Thermo Fisher Scientific Microbiology has achieved International Organisation for Standardisation (ISO) 17034 certification, making it an accredited reference material (RM) manufacturer of certified reference material (CRM) quality control products.
Accreditation certificate number 6559.01 was granted by the American Association for Laboratory Accreditation (A2LA) in November 2022 after a comprehensive evaluation and audit. The news provides Thermo Fisher Scientific’s customers with an additional level of confidence in their QC products and in their regulatory compliance.
The certification applies to the portfolio of quality control (QC) organisms. It means more than 400 Thermo Scientific Culti-Loops qualitative QC organisms have CRM status, and 25 Thermo Scientific Quanti-Cult Plus quantitative QC organisms have accredited RM status.
Quality control is essential in maintaining high levels of accuracy and proficiency regardless of variabilities such as changing methods or increasing sample sizes. Choosing products from an ISO 17034 accredited manufacturer assures high quality QC products and, by extension, QC processes. Accreditation also means product compliance with global regulations, standards, and guidelines covering pharmaceutical, clinical, and industrial settings.
These include ISO 15189 and ISO 17025, as well as various Pharmacopoeia standards. World Health Organisation (WHO), US Food and Drug Administration (FDA), and AOAC International guidelines all recommend the use of quality control reference materials from an ISO 17034 accredited supplier.
All laboratories that conduct any type of measurement activities need RMs to ensure the validity, precision, and accuracy of their measurements
To achieve certification, Thermo Fisher Scientific embarked on a three-year program of continual improvement that included: updating documentation to demonstrate controlled manufacturing and testing processes for products, evaluating metrological traceability and measurements of uncertainty, and improving production processes.
Kelly Black, President of Neptune and Company, Incorporated, worked closely with Thermo Fisher Scientific throughout the lengthy ISO accreditation process. She is the Chair of the ISO Technical Committee (TC) 69 (Applications of Statistical Methods) and the A2LA Reference Material Producer Technical Advisory Committee, and a member of ISO TC 334 (Reference Materials). Kelly Black stated: “All laboratories that conduct any type of measurement activities need RMs to ensure the validity, precision, and accuracy of their measurements. The more frequently materials from an accredited RM producer are used, the less risk laboratories have of false measurements. Facilities that make use of these high-quality materials will be at a reduced risk of laboratory or production errors."
The accreditation applies to the QC organisms portfolio:
- Culti-Loops qualitative QC organisms provide standardised cultures for quality control testing that can be prepared quickly, easily, and safely. These ready-to-use, disposable bacteriological loops contain stabilised viable microorganisms, and offer complete traceability to ATCC Licensed Derivative and NCTC cultures.
- Quanti-Cult Plus quantitative QC organisms are supplied as a film of preserved microorganisms inside the cap of a plastic vial. The matrix, which offers complete traceability to ATCC Licensed Derivative and NCTC cultures, is ready for rehydration and use in QC procedures.
Ultimately, robust and compliant microbiological QC processes rest on a foundation of quality materials and that foundation is assured by ISO 17034 accreditation.