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Claim Your Discount! 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...)
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