What Standards are Followed in Histology Manufacturing?
Histology manufacturing follows various national and international standards, such as:
- ISO 13485: Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services. - CLIA: The Clinical Laboratory Improvement Amendments regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS). - CAP: The College of American Pathologists provides accreditation programs that ensure laboratories meet high standards of excellence.
