By Caitlin Hines on August 6, 2018
Those within the toxicology industry serve society in a critical way. They are tasked with analyzing alcohol, drugs, and other toxic substances from within biological samples. The impetus for this analysis is because big questions hang in the balance. Sometimes, those questions relate to determining the cause of someone’s passing. Other times, they are related to gathering reliable evidence to use within court proceedings. There is a need for reliable data sets and results that can be trusted to provide answers. In order to ensure reliability of results, there is a need for data integrity, clearly documented processes, adherence to procedures, and well-trained staff, amongst other things. Ultimately, there is a need for a robust quality assurance system to support compliance within toxicology organizations.
When it comes to compliance for those within toxicology organizations there are two leading accreditations; accreditation based on ISO/IEC 17025 and ABFT Laboratory Accreditation.
What is ABFT Laboratory Accreditation?
ABFT stands for American Board of Forensic Toxicologists. As shared on their website, the objective of the ABFT Accreditation is to:
establish, enhance, and maintain standards of qualification for those laboratories that practice Postmortem Forensic Toxicology or Human Performance Toxicology and to accredit as qualified laboratories those applicants who comply with the requirements of the Board.
This third-party accreditation is a way for organizations to demonstrate their commitment to best practices, continuous improvement, and producing reliable results. It includes on-site peer review, successful proficiency testing, and demonstrated adherence to professional standards. To be clear, this accreditation is for the lab collectively. There is also an ABFT certification program that is used for individuals who work within Toxicology labs.
What is ISO/IEC 17025 based Accreditation?
ISO is the “International Organization for Standards”. It is non-governmental and independent, bringing together experts across a variety of industries to “give world-class specifications for products, services, and systems, to ensure quality, safety and efficiency.” Another benefit is that these international standards help organizations do business across the globe–as they create commonalities.
There are a variety of ISO standards and ISO/IEC 17025 contains the general requirements for the competence of testing and calibration laboratories. Labs accredited based on ISO/IEC 17025 will include those that perform chemical testing, food testing labs, and also those within forensics–like toxicology testing labs. The standards provide guidance for how to establish a quality management system and for how to conduct technical and management operations. It is applicable to all labs and is not limited by the size or number of personnel. Remember, these standards provide the foundation to ensure the quality of the test and calibration results reported.
What’s the connection between ABFT and ISO/IEC 17025?
ISO/IEC 17025, as mentioned, is not specific to toxicology testing labs only. However, ABFT is. With those two accreditations combined, it makes a powerful statement about the dedication of a toxicology laboratory to quality assurance, best business practices, and excellence within toxicology testing.
In October 2016 ABFT formed a strategic alliance with the ANSIASQ National Accreditation Board (ANAB). As part of this alliance, ANAB now administers the ABFT accreditation program on behalf of ABFT. ANAB is also a recognized accrediting body by the International Laboratory Accreditation Cooperation (ILAC). This strategic alliance provides toxicology labs with an avenue to become accredited based on ISO/IEC 17025, in addition to ABFT. This alliance recognizes the power of having both accreditations in place and is prompting many toxicology labs to not only pursue ABFT accreditation but also ISO/IEC 17025.
In the future, ANAB will require ABFT labs to transition to accreditation based on ISO/IEC 17025. Knowing this is on the horizon, many toxicology labs are beginning to evaluate what it will take to pursue this and are taking initial steps. Rather than waiting for the pressure of compliance to build, they are approaching it proactively.
Toxicology Labs Pursuing accreditation based on ISO/IEC 17025
Seeking and maintaining accreditation based on ISO/IEC 17025 as a toxicology lab does not have to be an arduous process. When establishing a Quality Management System that honors the standards set forth within ISO/IEC 17025 it is best to turn to a digital solution, rather than a series of binders, stacks of paper, or disparate digital storage mechanisms (i.e. complex spreadsheets).
Our software sets up toxicology labs for audit and accreditation success. In fact, ANAB uses Qualtrax themselves to manage their own quality assurance and compliance. That speaks to the power and effectiveness of our product!
It is our hope that we can come alongside more and more toxicology labs who are endeavoring to take their compliance from ABFT to a combined ABFT and ISO/IEC 17025 based accreditation. We believe in the purpose and impact of the important work they are doing–we hope to help.
Categories: Compliance Management, Forensic Labs, Testing Labs