What should be included in a Management Review document?

kkamp

Involved In Discussions
Hi everyone,
I understand that the document includes the entries mentioned in clause 5.6.2, which are:
  • feedback complaint handling;
  • reporting to regulatory authorities;
  • audits;
  • monitoring and measurement of processes;
  • monitoring and measurement of product;
  • corrective actions;
  • preventive action;
  • follow-up actions from previous management reviews;
  • changes that could affect the quality management system;
  • recommendations for improvement;
  • applicable new or revised regulatory requirements;
  • The review of risk management process.

But I want to know if there is anything else to consider in the document.
If someone could provide me with a template, I would be grateful.
 

Bev D

Heretical Statistician
Leader
Super Moderator
The list is fairly comprehensive. Additional items should be what is important to your organization. No template can help you with that. My suggestion is to become comfortable with the required items then add things as necessary. Management review should not be a checklist but a true discussion of the state of the organization’s quality system…
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Bev D says it with its a discussion among stakeholders and decision-makers about how the QMS is achieving the QMS goals and objectives. If you read the beginning of the 13485 text it says "The adoption of a quality management system is a strategic decision of an organization.

For my own MR I add anything I could think of that could have impacted our ability to achieve our stated goals. 2020 I added Pandemic to the list.
 

yodon

Leader
Super Moderator
Management review should not be a checklist but a true discussion of the state of the organization’s quality system…
Amen! I just finished an audit where they "legally" covered all the inputs but the meeting was clearly a "check the box" activity. For example, for feedback, the input was that they had x number of complaints. No analysis, no discussion, no trending, no actions, no conclusions. It's really not a big leap to ask what the data is telling us.
 

Philip B

Quite Involved in Discussions
In addition to the basics required by the standard, we include major projects, supplier performance, non-conforming product, bioburden & sterilisation validation, quality objectives, quality policy, PMS plan, stock write-offs and resources.

Make it a meeting worth having, not a meeting you have to have.
 

kkamp

Involved In Discussions
I appreciate your responses @Philip B, @yodon, @Ed Panek, @Bev D. It is the first time that I prepare the documentation for the standard, that is why I wanted a template for the Management Review document. I think it would be helpful for me to clarify what the document contains ;)
 

DanMann

Quite Involved in Discussions
You can also add an item to the agenda "Topics to be added to the next or future meetings".
 

DianaL

Registered
We incorporate the Data Analysis requirements in the Management Review. To ensure nothing gets overlooked we incorporate the topics in the opening statement for the Mgmt Review as well as outputs. We have developed Management Review Toolkits Powerpoint templates (9001, AS 9100, 14001, 9001/14001, 13485, 9001/13485 and we've done a version for companies not yet certified but to use as method to work towards certification. Working on the new 7101 Healthcare. msi-international. see our example of the Minutes form.
1. Attendees and Title/Position

2. High Level View of Management Review Process

3. Charter (i.e., Strategic Direction) Vision, Mission, Values and How the Quality Policy relates

4. Status of Actions from Previous Management Reviews

5. Quality Policy Statement and Current Org Chart

6. Company Program Changes

7. Feedback & Complaint Handling

8. Status of Quality Objectives

9. Process Interactions

10. QMS Processes’ KPIs & Targets

11. Product and/or Service Conformity (monitoring and measurement)

12. Nonconformities, Corrective and Preventive Actions

13. Monitoring & Measuring

14. Audit Results & Audit Schedules

15. Performance of External Providers (not officially required, but highly recommended)

16. Quality Policy Statement Evaluation

17. The Adequacy of Resources

18. Continued Suitability, Adequacy and Effectiveness of the QMS (Round Robin discussion)

19. Opportunities for Improvement (some would hopefully had been suggested and the through the Mgmt more would be Identified)

20. Reporting to and Applicable New or Revised Regulatory Requirements

21. Decisions & Actions Related to Opportunities for Improvement

22. Decisions & Actions Related to Improvement of Product Related to Customer Requirements

23. Changes Related to Applicable New or Revised Regulatory Requirements

24. Decisions & Actions Related to any Need for Changes to the QMS and Company Changes that could affect the QMS

25. Decisions & Actions Related to Resource Needs

26. Actions to be Taken / Needed Changes

27. The Next Management Review Date
 

Quality-Nation

On Holiday
We incorporate the Data Analysis requirements in the Management Review. To ensure nothing gets overlooked we incorporate the topics in the opening statement for the Mgmt Review as well as outputs. We have developed Management Review Toolkits Powerpoint templates (9001, AS 9100, 14001, 9001/14001, 13485, 9001/13485 and we've done a version for companies not yet certified but to use as method to work towards certification. Working on the new 7101 Healthcare. msi-international. see our example of the Minutes form.
1. Attendees and Title/Position

2. High Level View of Management Review Process

3. Charter (i.e., Strategic Direction) Vision, Mission, Values and How the Quality Policy relates

4. Status of Actions from Previous Management Reviews

5. Quality Policy Statement and Current Org Chart

6. Company Program Changes

7. Feedback & Complaint Handling

8. Status of Quality Objectives

9. Process Interactions

10. QMS Processes’ KPIs & Targets

11. Product and/or Service Conformity (monitoring and measurement)

12. Nonconformities, Corrective and Preventive Actions

13. Monitoring & Measuring

14. Audit Results & Audit Schedules

15. Performance of External Providers (not officially required, but highly recommended)

16. Quality Policy Statement Evaluation

17. The Adequacy of Resources

18. Continued Suitability, Adequacy and Effectiveness of the QMS (Round Robin discussion)

19. Opportunities for Improvement (some would hopefully had been suggested and the through the Mgmt more would be Identified)

20. Reporting to and Applicable New or Revised Regulatory Requirements

21. Decisions & Actions Related to Opportunities for Improvement

22. Decisions & Actions Related to Improvement of Product Related to Customer Requirements

23. Changes Related to Applicable New or Revised Regulatory Requirements

24. Decisions & Actions Related to any Need for Changes to the QMS and Company Changes that could affect the QMS

25. Decisions & Actions Related to Resource Needs

26. Actions to be Taken / Needed Changes

27. The Next Management Review Dat
Overly complex IMHO
 
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