AWS achieves ISO 13485:2016 for medical manufacture

The recently revised standard places greater emphasis on risk management and risk-based decision making, in addition to changes related to the increased regulatory requirements for organisations in the supply chain, according to the company.

“We strive to ensure our accreditations are up to the latest revision standards, not only to improve our internal processes and procedures, but also to ensure that we deliver on our strategy and commitment to customers,” said CEO Paul Deehan. “We are delighted to have updated our medical certification to ISO 13485:2016, with a number of our customers based in the sectors of medical and scientific instrumentation. This approval aligns with the many others we hold for the various sectors in which we work.”

It also has defence and aerospace accreditations NADCAP and AS 9100D, IATF 16949 for automotive and ISO 14001 for environmental. Working is in accordance with ATEX Intrinsically Safe.

AWS Group has facilities in the UK and Slovakia. It offers PCB and product assembly as well as turn-key solutions from concept design to through-life product support. Capbilities include design support, rapid prototyping, product testing, surface-mount, electromechanical assembly, cable assembly, harness assembly, repair and maintenance.

Image: a 75 board PCB stack for cancer treatment.