The new international standard was published on February 1, 2016. The guideline was developed to "minimize the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes." These requirements seek to improve the quality of forensic DNA testing by minimizing the risk of human DNA contamination during the manufacturing process.
"ISO 18385 provides guidance to manufacturers on how to minimize the chance of a contamination event and sets pass/fail criteria so that manufacturers can, for the first time, test their products against the requirements of the forensic industry," stated Dr. Linzi Wilson-Wilde, Director of the National Institute of Forensic Science, Australia/New Zealand and co-author of the Australian Standard upon which the ISO standard is based.
Two Promega scientists, Kristina Pearson, Bulk Production Manager, and Susan Wigdal, Senior Quality Assurance Scientist, were selected by the United States Technical Advisory Group to represent the U.S. on the development of ISO 18385. In addition to Dr. Wilson-Wilde, Promega scientists worked with forensic leaders such as Kermit Channel, the Executive Director of the Arkansas State Crime Laboratory and Chair of the U.S. Technical Advisory Group.
Dr. Channel notes, "Developing a specific ISO standard addressing the manufacturing of products used in forensic DNA laboratories across the globe was critical for our criminal justice stakeholders. We knew that developing this standard was going to be a difficult task requiring the right technical expertise. Fortunately for the U.S., we partnered with exceptional subject matter experts at Promega. The knowledge and expertise that Promega brought to the international table was invaluable in the creation of this ISO document that now provides DNA laboratories across the globe confidence in the products we use."
For more information about ISO 18385 and Promega’s efforts related to the standard, please visit: http://www.promega.com/ForensicGradeFAQ.
Promega first certified to international standards for quality management systems in 1998, and its commitment continues with our current ISO certifications. The ISO series of quality management system standards are developed and maintained by the International Organization for Standardization.