August 2022

Microchem maintains ISO 17025 accreditation through ANSI National Accreditation Board (ANAB).

ISO Accreditation is comprised of elements which focus on management, quality, and technical competence of a laboratory.

The accreditation process is voluntary and involves a series of laboratory assessments and technical reviews. After successful completion of all requirements, the laboratory is awarded an accreditation certificate and a document detailing the official scope of accreditation. In addition to ISO 17025 accreditation, Microchem maintains compliance with EPA and FDA Good Laboratory Practices (GLPs).

Microchem’s current scope of accreditation includes the following standards:

  • 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 the Antimicrobial Protection (Preservation) of Cosmetic Products

ISO 17025 was first adopted by the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) in 1999. Since then it has been updated to incorporate risk-based thinking into a process-approach similar to other standards, such as ISO 9001 – Quality Management Systems.

Microchem intentionally provides quality work for our clients by performing excellent studies, maintaining a top-tier laboratory environment, and constantly pursuing improvement.