--- title: "Quality Manual, Definition | MedTech Terms" description: "Top-level QMS document describing scope, processes, and their interactions. 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[Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Quality Manual [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system) # Quality Manual Top-level QMS document describing scope, processes, and their interactions. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition [ISO 13485](/terms/iso-13485) §4.2.2 requires a Quality Manual that documents QMS scope, justifications for any exclusions, references to documented procedures, and a description of process interactions. What the regulation says The FDA, under 21 CFR 820.20, mandates a Quality System Manual or equivalent document that outlines the quality system. Similarly, the [EU Medical Device Regulation](/terms/mdr) (EU [MDR](/terms/mdr-reporting)) 2017/745, while not explicitly naming a "Quality Manual," requires manufacturers to establish, implement, maintain, and continually improve a quality management system as described in Annex IX, which implicitly necessitates such a foundational document. [ISO 13485](/terms/iso-13485):2016, specifically clause 4.2.2, provides detailed requirements for the content of a Quality Manual, including the scope of the Quality Management System (QMS), documented procedures, and descriptions of processes and their interactions. ## What this means in practice Often the first document an auditor opens; clarity and accuracy here set the tone for the rest of the audit. ## Examples - A MedTech startup developing a new diagnostic device drafts a Quality Manual that details its quality policy, the scope of its QMS, and references to its design control procedures, as required by 21 CFR 820.30. - During an ISO 13485 certification audit, an auditor reviews a medical device manufacturer's Quality Manual to confirm that it clearly outlines the interactions between their production and post-market surveillance processes, as specified in ISO 13485:2016 clause 4.2.2. - A company expanding its product line updates its Quality Manual to include the new product categories within its QMS scope and adds references to new risk management procedures, aligning with EU MDR Annex I General Safety and Performance Requirements. Common pitfalls - • A common pitfall is treating the Quality Manual as a static document, failing to update it to reflect changes in the QMS or regulatory landscape. - • Another mistake is writing a Quality Manual that is too generic, lacking specific details about the manufacturer's unique processes and products. - • Manufacturers sometimes overlook the importance of linking the Quality Manual to other QMS documents, leading to an incoherent system. - • Failing to justify any exclusions from ISO 13485 requirements within the Quality Manual can lead to non-conformities during audits. - • An improperly organized Quality Manual can make it difficult for auditors to navigate, potentially delaying or complicating the audit process. ## Frequently asked questions What is the primary purpose of a Quality Manual? The primary purpose is to provide a high-level overview of an organization's Quality Management System, demonstrating how it meets applicable regulatory and standard requirements. It serves as a foundational document for the entire QMS. Who is the typical audience for a Quality Manual? How often should a Quality Manual be reviewed and updated? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Standards ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485) ### More in Quality & Risk · Same category [ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility)[ Quality & Risk CAPA Effectiveness Check Verification step confirming a corrective or preventive action actually fixed the problem. ](/terms/capa-effectiveness)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control)[ 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. Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 FDA· 1 1. [1 ISO 13485:2016 Verified ISO · iso.org ](https://www.iso.org/standard/59752.html) 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 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=quality-manual) Learn in 60 seconds Card Lesson Quiz Top-level QMS document describing scope, processes, and their interactions. - · Often the first document an auditor opens; clarity and accuracy here set the tone for the rest of the audit. Remember this Watch out: A common pitfall is treating the Quality Manual as a static document, failing to update it to reflect changes in the QMS or regulatory landscape. Related terms - [ISO 13485 ](/terms/iso-13485) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Document Control ](/terms/document-control) - [Production and Process Controls ](/terms/production-process-controls) - [Validation Master Plan(VMP) ](/terms/validation-master-plan) - [Corrective and Preventive Action(CAPA) ](/terms/capa) - [Change Control ](/terms/change-control) - [Servicing (21 CFR 820.200) ](/terms/servicing) [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. 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