Third TT electronics site achieves medical standard 

Rogerstone, South Wales facility accredited to ISO13485 for the manufacture of medical electronics 

TT electronics integrated manufacturing services today announced that the third of its five worldwide sites, Rogerstone in the UK, has qualified for ISO 13485:2003 allowing the facility to manufacture medical electronic systems. The TT electronics sites in Suzhou, China and Perry, Ohio already hold this approval. 

Commenting, TT electronics divisional director, John Molloy said, “TT electronics is focused on the manufacture of demanding, complex electronics systems in low to medium volumes. Medical instrumentation is a significant opportunity for us. The fact that we have achieved this approval at a third site is proof of our outstanding credentials in this market – and is evidence of our continuing investment in all of our sites around the globe.”

TT electronics in Rogerstone already fulfils internationally recognised and demanding standards for the manufacture of aircraft flight electronics, automotive electronics systems and for supplying the rail industry.

Mr. Molloy continued, “Our spread of locations in Europe, Asia and the US offers our customers the benefit of dealing with a Programme Management team based locally to them, giving access to a manufacturing capability that delivers a consistent and very high standard of quality in the geography that provides the best fit with their business objectives.”

All five TT electronics integrated manufacturing services facilities hold ISO9001. The ISO13485 standard goes beyond its requirements for issues associated with the production of products covered by demanding regulatory standards. These include the management promotion and awareness of regulatory requirements, controls in the work environment to ensure product safety, risk management during product development, specific inspection and traceability requirements, specific standards of documentation and process validation for sterile devices, and specific requirements for corrective and preventative actions.

The integrated manufacturing division of TT electronics has five manufacturing sites around the world: the USA, Malaysia, China and two in the UK. In addition to the new ISO13485 accreditation, the site holds ISO9001:2000, the ISO TS16949:2002 approval for the manufacture of automotive systems, and the AS9100 standard for the manufacture of safety critical electronic systems for the aerospace industry. It was the UK’s first EMS provider to pass the International Rail Industry Standard (IRIS), qualifying it to supply to the world’s rail industries. Rogerstone also conforms to the ISO14001:2004 environmental standard and uses Six Sigma processes, and is fully RoHS compliant.