客户服务

质量保障

R&D Systems质量方针

R&D Systems致力于最高水平的服务，不管是在生产，销售还是我们的产品支持上。无论在开发，制造，广告，销售，运输还是技术支持上，产品质量，遵守所有适用的法规要求，不断的改进以及客户满意度都是我们不断追求的目标。

关于R&D Systems是否有分装

答：没有分装试剂。R&D Systems公司不会分装，也没有授权任何公司进行分装。目前市场上所谓的“RD分装试剂”是没有品质保证的3无产品，R&D Systems公司不承担任何“RD分装试剂”的售后服务。在此，建议广大客户和经销商从R&D Systems中文网站上公布的正规经销商处订购。

 

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)).

Assurance of quality and integrity are the responsibility of:
  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 Parts 808, 812 and 820) Medical Devices; Current Good Manufacturing Practice (cGMP); Quality System Regulations, ISO 13485 Standard: 2003, the In Vitro Diagnostic Directive 98/79 EC and the Canadian Medical Device Regulations.

 

ISO 13485:2003/CMDCAS and ISO 9001:2000

Please click here to view the R&D Systems ISO 13485 Certificate (PDF, 160K).

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.

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 products are manufactured under the Food and Drug Administration’s Good Manufacturing Practices 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 using documented 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. Quality System Regulation (QSR) 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 contain the CE mark (please refer to the specific product insert for more details).

R&D Systems Hematology Intralaboratory Quality Control Program