ISO 13485:2016 Compliant
The GDL Quality System recently underwent an ISO 13485 Quality System full scope audit in the summer of 2025 by an independent 3rd party auditor. This was a comprehensive evaluation of our company's quality management system (QMS) to verify its conformity with the ISO 13485:2016 standard's requirements for products and processes. The audit included a Stage 1 Audit (Documentation Review): An initial review of the QMS documentation to ensure it meets the standard's requirements and to determine readiness for the Stage 2 audit. It also included a Stage 2 Audit (Full Scope On-Site Assessment): A comprehensive on-site evaluation where the auditor examined the QMS in detail, reviewed records, observed processes, and interviewed personnel. A formal audit report was generated including non-conformances and the proposed corrective actions. Copies of the audit report can be obtained for a fee. GDL is not accepting audit requests at this time but is asking our clients to obtain the 3rd party audit report to meet their own quality system requirements.
To obtain a copy of the audit report please email the 3rd party auditor at the following email: johnverzuh@peoplepc.com and copy our Quality Manager (email: Kurt@greatdividelabs.com).
You may also call the auditor, John Verzuh, at 406 570-4678 with any questions or to order the audit report.