a Starr, Senior VP at Volex comments: “The quality of our products has always been of the utmost importance to Volex.
“In applying for ISO 13485 approval we had to review and standardise all our quality management systems. We have learned a lot from this and improved the way we work in the process. This achievement demonstrates our commitment to quality control, as well as recognising an industry benchmark which our healthcare customers expect as standard”
The standard can be the differentiating factor in the vendor selection process in healthcare engineering as independent quality auditors will analyse back into the supply chain to establish and prove that the products supplied to the original equipment manufacturer are of the highest quality. For Volex’s OEM customers the new ISO standard means that applications for accreditation of their own products through organisations like ISO or FDA will be even smoother. Having the ISO 13485 seal of approval validates the quality system in the Tijuana plant and reduces the need for independent audits.
The Volex factory in Tijuana employs over 900 people and produces interconnect solutions for medical applications and devices like magnetic resonance imaging computed tomography nuclear medicine, ultrasound scanners, cardiac monitors and defibrillators used worldwide in hospitals and clinics.