Industries
Eight Sectors. One Discipline.
The clause numbers change. The question behind them does not: can you show, from your own records, that the thing you shipped is the thing you said you would ship? Pick your industry and see exactly what that means in it.
By Sector
What Applies to You, Standard by Standard
Each sector has its own page: the shape of its regulation, the working set of standards an auditor will actually open, the specific work in Marcia's record behind it, and three things that usually go wrong in it.
Medical Devices
The most heavily instrumented quality system there is, and since February 2026 the one where the American regulation and the international standard finally say the same thing.
Pharmaceutical
The industry where the procedure is the product. A batch that was made correctly and documented badly is a batch that was made badly, and every regulator on earth agrees on that point.
Automotive
The sector that industrialized quality planning. Nowhere else is so much of the work required to happen before the first good part, and nowhere else is the paperwork for it so completely specified.
Aerospace & Defense
Configuration control, first-article evidence, and a traceability chain that has to hold for decades. This is the sector where a record outlives the engineer who signed it, and is expected to still make sense.
Consumer Products & Toys
The only sector here where the end user is routinely a child, and the only one where a certificate naming a superseded standard is itself the violation.
Textiles & Materials
An industry whose specifications are almost entirely test methods, and whose hardest quality problem — color — is the one people assume is subjective.
Laboratories & Calibration
Every other system on this site rests on measurements. If the measurement is not defensible, neither is anything built on top of it — which is why calibration findings travel so far up an audit report.
General Manufacturing
Building products, electronics, ceramics, furniture, industrial components — the firms with no sector regulator, where the requirement arrives instead through a customer's purchase order.
What Is Not on This Page
The Sectors QES Does Not Claim
Food manufacturing is the obvious absence. FSMA 204 is on the research page because it is one of the significant regulatory changes in this window and clients ask about it — but Marcia has not run a food safety system, and HACCP, preventive controls and SQF or BRCGS certification are not hers to sell.
The same goes for clinical trials, cosmetics, cannabis, and nuclear. Where the underlying discipline transfers — document control, CAPA, root cause, supplier qualification, auditing, technical writing — she will say so and quote for that work specifically. Where it does not, she will tell you who to call instead. A consultant who has never said no to a sector has told you something about how they scope everything else.
How a Sector Engagement Starts
Against the Clause, Not Against a Feeling
A fixed-price gap assessment — two days on your floor and in your files, from $4,200 — produces a clause-by-clause table: what you have, what the standard in your column actually requires, what is missing, and what has to be written — with an owner and a date against each line.
You keep the findings whether or not you engage further. If the honest answer is that you need six hours of technical writing rather than a program, that is what the table will say.
On These Pages. The standards listed for each sector are the working set an auditor is most likely to open, not an exhaustive register; customer-specific requirements sit on top of them and frequently matter more. Dated statements are sourced on the research page. Experience described under each sector is drawn from Marcia Weeden's employment record and is available in full on her résumé. Canceled military specifications are marked as canceled where they are still cited in contract flowdowns. Checked October 24, 2026.