Quality

Quality Policy
GMP/Manufacturing
ISO Certification

Quality Policy:

ASB is committed to providing the highest quality innovative polymers that meet or exceed our customer’s requirements and expectations. We will strive to maintain compliance with ISO 9001:2008; ISO 13485:2003 and 21CFR Part 820 with a focus on continuous improvement as well as continual monitoring and measurement of our core process metrics to ensure effectiveness.

Quality Control

ASB has developed, documented, implemented, maintained and continually improves its Quality System to ensure compliance with national and international Quality Systems standards and regulations and to ensure that products adhere to specified requirements, including but not limited to: the FDA Quality Systems Regulations (QSR) 21 CFR Part 820; ISO 9001:2008 and ISO 13485:2003.

Quality Assurance

ASB provides the design, development, and testing for the manufacture of world-class biomaterials focused on customer-driven solutions for the medical device industry. Our material science technology allows clients to select from a family of customizable polymers which provide critical attributes to support their medical device design and development objectives.

We employ Good Manufacturing Practices throughout every stage of the manufacturing process. The company is ISO 9001:2008 and ISO 13485:2003 Certified, meets Code of Federal Regulations - 21CFR- Part 820 and continues to invest in state-of-the-art equipment and technological resources to ensure consistency in product offerings.

As a leading manufacturer of high-performance medical grade polyurethanes, we monitor efficiency in every stage of product development and are committed to providing our customers with leading edge technology, consistent processing and superior quality, as well as the peace of mind that allows.

We are certified by SGS United Kingdom, Ltd., as meeting the requirements of ISO 9001:2008 and ISO 13485:2003. Copies of our certifications may be viewed below. Please click on the image to view/print the documentation.