Quality Assurance

Quality Policy

Ranfac Corp. is devoted to maintaining the continuing effectiveness of the Quality Management System. Ranfac Corp. employees are committed to deliver products that consistently meet or exceed the requirements and reasonable expectations of our customers.

Ranfac Corp. is an ISO 13485:2016 certified medical device manufacturer.  We are also certified to Directive 93/42 EEC and maintain compliance with the FDA, CGMP/QSR.  Our system is designed to ensure that records are kept for trending purposes.  This trending is reviewed with executive management regularly to ensure the system is staying in compliance and resulting in conforming product being shipped to all of our customers.

Our Quality System is designed to identify and mitigate risk wherever possible.  Some of the tools we utilize are:

  • AQL sampling and Statistical Process Control to ensure product compliance.

  • A calibration system that ensures all of our gauges are within calibration and are NIST traceable.

  • FMEAs, Control Plans, Designs of Experiments, IQ/OQ/PQ protocols