--- title: "NCR, Nonconformance (NCR) | MedTech Terms" description: "Failure of a product, process, or system to meet specified requirements. Plain-English Quality & Risk definition for MedTech teams, with examples and related te" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/nonconformance#term", "name": "Nonconformance (NCR)", "alternateName": "NCR", "description": "A nonconformance is documented evidence that a product, process, or system did not conform to specified requirements. Investigation may lead to disposition (use as is, rework, scrap) and/or a CAPA.", "url": "https://medtechterms.com/terms/nonconformance", "termCode": "nonconformance", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/nonconformance#article", "headline": "NCR, Nonconformance (NCR)", "description": "Failure of a product, process, or system to meet specified requirements.", "url": "https://medtechterms.com/terms/nonconformance", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/nonconformance" }, "about": { "@id": "https://medtechterms.com/terms/nonconformance#term" }, "articleSection": "Quality & Risk", "inLanguage": "en", "keywords": "Nonconformance (NCR), NCR, Quality & Risk, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "21 CFR 820.90", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", "publisher": { "@type": "Organization", "name": "eCFR" } }, { "@type": "CreativeWork", "name": "FDA - Quality Systems", "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "ISO 13485 Standard Page", "url": "https://www.iso.org/iso-13485-medical-devices.html", "publisher": { "@type": "Organization", "name": "ISO" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/capa#term", "name": "Corrective and Preventive Action", "alternateName": "CAPA", "url": "https://medtechterms.com/terms/capa" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Quality & Risk", "item": "https://medtechterms.com/terms?cat=Quality%20%26%20Risk" }, { "@type": "ListItem", "position": 4, "name": "Nonconformance (NCR)", "item": "https://medtechterms.com/terms/nonconformance" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/nonconformance#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of documenting a nonconformance?", "acceptedAnswer": { "@type": "Answer", "text": "Documenting a nonconformance ensures that deviations from specified requirements are formally recorded, investigated, and addressed, providing a clear audit trail for quality assurance and regulatory compliance." } }, { "@type": "Question", "name": "How does risk management relate to nonconformances?", "acceptedAnswer": { "@type": "Answer", "text": "Risk management principles, particularly those outlined in ISO 14971:2019, are essential for evaluating the impact of a nonconformance on product safety and performance, guiding the decision-making for disposition and corrective actions." } }, { "@type": "Question", "name": "When does a nonconformance typically trigger a CAPA?", "acceptedAnswer": { "@type": "Answer", "text": "A nonconformance typically triggers a Corrective and Preventive Action (CAPA) when it indicates a systemic issue, a significant risk to product quality or patient safety, or a recurring problem that requires a more extensive investigation and resolution process, as per 21 CFR 820.100 and ISO 13485:2016 clause 8.5." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Nonconformance (NCR) [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system)NCR # Nonconformance (NCR) Failure of a product, process, or system to meet specified requirements. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A nonconformance is documented evidence that a product, process, or system did not conform to specified requirements. Investigation may lead to disposition (use as is, rework, scrap) and/or a [CAPA](/terms/capa). What the regulation says Regulators view nonconformances as critical indicators of quality system effectiveness and product safety. For example, FDA 21 CFR Part 820.90 requires manufacturers to establish procedures for controlling nonconforming product, including identification, documentation, evaluation, segregation, and disposition. Similarly, EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) Annex I, [General Safety and Performance Requirements](/terms/gspr), implicitly demands robust handling of nonconformities to ensure devices meet safety and performance objectives throughout their lifecycle. [ISO 13485](/terms/iso-13485):2016, clause 8.3, specifically details requirements for the control of nonconforming product, emphasizing documentation and appropriate action commensurate with the nonconformity. ## What this means in practice Trend analysis of NCRs is a key feedback loop into design and process improvements. ## Examples - During final inspection, a batch of sterilization pouches is found to have seals outside the specified width, leading to the generation of a nonconformance report. - A software validation test fails to produce the expected output for a critical function, initiating a nonconformance process to investigate the code defect. - Customer feedback indicates that a specific MedTech