--- title: "ISO 22301, Definition | MedTech Terms" description: "Standard for business continuity management systems. Plain-English Standards definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-22301#term", "name": "ISO 22301", "description": "ISO 22301 specifies requirements to plan, establish, implement, operate, monitor, review, maintain, and continually improve a business continuity management system. 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This minimizes patient impact, maintains market trust, and can help avoid regulatory scrutiny related to shortages." } } ] } ] } --- [ 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 22301 [All terms](/terms) Standards [Quality System](/ecosystems/quality-system) # ISO 22301 Standard for business continuity management systems. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO 22301 specifies requirements to plan, establish, implement, operate, monitor, review, maintain, and continually improve a business continuity management system. Increasingly relevant for MedTech given EO supply, semiconductor, and contract-manufacturer disruptions. What the regulation says The FDA encourages manufacturers to implement robust quality management systems that include elements of business continuity, as outlined in 21 CFR Part 820, [Quality System Regulation](/terms/qsr). While ISO 22301 is not directly mandated, its principles align with the FDA's expectations for ensuring product availability and addressing potential supply chain disruptions. The EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) also implicitly supports business continuity through requirements for risk management and supply chain oversight, particularly in Annex I, [General Safety and Performance Requirements](/terms/gspr), which emphasizes uninterrupted availability of devices. ## What this means in practice Hospital procurement teams and FDA shortage staff are both paying more attention to BCMS evidence from critical-device manufacturers. ## Examples - A MedTech manufacturer uses ISO 22301 to develop a plan for continuing production of life-sustaining devices during a regional power outage, including redundant power sources and alternative manufacturing sites. - Following an ISO 22301 framework, a company establishes agreements with multiple suppliers for critical components to prevent shortages caused by a single supplier's disruption. - A MedTech company simulates a cybersecurity attack as part of its ISO 22301 testing, identifying weaknesses in its data recovery and operational resumption procedures. Common pitfalls - • A common pitfall is treating ISO 22301 compliance as a checkbox exercise rather than integrating it deeply into the overall quality management system. - • Another mistake is failing to regularly test and update the business continuity plan, rendering it ineffective during an actual disruption. - • Organizations often overlook the importance of communication strategies during a crisis, leading to confusion and delayed responses. - • Some companies incorrectly assume that simply having an off-site backup for data constitutes a comprehensive business continuity plan. ## Frequently asked questions How does ISO 22301 relate to risk management in MedTech? ISO 22301 is a critical component of an organization's overall risk management strategy, specifically addressing the risks associated with disruptions to operations. It helps MedTech companies identify potential threats and implement controls to mitigate their impact on product availability and patient safety. Is ISO 22301 mandatory for MedTech companies? What is the primary benefit of ISO 22301 for MedTech manufacturers? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Manufacturing Supplier Controls Procedures to ensure purchased products and services conform to requirements. ](/terms/supplier-controls) ### More in Standards · Same category [ Standards ASTM F2503 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. ](/terms/astm-f2503)[ Standards Essential Performance Performance of a clinical function whose loss or degradation would result in unacceptable risk. ](/terms/essential-performance)[ Standards ICH E6(R3) Good Clinical Practice(E6(R3)) Revision 3 of the ICH Good Clinical Practice guideline, restructured around principles, modernized for risk-based and decentralized trials, finalized in 2023. ](/terms/ich-e6-r3)[ Standards IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. ](/terms/iec-60601-1) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 IEC· 1 1. [1 ISO 22301 Verified ISO · iso.org ](https://www.iso.org/standard/75106.html) 2. [2 ISO Standards Catalogue - Health Verified ISO · iso.org ](https://www.iso.org/ics/11/x/) 3. [3 IEC Webstore - Medical Equipment Verified IEC · webstore.iec.ch ](https://webstore.iec.ch/searchform&q=medical) 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 Updated 5/5/2026 [Compare with another term](/compare?a=iso-22301) Learn in 60 seconds Card Lesson Quiz Standard for business continuity management systems. - · Hospital procurement teams and FDA shortage staff are both paying more attention to BCMS evidence from critical-device manufacturers. - · Increasingly relevant for MedTech given EO supply, semiconductor, and contract-manufacturer disruptions. Remember this Watch out: A common pitfall is treating ISO 22301 compliance as a checkbox exercise rather than integrating it deeply into the overall quality management system. Related terms - [Supplier Controls ](/terms/supplier-controls) You may also need Auto-suggested from Standards and shared keywords. - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [ISO 13485 ](/terms/iso-13485) - [ISO/IEC 27001(ISO 27001) ](/terms/iso-27001) - [ISO 14971 ](/terms/iso-14971) - [IEC 60601-1-2 ](/terms/iec-60601-1-2) - [IEC 60825 ](/terms/iec-60825) [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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