About Stratos
We have sat on both sides of the audit table.
Stratos is a quality-systems practice for small and midsize US manufacturers in aerospace, medical device, and other regulated programs.
We are not an eQMS vendor or a staffing firm, and not a generic AI company.
Tony is a quality systems engineer and lead auditor for ISO 13485 and AS9100D. He sells the work and delivers it. You get the outcome, not a login.
The system has to work on a Tuesday, not only the week of the audit. Plants that run both ISO 13485 and AS9100 are who we work with most.
Credentials
ISO 9001
Quality systems
ISO 13485
Lead auditor
AS9100D
Lead auditor
FDA QMSR took effect 2 February 2026. An ISO 13485 certificate does not replace an FDA inspection. AS9100D is the aerospace standard now. The next revision is IA9100, not AS9100E. ISO 9001:2026 is due 16 September 2026.
Who we work with
Shops of 15–200 people, one or two sites. A quality leader who is short on hours, with a certification clock or a customer mandate. Usually the quality manager, ops, plant manager, or owner.
You have a certification clock, or a customer just mandated AS9100 or ISO 13485. Plants that run both ISO 13485 and AS9100 are who we work with most. We do not chase primes or 400-person plants with a quality department already in place.
How we work
We work in the system you already have. Evidence first, and you keep the signatures. If we are not the right fit, we will say so.