Documents, Certifications, and FAQs

We conveniently placed all of the quality documents you may need on this page along with a list of frequently asked questions regarding our quality and certifications.

Quality Manual

Download our quality manual here: R&D Systems Quality Manual (PDF, 787KB)

R&D Systems is committed to the highest level of quality in the manufacture, sale and support of our products. Product quality, compliance to all applicable regulatory requirements, continuous improvement and customer satisfaction shall underlie all of our efforts in development, manufacturing, advertising, sales, shipping and technical support.

Industry Standards and Regulatory Credentials

Our policies are in conformance with the requirements of the Code of Federal Regulations (21 CFR 820); Quality System Regulations for Medical Devices, ISO 13485:2003 Standard and ISO 9001:2008 Standard, the In Vitro Diagnostic Directive 98/79/EC and the Canadian Medical Device Regulations.

R&D Systems ISO 13485 Certificate (PDF, 505KB).

R&D Systems ISO 9001 Certification (PDF, 747KB).

R&D Systems Europe ISO Certificate (PDF, 276KB).

Statement Regarding R&D Systems Reagents and Testing with Human Cells/Tissues:

In conjunction with outside collaborators, some of R&D Systems research reagents are tested using embryonic, fetal, or adult human cells and tissues. All cells and tissues are collected under the ethical and regulatory considerations of each Institute's Internal Review Board. R&D Systems follows all state and federal laws and policies relating to its research and business practices.

Affidavit for Animal and Human Derived Products/Assurance of Sourced Animal Health and HIV and Hepatitis Testing

Affidavit for Natural Rubber Latex

FAQs Regarding R&D Systems® Quality System

Is R&D Systems registered with the U.S. Food and Drug Administration (FDA)?
R&D Systems is a registered Medical Device Establishment under the U.S. Food, Drug, and Cosmetic Act, registration number 2182501, and is routinely inspected by the FDA. Our In VitroDiagnostic (IVD) products are manufactured under the Food and Drug Administration's Quality System Regulations and compliant with ISO 13485. Our Research Use Only products are in compliance with ISO 9001; they are freely marketed in the U.S.; and are in compliance with all U.S. laws and regulations.

How do you ensure "product quality"?
Product quality is ensured from beginning to end with raw materials being controlled and inspected, in-process and final product testing against written specifications, and final inspection based on published sampling plans before a product is released for sale. Internal Quality Audits are performed periodically by qualified staff and vendor audits are performed on an as needed basis. Effectiveness checks are made through review and monitoring of product complaints, non-conforming materials, and corrective and preventative action programs.

Do you provide products qualified for in vitro diagnostic (IVD) use?
R&D Systems manufactures hematology controls and calibrators and several ELISA kits that are for in vitro diagnostic (IVD) use. As such, we are an FDA registered facility and comply with Quality System Regulations (QSR). Our registration number is 2182501.

Are your products CE-marked?
The majority of our IVD products are CE marked to the In Vitro Diagnostic Directive 98/79/EC (please refer to the specific product insert for more details).

R&D Systems Hematology Intralaboratory Quality Control Program