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Quality

R&D Systems Quality Policy

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.

Definitions:

Quality: The totality of features and characteristics that bear on the ability of a product to satisfy fitness for use, including safety and performance (§ 820.3 (s)).
Quality system: The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management (§ 820.3 (v)).

1. The President, who has responsibility for creation of an atmosphere of high standards;
2. The officers, directors, managers, and supervisors, who are charged with development and implementation of quality systems; and
3. Each employee, who is responsible for the quality of his or her work and for suggesting improvements in quality.

R&D Systems Quality Manual

The R&D Systems Quality Manual (PDF, 255K), is the top tier of our documentation system. It gives an overview of our Quality System. It is supported by corporate and division standard operating procedures (SOPs) which are the second tier of our Quality System documents and are listed in this Quality Manual. The third tier of the documentation system consists of manufacturing/testing documents, forms, and specifications developed by each operating unit.

Our policies are in conformance with the requirements of the Code of Federal Regulations (21 CFR); Quality System Regulations for Medical Devices, ISO 13485:2016 Standard and ISO 9001:2015 Standard, the In Vitro Diagnostic Directive 98/79 EC and the Canadian Medical Device Regulations.

ISO 13485:2003/CMDCAS and ISO 9001:2008

Please click here to view the R&D Systems ISO 13485 Certificate (PDF, 292K).

Please click here to view the R&D Systems ISO 9001 Certification (PDF, 348K).

Please click here to view R&D Systems Europe ISO Certificate (PDF, 291K).

Additional Certifications, Policies and/or Statements

• 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
• Affidavit for Mercury Content

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 Vitro Diagnostic (IVD) products are manufactured under the Food and Drug Administration’s Quality System ISO 13485, and our Research Use Only products are in compliance with ISO 9001 Regulations; 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 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).