ISO/IEC 17025 Accredited GMP/GLP Compliant Laboratory

Microchem has been ISO 17025 accredited for many years. The lab maintains ISO/IEC 17025 accreditation through Perry Johnson Laboratory Accreditation, Inc. The main facility near Austin, Texas is accredited across a range of critical biological methods, while the analytical chemistry and OTC lab near Dallas, Texas is accredited for both biological methods and chemistry (see details, below).

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.