QIAGEN Achieves ISO Certification in Forensics
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QIAGEN announced that its manufacturing and supply chain for consumables and other products for forensic and human identity testing has been certified by Bureau Veritas, a leading inspection agency, as meeting the latest international standards for products used in forensic testing. QIAGEN is a global leader in molecular testing solutions for human identification and has actively supported the development of global forensic standards. In pursuit of continuous improvement, QIAGEN has a long history of working with experts in forensic sciences and law enforcement to upgrade requirements designed to minimize the contamination of samples and to ensure the highest level of accuracy in DNA fingerprinting.
The Bureau Veritas certification represents a seal of approval that QIAGEN complies with the latest standard, known as ISO18385:2016, adopted to prevent contamination of products for DNA casework and reference databases. The requirements cover the manufacturing of products used in the collection, storage and analysis of human DNA during forensic testing, including sampling kits such as swabs, containers and packaging, and consumables used in the analysis of DNA samples by forensic laboratories.
“QIAGEN is a pioneer in developing international standards for forensic testing. DNA fingerprinting is essential to the modern justice system – and the results of forensic tests can have very significant consequences. We are very proud to have achieved this third-party confirmation that the manufacturing of our forensic workflows meets the state-of-the-art ISO standards for reliability and quality,” said Dr. Thomas Schweins, Senior Vice President and Head of QIAGEN’s Life Sciences Business Area. “The certification documents that QIAGEN inspection and documentation of controls as well as manufacturing processes are designed to ensure fail-safe accuracy of our sample kits, forensic assays and other products. We are very proud to deliver industry-leading quality in our forensic testing solutions. Our mission is to ensure that stakeholders of the legal system can with great confidence rely on QIAGEN’s Forensic DNA grade products.”
The latest ISO standards were adopted to eliminate the potential for contamination through introduction of DNA from a source other than the person or sample being tested. Because DNA profiling assays are designed to detect even the tiniest amounts of genetic material in ‘trace’ evidence, contamination could interfere with positive identification or cause misidentification – undercutting an important law enforcement tool and possibly endangering lives. The need for accuracy applies to casework samples, such as DNA collected from a knife handle or cigarette butt at a crime scene, and to reference samples from persons arrested or convicted of crimes, routinely collected and databased to help investigate future crimes.
In the most famous case of contamination, traces of DNA were found at 40 crime scenes in Europe over a 16-year period, including six homicides – leading investigators to suspect that an unknown female serial killer was at large. She was nicknamed “the Phantom of Heilbronn,” a town in Germany where one of the murders took place. The only connection between the crimes was the DNA. In 2009, after exhaustive investigation, detectives found that DNA recovered at various crime scenes was already present on the cotton swabs that had been used for the collection of the samples. The detected DNA had come from a woman who worked at one of the factories of a supplier of the cotton swab products. The "Phantom" serial killer therefore did not exist. Subsequently, international experts in forensic science and law enforcement developed the ISO18385:2016 standard to provide process and quality standards to control for contamination.
In announcing the certification of QIAGEN’s production, the international inspection and testing agency stated: "Bureau Veritas was pleased to work with QIAGEN to review QIAGEN's management system compliance to the ISO18385:2016 standard for production of human identity testing consumables and products. Bureau Veritas found QIAGEN's Management System to be in accordance with the requirements of the ISO18385:22016 with a high level of conformance demonstrated."
The Bureau Veritas certification represents a seal of approval that QIAGEN complies with the latest standard, known as ISO18385:2016, adopted to prevent contamination of products for DNA casework and reference databases. The requirements cover the manufacturing of products used in the collection, storage and analysis of human DNA during forensic testing, including sampling kits such as swabs, containers and packaging, and consumables used in the analysis of DNA samples by forensic laboratories.
“QIAGEN is a pioneer in developing international standards for forensic testing. DNA fingerprinting is essential to the modern justice system – and the results of forensic tests can have very significant consequences. We are very proud to have achieved this third-party confirmation that the manufacturing of our forensic workflows meets the state-of-the-art ISO standards for reliability and quality,” said Dr. Thomas Schweins, Senior Vice President and Head of QIAGEN’s Life Sciences Business Area. “The certification documents that QIAGEN inspection and documentation of controls as well as manufacturing processes are designed to ensure fail-safe accuracy of our sample kits, forensic assays and other products. We are very proud to deliver industry-leading quality in our forensic testing solutions. Our mission is to ensure that stakeholders of the legal system can with great confidence rely on QIAGEN’s Forensic DNA grade products.”
The latest ISO standards were adopted to eliminate the potential for contamination through introduction of DNA from a source other than the person or sample being tested. Because DNA profiling assays are designed to detect even the tiniest amounts of genetic material in ‘trace’ evidence, contamination could interfere with positive identification or cause misidentification – undercutting an important law enforcement tool and possibly endangering lives. The need for accuracy applies to casework samples, such as DNA collected from a knife handle or cigarette butt at a crime scene, and to reference samples from persons arrested or convicted of crimes, routinely collected and databased to help investigate future crimes.
In the most famous case of contamination, traces of DNA were found at 40 crime scenes in Europe over a 16-year period, including six homicides – leading investigators to suspect that an unknown female serial killer was at large. She was nicknamed “the Phantom of Heilbronn,” a town in Germany where one of the murders took place. The only connection between the crimes was the DNA. In 2009, after exhaustive investigation, detectives found that DNA recovered at various crime scenes was already present on the cotton swabs that had been used for the collection of the samples. The detected DNA had come from a woman who worked at one of the factories of a supplier of the cotton swab products. The "Phantom" serial killer therefore did not exist. Subsequently, international experts in forensic science and law enforcement developed the ISO18385:2016 standard to provide process and quality standards to control for contamination.
In announcing the certification of QIAGEN’s production, the international inspection and testing agency stated: "Bureau Veritas was pleased to work with QIAGEN to review QIAGEN's management system compliance to the ISO18385:2016 standard for production of human identity testing consumables and products. Bureau Veritas found QIAGEN's Management System to be in accordance with the requirements of the ISO18385:22016 with a high level of conformance demonstrated."
