ISO 13485 QMS software and Audit Checklist

ComplianceQuest Modern Cloud Enterprise Quality Management System (EQMS) supports the latest edition of ISO 13485 by automating the entire QMS requirements while maintaining full traceability. ComplianceQuest provides solutions that help top management with the oversight of their quality management system embedded in their organization and maintenance of its effectiveness by:

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  Monitoring operational and performance key trends through reports and dashboards
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  Gaining insight into the availability of employee resources based on their training competency and equipment resources to ensure the sustainability of equipment
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  Enabling collaboration/communication through tools such as Chatter and Social Median

Some of CQ’s ISO 13485 software features are listed below —

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  Risk assessments to determine the actions necessary for mitigation or to initiate changes to QMS processes
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  Dashboards and reports to provide insight into overall performance and efficacy
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  CQ Complaints Management solution to capture customer inquiries, cases, product quality issues, and adverse events
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  CQ Change Control and management software to capture all the information for any change to product, services, or the quality management system, including the relevant tasks to meet quality requirements and objectives
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  CQ Equipment Management software allows an organization to manage the schedule for equipment maintenance. It will enable the capture of equipment calibration output to determine their status and overall lifecycle performance
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  CQ Audit Management software allows an organization to perform internal safety audits for the work environment and contamination control
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  CQ Non-conformance solution enables organizations to streamline recording and manage all quality events from single or multiple sites in one centralized system
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  ComplianceQuest provides reports and dashboards to fully monitor quality processes across the organization based on key company metrics/goals, regulatory requirements, and customer satisfaction
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  All documents associated with production and service provisioning can be controlled and maintained in the CQ Document Management solution
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  ComplianceQuest provides an organization with a complete set of solutions for managing Suppliers, including supplier on-boarding, supplier audit, approved supplier list, receiving inspections, supplier corrective action (SCAR), supplier portal for document and data exchange, and supplier ratings/scorecard for monitoring a supplier’s quality performance
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  ComplianceQuest provides training management for job function and compliance through classroom sessions, online/SCORM content, or documents
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  CAPA allows the organization to identify and track correcting, preventing, or reducing issues while implementing continuous improvement and effectiveness checks