ISO 9001 quality system
We only believe in using the right steels for the correct surgical applications and will not substitute for poorer quality imported steels, where the instrument requires European quality only. This also ensures that our instruments wash and reprocess, as they should. In house nitric acid passivation on all instruments ensures that all impurities in the steel are detected prior to the instruments being despatched. As important as instrument quality, is your service, which we also approach in the same manner.
Surgical Holdings have ISO 9001 & ISO 13485:2003 quality systems in place. Our quality system has been assessed and was found to be in accordance with the requirements of the Medical Devices Directive 93/42/EEC Annex II, this means that we are able to CE mark stainless steel orthopaedic implants such Kirschner and Arthrodesis wires, pins, staples, compression plates, compression screws and of course instrumentation.
Throughout manufacture we maintain complete traceability for all materials used and if required, we will supply certificates of conformity for all materials used. All instruments and implants are made with guidance from pertinent international standards.