Continual Improvement of Systems
The Natech systems include the ISO 13485 and ISO 9001 Quality Systems for ongoing, repeated processes and the Project Management System for one-time endeavors such as product development. Continual improvement only happens through the continual development of our employees and processes.
ISO 13485 Quality Management System for Medical Devices
Our customers produce life-critical devices, so they need confidence in the quality of the designs and manufactured product they receive from us. We believe in achieving quality by establishing quality processes from the beginning - not by trying to inspect quality into the parts. We support this with our in-depth employee training program.
We have embraced Scientific Molding and Scientific Processing to qualify our injection molding and contract manufacturing processes during IQ/OQ/PQ. We establish the aesthetic process window, the dimensional process window, and the control process window to achieve statistical process control on an ongoing basis.
ISO 9001 Quality Management System
Continual improvement of the Natech ISO 9001 Quality System achieves faster cycles, better parts, and fewer rejects. Procedures, Work Instructions, and Forms comprise the tools of the Quality Management System. Customer Service Tickets and Corrective Action Plans focus on reviewing and improving the Procedures, Work Instructions, and Forms.
Managers track performance through the monitoring of external reject rates, internal reject rates, and on-time deliveries. We have embraced the Scientific Molding process development for validating medical molding in our IQ/OQ/PQ procedures. Regularly scheduled internal and external third-party audits monitor compliance to the system.
Project Management System
The Project Management Institute’s Project Management Professional (PMP) certification serves an important role in the development of Natech’s engineers. Seasoned Engineers with a strength in project management can deliver projects on schedule with lower risks and lower costs. With each completed project, the Program Engineer refines and improves the organization’s Project Management tools: Statement of Scope, Project Plan, Project Schedule, Risk Register, Change Log, and Open Items List.
Since hiring our first PMP-certified project manager, all multi-mold programs have delivered on schedule. Engineers embark on self-study in project management supported by incrementally greater project management responsibilities, receiving internal training, and attending external project management courses.