Frequently Asked Questions
Asked and
Answered.
The answers your quality manager, your IT team, and your GM will all want before anyone signs anything.
How does pricing work?
It's on the website, which is rarer in this industry than it should be. The standard plan is $500/month and includes 15 seats, with additional seats at $15 per seat per month, and a Startup Solution for qualifying new companies is $300/month with 5 seats on a 12-month term; at the end of the term you can offboard seamlessly with your data or move up to the 15-seat plan. The Startup Solution is not open enrollment: availability is limited, so contact us and we will confirm whether your company is eligible. An on-prem deployment is also available with no seat limit for $600/month, and for fully air-gapped sites there is the Air-Gapped Appliance: $15,000 one-time, hardware included. Every subscription includes all 12 modules; there are no feature gates or per-module add-ons. Volume discounts are available for organizations with 50+ seats.
Can we run it on-premise?
Yes. The on-prem option runs My ISO QMS inside your own network, on server infrastructure you already have, for $600/month with no seat limit. If you don't have a spare server (or don't want to touch the ones you do have), for a small additional one-time fee (subject to hardware pricing and availability at the time of order) we provision a compact, pre-configured appliance, bring or ship it to your site, and plug it into your network. Need a fully air-gapped deployment? See the Air-Gapped Appliance below. On-prem has no seat cap; the Startup Solution is cloud-only.
What is the Air-Gapped Appliance?
A business-class mini server with My ISO QMS pre-installed, for sites where the quality system must never touch the internet. It is $15,000 one-time with the hardware included, and carries a perpetual license with no seat limit that never expires, tied to the box it ships on. We build, license and lock it down before it ships; you plug it into your network and a guided setup configures it for your site. After that it needs no internet connection at all: no activation, no check-ins. The disk is encrypted and sealed to the hardware, with a recovery key only you hold, there is no remote access, and backups run automatically to media you control. A remote setup walkthrough is included; an on-site installation is available for an additional fee agreed at order based on location. Updates are optional and applied offline; contact us about update options. The hardware carries a two-year warranty for normal wear and failure, and every repair or replacement is handled by us, so your license and data move to the new box. Data migration and training packages are billed separately.
Is there an implementation fee?
Yes, and it's published: $3,000 for data migration (three days of consultant-led migration plus light guidance, with in-app user guides in place of formal training), or $6,000 for full setup (the same migration plus three days of hands-on training and continued support after go-live). It stays small because data import tooling is built into the product and setup is done by ISO consultants who already know how a QMS fits together, so you're not funding a months-long services project. It's a fraction of the onboarding packages typical of legacy eQMS. Both packages cover a defined scope; additional assistance outside that scope is billed reasonably on an hourly basis starting at $150 per hour, agreed with you before the work begins.
How long does it take to go live?
Days, typically, not weeks or months. The main variable is how much history you want to bring in. Existing My ISO consulting clients are fastest of all, since we already know how your quality system is structured.
Can we import our existing documents and records?
Yes. Import tooling brings in your document register, NCR logs, training records, calibration schedules, and supplier lists from the spreadsheets they live in today, and your controlled documents come along with their revision histories intact.
What happens to our data if we cancel?
You take it with you. Billing is monthly with no annual contract, and your records and documents export from the system at any time. We think retention should come from the product being good, not from making leaving painful.
Will our auditor accept electronic records?
Yes. ISO 9001 (and other quality standards) requires control of documented information, not paper. Electronic quality records are standard practice, and the system gives your auditor what they actually ask for: revision histories, approval records, and traceability from NCR to corrective action to closure, without anyone digging through a shared drive.
Which standards does it support?
The system is built around ISO 9001, and the same process structure carries the wider management-system family: AS9100 aerospace suppliers, IATF 16949-aligned automotive suppliers, medical device manufacturers working to ISO 13485 and 21 CFR Part 820, environmental and health & safety systems under ISO 14001 and ISO 45001, and food & beverage companies working under SQF or FSSC.
Do you provide software validation for ISO 13485 or 21 CFR Part 820?
Yes. ISO 13485 (clause 4.1.6) and 21 CFR Part 820 expect you to validate software used in your quality system, and “the vendor seemed reputable” is not a validation record. We provide assisted software validation packages: automated test suites run against the system, with visual evidence of each test passing, assembled per release and available for your current version on request. That covers the operational qualification (OQ) side, proving the system functions as specified; we help with the part that stays yours, confirming it fits your intended use.
We have processes that don’t fit standard modules. Can you handle them?
That's one of the reasons the product exists. Alongside the 12 standard modules, we build custom pages for bespoke workflows, the processes that make your business yours, without the professional-services price tag that usually comes with the word “customization.”
Is our data secure?
The platform is multi-tenant with strict tenant isolation, role-based permissions control who can see and change what, and data is encrypted in transit and at rest. If your IT team has a security questionnaire, send it over; we’d rather answer it up front.
Do you offer consulting as well as software?
Yes, My ISO is consultants first. The software exists because we spent years building and auditing quality systems for clients and got tired of watching good QMS drown in spreadsheets. Gap analysis, internal audits, and audit prep are available alongside the product.
Is there a free trial or demo?
Get started and we'll walk you through the system live, on your processes rather than canned demo data, and you'll already know the price before the call starts.
Something we didn't cover? Ask us directly. A consultant answers, not a chatbot.
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