Edition 2026-11 · Free sample page · 01-qmsr/crosswalk-qsr-to-iso-13485.md
Crosswalk: former QSR sections to ISO 13485 clauses
29 rows: each former QSR section and title mapped to the ISO 13485:2016 clause number and title it now arrives through, with the retained FDA section where one applies.
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- Type
- Reference page
- Source
- Written for the pack
- Edition
- Edition 2026-11
- Primary source
- www.ecfr.gov
- Tags
- qmsr, crosswalk, iso-13485
- Status
- Stable
- Licence
- Individual licence, Edition 2026-11; see LICENSE.md
Front matter, as shipped
--- type: "reference" title: "Crosswalk: former QSR to ISO 13485" description: "29 rows: each former QSR section and title mapped to the ISO 13485:2016 clause number and title it now arrives through, with the retained FDA section where one applies." source: "authored" date: "2026-11" edition: "2026-11" licence: "Individual licence, Edition 2026-11; see LICENSE.md" resource: "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820" tags: ["qmsr", "crosswalk", "iso-13485"] status: "stable" ---
Free sample of the QMSR Knowledge Pack, Edition 2026-11, published here by Koala Tea with Neel LLC. Reading this page needs no licence; the download and the full pack are licensed per person.
Every row reads former QSR section, title → where the subject now lives. The former sections are no longer current law; the requirement arrives through 21 CFR 820.10(a) and the incorporated standard, plus the retained FDA section where one applies. Clause titles are the standard's table of contents; the clause text is not reproduced. Use the row to translate old procedure numbering, old audit findings and warning letters issued before 2 February 2026.
| Former QSR section | Now (21 CFR Part 820 through ISO 13485:2016) | Notes |
|---|---|---|
| former QSR 820.5, Quality System | → ISO 13485 clause 4.1 (General requirements) and ISO 13485 clause 4.2 (Documentation requirements) | Similar requirements, update terminology |
| former QSR 820.20, Management Responsibility | → ISO 13485 clauses 5.1 to 5.6 (Management responsibility) | ISO 13485 has more detailed management review requirements |
| former QSR 820.22, Quality Audit | → ISO 13485 clause 8.2.4 (Internal audit) | The former QSR 820.180(c) exemption, which kept quality audit, management review and supplier audit reports out of routine FDA review, was removed: the final rule's preamble declines to keep it (89 FR 7496, at 7514, Comment 55 and FDA's response), and Compliance Program 7382.850 lists internal audits and management review among the elements an investigator evaluates. Internal audit, supplier audit and management review records are inspectable. |
| former QSR 820.25, Personnel | → ISO 13485 clause 6.2 (Human resources) | Substantially similar requirements |
| former QSR 820.30, Design Controls | → ISO 13485 clause 7.3 (Design and development) | ISO 13485 adds risk management throughout design process |
| former QSR 820.40, Document Controls | → ISO 13485 clause 4.2.4 (Control of documents) | Similar requirements |
| former QSR 820.50, Purchasing Controls | → ISO 13485 clause 7.4 (Purchasing) | ISO 13485 has more detailed supplier management requirements |
| former QSR 820.60, Identification | → ISO 13485 clause 7.5.8 (Identification) | UDI is linked to this clause by 21 CFR 820.10(b)(1). |
| former QSR 820.65, Traceability | → ISO 13485 clause 7.5.9 (Traceability) | Device tracking under 21 CFR Part 821 is linked to ISO 13485 clause 7.5.9.1 (General) by 21 CFR 820.10(b)(2); implant traceability under ISO 13485 clause 7.5.9.2 (Particular requirements for implantable medical devices) applies to life-supporting and life-sustaining devices by 21 CFR 820.10(d). |
| former QSR 820.70, Production and Process Controls | → ISO 13485 clauses 7.5.1 to 7.5.7 (Production and service provision) | ISO 13485 includes contamination control and cleanliness requirements |
| former QSR 820.72, Inspection, Measuring, and Test Equipment | → ISO 13485 clause 7.6 (Control of monitoring and measuring equipment) | Substantially similar |
