ISO 9001:2015 Cl. 9.3.1 - General Director doesn't participate in Management Review

[Helen238]

Hello everyone!
I would like to ask you a question about the nonconformity that was registered during an audit. The nonconformity report was initiated against 9.3.1 of ISO 9001:2015. The description is as follows: despite the fact that Quality Policy is approved by General Director of an organization, he is not participating in Management review process.
Now details to make the situation more clear: QMS covers only one department of an organization (not organization in whole). The management review process is conducted by Head of the department and Heads of offices included in this department.

Is it a nonconformity that Management review is conducted by Head of the department to which QMS applies and not by General Director?

Your advice, comments and opinion will be highly appreciated.

 

[Great Scotch]

Does your organisation have a standard proven management review form?

 

[somashekar]

Hello everyone!
I would like to ask you a question about the nonconformity that was registered during an audit. The nonconformity report was initiated against 9.3.1 of ISO 9001:2015. The description is as follows: despite the fact that Quality Policy is approved by General Director of an organization, he is not participating in Management review process.
Now details to make the situation more clear: QMS covers only one department of an organization (not organization in whole). The management review process is conducted by Head of the department and Heads of offices included in this department.

Is it a nonconformity that Management review is conducted by Head of the department to which QMS applies and not by General Director?

Your advice, comments and opinion will be highly appreciated.

Hi..
You perhaps mean that your Quality Policy statement that you might have displayed has the signature of your General director. There is no problem with that.
It looks like your auditor is expecting to see your General director reviewing your QMS performance. Perhaps your leadership is not defined, and therefore your top management is actually not constituted.
You say ... The management review process is conducted by Head of the department and Heads of offices included in this department.
Do they constitute the leadership as far as the QMS implementation is concerned. Are they the Top management who will and can take decisions and set directions with due authority. Has the General Director so stated in some place.
Perhaps your auditor has not dwelled into finding out who the top management are, and you are unsure too to respond.
The NC is poorly worded though. I feel your top management is not clearly stated and known to all working people in the organization.
Your General Director may have nothing to do with your management review.

 

[Helen238]

Thanks for your comment.
Correct. Quality Policy statement that we displayed has the signature of our General Director.
And yes, auditor is expecting to see that General Director is reviewing our QMS performance.
It is stated in our procedure that Top Management representatives are General Director, Head of the department and Heads of offices included in this department.

In accordance with ISO 9000:2015 3.1.1
“top management”
Person or group of people who directs and controls an organization at the highest level.
Note 2 to entry: If the scope of the management system covers only part of an organization, then top management refers to those who direct and control that part of the organization.

Considering that definition it becomes clear that Head of the department is representative of Top Management as well. 9.3.1 says that Top management shall review the QMS, but it does not state clearly what are the positions that shall do it. If I understand correctly, this shall be defined by the organization. Is not it right?

 

[Helen238]

Does your organisation have a standard proven management review form?

We have a form for Management Review that covers all the subjects to be reviewed in accordance with ISO 9001:2015 9.3.2 and also includes items given in 9.3.3 in relation to which decisions and actions are expected.

Did I understand your question correctly?

 

[somashekar]

Thanks for your comment.
Correct. Quality Policy statement that we displayed has the signature of our General Director.
And yes, auditor is expecting to see that General Director is reviewing our QMS performance.
It is stated in our procedure that Top Management representatives are General Director, Head of the department and Heads of offices included in this department.

In accordance with ISO 9000:2015 3.1.1
“top management”
Person or group of people who directs and controls an organization at the highest level.
Note 2 to entry: If the scope of the management system covers only part of an organization, then top management refers to those who direct and control that part of the organization.

Considering that definition it becomes clear that Head of the department is representative of Top Management as well. 9.3.1 says that Top management shall review the QMS, but it does not state clearly what are the positions that shall do it. If I understand correctly, this shall be defined by the organization. Is not it right?

What you tell as "becomes clear" from your interpretation of the standard., and what your procedure tells seems to clash.
For clarity, it is best that your General Director defines the roles, responsibilities and authorities, for the Head of the department / office, including reviewing the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.
It is stated in our procedure that Top Management representatives are General Director, Head of the department and Heads of offices included in this department. About this line, you also make suitable changes.

 

[Helen238]

What you tell as "becomes clear" from your interpretation of the standard., and what your procedure tells seems to clash.
For clarity, it is best that your General Director defines the roles, responsibilities and authorities, for the Head of the department / office, including reviewing the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.
It is stated in our procedure that Top Management representatives are General Director, Head of the department and Heads of offices included in this department. About this line, you also make suitable changes.

I agree that assigning responsibilities and authorities for management review by General Director will make clear who shall do it.

To avoid misinterpretation from my side, is it that nonconformity is not the fact that Management Review is conducted by Head of the department, but the fact that it is not clearly stated (for example by GD's Order) who is responsible and authorized to review the QMS?

 

[somashekar]

I agree that assigning responsibilities and authorities for management review by General Director will make clear who shall do it.

To avoid misinterpretation from my side, is it that nonconformity is not the fact that Management Review is conducted by Head of the department, but the fact that it is not clearly stated (for example by GD's Order) who is responsible and authorized to review the QMS?

Yes. Let the leadership (one or more persons) be defined by the General Director.

 

[Helen238]

Yes. Let the leadership (one or more persons) be defined by the General Director.

I thank you very much for your time and valuable advice.