From Old 21 CFR 820 Numbers to ISO 13485: A Practical Crosswalk
Re-cite your procedures to ISO 13485, then add the few places where Part 820 still asks for more.
In Short
- Old 820 numbers are history.
- Cite ISO 13485 first.
- Keep the US extras visible.
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- Map every issue from raised to human closure.
- Set CAPA effectiveness criteria before you act.
- Separate regulation, configured workflow and lab features.
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Since 2 February 2026, 21 CFR 820.10 requires a quality management system that complies with ISO 13485:2016 plus the remaining Part 820 requirements. Many procedures still cite retired sections such as 820.30 or 820.198. This crosswalk helps document owners re-cite them and spot where Part 820 still adds to the standard. It is orientation, not legal advice. Sources checked 4 Oct 2026.
What changed and what did not
The Quality Management System Regulation replaced most of the old Part 820 text with a reference to ISO 13485:2016. What remains in Part 820 is short: scope, definitions, incorporation by reference, the core requirement in 820.10, record content in 820.35 and labeling and packaging controls in 820.45.
More on what changed and what did not
Parts 803, 806, 821 and 830 still apply on their own terms. The work for most manufacturers is not a new quality system; it is re-citing, re-wording and checking that nothing US-specific fell out during the edit.
Using the Legacy Crosswalk
Use the table below to find where an old citation now lives in ISO 13485. The mapping is approximate, because the standard groups topics differently: design controls move to clause 7.3, purchasing to 7.4, production and process controls mostly to 7.5, and CAPA to 8.5.2 and 8.5.3.
Legacy QSR Section to ISO 13485 Clause
| Old 21 CFR 820 | ISO 13485:2016 |
|---|---|
| 820.20 Management responsibility | Clause 5 |
| 820.22 Quality audit | 8.2.4 |
| 820.25 Personnel | 6.2 |
| 820.30 Design controls | 7.3 |
| 820.40 Document controls | 4.2.4 |
| 820.50 Purchasing controls | 7.4 |
| 820.70 Production and process controls | 7.5.1, 7.5.6 |
| 820.72 Inspection and test equipment | 7.6 |
| 820.90 Nonconforming product | 8.3 |
| 820.100 CAPA | 8.5.2, 8.5.3 |
| 820.198 Complaint files | 8.2.2 plus current 820.35 |
- 820.20 Management responsibility
- ISO 13485:2016
- Clause 5
- 820.22 Quality audit
- ISO 13485:2016
- 8.2.4
- 820.25 Personnel
- ISO 13485:2016
- 6.2
- 820.30 Design controls
- ISO 13485:2016
- 7.3
- 820.40 Document controls
- ISO 13485:2016
- 4.2.4
- 820.50 Purchasing controls
- ISO 13485:2016
- 7.4
- 820.70 Production and process controls
- ISO 13485:2016
- 7.5.1, 7.5.6
- 820.72 Inspection and test equipment
- ISO 13485:2016
- 7.6
- 820.90 Nonconforming product
- ISO 13485:2016
- 8.3
- 820.100 CAPA
- ISO 13485:2016
- 8.5.2, 8.5.3
- 820.198 Complaint files
- ISO 13485:2016
- 8.2.2 plus current 820.35
More on using the Legacy Crosswalk
Where one old section maps to several clauses, read each clause rather than assuming the wording carried over.
Vocabulary that no longer appears
The QMSR does not use the old terms design history file, device master record or device history record as regulatory requirements. ISO 13485 uses the medical device file (4.2.3), the design and development file (7.3.10) and production records (7.5.1).
More on vocabulary that no longer appears
You can keep familiar internal names, but each procedure should say which ISO record it satisfies so an investigator can follow it.
The US extras to keep visible
Section 820.10(b) ties four ISO clauses to US rules: identification to UDI under Part 830, traceability to Part 821 tracking where applicable, reporting to Part 803 medical device reports, and advisory notices to Part 806. Section 820.10(c) keeps design controls for class II, class III and listed class I devices.
Where current Part 820 still adds to ISO 13485
| Current section | What it adds |
|---|---|
| 820.10(b) | Links to UDI (830), tracking (821), MDR (803), corrections and removals (806) |
| 820.10(c) | Design controls for class II, III and listed class I devices |
| 820.35 | Extra content for complaint, servicing and UDI records |
| 820.45 | Label and packaging examination, documented release, mix-up prevention |
- 820.10(b)
- What it adds
- Links to UDI (830), tracking (821), MDR (803), corrections and removals (806)
- 820.10(c)
- What it adds
- Design controls for class II, III and listed class I devices
- 820.35
- What it adds
- Extra content for complaint, servicing and UDI records
- 820.45
- What it adds
- Label and packaging examination, documented release, mix-up prevention
More on the US extras to keep visible
Section 820.35 adds complaint, servicing and UDI record content, and 820.45 adds label and packaging examination, documented label release and mix-up prevention.
Running the Re-Citation Project
List every controlled procedure and form, record its old citations, assign the new primary ISO clause and note any current Part 820 section it must also meet. Change each document through normal document control, train affected people before the new revision is used, and keep the old revision retrievable.
Worked Example: Re-Citing One SOP
More on running the Re-Citation Project
Internal audit should then sample records, not just procedures, against the new citations. Your quality team decides the final mapping and approves each revision.
Questions
Do the old section numbers still exist?
No. Sections such as 820.30, 820.100 and 820.198 were removed when the QMSR took effect on 2 February 2026. Keep them only as historical references in old records.
Is ISO 13485 certification enough for FDA?
No. FDA inspects against Part 820 and does not accept a certificate in place of inspection. The US-specific requirements in 820.10, 820.35 and 820.45 still apply.
Must we rename our DHF and DMR?
Not necessarily, but each internal name should be tied to the ISO 13485 record it satisfies, such as the medical device file or the design and development file.
Where does V5 fit?
V5 keeps controlled documents with revision history, training records, equipment, device production records, complaints and CAPA linked. It does not decide citations or approve procedures; your quality team does.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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