in
KPI sheet_TP405
Every year we are changing the goals >10 % for few of the KPI’s.
Few KPI’s wherever we should achieve less <10 %

2.2.2 The agenda for review meeting.

The below agenda for review meeting is prepared & circulated to all concerned well
in advance through electronic system.

Management Review Inputs

The management review meetings are planned and carried out taking into
consideration:

1. The status of actions from previous management reviews;

2. Changes in external and internal issues that are relevant to the quality
management system;
3. Information on the performance and effectiveness of the quality management
system, including trends in:
I. Customer satisfaction and feedback from relevant interested parties.
II. The extent to which quality objectives have been met;
III. Process performance and conformity of products and services.
IV. Nonconformities, corrective & Preventive actions;
V. Monitoring and measurement of Processes, Products & results.

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VI. Audit results;

VII. The performance of external providers.
4. The adequacy of resources.
5. The effectiveness of actions taken to address risks and opportunities.
6. Opportunities & recommendations for improvement.
7. Cost of poor quality (cost of internal and external non-conformance.
8. Measures of process effectiveness.
9. Measures of process efficiency.
10. Assessments of manufacturing feasibility made for changes to existing
operations and for new facilities or new product.
11. Warranty performance (where applicable).
12. Review of customer scorecards (where applicable);
13. Identification of potential field failure identified through risk analysis (such as
FMEA).
14. Actual field failures and their impact on safety or the environment.
15. Complaint handling;
16. Reporting to regulatory authorities.
17. Changes that could affect the quality management system.
18. Applicable new or revised regulatory requirements.

Management review outputs

The outputs of the management review meeting include decisions and actions
related to:

1. Opportunities for improvement.

2. Any need for changes to the quality management system.
3. Resource needs.
4. changes needed to respond to applicable new or revised regulatory
requirements
5. Improvement of product related to customer requirements.
6. Performance targets are not met then action plan should be in place

2.2.3 Provide details

Provide details to Concerned Person as given in agenda.

2.2.4 Compile details

Compile the details received from concerned person and all pending issue should be
discussed with concern persons.

2.2.5 Present the status

Present the status as per MRM agenda points.

2.2.6 Review the status & take decision

Review the status and take decisions for continual improvement.

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2.2.7 Prepare MOM

Prepare the MOM, obtain approval and forward to all management review members.

2.2.8 Take actions

Take actions as decided in MRM.

If the KPI target is not meet, then inform to respective department/process owner for
taking proper action plan against the same through continuous improvement plan.

2.2.9 Verify the effectiveness

Verify the effectiveness of action.

If it is ok, then inform to top management.

If it is not ok, then compile the details.

2.2.10 Inform to top management.

Inform to top management about MRM.

2.3 Verification & validation

Management review meeting is verified by MRM Template(TP450).

2.4 Exit criteria

Verified and inform to top management.

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3 Process Flow Chart

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