ISO 13485 8.5.2
Corrective action
ISO 13485 8.5.2 is the clause titled “Corrective action” 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 8.5.2 most often, as written in the letters.
- 1 letterFailure to document an adequate procedure to define requirements for corrective action, as required ISO 13485:2016 Clause 8.5.2
- 1 letterFailure to document corrective action procedures to define the requirements for determining the causes of nonconformities and reviewing the effectiveness of corrective action taken, as required by ISO 13485: 2016:…
- 1 letterFailure to document procedures for corrective actions and take action to eliminate the cause of nonconformities in order to prevent recurrence, as required by ISO 13485:2016, Clause 8.5.2
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 8.5.2.
- ISO 13485 7.1Planning of product realization3 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2 letters cite both
- 21 CFR 803.18What are the requirements for establishing and maintaining MDR files or records that apply to me?2 letters cite both
- 21 CFR 803.20How do I complete and submit an individual adverse event report?2 letters cite both
- 21 CFR 803.3How does FDA define the terms used in this part?2 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?2 letters cite both
- ISO 13485 7.3.9Control of design and development changes2 letters cite both
- ISO 13485 7.4.1Purchasing process2 letters cite both
Latest letters citing it
The 3 letters citing ISO 13485 8.5.2 that FDA posted most recently.
- DevicesView O.N. Diagnostics, LLCVirtuOst and VirtuOst VFA softwareIssuedSep 1, 2026PostedOct 6, 2026
- DevicesView Lion Street Medical, d/b/a Pensar Medical LLCWoundPro Negative Pressure Wound Therapy (NPWT) System, WoundPro+ NPWT System, and MicroDoc (PocketDoc) Portable NPWT SystemIssuedAug 21, 2026PostedSep 22, 2026
- DevicesView Nipro Renal Solutions USA, CorporationDry and liquid hemodialysis dialysate concentrate solutionsIssuedJul 24, 2026PostedAug 18, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.