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ISO 9001:2015, Cl. 9.3.1, Gen Director does not participate in Management Review

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Helen238, Sep 20, 2017.

  1. Helen238

    Helen238 Member

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    Hello Everyone!
    I would like to ask you a question about participants of Management Review. I would like to quote the initiated nonconformity and in order to make it clear I will give some details below:
    - QMS is established not in whole organization, but in one department. Management review is conducted by the Head of this department, not by General Director of an organization.
    - Quality Policy has a signature of General Director (approved by GD).

    Now the nonconformity: Despite the fact, that Quality Policy is approved by General Director, he is not participating in Management Review process.

    Cl 9.3.1 states that "Top Management shall review the organization's qms...." Head of the department is also Top Management representative. Is it a nonconformity that Head of department (and not General Director) conducts Management review?

    Your comment and opinion will be appreciated much. Thanks.
     
  2. Golfman25

    Golfman25 Well-Known Member

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    Not really sure how you can only apply to a department, but I would say if the Director signed the policy he should probably participate in management review. One of the items to be reviewed it the quality policy which he is accountable for. And given that he is the ultimate top management I think you'll have a hard time not having him participate.
     
  3. RoxaneB

    RoxaneB Moderator Staff Member

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    I have experienced Management Reviews that proceeded as long as a majority of top management was in attendance. However, like Golfman, I'm uncertain how you applied a QMS to only one department.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Helen: We seek some clarifications before we can really be of help...

    Is this an external (Certification Body) audit? What's the scope of your QMS? Do you hold review meetings? Do you know why the DG doesn't want to be involved?
     
  5. Helen238

    Helen238 Member

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    I thank you for reply.

    The organization contains several departments, that departments have different regulations. Regulation of our department says that we must develop, implement and maintain QMS. No requirements for other departments. The decision was made to establish QMS scope covering only our department. The possibility of such approach is mentioned in ISO 9000:2015, item 3.1.1, Note 2.

    If we go back to the nonconformity - 9.3.1 does not specify who is Top Management representative who shall review QMS. Head of department is Top Management representative as well as Gen Director. I feel like stating that it definitely shall be done by General Director needs more specified requirement.
     
  6. Helen238

    Helen238 Member

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    Local Regulator Body conducted audit on conformance with ISO 9001:2015. Our QMS scope applies to only one department of an organization. DG is involved in review of resources, making decisions, etc. but not in the scope of Management review process. For example, he reviews resources need with Financial department and that is out of our QMS scope. Thus, we include in management review analysis of resources need by Head of department. In result of review there is established required action, like submitting request to Financial dpt (which afterwards reviews it with DG).

    DG is ready to be included in review of our departments activity, it is not a problem. However, it is interesting to establish whether ISO 9001:2015 strictly requires that DG shall conduct management review.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It seems to me that they -the regulator - will call the shots on if you comply or not. If it was a CB, then the situation is going to be different. I'm still concerned that a department can implement a QMS in compliance with the requirements of ISO 9001:2015. How many people are in this department?
     
  8. Helen238

    Helen238 Member

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    I have mentioned in my previous post, ISO 9000:2015; 3.3.1, Note 2 determines "Top management" for situation when QMS covers a part of an organization. That is our case.

    There are 40 staff members in our department.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Since we're not talking about being certified, there's no (good) reason NOT to be in compliance in a department of 40 people...
     
  10. Helen238

    Helen238 Member

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    Could you please specify, you mean, there's no reason to NOT include DG in management review process?
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's not what I posted. I was commenting on the application of ISO 9001 to a department of 40.
     
  12. Golfman25

    Golfman25 Well-Known Member

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    Look I thimk what the auditor did is pretty simple. You have a high level document signed by a high level person. That by definition seems to be top management. Top management has to do management review. Thus your director should be in management review. Or take his name off the quality policy.
     
  13. tony s

    tony s Well-Known Member

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    Can we know the products and services of this department? Who is/are the customer/s of this department? What is the nature of business of the whole organization?

    In large organizations with various products/services, the highest official (e.g. company president) usually signs the QP. They may opt to limit their scope depending on their needs. For example, a universal bank that provides a variety of financial services may elect to obtain ISO 9001 certification for its trust products or lending products only. The head (usually, a senior vice president) of the department that provides such products to specific customers can be the top management.

    There is no requirement in ISO 9001 that the one who signs the QP must be present during a management review.
     
  14. john moreton

    john moreton New Member

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    Sounds like a very large/global company that offers a different range of products and/or services under the umbrella of the one company. If each department/site has its own QMS i would imagine that each department/site has their own 9001 ?
    Also as long as there is sufficient representation from senior management with the authority to make relative decisions then you do not need every one there or even the very top person. Some of our Global policies are signed of by Global President. there is no way he will be at all of our different site Audits.
     
  15. Jay Carron

    Jay Carron New Member

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    As mentioned in another forum, Management Review doesn't require a meeting. Only documented evidence that the required inputs are reviewed. Those inputs which require top management's review are all that's required of them. These reviews may be ongoing throughout the course of the year. But make sure you document the reviews and the outputs.
     

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