What’s New in the 2025 FBI Quality Assurance Standards? Notes from a Former SWGDAM Member

It’s SWGDAM week, and I’m here at my kitchen table.

Although I’m no longer a voting member of SWGDAM (the Scientific Working Group on DNA Analysis Methods) since leaving AFDIL in May, I still serve as a SME on the NGS Committee—so think of me as a retired SWGDAM “emeritus” (minus the government pension). I’m not in the meeting room this week, collecting a few more “helmet-stickers” for my lanyard—SWGDAM pins handed out for a job well done, so I have time to break down the new 2025 Quality Assurance Standards (QAS) for Forensic DNA Testing Laboratories that were just published on July 1st. To double-check my memory (I voted on these revisions last year), I ran a PDF-to-Word “compare documents” exercise and flagged every notable tweak. Below is the TL;DR recap for busy lab managers who don’t have an afternoon to comb through 50 pages of standards.

Coursework requirements

Then (2020): Technical leaders needed 12 credit hours in Biochemistry, Genetics, Molecular Biology, and Statistics/Population Genetics across undergrad/grad coursework.
Now (2025): Technical leaders need 9 credit hours in any biology/chemistry courses that underpin DNA analysis plus dedicated coursework in statistics or population genetics, with one course at the graduate level. Analysts now follow the same 9 hours + stats formula at the undergraduate level.

Why it matters: This is a softening of the language to allow for varied course titles covering the same general content, which eases the administrative burden on hiring managers and technical leaders. Previously, if someone's transcript showed "Forensic Molecular Biology" instead of “Molecular Biology," then a syllabus, letter from the instructor, or other document was necessary to demonstrate compliance with the course requirement. The explicit stats/pop-gen requirement underscores the need for solid quantitative chops in the age of probabilistic genotyping.

Validation

The QAS no longer requires a peer-reviewed publication to prove a novel method’s scientific principle. Labs must still document that the underlying science is sound, but publication is no longer the only path. The developmental-software validation section was likewise trimmed—sensible, since most forensic labs aren’t writing code themselves anyway.

Quantification

Standard 9.4.2 now permits labs to quantify DNA during or after STR amplification, as long as the kit includes internal QC and validation shows equivalence to pre-amp qPCR. That accommodates Rapid-DNA chemistry for forensic DNA casework, and it permits short turnaround time samples to move straight to STRs without waiting on qPCR results.

Proficiency testing

When an ISO-accredited proficiency-test provider doesn’t offer an appropriate test, Standard 13.1 now allows labs to meet the requirement by monitoring performance “in accordance with the laboratory’s accreditation requirement.” This change opens the door for alternative proficiency testing mechanisms such as in-house programs or peer-to-peer laboratory sample swaps. However, the external provider is still a necessary ISO 17025 requirement; therefore labs that maintain ISO accreditation in addition to QAS compliance won’t be able to run an internal proficiency testing program.

Audits

Then (2020): Two successive external audits were required for approving a scientist’s qualifications and training. This placed a significant burden on quality managers in tracking the audit history of each staff member, accounting for parental leave and other skipped audits that could delay “memorialization” as a QAS-approved scientist.
Now (2025): Only one external audit cycle is required for checking the qualifications and training of scientific staff.

Why it matters: This will be a huge, welcome relief for quality managers and will streamline the auditing process.

Rapid DNA and NDIS

I’m a slow-DNA person (think ancient DNA), so Rapid doesn’t hold my attention for very long—and the same goes for NDIS rules around Rapid profiles. If you run Rapid systems now or plan to validate Rapid DNA for casework in your laboratory, make sure you spend time reading the new QAS in full; pages of additions await you.

Editorial & housekeeping tweaks

• Proper nouns – “Technical Leader” and “Casework CODIS Administrator” are now capitalized throughout.
• Definitions updates – Terms were removed and additions were made to stay consistent with the new content.

Final thoughts from the makeshift desk

The 2025 QAS revisions look subtle on the surface, but they simplify many aspects of quality management—from hiring to validation, proficiency-testing logistics, and staff memorialization. The new standards reflect diversification in DNA methods and the need for advanced statistics. They accommodate newer technologies—probabilistic genotyping, Rapid DNA, and NGS/MPS—that are beginning to outpace accreditation infrastructure, such as forensic DNA proficiency testing options.

SWGDAM emeritus or not, I’m always up for a QAS nerd-fest—drop a comment or ping me with your implementation questions!