ACD, a leading supplier to the electronics industry, announces that it has passed its ISO 13485 recertification. Additionally, the company has upgraded to ISO 13485:2012 Medical Devices, Quality Management Systems, and Requirements for Regulatory Purposes.
This achievement will allow ACD to further its support in the medical electronics market while allowing manufacturing partnerships with non-medical customers where complete traceability down to component levels is an important part of end-item product tracking and history. For more than 28 years, ACD has supported the printed circuit board (PCB) industry in a variety of ways; from design to laser photoplotting, to supporting engineering software, to final test. ACD offers the support required to get products to market as quickly as possible.
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. It provides assurance to medical device end-users outside of the United States and assurance of compliance to the European legislation.
The ISO 13485 standard supplements the ISO 9001 standard and is specific to medical device quality systems. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions that are critical to the medical electronics device industry.
For more information about ACD’s design and contract assembly services, or the company’s world-class quality management system, visit www.ACDUSA.com.
Founded in 1984, ACD is an AS9100 and ISO 13485 certified full service EMS company. The company’s services comprise complete board layout, DFM/DFA capability, printed circuit fabrication, component procurement, thru-hole, SMT and part-on-part mixed technology assembly, box build, rework, flying probe, functional and JTAG test, and development. For more information, visit www.ACDUSA.com.