Compliance overview
How Open Gauge's calibration and traceability features map to the regulatory and certification standards labs are assessed against.
Open Gauge is built to be usable as the system of record behind an accredited or certified quality/metrology programme, not just a database of sensors. This section documents, standard by standard, exactly which clauses Open Gauge's features address today, which are partially addressed, and which remain the responsibility of the operating organization rather than the software.
How to read these pages
Each standard gets its own page with three parts:
- Summary — publisher, edition, scope, and why it's relevant to a self-hosted calibration platform.
- Compliance table — one row per relevant clause, with a status and a pointer to where in Open Gauge that clause is addressed.
- Detail — one section per clause, with a short excerpt of the requirement and an explanation of how Open Gauge addresses it (or the concrete gap, if it doesn't yet).
Status legend
| Status | Meaning |
|---|---|
| ✅ Met | The feature exists today and satisfies the clause as written. |
| ⚠️ Partial | Open Gauge provides part of what the clause requires, but a real gap remains — described in the clause's detail section. |
| ❌ Not met | Open Gauge does not currently address this clause. |
| ➖ N/A | The clause governs something outside what a software system can satisfy on its own (see below). |
Scope: what these pages do and don't cover
Certification and accreditation standards mix two kinds of requirements: things a software system can implement (traceability chains, uncertainty calculation, record immutability, report content, access control), and things that are inherently an organizational/process matter — personnel competence records, impartiality policy, internal audit programmes, facilities and environmental control, complaint handling. Open Gauge's compliance tables only include clauses of the first kind; the organizational clauses are real requirements a certified lab must still satisfy, just not ones a documentation page about software can meaningfully mark "met."
Quoting policy
Where a clause's exact wording matters, these pages quote it — briefly, one clause at a time, for the purpose of explaining how Open Gauge addresses it. Several of the standards referenced here (the ISO and SAE/IAQG documents) are commercially licensed, copyrighted publications; these pages do not reproduce them beyond what's needed to ground each explanation. For the authoritative full text, obtain a licensed copy from the publisher (ISO, SAE International, etc.) — publicly available documents (JCGM/BIPM guides, EA publications, US federal regulations) are the exception.
This is not a certification
These pages describe the software's capabilities as implemented and verified against the current codebase at the date noted on each page. They are engineering documentation, not a legal opinion, an accreditation, or a guarantee that any specific deployment is compliant — actual conformance depends on how an organization configures and operates Open Gauge, and on the rest of its quality system.
Standards covered
| Standard | Status |
|---|---|
| ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories | Published |
| EA-4/02 — Evaluation of the uncertainty of measurement in calibration | Published |
| ISO 9001:2015 — Quality management systems | Published |
| ISO 10012:2003 — Measurement management systems | Published |
| ISO 13485:2016 — Medical devices quality management systems | Published |
| JCGM/GUM suite — Uncertainty of measurement | Published (GUM 100, GUM-6, JCGM 106; the VIM and GUM-1 roadmap are vocabulary, folded into Standards & glossary) |