The audit included a review of standard operating procedures, management structure and activities, quality assurance processes, and test methods. Technical competence was demonstrated for all methods within Microchem’s scope of accreditation.
The following methods, which appear on the lab’s scope of accreditation, were examined in detail:
AAMI TIR12 – Disinfection Validation – Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: A Guide for Medical Device Manufacturers
AAMI TIR30 – Cleaning Validation – A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices
ISO 11930 – Evaluation of Antimicrobial Protection (Preservation) of Cosmetic Products
In addition to ISO 17025 accreditation, Microchem maintains compliance with EPA and FDA Good Laboratory Practices (GLPs).