ELVERSON, PA – Whitford Corp., a manufacturer of fluoropolymer coatings, has officially received its ISO 13485 certification for its new medical coatings facility.
To receive an ISO certification, a company is required to meet demanding standards and prove, through audits, that it has a strict quality system in place. ISO 13485, a standard established specifically for the medical-device field, provides customers with the assurance that Whitford’s Medical Coatings Group will produce a quality, reproducible product. Should the customer have any trouble with the product quality, ISO 13485 provides that the Medical Coatings Group has procedures in place to assist the customer and correct the issue quickly and appropriately.
“This ISO certification reassures customers when ordering Whitford coatings. Whether the products are catheter guide-wires, scalpel blades, or other devices that benefit from a PTFE, FEP or other fluoropolymer coating, customers know that this coating is reproducible, and they will receive the same formula every single time,” explained Greg Lundell, Industry Manager of Medical Coatings for Whitford. “This guarantee is vital with medical coatings. It’s important to note that all of our processes are reviewed on a regular basis. ISO 13485 tells customers that we will be a strong, reliable link in their supply chain, able to support them with documentation above and beyond what ISO 9001 requires.”
The ISO 13485 certification adds value to the entire product portfolio of Whitford’s Medical Coatings Group. While Whitford invested a huge amount of time and money into building a new, dedicated medical facility, even more time was invested in standardizing and documenting processes in order to be certified. Customers are now able to save time and money by eliminating certain steps from their supplier search process.
“Customers know that we have been audited to the full ISO extent, and they no longer need to invest their own time into an additional audit. Many of them will be able to set us up as a critical supplier due to the quality system certificate that we now possess. Customers can trust that we will provide support should they decide to submit to the FDA. Overall, ISO 13485 improves the customer experience and ensures that the Whitford Medical Coatings group continuously works to improve our products and process,” said Lundell.
The construction of the new Medical Coatings Group facility was completed this past summer at the company headquarters in Elverson, PA. The facility includes new, dedicated equipment, as well as its own quality-control laboratory with management and operations personnel. For more information, visit www.whitfordww.com.