ISO 17025 accredited
APS operates a comprehensive quality management system accredited to ISO 17025, which applies to our processes for identification of client needs, test selection, test validation, test documentation, and reporting of results. Biocompatibility tests are also included under our scope of accreditation.
As a GLP compliant laboratory, APS meets or exceeds FDA standards for data integrity and documentation practices. The United States FDA does not have a formal licensure, accreditation or registration program or requirement for GLP laboratories. APS has all the necessary management systems, functional roles (i.e. Test Facility Management, Study Directors, and Quality Assurance Unit) and documented standard operating procedures necessary to comply with the FDA GLP regulations.
Animal Welfare Standards
- USDA Class R Facility License
- USDA Class R License
- AAALAC Accredited (Association for Assessment and Accreditation of Laboratory Animal Care)
Laboratory Quality Standards
- FDA 21 CFR Part 58 - Good Laboratory Practice (GLP)
- ISO/IEC 17025 - Requirements for the Competence of Testing and Calibration Laboratories
- Public Health Services (PHS) 42 USC Chap 16B - Contracts for Scientific and Technological Research