Regulatory Open Forum

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  • 1.  Organizational chart of the quality manual

    Posted 28-Apr-2023 11:14

    Hi everyone , 

    Do you recommend including the organizational chart within the QM or as a separate appendix? Another question is whether you recommend adding only titles or employee names.


    Nawal Tiouri
    Quality & Regulatory Engineer
    Ypsilanti MI
    United States

  • 2.  RE: Organizational chart of the quality manual

    Posted 28-Apr-2023 11:28

    I recommend not putting the organization chart in the QM.

    If you are implementing QSR, then you don't need a QM. I recommend not having one. In QSR, the organization chart belongs in the 820.186 Quality System Record.

    In ISO 13485:2016, there are only three required items in the QM, scope, procedures, and process interactions. I recommend limiting the QM to these three items.

    The "heavy lifting" in the QMS belongs in the procedures not the QM. When I audit companies, I always start with the QM which is usually 20 to 30 pages. Then I compare the QM requirements to procedures. Since the QM takes precedence, any differences are non-conformances. The problem is that nearly all companies revise the procedures without checking the revisions against the QM.

    For the organization chart, use titles only. Adding names creates a lot of extra document control work since every change of a name needs a new revision.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States

  • 3.  RE: Organizational chart of the quality manual

    Posted 29-Apr-2023 06:46

    Hello Nawal,

    An organisational chart would usually be recommended at least as a separate document referenced by a Quality Manual.  This allows the organisational chart flexibility in being updated without having to update the Quality Manual each time.  It could be as an Appendix, but is a bit better as a separate document.

    For the content, the "official" version should just have titles because this does not change too much or should not change too much.  Then have an "unofficial" version which has names linked to them.  People have many different opinions about this - really just do what you are comfortable with and can support through your quality system.  For me, I like an official version which can provide to any party as needed - it is fairly vanilla.  Then the unofficial version is for when an auditor comes in to help them see who is who.  As an auditor, that is helpful to see who is who - definitely not required, but it is helpful.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: Organizational chart of the quality manual

    Posted 29-Apr-2023 07:37

    I would highly recommend a separate document. As Dan & Richard outlined, the use of titles without names is preferred. Having it separate allows you to update it as the titles change without a more cumbersome change to the quality manual and not having names allows you to keep the chart without changes as people come and go. In addition, I recommend indicating on the org chart which positions are considered "top management" so that you don't need to further designate who the decision makers (management review) are and this communicates that to the organization (the org chart is not just for auditors).

    I would disagree on not having a quality manual. This is the necessary planning document for the quality management system. On top of which at this point, the transition to the QMSR is a foregone conclusion and will be needed. In addition, I would look to future expansion and having a maturing quality manual will prevent future work if you look to expand your markets. 

    On the quality manual, I completely agree with just the 3 items (although there are some other items I would add there like mission & vision). We have made a fully compliant quality manual as a single page trifold (the inside is a process diagram that lists the SOPs/shows top level interactions).

    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States

  • 5.  RE: Organizational chart of the quality manual

    Posted 29-Apr-2023 07:54

    Hi Nawal,
    The short answer is not to include individuals' names as people move and the document can become obsolete quickly.  It's best to use organizational titles in documents such as a Quality Manual to avoid frequent (and unnecessary) revisions. 

    For drugs, there is no specific requirement in Parts 210/211 for a Quality Manual as such, but 211.22 requires written procedures and responsibilities for the quality control unit.  However, a Quality Manual presents logical, concise document to outline the roles and responsibilities, as well the quality programs.  ICH Q10, Pharmaceutical Quality System, which FDA has adopted, includes the need for a Quality Manual to describe the Quality System and the processes within the Quality System.

    Peter Smith
    Smith GMP Consulting
    Narragansett, Rhode Island

  • 6.  RE: Organizational chart of the quality manual

    Posted 01-May-2023 07:36

    Hi Nawal,


    I would highly suggest not to use names in any QMS documents so that revisions do not have to occur with promotions or turnover.  Our org chart is an Appendix to the QM since that it is always requested with the QM during an audit.


    Good Luck,



    D. Michelle Williams, CESCO

    VP – Operations


    Action Products, Inc.

    301.797.1414 X1022






  • 7.  RE: Organizational chart of the quality manual

    Posted 01-May-2023 09:03

    I agree with all the contributors above about the pros and cons of the contents and place of an org chart.

    Why do you need/want an org chart in the QMS? There is no explicit requirement in ISO 13485:2016 for an org chart. The closest I can find is clause 5.5.1 which states: "top management shall document the interrelations of all personnel who ......".
    One can use an org chart for that, but maybe the documented procedures already identify those relations, or one can find this in the job descriptions (by the way, also not specifically required by ISO 13485:2016).

    I think that an org chart and job descriptions are very valuable, but not necessarily as part of the QMS.

    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training

  • 8.  RE: Organizational chart of the quality manual

    Posted 01-May-2023 09:42

    Hi Nawal - 

    As usually is true you have gotten many very highly experienced answers to your original question but I would like to chime in with a simple piece of general advice: comply with the rules as written; consider rules as interpreted; don't go out of the way to create new requirements for yourself that are not part of the rules.  This essentially means that you should make sure that your documentation complies with the requirements as they are written.  If it does, then you are home free from a "technical" perspective.  Next, look at the way(s) the regulatory agencies have interpreted the rules previously if such information is available.  Consider how this interpretation interacts with the actual written requirements in the regulations and then determine what if any additional details make sense to include in your documents.  But most importantly don't go out of your way to add extra information in the documents that will ultimately be seen as a commitment on your part to go above and beyond the requirements.  As has been previously mentioned, if you go down that road you are essentially asking for auditors to find non-conformances in your documents because people invariably will forget to update something in the documents (whether that is the QM information itself or something else) which will lead to discrepancies between your documents and an easy non-conformance to document for an auditor.

    As for organizational charts, I tend to be in the camp with the idea similar to Richard - turn your organization chart into a "reference" in your documentation and don't make it a part of the documents themselves.  Again, if something changes on the organizational chart and the document isn't updated properly (including any required document control procedures being followed everytime you update your organizational chart for any reason) you have a non-conformance.  Avoiding names on your official chart also minimizes the chances of non-conformance.  Think about it - how many times have you seen employees promoted or someone leaves the company and they are replaced?  If the chart is part of your controlled documents, you would need to update the chart (and any associated procedures or other items in your system) every time that there is any change in who moves into what position (even with internal promotions).  I do also like the suggestion from Mark regarding annotating who the decision maker(s) might be in the organization on your official organizational chart (without naming specific people but positions) to make it a little easier on the auditor.  But it also provides a certain ability of non-decision makers to answer questions from regulators about specific issues with "Please speak with __________ who is considered the decision maker for such a situation" rather than potentially having different employees answering questions differently...

    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States