StelKast Company designs, manufactures and distributes orthopedic implants, providing premium orthopedic implants with a reliable clinical history at a reasonable price. Founded in 1992, this subsidiary of Trigon, Inc. employs 12 at its facilities in McMurray, Washington County.
StelKast developed an internal quality system that met FDA requirements and was looking to expand their systems to pass an ISO 9000 Registrar’s Audit in order to market and distribute its products in Europe.
Catalyst Connection conducted a quality system audit that compared StelKast’s system to ISO 9000. Catalyst Connection then provided project management assistance that helped the company develop an ISO 9000 compliant quality system that was ready for certification. Catalyst Connection also audited StelKast for compliance to 21CFR820, the Food and Drug Administration’s quality system requirement. Catalyst Connection conducted an ISO 9000 Quality Audit of StelKast. As part of the audit, Catalyst Connection reviewed the company’s procedures and documentation, physically toured the facilities and interviewed the company’s department heads, gaining insight into each specific area and its needs. Findings of this audit were presented to StelKast management and documented in a written report.
With Catalyst Connection’s assistance, StelKast succeeded in revising its procedures and documents to be both ISO 9000 and 21CFR820 compliant. In addition to increasing its customer base, the company expects to eliminate redundant processes, reduce process errors and further increase efficiencies.