The Accreditation Scheme for Conformity Assessment (ASCA) Program
Perry Johnson Laboratory Accreditation, Inc. (PJLA) was selected as one of the first five FDA ASCA accredited Accreditation Bodies for this program. Under this scheme, ASCA-recognized accreditation bodies accredit testing laboratories using ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories and the ASCA program specifications associated with each FDA-recognized consensus standard and test method included in the ASCA Program.
Although, this program is voluntary for laboratories it provides them a market advantage and demonstrates their ability to go above and beyond the ISO/IEC 17025 standard. Evidence of conformity to one or more FDA-recognized consensus standards is often a thorough and efficient way for a manufacturer to address certain questions of safety and/or effectiveness.
For laboratories to be part of the ASCA approved laboratory listing, they must utilize an accreditation body approved by the FDA to conduct their assessment to ISO/IEC 17025 and to the ASCA requirements. Laboratories must be accredited to perform test methods as outlined in either or both guidance documents:
- Basic Safety and Essential Performance Standards – Specific guidance: Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program.
- Biocompatibility Standards – Specific guidance: Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program.
Laboratories seeking more information should complete our application.
To receive additional information about our accreditation programs, please contact our office at 1-877-369-LABS (5227) • (248) 519-2603 or email us at [email protected].