Off-site quality system document review against the standard you choose — ISO 9001, ISO 13485, 21 CFR 820, ISO 14001, or ISO 45001. You send the documentation. I read it against the standard. You get a written gap report with action items within one business day of receipt. Two tiers, depending on how deep you want me to go.
Most quality system review services come in two flavors. Either it's a registrar walking your floor for a week and writing $20,000+ of findings against a cert date that's already been booked. Or it's a junior consultant running a checklist for a few hundred dollars and giving you back a template that doesn't really catch anything.
This service sits between the two. One senior US quality engineer with 20+ years of ISO 9001 / 13485 audit experience reads your QMS documentation, clause-by-clause against the standard you pick, and writes you a gap report you can act on. No on-site visit. No travel cost. No day-rate billing. You upload the docs, the report lands in your inbox by close of business the next day, and we walk it together on a 30-minute call.
Use it as a pre-check before you commit to a full mock audit. Use it as a sanity check on a QMS you inherited. Use it during a due-diligence window when you have 72 hours to assess a target company's compliance posture. Use it whenever you need a senior independent read and you don't need a registrar.
If your standard is named, your documents are in a shareable folder, and you need a senior engineer to read them — this is the service.
Considering ISO 9001 or 13485 certification. Want to know how close you are before spending on a full mock audit.
Surveillance audit on the calendar. Want a fresh-eyes pass over the QMS before the registrar arrives.
Looking at acquiring a manufacturer. Need an independent read on the target's QMS during the diligence window.
Just took the QMS over. Need to know what you inherited and where the actual gaps are before you start fixing things.
Same engineer. Same standard. Same 1-business-day turnaround. The difference is how far down the document tree we go.
Plain-English flow. You send. I read. You get back. No discovery phase. No scoping creep.
QESaaS is a credentialed lead auditor against the standards below. Other standards (AS9100, IATF 16949, ISO 17025, 21 CFR 211) are available on quote.
Other standards (AS9100, IATF 16949, ISO 17025, 21 CFR 211) supported on custom quote — same engineer, same review approach, longer turnaround based on scope. Email and ask.
Same methodology spine as every QESaaS engagement. The 1-business-day turnaround works because the review is bounded — fixed scope, fixed standard, fixed deliverable shape — and because the engineer doing the work is the engineer who wrote the methodology.
Documents land in the secure share. Inventory pass to confirm the doc set is complete versus the standard's scope.
Each clause of the chosen standard mapped to the document that addresses it. Gaps flagged as Major / Minor / OFI per ISO 17021 conventions.
Consistency check across documents. Findings prioritized by certification impact and effort to close.
Gap report drafted, reviewed, signed by the engineer who did the work. No anonymous "an auditor" — same name on the byline as on the LinkedIn profile.
Engineer sign-off is non-negotiable. The methodology is published — clients can read what they're paying for before invoicing.
Knowing the limits is what makes the price quotable and the deliverable clean.
If any of the items below are what you actually need, this is not the right service. We'll tell you so on the scoping call before invoicing.
The questions that come up most often.
ISO Audit Prep is the full mock audit — on-site, multi-day, day-rate billing, focused on a registrar walking your floor in the next 4–8 weeks. This service is a document-only review, off-site, fixed-fee, 1-day turnaround. Use this service first to find out where you stand. Use ISO Audit Prep when you have a cert date booked and need the registrar-style walk.
If we sign the engagement letter and you upload the documents on Monday before noon ET, you get the gap report by close of business Tuesday. If you upload Friday afternoon, you get it Monday. The clock starts when the documents land in the share and the engagement letter is signed — not when the scoping call is booked.
Mutual NDA before any documents change hands — one-page template available, or send yours. Documents are received via a secure file-share link (Tresorit, Sync, or your platform of choice), stored only for the duration of the engagement, and deleted within 14 days of report delivery unless you specifically ask us to retain them.
Top-Level tier ($750) is calibrated for any QMS — the scope is fixed at the top-level documents regardless of company size. Full Doc Review ($2,000) is calibrated for QMS document sets up to roughly 150 documents (Quality Manual + ~25–35 Procedures + ~50–100 Work Instructions). Above that, we'll quote a custom price on the scoping call — same approach, just sized to the doc set.
Default delivery is a PDF report on QESaaS letterhead. If you need the findings in a specific tracker format (your CAPA system, JIRA, Excel template) the gap report includes a structured CSV addendum mapping each finding to standard clause, severity, document reference, and recommended action. Most CAPA systems will ingest that directly.
This isn't the right service for that. The right service is a Document Build engagement — quote on request. We don't have a productized version of that yet because every from-scratch QMS build is its own animal. Email and we'll talk.
No quality engineering service can guarantee that — the cert auditor's verdict belongs to the cert auditor. What is guaranteed: the gaps visible in the documents will be in the report, with specific evidence references and a recommended action per finding. What you do with the findings is your call.
That's what the 30-minute review call is for. Walk through every Major finding, hear the auditor's reasoning, agree or push back. The report can be amended after the call if you have evidence we didn't see in the document set — we add an addendum noting the new evidence and the revised finding.
Book a free 20-minute scoping call. We'll confirm the standard, the tier, the doc set, and the timeline. If it's a fit, you'll get a one-page engagement brief and a 50% deposit invoice. If it's not, we'll tell you why and recommend the right path.