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1450 Brooks Road Memphis, TN 38116 USA19013962121 18008215700 www.smithnehew.comUrgent Medical Device Recall Notice R201837 December 13, 2018Insert Address Dear Customer, cc: Chairman Medical Board
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What is quality realignment?
Quality realignment refers to the process of reassessing and adjusting the quality standards or criteria for a particular product or service.
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Any organization or individual that is responsible for maintaining quality standards or ensuring compliance with quality regulations may be required to file quality realignment.
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Quality realignment can be filled out by gathering relevant data and documentation related to quality standards, reviewing and assessing current quality practices, and making necessary adjustments to improve quality processes.
What is the purpose of quality realignment?
The purpose of quality realignment is to ensure that products or services continue to meet or exceed quality standards, address any deficiencies or gaps in quality processes, and improve overall quality performance.
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Information that must be reported on quality realignment may include current quality standards, proposed adjustments to quality criteria, anticipated impact on quality performance, and a timeline for implementation.
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