ISO 13485 Certification is Proof Positive for our Medical Sector Customers
Circuit Works (CSC) is both ISO 9000 Quality Certified as well as ISO 13485 Certified. ISO 13485 demonstrates CWC’s qualifications within the medical sector. It is considered the standard and requirement for medical manufacturing / medical products.
CWC became ISO 9000 certified in 2014 after an in-depth audit which will take place every 2 years. Adding the ISO 13485 standard addresses the medical sector specifically. This certification is a proud accomplishment for CWC as far fewer companies achieve this registration.
ISO 13845 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 traceability
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.