Absolute Turnkey, a leading manufacturer of the complete end-to-end EMS solution, has received its ISO 13485:2003 certification.
UL DQS Inc. Management Systems Solutions certifies that Absolute Turnkey has implemented and maintains a Quality Management system. “We are ecstatic to have received our medical certificate. This will help us better manage our customers’ medical device through its lifecycle and add more traceability throughout our manufacturing process,” commented Michelle Barbe, COO.
The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, the certification includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.
“With our ISO 13485 certification, we can provide our existing and new customers in the medical industry with assurance that we meet the regulatory requirements with high efficiency and excellent quality in our process and documentations,” commented Roy Amri, VP Sales.
“Obtaining the ISO 13485 certification means that we can further develop our long standing relationships with our customers in the medical industry. We help to develop next-generation products while maintaining high levels of efficiency and quality by adhering to documented processes and quality checks,” added Eric Butler, Sales Manager. “We do all we can to support our customers and put their minds at ease. Adding this to our existing ISO 9001 certification supports our mission of having a well documented process with exceptional quality and customer service.”
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Founded in 1996, Absolute Turnkey is a leader in manufacturing the complete end-to-end EMS solution. This end-to-end EMS solution helps customers rapidly introduce innovative new technology by providing speed-to-market to their OEM customers. Speed-to-market starts with engineering services, and extends into prototypes, pilots and then into production.