Quality Management System & Certifications

A strong quality system leads to consistently high-quality products. At ATL, quality is paramount to both our customers and us. Our Quality Management System is registered to ISO 13485:2016. ATL is an FDA registered medical device manufacturer and cGMP compliant to 21 CFR 210, 211, and 820. We have ISO Class 7 and ISO Class 8 manufacturing clean rooms.

ISO 13485 Certification 

ISO 13485 is an official Quality Management System Certification set by the International Organization for Standardization for the manufacture of medical devices. This certification enforces regulatory requirements that must be met by the organization. ISO 13485 registered manufacturers are periodically audited to ensure continued compliance and recertification as the regulations evolve.  

As an ISO 13485 certified manufacturer, our Quality Management Team ensures all requirements are met. This is done by documented all processes and procedures. Rest assured knowing ATL is committed to maintaining a robust Quality Management System while manufacturing products. Click here for certification 

Cleanroom Manufacturing 

Our ISO Class 7 and ISO Class 8 cleanroom is a controlled environment that has a low level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. A typical city environment contains 35,000,000 particles per cubic meter, 0.5 micron and larger in diameter which is similar to a ISO Class 9 cleanroom.  

As an ISO 13485 contract manufacturer, the raw material, production lot, staff, and equipment traceability used to produce every order is an integral part of our operations. 

We maintain a strict internal audit function in conjunction with ISO registrant re-certifications, regulatory agency reviews, and customer audits.

Continuous Improvement (CI) is critical to our ongoing success. We are driven by our customers, competition, and, most importantly, our employees, who recognize the value of getting better every day and moving our business forward.

Let’s Make It Happen!

Contact Us