--- title: "ISO 13485, Definition | MedTech Terms" description: "International standard for medical device quality management systems. 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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." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Standards](/terms?cat=Standards) 6. / 7. ISO 13485 [All terms](/terms) Standards [Quality System](/ecosystems/quality-system) # ISO 13485 International standard for medical device quality management systems. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ## What this means in practice ISO 13485 is referenced or required by regulators worldwide, including the EU (under [MDR](/terms/mdr-reporting)/ [IVDR](/terms/ivdr)) and Health Canada. FDA's [Quality Management System Regulation](/terms/qmsr) (QMSR), effective February 2, 2026, explicitly incorporates ISO 13485:2016 by reference, replacing the previous 21 CFR Part 820 [Quality System Regulation](/terms/qsr). Certification is issued by accredited third-party registrars and is renewed on a three-year cycle with annual surveillance audits. ## Examples - A Class II diagnostic manufacturer maintaining a single ISO 13485 QMS used to satisfy FDA QMSR, EU MDR, and Health Canada requirements. - A contract manufacturer holding ISO 13485 certification to support MDSAP audits across five participating regulators. ## Use cases 1 scenario 1 ### Contract manufacturer onboarding a new medical device customer Quality Manager A CMO holds an ISO 13485 certificate from a [notified body](/terms/notified-body). A new EU [MDR](/terms/mdr-reporting) customer audits the QMS, confirms [design transfer](/terms/design-transfer), supplier control, and [CAPA](/terms/capa) processes meet the standard, and adds the CMO to their approved supplier list. Outcome Onboarding takes 6 weeks instead of 6 months because the QMS is already evidence-based and audited. Common pitfalls - • Treating ISO 13485 certification as proof of regulatory approval. Certification confirms QMS conformity; individual products still require the appropriate marketing authorization (510(k), PMA, CE mark, etc.). - • Copying an ISO 9001 QMS without adding medical-device-specific requirements (design controls, risk management, UDI, post-market surveillance, complaint handling). - • Weak supplier controls. ISO 13485 expects documented supplier evaluation, monitoring, and re-evaluation proportional to component risk. - • Under-scoping the QMS. Software design, cybersecurity, and contract-manufacturer activities all fall within scope when they affect the finished device. ## Frequently asked questions What is the difference between ISO 13485 and ISO 9001? 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](/terms/design-controls), and traceability. An ISO 13485 QMS is not a superset of ISO 9001; the two have diverged. Is ISO 13485 required by FDA? How long does ISO 13485 certification take? What is MDSAP and how does it relate to ISO 13485? ## Cross-references ### Used by Things that build on this term. - [ Quality Management System Regulation(QMSR) ](/terms/qmsr) ### Contains Sub-elements or required artefacts of this term. - [ Corrective and Preventive Action(CAPA) ](/terms/capa) - [ Document Control ](/terms/document-control) - [ Training Records ](/terms/training-records) - [ Supplier Controls ](/terms/supplier-controls) ### Overlaps with Covers some of the same ground; not interchangeable. - [ Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Standards ISO 14971 International standard for the application of risk management to medical devices. ](/terms/iso-14971)[ Quality & Risk Design Controls Structured process governing the design of medical devices. ](/terms/design-controls)[ Quality & Risk Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. ](/terms/qmsr)[ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa) ### QMS Foundations · From this learning path [ Quality & Risk Quality System Regulation(QSR / 21 CFR 820) FDA's current good manufacturing practice (cGMP) requirements for medical devices. ](/terms/qsr?from=qms-foundations)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling?from=qms-foundations)[ Quality & Risk Design History File(DHF) Compilation of records describing the design history of a finished device. ](/terms/design-history-file?from=qms-foundations)[ Quality & Risk FDA Form 483 Notice of inspectional observations issued at the conclusion of an FDA inspection. ](/terms/form-483?from=qms-foundations) ### Standards Stack for Medical Devices · From this learning path [ Standards IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. ](/terms/iec-60601-1?from=standards-stack)[ Standards IEC 60601-1-2 EMC requirements for medical electrical equipment. ](/terms/iec-60601-1-2?from=standards-stack)[ Standards IEC 62304 Lifecycle requirements for medical device software. ](/terms/iec-62304?from=standards-stack)[ Standards IEC 62366-1 Application of usability engineering to medical devices. ](/terms/iec-62366-1?from=standards-stack) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [QMS Foundations](/paths/qms-foundations)Lesson 3 of 10 - [Standards Stack for Medical Devices](/paths/standards-stack)Lesson 1 of 10 Ecosystems (1) - [Quality System](/ecosystems/quality-system) Comparisons (1) - [ISO 13485 vs 21 CFR 820 (QSR / QMSR)](/compare/iso-13485-vs-qsr)vs Quality System Regulation ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 ISO· 1 FDA· 2 1. [1 ISO 13485:2016 Verified ISO · iso.org ](https://www.iso.org/standard/59752.html) 2. [2 FDA Quality Management System Regulation (QMSR) Unchecked FDA · fda.gov ](https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/quality-management-system-regulation-final-rule-amending-quality-system-regulation-part-820) 3. [3 FDA Recognized Consensus Standards Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Implementing this standard on a device program? Blue Goat Cyber helps MedTech teams operationalize cybersecurity standards across the design and post-market lifecycle. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Standards Sources 3 Use cases 1 Updated 5/5/2026 [Compare with another term](/compare?a=iso-13485) Learn in 60 seconds Card Lesson Quiz International standard for medical device quality management systems. - · ISO 13485 is referenced or required by regulators worldwide, including the EU (under MDR/IVDR) and Health Canada. - · FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, explicitly incorporates ISO 13485:2016 by reference, replacing the previous 21 CFR Part 820 Quality System Regulation. - · Certification is issued by accredited third-party registrars and is renewed on a three-year cycle with annual surveillance audits. Remember this Watch out: Treating ISO 13485 certification as proof of regulatory approval. Certification confirms QMS conformity; individual products still require the appropriate marketing authorization (510(k), PMA, CE mark, etc.). Related terms - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [Quality Management System Regulation(QMSR) ](/terms/qmsr) - [ISO 14971 ](/terms/iso-14971) - [Corrective and Preventive Action(CAPA) ](/terms/capa) - [Medical Device Single Audit Program(MDSAP) ](/terms/mdsap) - [Design Controls ](/terms/design-controls) You may also need Auto-suggested from Standards and shared keywords. - [Supplier Controls ](/terms/supplier-controls) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [ISO 22301 ](/terms/iso-22301) - [AAMI SW96 ](/terms/aami-sw96) - [Contract Research Organization(CRO) ](/terms/cro) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) [All Standards terms](/terms?cat=Standards) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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