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Likewise, web-based tracking of patient services and digital recordmanagement streamline workflows while improving accessibility. August 26, 2016. Automated back- and front-office processes reduce human activities, freeing staff to focus on direct patient care. October 26, 2021. link] Griffiths, S. link] Safavi, K.,
ISO 9001 can form the base for any QMS even a Quality Management System for Manufacturing. Those who require a QMS for Medical Device must meet the requirements of ISO 13485:2016 for regulatory purposes. Quality Management Obstacles. It is the heart of Medical Device Regulations.
Additional findings included concerns with respect to document control, recordsmanagement, and lack of compliance with Standard Operating Procedures (SOPs). In addition, SOPs did not align with specified requirements and did not have a standardized format.
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