Quality

Lives Depend on Us

Quality is our number one priority because lives depend on us. We design and manufacture components and finished devices that have a direct and positive impact on the lives of countless patients around the world. From our line workers to our design engineers, we hold ourselves to the highest standards of quality. Our quality mantra is Quality Works Here. This summarizes our commitment to world-class quality in everything we do:

We take personal responsibility for quality
We monitor and continually improve our Quality Management System
We deliver customer-focused quality

Quality and Regulatory Compliance

With over 50 years of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to exact specification, in full compliance with FDA guidelines, at one of our ISO-certified facilities. We host over 100 audits per year from customers and regulatory bodies.

Our certifications and registrations:

ISO 13485 and 14971 Risk Management certified
FDA registered and compliant with the Quality System Regulation
Class I, II, and III medical devices, including Premarket Approval (PMA) products
Class 7 and Class 8 clean room-controlled environments
US FDA 21 CFR part 820 compliance
Canadian Medical Device Conformity Assessment System compliance
Medical Device Single Audit Program (MDSAP)

Global Quality Systems

Our enterprise-wide quality policy and program are designed to ensure consistent high quality and compliance at every location, on every project, at every stage of the product lifecycle. Dedicated on-site teams ensure compliance with rigorous internal quality systems, some of which include:

Supplier management
Internal audit processes
Validation strategy
Design controls
DHF-ready documentation

Nordson's Progress with PFAs

The Nordson Corporate Product Compliance department is diligently monitoring the growing global requirements surrounding Per- and Poly- Fluoroalkyl Substances (PFAS). We are working with all Nordson divisions to determine where PFAS are currently being used, and to identify our risks moving forward. These risks include current and potential restrictions and notification requirements, customer requirements, and supply chain disruptions due to supplier phase out of PFAS containing materials. Our goal is to meet all of our legal requirements while minimizing the impact on our customers.

Registrations and Certifications

Download our location-specific registrations and ISO certifications.