RK Manufacturing has developed and implemented a Quality Management System (QMS) to ensure our ability to consistently provide products that meet customer requirements and all applicable statutory and regulatory requirements.
The QMS processes have been developed and applied taking into account the roles undertaken by the organization. A risk-based approach is utilized for control of the appropriate QMS processes. We are focused on customer satisfaction and continual improvement through the effective application of the Quality Management System.
Our Quality Management System complies with ISO 13485:2016 with no exclusions. Our scope of registration is for the manufacture of sterile and non-sterile suture, spinal implants, instruments and other medical products, with design capabilities. Our Quality Management System is also compliant with 21CFR part 820.