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Do we need to have the word SHALL in our QMS as it is in ISO 13485 ?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Rachel, Sep 2, 2015.

  1. Rachel

    Rachel Member

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    I have a question In ISO 13485 I know the word SHALL is in there. In our company QMS do we need to have the word SHALL written as it is in the ISO standard or just verbiage that would insist it being done?
     
    Last edited by a moderator: Sep 3, 2015
    Rachel, Sep 2, 2015
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  2. Ganesh Sundaresan

    Ganesh Sundaresan Active Member

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    Unless otherwise I am seriously wrong with my presumption towards ISO 13485, there is no requirement for the word "SHALL" to be used in Procedures as it exists in the Standard. Please prepare Procedures that are required by your Organization in a simple language that are easily, commonly and unmistakably understood by all users.
     
    Ganesh Sundaresan, Sep 6, 2015
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  3. Gert Sørensen

    Gert Sørensen Member

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    In ISO 13485 and - I believe - all other regulatory systems the word Shall implies a mandatory activity. What verbiage you use in your own QMS is entirely up to you, but the paragraphs with a Shall must be fulfilled by your system.

    In line with Ganesh' comment, don't use high level words in your procedures etc. Write for the benefit of the reader, not for the auditor.
     
    Gert Sørensen, Sep 8, 2015
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  4. Jim Hagenbaugh

    Jim Hagenbaugh Member

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    I agree with the others in that there is no requirement on having "Shall" in your documentation and that your docs need to be written for the user, not the auditor.

    Don't turn you back on the word however. I have found it useful to reign in various groups that are smart enough to know it means its required, and if it doesn't show up in their SOP's means it a suggestion and not a requirement. Personally I use it sparingly, except in the Quality Manual, but I use it.
     
    Jim Hagenbaugh, Sep 8, 2015
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  5. BradM

    BradM Moderator Staff Member

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    I don't think you must use the word "shall". I do think you need to clearly specify the actions needed in the procedures to satisfy the requirements of the "shall" statement in the standard.
     
    BradM, Sep 8, 2015
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  6. Rachel

    Rachel Member

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    Thank you all who have responded and cleared things up for me .
     
    Rachel, Sep 8, 2015
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