Quality Systems
Quality systems that meet and exceed standards.
rms Surgical has developed and implemented a Quality Management System (QMS) that conforms to the rigorous requirements demanded by today’s medical device industry. The QMS focuses on providing products and services that meet your requirements by ensuring conformance to each and every specification, offering continuous process improvements and delivering robust training programs — so you can be confident you’re working with the highest skilled manufacturers in the industry.
High-Level Project
Quality Support
- Advanced Product Quality Planning (APQP)
- Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
- Production Part Approval Process (PPAP)
- Process Failure, Modes, and Effects Analysis (PFMEA)
- Gauge Repeatability and Reproducibility (GR&R)
- Capability analysis
- Statistical support for validation planning and execution
State-of-the-art
Quality Lab
- Coordinate Measuring Machines
- Vision systems
- Precision contour measuring equipment
- Profilometers
- Statistical software packages include Mini-Tab and QC Calc Real-time
Quality Policy
The Cretex Medical group of companies is committed to:
- Achieving or exceeding customer expectations
- Ensuring the effectiveness of the quality management system while complying with regulatory requirements
- Empowering and developing employees
- Fostering a culture of operational excellence and continual improvement
Certified and Registered QMS
- EN ISO 13485:2016 View/Download
FDA Registration as a Contract Manufacturer
- rms Surgical, Anoka, Minn., facility registration number: 3010009693