| former QSR 820.75, Process Validation | → ISO 13485 clause 7.5.6 (Validation of processes for production and service provision) | Substantially similar |
| former QSR 820.80, Receiving, In-Process, and Finished Device Acceptance | → ISO 13485 clause 7.4.3 (Verification of purchased product) and ISO 13485 clause 8.2.6 (Monitoring and measurement of product) | Similar acceptance activities |
| former QSR 820.86, Acceptance Status | → ISO 13485 clause 7.5.8 (Identification) | Covered under identification requirements |
| former QSR 820.90, Nonconforming Product | → ISO 13485 clause 8.3 (Control of nonconforming product) | Similar requirements |
| former QSR 820.100, Corrective and Preventive Action | → ISO 13485 clause 8.5.2 (Corrective action) and ISO 13485 clause 8.5.3 (Preventive action) | Substantially similar CAPA requirements |
| former QSR 820.120, Device Labeling | → ISO 13485 clause 7.5.1 (Control of production and service provision) + 21 CFR 820.45 (retained FDA section) | FDA keeps specific labeling controls in 21 CFR 820.45. |
| former QSR 820.130, Device Packaging | → ISO 13485 clause 7.5.11 (Preservation of product) + 21 CFR 820.45 (retained FDA section) | FDA keeps specific packaging controls in 21 CFR 820.45. |
| former QSR 820.140, Handling | → ISO 13485 clause 7.5.11 (Preservation of product) | Covered under preservation |
| former QSR 820.150, Storage | → ISO 13485 clause 7.5.11 (Preservation of product) | Covered under preservation |
| former QSR 820.160, Distribution | → ISO 13485 clause 7.5.11 (Preservation of product) | Covered under preservation |
| former QSR 820.170, Installation | → ISO 13485 clause 7.5.3 (Installation activities) | Similar requirements |
| former QSR 820.180, General Requirements (Records) | → ISO 13485 clause 4.2.5 (Control of records) + 21 CFR 820.35 (retained FDA section) | FDA adds specific record contents in 21 CFR 820.35. |
| former QSR 820.181, Device Master Record | → ISO 13485 clause 4.2.3 (Medical device file) | Different term, similar concept: the medical device file. |
| former QSR 820.184, Device History Record | → ISO 13485 clause 7.5.1 (Control of production and service provision), ISO 13485 clause 7.5.8 (Identification) and ISO 13485 clause 7.5.9 (Traceability) + 21 CFR 820.35(c) (retained FDA section) | Manufacturing records equivalent |
| former QSR 820.186, Quality System Record | → ISO 13485 clause 4.2.1 (General) | QMS documentation requirements |
| former QSR 820.198, Complaint Files | → ISO 13485 clause 8.2.2 (Complaint handling) + 21 CFR 820.35(a) (retained FDA section) | Complaint handling arrives through the standard; FDA adds the record contents in 21 CFR 820.35(a) and links reporting to 21 CFR Part 803 through 21 CFR 820.10(b)(3). |
| former QSR 820.200, Servicing | → ISO 13485 clause 7.5.4 (Servicing activities) + 21 CFR 820.35(b) (retained FDA section) | Similar requirements |
| former QSR 820.250, Statistical Techniques | → ISO 13485 clause 8.4 (Analysis of data) | Similar application requirements |
Reading notes
- A range such as "clauses 5.1 to 5.6 (Management responsibility)" means the whole of that clause family.
- "+ 21 CFR 820.x (retained FDA section)" means FDA adds requirements of its own on top of the clause; see fda-supplements.md (full pack).
- Former sections 820.1 and 820.3 are not in the table because they were rewritten rather than removed.
- Four rows to read with care: former QSR 820.130, Device Packaging → ISO 13485 clause 7.5.11 (Preservation of product), the clause whose subject is preservation, not clause 7.5.5, which is the sterile-devices clause; and former QSR 820.184, 820.198 and 820.200 name the retained record contents in 21 CFR 820.35(c), (a) and (b) beside their clauses. The reasoning for each is in log.md (full pack).
QMSR Knowledge Pack, Edition 2026-11. Professional reference material, not legal or regulatory advice. Licensed per person; see LICENSE.md.
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