At Circuit Works (CWC), our valued customers receive top quality products from our ISO 9000 Total Quality Program which encompasses every aspect of our business; and now we’ve improved upon that even more. CWC is now ISO 13485 registered—a certification that demonstrates the company’s qualifications within the medical sector. ISO 13485 certification is now considered to the standard and requirement for medical manufacturing / medical products.
CWC became ISO 13485 certified in 2014 after an in-depth. These in-depth audits will continue in order to maintain our ISO 13485 certification. Adding to our existing ISO 9000 certification which represents CWC’s compliant, controlled quality management system (nearly 30,000 US companies are ISO 9000 certified), the ISO 13485 certification standard addresses the medical sector specifically. This certification is a proud accomplishment for CWC as far fewer companies achieve this registration.
ISO 13845 certification ensures that CWC will meet and exceed the quality standards our valued clients in the medical sector expect. Our quality processes as an organization are much more granular as a result of the processes put in place to meet this certification. Quality trace-ability is now more drilled down, moving beyond tracking at the assembly level—and down to the component level. In order to achieve ISO 13485 certification, organizations must prepare written policies for the following functions:
- Document and record controls
- Internal auditing procedures
- Controls for non-conformance
- Corrective and preventative actions
- Process and design controls
- Record retention
- Accountability and trace-ability
Our goal at CWC is 100% customer satisfaction through quality; and, we meet that goal with our program that includes a combination of training, technology and, most importantly, teamwork.
Our Facility is capable of complying with FDA regulations for CLASS II products.
In additional to our regular ISO 9000 and ISO 13485 audits, we are regularly audited by UL for UL Registered Products.