Reading time ( words)
AWS Electronics has announced successful transition to the latest revision of globally recognised quality standard, ISO 13485:2016, at its Newcastle-under-Lyme manufacturing facility.
An internationally agreed standard, ISO 13485:2016 sets out the requirements for a quality management system specific to the medical devices industry. 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. With a growing customer base in the medical sector, achievement of the standard demonstrates AWS’ ongoing commitment to ensure the highest levels of quality are met in the development and manufacture of medical devices.
Paul Deehan, CEO AWS Electronics Group, comments: “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. 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.”
AWS are pleased to support customers in a large number of industries, with accreditations held in defense and aerospace (NADCAP & AS 9100D); automotive (IATF 16949); environmental (ISO 14001) and more. AWS also work in accordance with numerous other standards such as ATEX Intrinsically Safe, ensuring that clients’ specific process and procedural requirements are met at all times.