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Equipment validations

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by duff999, Sep 26, 2019.

  1. duff999

    duff999 New Member

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    I have been asked to write a quality assessment for equipment that has already been installed to be used as an assessment against no IQ performed, Also I have asked to perform an assessment of the PQ that has not been performed, any good advice on where to start. This is for an existing very small manufacturer who is in the process of getting ISO 13485 accreditation.
     
    duff999, Sep 26, 2019
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  2. Gözde Aktener

    Gözde Aktener New Member

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    Acording to GHTF/SG3/N99-10:2004, you can prepare a check list for equipment (also you can add document whatever they can find about installation, for example calliabration certificate). At the same time you have to decide important parameters then you will start PQ tests, actually if you write equipment name directly someone instruct you more easily :))

    best wishes,

    Gozde
     
    Gözde Aktener, Jan 27, 2020
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  3. duff999

    duff999 New Member

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    Good info, thanks
     
    duff999, Aug 26, 2020
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