A2LA’s biological testing program covers a wide range of tests. Subprograms include, but are not limited to:
- AOAC – Food/Dietary/Pharmaceutical analytes
- Threat Agent Testing
- FDA ASCA
This program follows the ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories.
- ISO/IEC 17025:2017 contains requirements for testing and calibration laboratories that range from the organization, personnel and training, method validations/verification, internal audits, management review, and more.
- R101 – General Requirements for Accreditation of ISO/IEC 17025 Laboratories
- R102 – Conditions for Accreditation
- R103 – General Requirements- Proficiency Testing for ISO-IEC 17025 Laboratories
- R105 – Requirements When Making Reference to A2LA Accredited Status
- P102 – Policy on Metrological Traceability
- P103b – P103b – Annex – Policy on Estimating Measurement Uncertainty for Life Sciences Testing Labs
- See our ISO/IEC 17025 FAQ for more information.
Organizations seeking ISO/IEC 17025:2017 accreditation in the biological field are also subject to the requirements and policies set forth by A2LA. The policies and details can be found in the A2LA R101 – General Requirements for Accreditation of ISO/IEC 17025 Laboratories which includes:
- Proficiency testing requirements
- Requirements for using the accredited symbol once accreditation is granted
- Requirements for equipment metrological traceability
Optional Additional Standards
This program also offers two optional additional standards:
- Good Manufacturing Practice (cGMP)
- Good manufacturing practice (cGMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. This is typically applied to medical products.
- Good Laboratory Practice (GLP)
- Good laboratory practices (GLP) are the recognized rules governing the conduct of non-clinical safety studies.
Optional Biological Subprograms
Along with the general biological field, subprograms are designed to be more tailored toward a specific industry or need, which includes specified knowledge and additional requirements. These subprograms can be applied to different fields of testing, such as Biological and Chemical. The following subprograms are part of the Biological testing field:
- Food and Pharmaceutical Testing Laboratory Accreditation Program (AOAC)
- Veterinary Laboratory Accreditation Program
- Cannabis Testing Laboratory Accreditation Program
- Threat Agent Testing Laboratory (TATL) Accreditation Program
- FDA ASCA Basic Safety and Essential Performance
- FDA ASCA Biocompatibility