Microchem’s Scope of Accreditation
Microchem maintains ISO 17025 accreditation through ANSI National Accreditation Board (ANAB). Accreditation provides our clients with additional confidence in the laboratory’s quality system and technical competence. 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/IEC 17025 History and Purpose
ISO/IEC 17025, the “general requirements for the competence of testing and calibration laboratories,” was first adopted by the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) in 1999. In 2005 it was updated to better align with the most recent version of ISO 9001 – Quality Management System Requirements. In 2017, it was updated to incorporate risk-based thinking into a process-approach similiar to other standards, such as ISO 9001 – Quality Management Systems, as well as to cover technical changes, vocabulary, and developments in Information Technology techniques.
The international standard is comprised of elements which focus on management, quality and technical competence. 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.
Companies working with a certified laboratory can have confidence in the lab’s ability to generate accurate and reproducible data. Additionally, and similar to GLP compliance, in-process tests and final reports are audited by a quality assurance specialist to insure study integrity and data validity.
Microchem Laboratory is excited to make this announcement and offer its customers a broader selection of capabilities. Contact the lab for more information and for a copy of the lab’s certificate and scope of accreditation.