# FDA 21 CFR Part 820 to ISO 13485 Clause Crosswalk > Source: https://netray.co/tools/fda-21-cfr-820-to-iso-13485-clause-crosswalk > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer Map each 21 CFR 820 quality system topic to the corresponding ISO 13485 clause to speed up QMSR gap assessments and procedure rewrites. ## Category compliance-legal ## Industry Medical Devices ## Region United States ## Audience - Quality engineer - Regulatory affairs - Quality manager ## Tool **Kind:** worksheet **Mode:** reference **Columns:** #### 21 CFR 820 section (legacy QSR) **Key:** cfr **Type:** text #### Topic **Key:** topic **Type:** text #### Closest ISO 13485 clause **Key:** iso **Type:** text #### Note **Key:** note **Type:** text **Rows:** #### Management responsibility **Cfr:** 820.20 **Iso:** 5 Management responsibility **Note:** Includes quality policy, planning and management review #### Management review **Cfr:** 820.20(c) **Iso:** 5.6 Management review **Note:** ISO 13485 specifies review inputs and outputs in more detail #### Quality audit **Cfr:** 820.22 **Iso:** 8.2.4 Internal audit **Note:** Audit procedure, auditor independence, follow-up #### Personnel, training **Cfr:** 820.25 **Iso:** 6.2 Human resources **Note:** Competence, training and awareness #### Design controls **Cfr:** 820.30 **Iso:** 7.3 Design and development **Note:** Planning, inputs, outputs, review, verification, validation, transfer, changes #### Document controls **Cfr:** 820.40 **Iso:** 4.2.4 Control of documents **Note:** Approval, distribution, change control of documents #### Purchasing controls **Cfr:** 820.50 **Iso:** 7.4 Purchasing **Note:** Supplier evaluation, purchasing information, verification of purchased product #### Identification **Cfr:** 820.60 **Iso:** 7.5.8 Identification **Note:** Product identification through all stages #### Traceability **Cfr:** 820.65 **Iso:** 7.5.9 Traceability **Note:** Required for implants and life-supporting devices in particular #### Production and process controls **Cfr:** 820.70 **Iso:** 7.5.1 Control of production and service provision **Note:** Includes environmental control, personnel health, equipment #### Inspection, measuring and test equipment **Cfr:** 820.72 **Iso:** 7.6 Control of monitoring and measuring equipment **Note:** Calibration and calibration records #### Process validation **Cfr:** 820.75 **Iso:** 7.5.6 Validation of processes for production and service provision **Note:** Validation where results cannot be fully verified by inspection #### Receiving, in-process and finished device acceptance **Cfr:** 820.80 **Iso:** 7.4.3 and 8.2.6 Monitoring and measurement of product **Note:** Acceptance criteria and release records #### Acceptance status **Cfr:** 820.86 **Iso:** 7.5.8 and 8.2.6 **Note:** Status identification through the process #### Nonconforming product **Cfr:** 820.90 **Iso:** 8.3 Control of nonconforming product **Note:** Disposition, rework, concessions #### Corrective and preventive action **Cfr:** 820.100 **Iso:** 8.5.2 Corrective action, 8.5.3 Preventive action **Note:** Investigation, verification of effectiveness #### Device labeling **Cfr:** 820.120 **Iso:** 7.5.1 and 4.2.3 as applicable **Note:** Labeling control requirements are partly regulatory rather than in the standard #### Device packaging **Cfr:** 820.130 **Iso:** 7.5.11 Preservation of product **Note:** Packaging and handling that protect product #### Handling **Cfr:** 820.140 **Iso:** 7.5.11 Preservation of product **Note:** Handling that prevents mix-ups, damage, contamination #### Storage **Cfr:** 820.150 **Iso:** 7.5.11 Preservation of product **Note:** Storage areas and receipt and dispatch authorization #### Distribution **Cfr:** 820.160 **Iso:** 7.5.1 and 7.5.11 **Note:** Distribution records and review of orders #### Installation **Cfr:** 820.170 **Iso:** 7.5.3 Installation activities **Note:** Where installation is a requirement of the device #### General records requirements **Cfr:** 820.180 **Iso:** 4.2.5 Control of records **Note:** Retention periods set by device life and regulation #### Device master record **Cfr:** 820.181 **Iso:** 4.2.3 Medical device file **Note:** ISO 13485 uses the medical device file concept #### Device history record **Cfr:** 820.184 **Iso:** 7.5.1 Production records **Note:** Per batch or unit production record #### Complaint files **Cfr:** 820.198 **Iso:** 8.2.2 Complaint handling **Note:** Includes evaluation for reportability #### Servicing **Cfr:** 820.200 **Iso:** 7.5.4 Servicing activities **Note:** Service records and analysis #### Statistical techniques **Cfr:** 820.250 **Iso:** 8.1 and 8.4 Analysis of data **Note:** Valid statistical methods for sampling and analysis **Notes:** Since the Quality Management System Regulation (QMSR) took effect, 21 CFR Part 820 incorporates ISO 13485 by reference and keeps some FDA-specific requirements. The legacy section numbers in this table are a familiar index for existing procedures, and the mapping is approximate. Read the current text of Part 820 and ISO 13485 before relying on it in an audit response. ## Content **Intro:** Many US device manufacturers wrote their procedures against the old Quality System Regulation and now need to show they meet ISO 13485 as well. This crosswalk lines up the familiar 21 CFR 820 sections with the closest ISO 13485 clause so you can see where each procedure lives. **Sections:** #### How to use it **Body:** Search by topic (for example complaint, traceability or calibration) and read across to the matching clause. Export the list to Excel and add columns for your procedure number, current revision, owner and gap status. Reviewing one row at a time during a gap assessment is faster than reading both documents end to end, and it gives auditors a clear map of where each requirement is addressed. **Bullets:** - Search by topic, section or clause number - Export and add procedure and gap columns - Treat the mapping as an index, not a conformity claim #### Where the two frameworks differ **Body:** ISO 13485 is organized by management, resources, realization and measurement, while the legacy QSR was organized by subpart. The content overlaps heavily, but ISO 13485 adds explicit requirements around risk management throughout the life cycle, software validation, and a stronger link to regulatory requirements. FDA retains specific expectations, for example around medical device reporting and certain labeling and unique device identification requirements. #### Using the crosswalk for a gap assessment **Body:** For each row, locate the procedure that implements the requirement, confirm it cites the right documents and records, and sample recent records to check it is followed. Note any ISO 13485 clause with no procedure, any FDA-specific requirement not covered by the standard, and any procedure that still cites only legacy section numbers. Prioritize gaps by patient risk and audit exposure. #### Common mistakes **Body:** Teams sometimes assume that holding an ISO 13485 certificate means full compliance with FDA-specific requirements, or rename procedures without updating the underlying content. Others forget records such as the device master and history record, which ISO 13485 handles through the medical device file and production records. Keep a controlled version of the crosswalk and update it when regulations or procedures change. **Cta:** If device history records and complaint data sit in your ERP and a separate QMS, Netray can discuss connecting them so audit evidence is easier to pull. **Faq:** #### Is this crosswalk an official FDA document? **Answer:** No. It is an unofficial orientation aid by topic. FDA and ISO publish the authoritative texts, and the mapping here is approximate because some requirements do not align one for one. #### Why use legacy section numbers if the regulation changed? **Answer:** Many procedures, audit findings and training records still use the legacy numbering. A familiar index helps teams find where each topic moved to under the current structure. #### What does ISO 13485 add compared with the QSR? **Answer:** It places more emphasis on risk based approaches across processes, on software validation for quality system tools, on supplier controls and on documenting regulatory requirements. Check the current standard for the details. #### Does the crosswalk cover MDSAP or EU MDR? **Answer:** No. It covers the US regulation and ISO 13485 only. MDSAP and EU MDR add jurisdiction-specific requirements that need separate mapping. ## Search terms 21 cfr 820 iso 13485 crosswalk, qmsr iso 13485 mapping, qsr to qmsr gap analysis, 21 cfr 820 sections list, iso 13485 clause mapping fda, qmsr transition checklist, design controls iso 13485 7.3 820.30, qsr vs iso 13485 table --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json