Thermo Fisher Scientific Manufacturing Site First in Forensic Industry to Meet Proposed Guidelines for ISO 18385 Certification

The Warrington, Great Britain manufacturing site for Thermo Fisher Scientific now meets the guidelines for 18385 certification, a new standard proposed by the International Organization for Standardization (ISO). By achieving this milestone, the company helps set a new standard for manufacturing key products and technologies that international forensic laboratories rely on to solve crimes around the world.

The Warrington site worked closely with a forensic quality and validation expert, formerly with the UK Forensic Science Service, who confirmed its adherence to the proposed ISO 18385 guidelines. Thermo Fisher is the first company in the DNA forensics industry to demonstrate compliance with the proposed standard, which is designed to minimize human DNA contamination in the manufacture of reagents and consumables used for forensic DNA analysis.

“My assessment has shown that there is a good correlation between the production of consumables at the Thermo Fisher Scientific sites in Warrington - Kingsland Grange and Newton House - and the requirements stipulated in the draft standard ISO18385, ‘Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes,’ ” said Kevin Sullivan, Ph.D., director at Principal Forensic Services, an internationally recognized and respected forensic scientist with more than 25 years of experience in validation and quality assurance gained through working for the Forensic Science Service.

As part of its commitment to customers, Thermo Fisher collaborated with forensic practitioners and industry experts to define the draft manufacturing standard. Although uncommon, DNA contamination in a forensic DNA analysis laboratory can lead to erroneous results and thereby negatively affect the outcome of criminal investigations.

“As a global leader in the forensics space, Thermo Fisher remains focused on serving its customers with products that meet the highest standards in the industry,” said Rosy Lee, vice president and general manager of human identification for Thermo Fisher. “Our decision to raise the bar and comply with the draft manufacturing standard is in line with our heritage of providing high-quality tools that enable forensic labs to trust the results when using our products.”

ISO certification facilitates compliance with global regulations by setting the framework for maintaining effective manufacturing processes specific to product design, safety, and distribution. It also establishes a foundation on which various country-specific regulatory and customer compliance requirements can be built upon.