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Absolute EMS, Inc., a leading provider of turnkey and consignment manufacturing services, is pleased to announce that it has successfully completed its ISO 13485:2016 surveillance audit. The company provides traceability, state-of-the-art quality, and reliable delivery in a committed partnership as it applies to medical engineering.
Doug Dow, Chief Operating Officer, commented: “Absolute EMS got started in this industry by servicing medical customers. For 24 years, quality, traceability and full factory controls have remained at the forefront of our focus. Medical helps us stay at the top of our game! We are honored to have received another ISO 13485 surveillance audit.”
The ISO 13485 standard supplements the ISO 9001 standard and is specific to medical device quality systems. ISO 13485:2012 was published in January 2012 and supersedes ISO 13485:2003. The new version of the standard was developed to harmonize with the EU Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
Absolute EMS specializes in medical board layout and design and can turn your design description into a workable prototype. The company provides manufacturing services to OEs and medical engineering firms that need the highest levels of product quality and traceability in component certification.
In addition to its ISO 13485 certification, Absolute EMS is ISO 9001: 2015 and AS9100D certified. The company continues to take the necessary steps to improve the quality of its products and services and to enhance customer satisfaction. The company manages, controls and audits its own processes, in addition to having outside certification bodies verifying that its QMS meet requirements.
Absolute EMS is a leader in end-to-end electronic manufacturing services solutions that help its customers rapidly introduce innovative new technology by facilitating speed-to-market in their marketplace. Speed-to-market starts with engineering services, and extends into prototypes, pilots and then into production.
A long-time commitment to sustainability contributes to Absolute EMS leading the way for manufacturing operations among EMS organizations