Template of a Management Review Agenda or Report in compliance with ISO 13485:2016

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Mark Meer

Trusted Information Resource
#4
A simple formula for a Management Review report "template":

1. Create headings for each of the review inputs from the standard (ISO 13485:2016, 5.6.2)

2. Under each heading, have the following subheadings and content:

a. Data - Present the available data in a suitable format
b. Objectives - How does the data relate to established objectives? Are they being met? If not, why? Is the objective(s) still suitable?
c. Trends - Are there any relevant trends to be gleaned from the data? What is the impact (risk assessment) of such trends?
d. Resources - Any indication that resource needs are lacking? Any problems with facilities, equipment, personnel (incl. training), etc.?
e. Conclusions / Actions:
- Overall, how is the process functioning (adequacy of process/objectives, management, resources, training, meeting customer requirements, etc.)
- Are any investigations and/or corrective or preventive actions necessary?
- Are there any opportunities for improvement / changes warranted? (also consider in light of any other changes - regulatory, risk, product, etc.)

Good Luck!
MM
 

JoshuaFroud

Involved In Discussions
#5
The mandatory items for discussion in Management review in ISO 9001:2015 and ISO 13485:2016 are not identical. There is some overlap but not complete. You can run a management review that satisfies both sets of requirements but creating your agenda based on the requirements from both the standards.

As Mark has said above, the standard fairly clearly outlines the minimum required inputs and outputs for management review. If you use these inputs to create the agenda and the outputs to create the report you should be on to a winner.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#6
ISO 13485:2016(E)
5 Management responsibility

The organization shall document procedures for management review. Top management shall review
the organization’s quality management system at documented planned intervals to ensure its
continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for
improvement and the need for changes to the quality management system, including the quality policy
and quality objectives.

That section is what you should address with the following questions:

1) Was the QMS implemented and maintained - Evidence and discuss
2) What were the results - Evidence and discuss
3) What should be improved?
4) What will be changed and new objectives?

A risk based approach should also consider

1) New Products
2) New Technology
3) Competition
4) Competence
5) Regulatory changes
6) Infrastructure changes

Iso also requires:

The input to management review shall include, but is not limited to, information arising from:
a) feedback;
b) complaint handling;
c) reporting to regulatory authorities;
d) audits;
e) monitoring and measurement of processes;
f) monitoring and measurement of product;
g) corrective action;
h) preventive action;
i) follow-up actions from previous management reviews;
j) changes that could affect the quality management system;
k) recommendations for improvement;
l) applicable new or revised regulatory requirements.

I would add a slide for each subitem in section 5.
 

CindyG

Involved In Discussions
#7
A simple formula for a Management Review report "template":

1. Create headings for each of the review inputs from the standard (ISO 13485:2016, 5.6.2)

2. Under each heading, have the following subheadings and content:

a. Data - Present the available data in a suitable format
b. Objectives - How does the data relate to established objectives? Are they being met? If not, why? Is the objective(s) still suitable?
c. Trends - Are there any relevant trends to be gleaned from the data? What is the impact (risk assessment) of such trends?
d. Resources - Any indication that resource needs are lacking? Any problems with facilities, equipment, personnel (incl. training), etc.?
e. Conclusions / Actions:
- Overall, how is the process functioning (adequacy of process/objectives, management, resources, training, meeting customer requirements, etc.)
- Are any investigations and/or corrective or preventive actions necessary?
- Are there any opportunities for improvement / changes warranted? (also consider in light of any other changes - regulatory, risk, product, etc.)

Good Luck!
MM
Thanks, Mark! I appreciate your help!
Do you have your mgmt review presentation you used to present just as you said?
If so, could i get a look at it?!
Thank you! :)
 
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