To ensure quality, an internationally recognized certification is required. Smalley got the ISO 13485:2016 certification, after a rigorous, nearly year-long application process and aggressive quality audit with a third-party registrar (DQS). This international Quality Systems Standard, written specifically for medical device manufacturers, has its foundation based on ISO 9001.
As a preferred supplier to medical device manufacturers, Smalley’s Spirolox® Retaining Rings and Wave Springs are found in everything from surgical instruments to implantables.
Smalley’s manufacturing process—which involves coiling rather than stamping—enables a high degree of flexibility, from high-volume runs to prototyping and custom designs. This ability to deliver custom capabilities in small runs of certified components is a particular benefit to medical companies globally, where certifying to ISO 13485:2016 is often the first step in complying with strict regulatory requirements.
Being ISO 13485:2016-certified is recognized globally as an industrywide “stamp of approval,” says Smalley Senior Vice President Bill McClelland, who has been working in the areas of Quality, Engineering and Sales for over 35 years. The certification is also a bit unusual for a company like Smalley, he adds. “This certification has become an industry standard among medical device manufacturers, but it is unique for a component manufacturer like Smalley to receive it,” he says.
“Certification makes establishing a trusted relationship much easier, saving prospective customers time and money,” says McClelland.
This is the first medical certification for the company. Smalley maintains a Quality Management System that encompasses other industry standards. These standards include Automotive (ISO/TS 16949:2009) and Aerospace (AS9100C). Smalley is also certified to ISO 9001 and ISO 14001 and maintains status as an ITAR-registered (International Traffic in Arms Regulations) facility.