verified Certified Quality Management System

ISO 13485:2016 Certified —
Zero Non-Conformances at 2026 Audit

Pro-Lab Diagnostics USA closed our 2026 surveillance audit with zero non-conformances, conducted by NQA (National Quality Assurance, USA) — an ANAB-accredited certification body under ISO/IEC 17021-1. We have held continuous ISO 13485 certification since October 2015.

Certificate of Registration

Issued by NQA, USA — verifiable on request.

Pro-Lab Diagnostics — ISO 13485:2016 Certificate of Registration, NQA Cert #15775, valid through September 30, 2027
Click certificate to download the original NQA-issued PDF
Certificate Number
15775
Standard
ISO 13485:2016
Scope
Design, Development, Manufacture and Distribution of In Vitro Diagnostic Products. Distribution of Related Laboratory Equipment, including Freezers and Airflow Cabinets.
Certified Site
Pro-Lab Diagnostics
1301 Blue Ridge Drive, Suite 101
Georgetown, TX 78626, USA
Registrar
NQA, USA — ANAB-accredited (ISO/IEC 17021-1)
289 Great Road, Suite 105, Acton, MA 01720
EAC Code
12, 29
Certified Since
October 1, 2015 (continuous)
Current Cycle Issued
October 1, 2024 (reissued February 13, 2025)
Valid Until
September 30, 2027
Last Audit
June 22, 2026 — surveillance audit, zero non-conformances
picture_as_pdf
Certificate PDF
Full NQA Certificate of Registration (cert #15775). Drop straight into your supplier-qualification file.
Download →
Verify with NQA directly
For independent verification, your QA team can contact our NQA account representative:

Shawn McGovern
Client Support Representative, NQA USA
Direct: +1 (978) 893-0142
Shawn.McGovern@nqa.com
Reference: Pro-Lab Diagnostics, file 16054

What this means for your supplier file

Three audiences, three reasons our certification is operationally useful — not just a logo.

Clinical & Reference Labs
Preparing for CAP, ISO 15189, or CLIA inspection

A zero-NC ISO 13485 supplier removes a line item from your supplier-qualification file. Cert PDF + scope statement + the NQA verification contact above are everything your inspector needs from us.

IVD & Dx Manufacturers
21 CFR 820 and EU MDR supplier controls

FDA QSR (21 CFR 820.50) and EU MDR Article 10(9) require your component and reagent suppliers to operate a controlled QMS. Our scope covers IVD design, development, manufacture, and distribution — no audit back-and-forth required.

Distributors & Resellers
Transfer-ready supplier qualification

Our cert and scope drop cleanly into your own supplier file. If you need a counter-signed supplier-qualification form on your template, the contact below routes it to our QA team.

Need the full supplier-qualification packet?

We can send the certificate PDF, scope statement, recent audit history, quality manual table-of-contents, and a counter-signature on your supplier-qualification form within one business day.

mail Request packet from QA download Download certificate only

Direct line: Tanner Freydberg, Operations Manager — (512) 832-9145 — tanner@pro-lab.us