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: pricing is being finalized and will include 15 seats, with a per-seat rate after that. 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.

Is there an implementation fee?

Yes: a one-time fee, quoted up front before you commit. 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.

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.

How does early access work?

Access is limited right now. We're onboarding a small number of organizations while we refine the platform, and early-access Org accounts are currently capped at 6 users. Request access and, if your organization is a fit for this phase, a consultant will reach out to get you set up.

Is there a free trial or demo?

We're in limited early access. Request access and, if accepted, 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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