device is intermittently freezing, prompting a nonconformance investigation into potential underlying hardware or software issues. Common pitfalls - • Confusing a nonconformance with a deviation; a nonconformance indicates failure to meet a requirement, while a deviation is a departure from an approved procedure without necessarily failing a requirement. - • Failing to adequately investigate the root cause of nonconformances, which can lead to recurrence and persistent quality issues. - • Treating all nonconformances with the same level of urgency rather than prioritizing based on risk to patient safety or product quality. - • Not integrating nonconformance data into broader quality system processes like management review, risk management, and CAPA. - • Failing to ensure that disposition actions for nonconforming product are properly implemented and verified. ## Frequently asked questions What is the primary purpose of documenting a nonconformance? Documenting a nonconformance ensures that deviations from specified requirements are formally recorded, investigated, and addressed, providing a clear audit trail for quality assurance and regulatory compliance. How does risk management relate to nonconformances? When does a nonconformance typically trigger a CAPA? ## Cross-references ### Precedes Comes before in a typical workflow or lifecycle. - [ Corrective and Preventive Action(CAPA) ](/terms/capa) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa) ### Manufacturing & Supply Chain · From this learning path [ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility?from=manufacturing-and-supply-chain)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control?from=manufacturing-and-supply-chain)[ Manufacturing Design Transfer Translating design into production specifications. Adjacent lesson ](/terms/design-transfer?from=manufacturing-and-supply-chain)[ Quality & Risk IQ / OQ / PQ Installation, Operational, and Performance Qualification - the three stages of equipment and process qualification. ](/terms/iq-oq-pq?from=manufacturing-and-supply-chain) ### More in Quality & Risk · Same category [ Quality & Risk Shelf Life Period during which a device remains suitable for its intended use under specified conditions. ](/terms/shelf-life)[ Quality & Risk CAPA Effectiveness Check Verification step confirming a corrective or preventive action actually fixed the problem. ](/terms/capa-effectiveness)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Manufacturing & Supply Chain](/paths/manufacturing-and-supply-chain)Lesson 13 of 14 Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Mentioned in recent activity 3 entries Recalls (3) [Flamingo Funnel Medium, Model Number SQ20012-02 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1925-2026) Class II · 2026-03-16 [Flamingo Funnel Large, Model Number SQ20012-03 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1926-2026) Class II · 2026-03-16 [Flamingo Funnel Small, Model Number SQ20012-01 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1924-2026) Class II · 2026-03-16 ## Latest in MedTech [View all](/latest?term=nonconformance) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - Recall 2026-03-16 [Flamingo Funnel Medium, Model Number SQ20012-02 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1925-2026) Class II · SurgiSmoke Solutions - Recall 2026-03-16 [Flamingo Funnel Large, Model Number SQ20012-03 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1926-2026) Class II · SurgiSmoke Solutions - Recall 2026-03-16 [Flamingo Funnel Small, Model Number SQ20012-01 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1924-2026) Class II · SurgiSmoke Solutions ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 FDA· 1 ISO· 1 1. [1 21 CFR 820.90 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) 2. [2 FDA - Quality Systems Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) 3. [3 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [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 Quality & Risk Acronym NCR Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=nonconformance) Learn in 60 seconds Card Lesson Quiz Failure of a product, process, or system to meet specified requirements. - · Trend analysis of NCRs is a key feedback loop into design and process improvements. - · Investigation may lead to disposition (use as is, rework, scrap) and/or a CAPA. Remember this Watch out: Confusing a nonconformance with a deviation; a nonconformance indicates failure to meet a requirement, while a deviation is a departure from an approved procedure without necessarily failing a requirement. Related terms - [Corrective and Preventive Action(CAPA) ](/terms/capa) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Production and Process Controls ](/terms/production-process-controls) - [Verification & Validation(V&V) ](/terms/verification-validation) - [Supplier Controls ](/terms/supplier-controls) - [Complaint Handling ](/terms/complaint-handling) - [Failure Mode and Effects Analysis(FMEA) ](/terms/fmea) - [Management Review ](/terms/management-review) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)