--- title: "ISO 13485 vs 21 CFR 820 (QSR / QMSR) - side-by-side comparison | MedTech Terms" description: "International QMS standard vs the US FDA quality system regulation" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "WebPage", "@id": "https://medtechterms.com/compare/iso-13485-vs-qsr", "name": "ISO 13485 vs 21 CFR 820 (QSR / QMSR) - MedTech Terms", "description": "International QMS standard vs the US FDA quality system regulation", "url": "https://medtechterms.com/compare/iso-13485-vs-qsr", "about": [ { "@type": "DefinedTerm", "name": "ISO 13485", "url": "https://medtechterms.com/terms/iso-13485" }, { "@type": "DefinedTerm", "name": "Quality System Regulation", "url": "https://medtechterms.com/terms/qsr" } ], "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" } }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Compare", "item": "https://medtechterms.com/compare" }, { "@type": "ListItem", "position": 3, "name": "ISO 13485 vs 21 CFR 820 (QSR / QMSR)", "item": "https://medtechterms.com/compare/iso-13485-vs-qsr" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/compare/iso-13485-vs-qsr#faq", "mainEntity": [ { "@type": "Question", "name": "Does QMSR eliminate 21 CFR Part 820?", "acceptedAnswer": { "@type": "Answer", "text": "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." } }, { "@type": "Question", "name": "If I am ISO 13485 certified today, am I automatically QMSR compliant?", "acceptedAnswer": { "@type": "Answer", "text": "You are most of the way there. QMSR keeps FDA-specific requirements around labeling controls, UDI, records identification, and reporting that go beyond ISO 13485. A gap assessment before February 2026 is the standard approach." } }, { "@type": "Question", "name": "Can one QMS satisfy both frameworks?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, and this is the norm. Most global manufacturers build a single QMS to ISO 13485 with country-specific procedures layered on top for FDA, Health Canada, PMDA, ANVISA, and TGA. MDSAP formalizes that model for participating regulators." } }, { "@type": "Question", "name": "What is the difference between ISO 13485 and ISO 9001?", "acceptedAnswer": { "@type": "Answer", "text": "ISO 9001 is a general quality management standard focused on continual improvement and customer satisfaction. ISO 13485 is medical-device-specific and emphasizes regulatory compliance, risk management, design controls, and traceability. An ISO 13485 QMS is not a superset of ISO 9001; the two have diverged." } }, { "@type": "Question", "name": "Is ISO 13485 required by FDA?", "acceptedAnswer": { "@type": "Answer", "text": "Effective February 2, 2026, FDA's QMSR incorporates ISO 13485:2016 by reference for finished device manufacturers. This replaces the previous 21 CFR Part 820, though FDA retains additional US-specific requirements layered on top." } }, { "@type": "Question", "name": "How long does ISO 13485 certification take?", "acceptedAnswer": { "@type": "Answer", "text": "Implementing a compliant QMS typically takes 6 to 12 months for a small manufacturer, followed by a Stage 1 documentation audit and a Stage 2 on-site audit by an accredited registrar. Certificates are valid for 3 years with annual surveillance audits." } }, { "@type": "Question", "name": "What is MDSAP and how does it relate to ISO 13485?", "acceptedAnswer": { "@type": "Answer", "text": "The Medical Device Single Audit Program lets a single audit satisfy the QMS requirements of five regulators (US FDA, Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW/PMDA). MDSAP audits are built on ISO 13485:2016 with country-specific supplements." } }, { "@type": "Question", "name": "What is the primary purpose of the Quality System Regulation?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose is to ensure that medical devices are safe and effective for human use by requiring manufacturers to follow current good manufacturing practices." } }, { "@type": "Question", "name": "How does the Quality System Regulation relate to ISO 13485?", "acceptedAnswer": { "@type": "Answer", "text": "While 21 CFR Part 820 is a US legal requirement, ISO 13485 is an internationally recognized standard for quality management systems in the MedTech industry. The upcoming Quality Management System Regulation (QMSR) aims to harmonize US requirements with ISO 13485:2016." } }, { "@type": "Question", "name": "Who must comply with the Quality System Regulation?", "acceptedAnswer": { "@type": "Answer", "text": "Manufacturers of finished medical devices intended for human use in the United States must comply with the Quality System Regulation." } }, { "@type": "Question", "name": "Which areas does the Quality System Regulation cover?", "acceptedAnswer": { "@type": "Answer", "text": "It covers various aspects of a medical device's lifecycle, including design, manufacturing, packaging, labeling, storage, installation, and servicing." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All comparisons](/compare) Compare # 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](/terms/iso-13485) Quality & Risk [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) 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](/terms/iso-13485) 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](/terms/qsr) ## Frequently asked questions Does QMSR eliminate 21 CFR Part 820? No. [QMSR](/terms/qmsr) replaces the content of Part 820 by incorporating [ISO 13485](/terms/iso-13485):2016 by reference and adding FDA-specific requirements. The regulation still lives at 21 CFR Part 820, it is amended, not deleted. If I am ISO 13485 certified today, am I automatically QMSR compliant? Can one QMS satisfy both frameworks? What is the difference between ISO 13485 and ISO 9001? Is ISO 13485 required by FDA? How long does ISO 13485 certification take? What is MDSAP and how does it relate to ISO 13485? What is the primary purpose of the Quality System Regulation? How does the Quality System Regulation relate to ISO 13485? Who must comply with the Quality System Regulation? Which areas does the Quality System Regulation cover? 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. MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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