Quality Policy
It is our mission at Pel-Freez Biologicals to manufacture and market quality biological products that meet and/or exceed the requirements and expectations of our customers, as well as continually striving to improve the effectiveness of our Quality System.
Our quality objectives, set and reviewed by the management review team, are to provide products in a timely manner, to reduce variation through standardized procedures and employee training, and to increase customer satisfaction through open communication with our customers about their needs.
ISO 9001:2015 Quality Management System
Our QMS is certified to ISO 9001:2015 by NSF International Strategic Registrations (NSF-ISR), an accredited independent registrar, and is audited for conformance at regular intervals. The scope of certification is the processing and distribution of biological products for use in the scientific research, diagnostic and pharmaceutical industries.
The certificate covers all four of our Rogers, Arkansas sites: biological processing and manufacturing, quality control and laboratory testing (205 N. Arkansas Street); receiving, storage and shipping (219 N. Arkansas Street); collection of animal blood and tissue for further processing (404 N. Arkansas Street); and warehousing (500 N. Arkansas Street).
The system is built on a tiered set of controlled documents: a quality systems manual, procedures, and the work instructions, test methods and batch records that define how work is performed and verified, from animal care through production, quality control and shipping. Document changes go through a formal change-control procedure, and records are retained under a written retention policy.
Our facilities are also inspected by the USDA, and are listed by USDA APHIS for the export of animal blood products to the European Union under Regulation (EC) 1069/2009.
View our current ISO 9001:2015 certificate (PDF): certificate number C0318180-IS10, issued 15 June 2026 and valid through 20 June 2029. Certification can be verified with NSF-ISR at nsf-isr.org.
In-house quality control
Products are tested against written specifications before release, using controlled test methods run in our own laboratory. Our in-house capabilities include:
- High-performance liquid chromatography (HPLC), including IgG, IgM and IgA quantitation
- Serum protein electrophoresis (SPE) and immunoelectrophoresis (IEP)
- SDS-PAGE
- ELISA (IgG, IgM, C1q)
- Complement activity (CH50), qualitative and quantitative
- Coagulation assays: prothrombin time, INR and fibrinogen
- Endotoxin testing by gel-clot and kinetic Limulus amebocyte lysate (LAL)
- Sterility, bioburden and environmental monitoring
- Protein by Biuret and UV absorbance (OD280), hemoglobin, cholesterol, protease activity
- pH, specific gravity, turbidity and moisture
Inspection, measuring and test equipment is on a calibration schedule against standards traceable to NIST, and out-of-calibration equipment is pulled from use until it is investigated. Retained samples of each lot are kept for complaint investigations, process improvements and stability studies.
Performing release testing on site gives us direct control over the lot-to-lot consistency our customers rely on.
Quality documentation with every order
Every lot carries a unique lot number that ties it to its raw materials, production records and QC results. Before a lot is released, quality assurance reviews the final QC results, the Certificate of Analysis, the labeling and the production batch record, and documents the disposition.
Products ship with a Certificate of Analysis or a Certificate of Conformity documenting lot-specific test results against established specifications. For custom and contract work, protocol-specific documentation, traceability records and additional QC data are available on request.
You can easily search for some Pel-Freez CoAs online by entering the lot number on our Certificates of Analysis page. For CoAs that are not available with the search tool, please contact us with your request and we will send it via email.
Additional product information and safety datasheets are available online or upon request.
Continuous improvement
Internal audits, nonconformance reports, corrective and preventive actions, customer complaints and customer surveys are tracked and reviewed at management review, along with supplier performance and incoming material inspection results. Process risks are assessed by failure mode and effects analysis (FMEA), and what we learn is fed back into our documented procedures.