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    Clause 8.4 elaborates analytical requirements as:

    Plan how your organization is going to evaluate your QMS.
    Establish procedures to evaluate organization's QMS.
    Utilize analytical results to improve organization's QMS.

    Clause 8.5.1 is the sub-clause of Clause - 8.5 i.e. Improvement. This sub-clause is about taking actions to change QMS and products:

    Recognize any changes that are necessary for improvement.
    Recognize changes that maintain QMS suitability, adequacy, and effectiveness.
    Figure-out changes needed to ensure medical device safety and performance.
    Initiate changes that must be made.

    Clause 8.5.1 is the sub-clause of Clause - 8.5 i.e. Improvement. This sub-clause is about taking actions to correct actual non-conformities. Requirements are:
    • Document a corrective action procedure.
    (Continued...)