[ 04 · BUILDING THE EVIDENCE ]
A quality system proportionate to where you actually are
“Everyone says I need a QMS. Do I need one now, and how much of one?”
The failure mode here runs in both directions and the expensive one is not the one founders fear. A twelve-person company that installs an enterprise quality system spends a year administering it; a company that installs nothing arrives at its first audit with no design history and no way to build one retrospectively.
WHAT THIS IS NOT
Orientation for translating research toward a regulated product — not a determination of device status, regulatory pathway, submission type or clinical adequacy, and not a substitute for qualified regulatory advice. SPEQ is independent: linked institutions, incubators and agencies are third parties, and nothing here implies affiliation, endorsement or partnership with any of them.
ARE YOU HERE?
- Someone — an investor, a partner, a contract manufacturer — has asked whether you have a quality system
- You have procedures in the sense that people know how things are done, and not in the sense that anyone could read them
- A consultant has quoted for a full QMS implementation and you cannot tell whether it is proportionate
WHAT TO DECIDE NOW
- Which processes genuinely need control NOW — usually design control, document and record control, and supplier oversight, because those three produce records you cannot recreate later
- What is deliberately deferred, written down as deferred rather than simply absent, so the decision is visible and revisitable
- Who owns quality, even if it is you part-time. An unowned quality system does not degrade gracefully; it stops.
START KEEPING THESE RECORDS NOW
- Design history from the beginning — the inputs, the decisions and why alternatives were rejected. This is the record most often missing and least possible to rebuild.
- Supplier and contract-organisation selection rationale, because oversight of an outsourced activity is a responsibility that never transfers with the work
- Training and competence for anyone performing work that will support a submission, including yourself
PUT IT TO WORK
SPEQ templates and tools for the work above. They structure it; they do not decide it for you.
- TEMPLATE · PLANRegulated Operating Model Establishment Plan →Sequence what to stand up now and record what you are deliberately deferring.
- TEMPLATE · SOPSOP Development Template →One procedure format for the few controls you do need now: design, documents and records, suppliers.
- TOOL · ~10 MINQuality Systems Maturity Assessment →A free Quick Scan baseline of where your quality system stands, to revisit as it grows.
THE PROBLEM THIS ANSWERS
A quality system is treated as a single all-or-nothing artefact bought at a milestone, rather than as a set of controls that each become worth their cost at a different point.
What it costs: Either it arrives too late to have produced any record, or it arrives so heavy that it is not used — and an unused system produces the same evidence as no system.
WHERE THIS GOES WRONG
- Buying an eQMS before knowing what processes it will hold. The tool then defines the process, and the process is somebody else’s.
- Starting the quality system at manufacturing. Design control produces the records earliest and is the part that cannot be added afterwards.
- Treating ISO 13485 certification as the goal rather than as evidence. Certification of a system nobody follows is a finding waiting to be made.
WHAT THIS DOES NOT ANSWER
- Which standard your system will eventually be certified or inspected against, which follows from the product and the market rather than from preference
- Whether a phased implementation satisfies a specific partner’s diligence, which is a question for that partner
OFFICIAL SOURCES · INDEPENDENT THIRD PARTIES
21 CFR Part 820 as it stands from 2 February 2026, incorporating ISO 13485:2016 by reference.
FDA — Current Good Manufacturing Practice (CGMP) Regulations ↗The drug-side counterpart: the CGMP parts a drug or biologic quality system answers to, so a founder can see what is phase-appropriate now and what arrives with commercial manufacture.
GO DEEPER ON SPEQ
NEXT IN THE STARTUP JOURNEY · 5 OF 10
- GUIDE 5Preparing questions and evidence for a regulator meeting →I can request a meeting with the agency. What do I ask, and what will they expect me to already know?
- PREVIOUS · GUIDE 3The evidence map before your next experiment →
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