United States
FDA Quality Management System Regulation (QMSR)
On record: 13 controls
Applies when the software is part of a medical device placed on the United States market. The regulation governs the quality system, not the product quality measure, and it sits beside Part 23 rather than replacing it.
European Union
EU Medical Devices Regulation (MDR 2017/745)
On record: 26 controls
Applies when the software is a medical device or part of one in the European Union. The regulation requires evidence about the device; Part 23 is one way to produce the product quality part of that evidence.
United Kingdom
UK Medical Devices Regulations 2002, as amended
Named only, not in this record
The United Kingdom regime applies to medical device software on the UK market. This record does not hold the instrument, so it is named here without its requirements, and no text is stated.
Not in this record; no link.
Australia
Therapeutic Goods (Medical Devices) Regulations 2002
On record: 75 controls
Applies when the software is a medical device for the Australian market. The essential principles include evidence about the device, and product quality measurement is one input to it.
The standard itself
ISO/IEC DIS 25000-23.2 is a draft International Standard from ISO/IEC JTC 1/SC 7. Nothing in it creates an obligation, and publication will not create one either: a standard becomes an obligation only when a regulator, a contract or a scheme adopts it. A team can use it because a customer asks for measured product quality, because a tender requires evidence, or because it wants a repeatable measure. Those are commercial reasons, and they are enough.
The requirements, in our words and cited
The record is carried as 63 pages, one for each part of the draft a team acts on. Every page states the heading in our own words and cites it to the public contents, so you can check it. The register index is the place to read them in order, and this is the page to start from if you need to show a reviewer that the reading is traceable.
Read the 63 record pages Open the framework page
The frameworks this record reads
Two members of the SQuaRE family are used here. ISO/IEC 25059:2023, the quality model for AI systems, is where the 2023 product quality model table was read, including the subcharacteristics marked as added or modified. ISO/IEC 25012:2008, the data quality model, governs the quality of the data a measure is computed from, which is the population question every page on this site asks. Neither is Part 23, and neither is a substitute for it.
The sector regimes above are named because a software quality team in those sectors has to produce evidence. They are not product quality measurement standards, and this site does not state their requirements. The control counts are the size of the framework on record, read 22 October 2026, not a claim about your obligations. Where a regime is not in this record, the page says so rather than paraphrasing it.
What to do with this page
- Decide whether your product is in a regulated sector. If it is not, Part 23 is a commercial and engineering choice, and the four sector regimes do not apply.
- If it is, name the regime and put it beside the measurement plan, not inside it. The regime sets the evidence obligation; Part 23 supplies the measure.
- Read the framework page for the regime that applies to you, and check the clauses yourself.
- Keep the product quality result separate from the conformity evidence in the report, so a reader can tell which claim is which.
The rules this is built from
Read from the real rules, not invented.
The four market regimes are named from a scan of the frameworks on record; the two SQuaRE frameworks are on record and linked. No regime is presented as a requirement of Part 23.
- Read from the real rules
- 63 record pages behind it
- 116 public headings checked
- Check any line yourself
The measure set is read from the public contents; the model table is read from the public 25010:2023 model. Where the draft text is not public, the page says so instead of filling the gap.