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Documentation Statement after being Acquired by new company

Discussion in 'Documentation Control, Procedures, Templates,...' started by Rachel, Nov 5, 2020.

  1. Rachel

    Rachel Member

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    Afternoon, We are a ISO13485:2016 Company. I am in need of an example statement to put into my control of document procedures. We were bought in June and they have just sent us the logo for all our internal documents. We have decided as a group to not complete this task all at one we over a thousand. How can I write that as we make changes or reviews or electronically alerted for 1 year review. That we are still compliant to the new company and Certain documents have had the changes as we move forward.
     
    Rachel, Nov 5, 2020
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You should have something recorded in your management review records for a start. Have you considered this?
     
    Andy Nichols, Nov 6, 2020
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  3. Miner

    Miner Moderator Staff Member

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    You should also make sure that you have given yourself the leeway to make certain changes (e.g., correct spelling errors, make cosmetic changes such as logos, change company name, etc.) without a formal review/approval process.
     
    Miner, Nov 6, 2020
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  4. Rachel

    Rachel Member

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    Thank you all but I was really looking for a statement that I cold just right as we are moving forward and documents will talk awhile to address all the logo changes and footers plus the review.
     
    Rachel, Nov 6, 2020
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's not needed. As far as the QMS is concerned, it's the CONTENT which matters, not the frilly things like logos etc.
     
    Andy Nichols, Nov 6, 2020
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  6. yodon

    yodon Well-Known Member

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    How do you normally authorize / track changes to documents? If you have a change control system, you can write a blanket one to change the logos and such over time. I wouldn't update my document control procedures for this.

    Are you going to be autonomous? You do now have new 'top management' so it would be a good time to visit those procedures and coordinate with the new company to ensure everybody is aligned.
     
    yodon, Nov 6, 2020
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  7. Eric Twiname

    Eric Twiname Well-Known Member

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    "The {Corporation} has determined that it is desirable to update all documents to reflect the logo on this document. This update will be performed over time, and as time allows, but be complete no later than {whatever deadline you were given}. Prior to completion, all logos on all documents shall be considered equivalent to those on this document for the purposes of compliance to the above referenced determination and any other requirements. Any extensions of this project will be handled either by updating this document or through the Corrective Action system, or equivalent means."

    As said above, you don't need this. But if it makes you (or those above you) feel better...here's a draft to start with...HTH

    (Note: I wrote it in the typical ISO-ese slang to keep parent company auditors happy so you can do the "real work")
     
    Eric Twiname, Nov 6, 2020
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