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.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-Apr-2023 11:28
From: Dan O'Leary
Subject: Organizational chart of the quality manual
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.<o:p></o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 28-Apr-2023 11:14
From: Nawal Tiouri
Subject: Organizational chart of the quality manual
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.
Best,
Nawal
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Nawal Tiouri
Quality & Regulatory Engineer
Ypsilanti MI
United States
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