| Standard | Revision | Scope | Auditable clauses | Status |
|---|---|---|---|---|
| Medical devices5 standards | ||||
| ISO 13485 | 2016 | Quality management system | 292 | Live |
| FDA QMSR | 21 CFR 820 · 2026 | United States regulation | 302 | Live |
| EU MDR | 2017/745 | European Union regulation | 266 | Beta |
| MDSAP | AU P0002.010 | Five-jurisdiction audit | 90tasks | Beta |
| ISO 14971 | 2019 | Risk management | 133 | Beta |
| Pharmaceutical2 standards | ||||
| ICH Q10 | 2008 | Pharmaceutical quality system | 58 | Beta |
| ICH Q7 | 2000 | Active ingredient GMP | 350 | Beta |
| Aerospace1 standard | ||||
| AS9100D | 2016 | Aviation, space and defence | 328 | Live |
| Any industry1 standard | ||||
| ISO 9001 | 2015 | Quality management system | 235 | Live |
We do not republish the standard
You hold your licensed copy; Aligntra reads your documents against it. This site lists which standards we cover and how completely. It does not reproduce their text, which the standards bodies license. What you are buying is the review of your own documents.
What “indexed” means here
Coverage varies between tools, so it is worth stating precisely.
An obligation is its own unit
Where a clause carries lettered sub-requirements, each is indexed separately. A finding names the specific obligation, so it is actionable.
Each standard has one canonical source
Clause identity and numbering come from a single source per standard and are regenerated when a revision lands, so what the review reads and what this page counts never drift.
Structure follows the standard
Section-based, task-based and obligation-based standards are indexed the way they are actually written — MDSAP by task, EU MDR by obligation, ISO by clause.
See a standard applied to a real quality system
We read a complete quality system against ISO 13485 and cite each finding to a page.