Quality Statement

Quality matters most when it comes to the results in your laboratory!
That's why companies and laboratories alike rely on Polysciences’ products to support their Quality Control and Assurance programs.

Polysciences, Inc. holds certifications that formally recognize the quality of our customer service, manufacturing processes and products. We want you to purchase our products with 100% confidence, knowing they are manufactured to the highest possible standards.

Below are brief explanations of each of our quality credentials and their benefit to you.

ISO 13485:2016 Certification (view certificate)

  • Certifies a company's Quality Management System. The company must demonstrate that products and/or services are developed, produced and distributed in accordance with the Quality Management System.
  • The Quality Management System involves official written procedures and training documentation. It also requires all complaints to be documented and corrective and/or preventative actions to be established.

This assures customers that Polysciences, Inc. provides services and manufactures product in accordance with a compliant and robust Quality Management System.

Food and Drug Administration Establishment

  • Applies to the facility, methods and controls used for the design, purchase, manufacture, packaging, labeling, storage and distribution of in-vitro medical diagnostic products.
  • Ensures that finished products are safe, effective and in compliance with Federal Food and Drug and Cosmetic Act.

Our active registration (#2518071) with the FDA provides evidence that Polysciences, Inc. adheres to all applicable Current Good Manufacturing Practices (cGMP).