In the past, FDA’s Regulatory laboratories operated under a variety of formal and informal quality management systems. All of these systems had the same aim – to assure the quality of laboratory results upon which regulatory decisions are made. However, these systems differed in their rigor and in the amount of independent oversight exercised.
A quality management system that is accredited to international standards (ISO/IEC 17025) enabled Laboratory managers to better maintain high quality laboratory operations, to more easily control resources, and to act with more confidence in meeting the needs of their customers and stakeholders. More effective operations result in greater regulatory impact and better consumer protection. Uniform laboratory procedures enhance data reliability and resource sharing with FDA domestic and international partners.
Through laboratory accreditation, FDA Regulatory laboratories maintain their reputation as a source of scientifically sound information and guidance. The accreditation process started in 2003 and FDA Regulatory laboratories undergo a full on-site assessment every two years depending upon the expiration of their Accreditation Certificate.
The objective of an accreditation assessment is to establish whether or not a laboratory complies with the accrediting body’s requirements for accreditation and can competently perform the types of tests or calibrations for which accreditation is sought. Accreditation is required to demonstrate compliance with additional criteria of the “AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, Pharmaceuticals, and Cannabis”. The purpose of this contract is to have an independent, third-party Contractor perform the accreditation assessments and make the proper determinations and to identify any deficiencies.
