Architecture Decision Record (ADR) template
Artifact · Architecture Documentation
An architecture decision record captures what was decided, why, and which alternatives were rejected, and in a regulated build it maps to 2 clauses: the ISO 13485 design-outputs clause that carries former 21 CFR 820.30(d) under the QMSR, and ISO 14971 Clause 7.1, whose Risk Control Options Analysis the ADR's Risk Drivers field documents.
What is an architecture decision record in a regulated build?
An architecture decision record captures what was decided, why, and which alternatives were rejected. In a regulated build it maps to the ISO 13485 design-outputs clause and to ISO 14971 Clause 7.1 risk control options analysis.
In a regulated build, an ADR isn't just engineering hygiene.
What an ADR needs to carry in a regulated build
Beyond the usual context / decision / consequences shape, a regulated-build ADR needs two things a generic template doesn't: a named regulatory mapping, and an explicit Risk Drivers field.
Regulatory mapping
- ISO 13485:2016 §7.3.4 — Design Outputs (former 21 CFR §820.30(d), replaced under the QMSR from February 2, 2026). An ADR, alongside a System Design Document, is one of the artifacts that can satisfy this requirement — it is a documented output of the design process.
- ISO 14971 Clause 7.1 — Risk Control Options Analysis. Under ISO 14971 Clause 7.1, an ADR records the Risk Drivers behind a MedTech design decision: which risks the chosen option controls, and which risks the rejected alternatives would have left unaddressed.
Where the ADR sits among the other architecture templates
The architecture template group in the source corpus lists four templates:
- Architecture Decision Records (ADRs) — context & trade-off records (this page).
- System Design Document (SDD) — component & failure flow.
- API Specification — REST / OpenAPI schemas.
- Data Model Spec — tables, foreign keys, and ePHI (electronic protected health information) rules.
A worked example
This repository's own
docs/decisions/adr-001-core-tech-stack.md is a live example of
the pattern: a scored-candidate Context section, a concrete Decision, and a
Consequences section separating positive and negative trade-offs — the same
shape this template describes, applied to this project's own stack choice.
Starter template guidance only. The regulatory mappings above describe how an ADR can contribute evidence to ISO 13485:2016 §7.3.4 (former 21 CFR §820.30(d)) and ISO 14971 §7.1 — they are not a statement that any specific ADR satisfies those clauses without your own quality system's review.
Provenance & review state
- Last reviewed
- Sources
-
- ISO 14971:2019 — International Organization for Standardization
- ISO 13485:2016 §7.3.4 Design and development outputs — International Organization for Standardization
- Former FDA 21 CFR §820.30 (in force until February 2, 2026) — U.S. Food and Drug Administration
- Ingested from