ISO 13485 certification opens £1m opportunity for wire manufacturer

Securing a new medical quality standard is set to open up a £1 million opportunity for Alloy Wire International (AWI) a manufacturer of round, flat and profile wire.

The company offers a 60-strong range of Exotic alloys, has taken nine months to refine its systems to achieve ISO 13485. This accreditation means new and existing customers can purchase material from the firm’s two sites in the West Midlands and Yorkshire. 

Paul Chatterley, sales executive at AWI, said: “Companies in the medical sector demand exacting quality, full traceability and superior performance, after all they are often producing devices that improve or save lives.

“We had been aware for some time that our wire has been purchased to undergo further processing for use in this industry, but COVID-19 really brought it into focus how critical a supplier we could be to clients in this field.

“From supplying 5km of wire in unbelievably strict timescales for use in the Nightingale Hospital to meeting the needs of a spring maker working with the VentilatorChallengeUK consortium, our team has really stepped up to the challenge over the last nine months.

“This got us thinking…are there more opportunities out there than we actually realise? Are we missing out by not holding the necessary quality accreditation? The answer to both questions was yes!”

AWI, which holds more than 200 tonnes of EU/DFARS compliant stock at any one time, assigned its quality and technical team to work towards ISO 13485, starting with integrating the clauses into the firm’s QUENSH (Quality, Environmental, Safety & Health) Management System.

Care was taken to ensure that the medical clauses didn’t contradict ones used in aerospace and, once this was completed, the business was ready for its two-stage audit by URS, an audit the company passed with no non-conformances raised.

Chatterley added: “ISO 13845 gives our clients peace of mind that we operate to the highest standards and we believe could deliver an additional £1 million of sales in this sector.

“We’re already seeing clients in China purchasing Phynox and other alloys for medical applications, whilst European customers are investing in Alloy MP35N, stainless steel 316LVM and 304V (vacuum melted grades).”

In 2020 Alloy Wire International spent over £1 million on material to ensure it can meet demand from sectors including medical. 

There has also been the redevelopment of its offices in the West Midlands and the introduction of the latest wet drawing machine for producing wire from 0.063” (1.6mm) to 0.028” (0.7mm) diameter, plus a take-up spooler that can handle and store larger weight rolled wire profiles.