Supplier Qualification Information

For more than 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and delivering trusted solutions for research and discovery.

We service customers in two segments: Diagnostics and Life Science.

For the Diagnostic segment, our vision is advancing healthcare for every person. Our mission is working with every customer to deliver innovative, reliable and efficient diagnostic solutions for patients across the globe.

In keeping with our vision and mission statements, our focus is helping to create the world's most efficient laboratories. For our top competitors, biomedical testing is one business among many; for us, it is our sole focus. In today's market, we are one of the few participants with full capacity to design, develop, manufacture, sell and service our products.

Following is information which you should find helpful as you consider initiating business with us or continuing to do so. If you request an on-site audit, prior approval and signed copies of non-disclosure agreements are required in advance of a visit.

Quality is the single most important function of every one of our employees.

We are regulated by:

• United States Food and Drug Administration (FDA); to find and view our FDA registrations: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm
  and enter “Beckman Coulter” as the Establishment Name
• Canadian Health Protection Branch 
• European Union

To ensure that we are consistently providing medical devices that are safe and effective, we operate under a documented Quality Management System which includes:

• a document control system for all manufacturing and testing procedures
• documented procedures in place for contacting customers concerning changes on either material or services purchased
• documented and trained policy and procedures for handling customer complaints
• an established CAPA system as part of our GMP
• internal and external audits for all facets of the company on a regular basis
• employee selection based on background, training and requisite skill sets
• training provided and tracked for all categories of employees
• appropriate certifications for the use and disposal of all materials used in our manufacturing processes

Our business model adheres to a policy of continuous improvement.

View our View our Certificate of Insurance ›

Currently, we have the following ISO Certifications:

• ISO 9001
• ISO 13485

We are a member of and subscribe to the AdvaMed Code of Ethics. 

We have a formal records management and retention system appropriate for our industry.

As a global manufacturing and distributing citizen, our facilities are carefully managed and maintained and meet GMP standards. Both pest and contamination controls are part of a regularly scheduled preventive maintenance program.

In addition, products are manufactured and stored in environmentally controlled facilities. Care is taken to protect products from contamination as well as deterioration. All products are carefully segregated and shipped with packaging and packing materials as appropriate to the product.

As a member of the diagnostic companies of Danaher, Beckman Coulter carefully screens all suppliers. You can review Danaher’s supplier policy at www.danaher.com/suppliers.

In addition, our company 

• meets all applicable NIST (National Institute of Standards and Technology) standards
• is not a member of C-TPAT (Customers-Trade Partnership Against Terrorism) 
• is compliant for electrical and electronic devices under ROHS (Restriction of Hazardous Substances) 
• is compliant with the Conflict Minerals Purchase Policy 
• does not apply under ITAR (International Traffic in Arms Regulations) 
• has updated IFUs (Instructions for Use), CISs (Chemistry Information Sheets), and MSDS (Material Safety Data Sheets)–now SDS (Safety Data Sheets)–for GHS (Globally Harmonized System) of Classification and Labeling of Chemicals

Supplier Guidebook

Download our Supplier Guidebook to learn more about our global approach to supplier quality management as well as our expectations of material and service suppliers.

Standard Terms and Conditions for the Purchase of Equipment, Supplies and Materials

View the standard Supplier Terms and Conditions for the purchase of equipment, supplies, and materials.

Contact us for additional help with supplier qualification

Still have questions or need additional information? Call us at 1-800-526-3821, Option 5.