Design and Development Maturity Check
Eight elements, four levels each, scored against what your design process actually does on a busy week — not on a good one. Under five minutes.
Which standard applies to you?
No email needed to see your score and your band. An email address unlocks the element-by-element breakdown and the priority order.
Train the people who run the process
A procedure states what the design process must produce. These build the judgment behind it — how the inputs are captured, how a gate is actually decided, and how an auditor will ask about both.
Get the element-by-element breakdown
Your score above is yours to keep. The breakdown below shows how you scored on each of the eight elements, and the order to fix them in. We will also email you the full maturity framework — every element, all four levels, with a blank scoring worksheet you can take to a management review.
Your breakdown
Fix them in this order
We could not find your score
Your answers are kept in your browser only, and they were not available when you came back — usually because the browser cleared them or you returned in a different tab.
The check takes under five minutes. Your framework email is on its way regardless.
Questions people ask about this check
Is a low score a problem?
Not by itself. Most organizations score in bands 1 and 2 the first time, and the elements they miss are consistently the same ones. The score is a starting position, not a verdict.
What is a good score on a design and development maturity check?
Level 3 across the elements — which lands in band 3 — is a well-implemented certified system. Band 4 costs real money and real management attention, and moving there is a business decision rather than a compliance one.
Does this tell me whether I would pass an audit?
No. A procedure does not pass an audit; an organization does. This tells you where your design process sits structurally, which is a different and more useful question than whether a particular auditor would write a finding this year.
Why does it ask about things the standard does not require?
A few questions cover requirements that come from regulation rather than from a clause — design transfer records, the design and development file, cybersecurity for cyber devices. No clause checklist points at those, which is exactly why they go missing.
Can I score this with my team?
Yes, and it works better that way. The framework we email you includes a blank worksheet built for exactly that. Expect disagreement on two or three elements — the disagreement is the useful part.
Do you keep my answers?
Your answers stay in your browser. If you give us an email address we use it to send you the framework and to follow up; you can unsubscribe at any time.
Which ISO standards does the check cover?
Six paths: ISO 9001:2026 Clause 8.3, ISO 13485:2016 Clause 7.3, both standards together, ISO 9001 with ISO 14001:2026, the full ISO 9001 / 14001 / 45001 integrated system, and ISO 7101:2023 Clause 8.7 service design in healthcare. The device paths add three questions covering requirements with no ISO 9001 equivalent. The integrated paths add environmental and OH&S questions inside the inputs and change elements, because in an integrated system those are design inputs rather than a separate subject.
How long does the design and development maturity check take?
Under five minutes. Seventeen questions on the ISO 9001 and ISO 7101 paths, twenty on the device and Q/EMS paths, twenty-two on the full integrated path. No email address is needed to see your score and your band.
If you would rather just talk to someone
MSI has supported more than 80 organizations through ISO certification across 28 years and 200+ audits. A 30-minute call will usually tell you whether your lowest-scoring element is a documentation problem or a process one, which decides what to do about it.
Related checks and next steps
Related maturity checks: Design and Development Gap Assessment · Production, Service and Operational Control · Purchasing and Supplier Control. Or start with the Management System Maturity Guide.
Next steps: browse ISO Procedure Templates & Guides, see how MSI supports ISO 13485 and ISO 9001 consulting, or book a time with an MSI expert.