Falcon Quality ISO 9001, step by step
About

I'm Steve Kent. I've spent over forty years making quality systems work.

Most of that time as a Quality Manager and then a Quality Director, building systems from nothing, rebuilding ones that had quietly stopped working, and taking companies through certification. Roughly twenty of those years were spent specifically on ISO 9001 and its derivatives — AS9100 in aerospace and ISO 13485 in medical devices.

Falcon Quality is what I do with all of that now: a one-person practice, by choice, for small manufacturers who deserve better advice than they usually get.

Steve Kent, founder of Falcon Quality
Steve Kent · Danville, California
40+years in quality management
14consecutive audits, one minor finding
Auditorqualified for ISO 9001 and aerospace
1person doing the work

Where the forty years went

Over four decades I've worked as a Quality Manager and then a Quality Director in semiconductor companies, mainframe and personal computer manufacturers, aerospace companies and small manufacturing businesses, as well as startups and contract work with contract manufacturers.

That range matters more than any single role in it. I've seen what a quality system looks like inside a large, demanding operation, and inside a startup still working out what it makes. What I've learned is that the size of the company changes almost everything about what the system should look like, and almost nothing about what the auditor expects to see.

I've led ISO 9001 and AS9100 certifications from inside the company. I've also sat on the other side of the table — and I still do. I'm a qualified ISO 9001 and aerospace auditor, and I work under contract for an accredited certification body, conducting ISO 9001 audits.

That matters more than it sounds. Knowing what a clause says and knowing what an auditor is actually looking for are two different skills, and most of the value I bring comes from the second one. When I tell you what a registrar will ask, it isn't secondhand. I'm often the one asking.

One rule I hold to without exception

I never audit a company I've consulted for, and I never consult for a company I've audited. Accreditation rules require that separation, and so does common sense. If you work with me, your certification audit will be conducted by someone independent of both of us.

A few of the jobs

An aerospace company that had lost its certification
The quality system had failed so completely that the company lost its certificate before they brought me in. I rebuilt it and got the certification back. Then came a run of fourteen consecutive audits that produced a single minor finding between them.
A startup, from nothing
I built the entire quality management system from scratch at a startup that went on to be acquired for more than $10 billion. No inherited procedures, no legacy system to fix — just a blank page and a company growing faster than its paperwork.
Small semiconductor companies
ISO certification built from the ground up, in companies small enough that the quality function was often one person wearing several hats. The same situation most of my clients are in today.
A large mainframe computer company
ISO program manager, responsible for taking the organization through certification. The opposite end of the scale from a startup, and the place I learned how much of a quality system is really about getting a large number of people to do the same thing the same way.

What I believe about this work

Forty years produces opinions. These are the ones that shape everything I sell.

The system has to fit the shop

A twelve-procedure manual nobody opens will pass an audit once and then rot. What survives is documentation people actually use — which usually means less of it, written in the language the shop floor already speaks.

Knowing what is required isn't knowing how

Most ISO training explains what each clause demands. Very little of it shows you how to produce the thing. Everything I've built is aimed at the gap between understanding a requirement and having the procedure, the form and the record in hand.

Honest beats comfortable

If your system isn't ready, I'll say so. If you can do this without me, I'll say that too. And if a consultant tells you the 2026 revision means rebuilding your QMS, I'd find a different consultant.

Why Falcon Quality exists

I started Falcon Quality because I got tired of watching consultants give vague answers to direct questions, then charge far too much for them.

I know what it's like to need those answers. Twice, back in the early days of ISO 9001, I took a company through certification largely on my own — finding the answers one requirement at a time, and working out how to tune a quality system to meet ISO 9001 and then the aerospace requirements on top of it. It taught me how hard it is to get a straight answer when you actually need one.

Small manufacturers still get handed advice designed for companies twenty times their size. They're told they need a document controller they can't afford, a consultant on retainer for a year, and a quality manual thick enough to stop a door. None of that is true. A shop with a few dozen people can build a system that passes a registrar audit and genuinely helps them run the business.

So the course is built around the struggles I had early on: the requirements I didn't understand at first, and the places I got stuck. It comes with the templates, forms and detailed instructions to get past them, at a price a small shop can actually justify. Making that available has been a goal of mine for a number of years. I wrote every part of it myself, out of what I've watched succeed and fail in real shops.

What I do, and what I don't

What I do

  • Build and rebuild quality systems for ISO 9001, AS9100 and ISO 13485
  • Teach small manufacturers to do it themselves, through the course
  • Review procedures, close audit findings, and prepare companies for registrar audits
  • Tell you plainly how far you are from certifiable

What I don't

  • Issue certificates. I'm not a registrar or certification body, and I'll help you choose one
  • Act as your regulatory affairs consultant for FDA or EU submissions
  • Sit in your certification audit answering for you — registrars don't allow it
  • Sell you a rebuild you don't need

Outside of work

When I'm not thinking about clause 8.4, I'm usually outside — hiking, biking, or camping with friends.

I also try to learn something genuinely new every year, mostly to keep my mind working. Over the years that has meant taking acting lessons at Berkeley Rep, singing lessons with a coach, learning to oil paint, building guitars, and photography. At the moment I'm working on a murder mystery novel. The list keeps getting longer.

Oil painting by Steve Kent of a woman in a straw hat and yellow dress seated on a harbor wall, sailboats on blue water behind her
One of my oil paintings
San Francisco skyline at dusk seen across the bay from Treasure Island, with the Transamerica Pyramid and Embarcadero towers lit
San Francisco at dusk, from Treasure Island

Find out where you stand before you spend anything.

Sixty-seven questions across every clause of ISO 9001, scored by section. Set aside 30 to 45 minutes. Free, and your answers save as you go.

Falcon Quality

ISO 9001, AS9100 and ISO 13485 consulting and courses for small and medium manufacturers. A one-person practice — you work with me, not an account manager.

Phone
(925) 557-8570
Email
[email protected]
Office
499 Highland Dr
Danville, CA 94526
© 2026 Falcon Quality. All rights reserved.

Falcon Quality is an independent consultancy. It is not a certification body, a registrar or an accreditation organization, and it does not issue certificates. ISO 9001, AS9100 and ISO 13485 are the property of their respective standards organizations.