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    ISO 13485 vs 21 CFR 820 (QSR / QMSR)

    International QMS standard vs the US FDA quality system regulation

    ISO 13485 and 21 CFR Part 820 both define quality management system (QMS) requirements for medical device manufacturers, but they come from different authorities and satisfy different market obligations. FDA's Quality System Regulation (QSR) is being harmonized with ISO 13485 under the new Quality Management System Regulation (QMSR), effective February 2, 2026. Understanding where they still diverge matters for design controls, complaint handling, and inspection readiness.

    Attribute
    Standards
    ISO 13485
    Issuing authority
    ISO (International Organization for Standardization), TC 210
    US FDA under section 520 of the FD&C Act
    Legal status
    Voluntary international standard, mandatory in EU, Canada, UK, Japan, and most other markets
    US federal regulation, mandatory to market a finished device in the United States
    Current version
    ISO 13485:2016
    21 CFR Part 820 (QSR); becomes QMSR on Feb 2, 2026, incorporating ISO 13485:2016 by reference
    Structure
    Process-based, aligned with ISO 9001 high-level clauses
    Subpart-based (A through O), organized by function (design, production, CAPA, records)
    Risk management
    Requires a risk-based approach throughout the QMS; references ISO 14971
    Historically less explicit; QMSR aligns to ISO 14971 through ISO 13485 incorporation
    Design controls
    Clause 7.3, Design and development
    21 CFR 820.30, Design controls (largely parallel scope)
    CAPA
    Clause 8.5.2 (Corrective) and 8.5.3 (Preventive)
    21 CFR 820.100, Corrective and preventive action
    Management review
    Clause 5.6: defined inputs and outputs at planned intervals
    21 CFR 820.20(c): similar intent; FDA historically did not require review records be produced in inspection
    Complaint handling
    Clause 8.2.2: documented procedure required
    21 CFR 820.198: specific record-keeping and a formally-designated complaint unit
    Recordkeeping terminology
    Medical Device File (MDF) per clause 4.2.3
    Device Master Record (DMR), Device History Record (DHR), Design History File (DHF), being consolidated under QMSR
    How compliance is demonstrated
    Certification by an accredited Notified Body or Registrar; MDSAP for participating regulators
    FDA inspection (QSIT / CDRH BIMO); QMSR aligns FDA inspections with the ISO 13485 audit approach
    MDSAP relationship
    MDSAP audits are conducted against ISO 13485 plus country-specific requirements
    FDA accepts MDSAP audit reports in lieu of routine inspections for most Class II and III manufacturers
    Common misuse
    Treating ISO 13485 certification as evidence of product safety, it certifies the QMS, not the device
    Assuming QMSR removes the need for FDA inspection, inspections continue under the new framework

    When to use which

    Choose ISO 13485

    Use ISO 13485 as the baseline QMS if you market outside the US, participate in MDSAP, or want a single QMS that satisfies most global regulators. Certification is granted by a Notified Body or Registrar.

    Full ISO 13485 page
    Choose QSR / 21 CFR 820

    Follow 21 CFR Part 820 (transitioning to QMSR on Feb 2, 2026) if you market a finished device in the US. After QMSR takes effect, an ISO 13485-based QMS will satisfy the core requirements, with FDA-specific additions for labeling, UDI, and reporting.

    Full QSR / 21 CFR 820 page

    Frequently asked questions

    No. QMSR replaces the content of Part 820 by incorporating ISO 13485:2016 by reference and adding FDA-specific requirements. The regulation still lives at 21 CFR Part 820, it is amended, not deleted.
    Comparison built from the sourced definitions and FAQs on the linked term pages. MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.