ISO 13485 7.4.1
Purchasing process
ISO 13485 7.4.1 is the clause titled “Purchasing process” in ISO 13485, the medical device quality management standard. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 4 against 0 on the same dates in 2025
- Most often cited with
- ISO 13485 7.1, in 3 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 42026
What FDA writes when it cites it
The finding headings that cite ISO 13485 7.4.1 most often, as written in the letters.
- 1 letterFailure to adequately document procedures to ensure that purchased product conforms to specified purchasing information and plan the monitoring and re-evaluation of suppliers, as required by 21 CFR 820, ISO 13485: 2016…
- 1 letterFailure to adequately establish criteria for the evaluation and selection of suppliers, as required by ISO 13485:2016 Clause 7.4.1
- 1 letterFailure to establish criteria for the evaluation and selection of suppliers, as required by ISO 13485:2016 Clause 7.4.1
The standard
This is a clause reference cited in an FDA letter. Full ISO 13485:2016 text is not reproduced here. Read the standard for the complete requirements.
Cited alongside it
Regulations that appear in the same letters as ISO 13485 7.4.1.
- ISO 13485 7.1Planning of product realization3 letters cite both
- ISO 13485 7.3.1General2 letters cite both
- ISO 13485 7.3.9Control of design and development changes2 letters cite both
- ISO 13485 7.6Control of monitoring and measuring equipment2 letters cite both
- ISO 13485 8.5.2Corrective action2 letters cite both
- 21 CFR 1010.2Certification1 letter cites both
- 21 CFR 1040.20Sunlamp products and ultraviolet lamps intended for use in sunlamp products1 letter cites both
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
Latest letters citing it
The 3 letters citing ISO 13485 7.4.1 that FDA posted most recently.
- DevicesView Unilam Co., LTDSUV 600-800/KT/GYU UV SunlampIssuedSep 22, 2026PostedOct 6, 2026
- DevicesView O.N. Diagnostics, LLCVirtuOst and VirtuOst VFA softwareIssuedSep 1, 2026PostedOct 6, 2026
- DevicesView Nipro Renal Solutions USA, CorporationDry and liquid hemodialysis dialysate concentrate solutionsIssuedJul 24, 2026PostedAug 18, 2026
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.