APSCO EARNS ISO 13485 CERTIFICATION FOR MEDICAL DEVICES

To demonstrate its long-term commitment to the medical industry, APSCO applied for and is now proud to announce its recent certification for ISO 13485 -- a quality system standard designed specifically for manufacturers of electronic and electro-mechanical assemblies for medical devices. Compliance with this new stand-alone regulation means that APSCO has been officially identified as an EMS provider who can consistently produce products and devices that meet the strict standards of the medical industry. And there is probably no other industry where the importance of product conformity is more critical than in the design and manufacture of medical devices.

"ISO sets the standard that the global marketplace recognizes and respects. Our ISO 13485 certification not only gives our medical customers even greater confidence in our systems and processes, it further demonstrates our continued commitment to excellence," states Mark Kray, VP of Sales & Marketing.

While the ISO 13485 standard supplements those of ISO 9001 (for which APSCO has already been certified), it also mandates additional requirements for process control, design control, retention of records, accountability, traceability, customer satisfaction and more. These standards are an important way to safeguard product conformity, while simultaneously harmonizing medical requirements nationally and internationally. This becomes especially important when marketing products within the European Union, since ISO 13485 is recognized as an aid in supporting compliance with the internationally-inspired Medical Device Directive and CE marking process.

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