Quality Assurance

Genesys is ISO 13485:2016 certified. ISO 13485 is the international quality standard applied to the development and production of medical devices, and surpasses the requirements of the more common ISO 9001 standard.

Genesys operates in accordance with a fully documented Quality Management System, which has been tailored to optimise efficiency whilst ensuring consistently high levels of quality. Highlights of our Quality Assurance procedures are:

  • Engineering tasks are undertaken only by fully qualified and experienced Professional Engineers who are members or eligible for membership of the Institution of Engineers, Australia.
  • Customers are provided with a detailed formal quotation that forms the basis of each development project.
  • Product development is controlled by a formal Product Specification, supported by hardware and firmware design manuals.
  • Projects are controlled by a project Work Breakdown Structure and plan using PERT/GANTT critical path management techniques.
  • The level of formalisation of project management and reporting is tailored to suit the requirements and budgetary constraints of each customer, and any specific regulatory requirements.
  • At each stage of the development process, designs are subject to thorough peer review and sign-off by a principal engineer.
  • Design documentation is controlled by a formal numbering, revision control and storage system.
  • Production documentation packages are maintained under a formal configuration control system using Engineering Change Notification (ECN) procedures.
  • Design verification testing of designs is undertaken in accordance with a documented test plan agreed with the customer.
  • Design control, traceability and documentation procedures in accordance with medical, aerospace and military requirements are applied where appropriate.
  • Hardware and firmware/software designs are documented using formal design description documents.
  • Machine-readable documents are maintained with on-site and off-site backups and a formal archiving procedure.
Our quality processes and quality culture allow us to produce quality designs

Our quality processes and quality culture allow us to produce quality designs of high complexity in One Pass To Production™.