Quality System

Quality System

XQ Instruments is audited yearly and is compliant to the ISO 13486:2016 quality management system for medical devices. This quality system covers the life cycle of a product, including the design and development, production, storage and distribution, installation and servicing.  This quality management system provides assurances to our customers that XQI products are meeting well established industry quality standards

ISO 13485 takes a process approach to quality management.  Any activity that receives an input and converts it to an output can be considered as a process.  Often the output from one process directly forms the input to the next process.

The quality management system covers the entire day to day operations at XQI:

  • Management Responsibility
  • Resource Management
  • Product Realization, which includes
    1. Product roadmap and planning
    2. Design and development
    3. Purchasing of components or raw material
    4. Production, manufacturing
    5. Sales and customer support
    6. Servicing and maintenance
  • Monitoring, Analysis and Improvement of the Quality Management System

For this quality management system to work, XQI has to:

  • Determine the sequence and interaction of these processes
  • Determine the criteria and methods needed to ensure that both the operation and control of these processes are effective
  • Ensure the availability of resources and information necessary to support the operation and monitoring of these processes
  • Monitor, measure and analyse these processes
  • Establish and maintain records needed to demonstrate compliance with the quality system and traceability for corrective actions