Janie Havel, North Texas Representative of The Office of Governor Rick Perry, presented a plaque from TMAC to Otis and Fran Blackwell, Owners, and Robert England, Partner, of RF Precision, LLC, in recognition of the company’s achievement of the ISO 13485 Medical and ISO 9001 quality Management systems.
RF Precision specializes in precision parts, prototype development and production runs for the medical and dental industries, where tight tolerances are critical. Applications include screws, implants and instruments. RF Precision operate two shifts (19 hour days) to ensure quick turnaround and customer satisfaction. “RF Precision’s goal is to offer quality parts with aggressive pricing and lead times,” said Otis Blackwell, Owner. Located in Denton, TX, RF Precision was established in 2003 and operates nationally from its 8,200 square foot facility. RF Precision is FDAandGMP (GoodManufacturing Practices) compliant.
RF Precision needed to be registered to ISO 13485 to enable the company to direct-bid andwork on projects for medical equipment supplies. ISO 13485 enables the company to retain work from existing customers and acquire work from new customers. The ISO 13485 Quality Management System (QMS) certifies quality control for contract manufacturers of medical and dental devices and implants. Registration opens markets to RF Precision for a wide variety of customers in North America and Europe.
President Otis Blackwell asked their ISO 9000 registrar for an ISO 13485 referral in early 2008. He was referred to the TMAC. TMAC is the US Department of Commerce Manufacturing Extension Partnership Center for the State of Texas. RF Precision contracted with TMAC to design and implement a Medical Quality Management System compliant to ISO 13485.
TMAC Manufacturing Specialist Mike White worked with RF Precision’s management team which included the owner, the lead operators and their lead inspector. Research for a gap analysis was conducted to fully understand problems and the uncertainties of the current operating environment.White then workedwith staff on flow-charting the organization t o determine compliance and are as for improvement.
The group teamed to create the quality policy manual, procedures, work instructions and records/forms required to meet the requirements of ISO 13485. Personnel were then trained on documentation that affects their work area.
RF Precision reports it has enhanced routing systems and inspection techniques. The company now measure re-work which has led to increased capacity for more value-added activities.
Work processes are simplified, taking less steps and shorter lead times.
They have also enabled their operators to have more control at the source to correct quality issues.
Impact of ISO 13485 Medical and ISO 9001 at RF Precision:
• 80% reduction of inspection process time.
• $160K projected annual sales impact.
• $17K investment in its workforce.
• 12 jobs retained.
• $70K reduction in costs.
RF Precision successfully passed its ISO 13485 audit with no nonconformances.The company is now positioned to direct-bid for work instead of contracting with other companies already ISO 13485 registered.
“TMAC has been very helpful in both obtaining and maintaining RF Precision’smedical equipment ISO registration,” said Tammy Tindal, RF Precision QualityManager. “In addition to doing a great deal of work during the initial registration process, TMAC has also been very helpful in the period following registration. Their assistance has been very valuable in keeping the company headed in the right direction and setting a new course in many ways. Our ISO registration status has opened up our available customer base to several new markets that we would not have been able to enter into without being ISO 13485 registered. As we continue to grow our company and mature our QMS, the lessons learned from our collaboration with TMAC will long remain with this company well after their presence is no longer needed.”