Frameworks / FDA Quality Management System Regulation (QMSR) / QMSR-ISO13485-Sec5 FDA Quality Management System Regulation (QMSR)
QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)
FDA Quality Management System Regulation (QMSR) QMSR-ISO13485-Sec5: Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10) ISO 13485:2016 Section 5 (Management Responsibility) incorporated via §820.10. ELEMENTS: (5.1) MANAGEMENT COMMITMENT to develop + implement + maintain the QMS + improve its effectiveness; (5.2) CUSTOMER FOCUS - identify + meet customer + regulatory requirements; (5.3) QUALITY POLICY appropriate to the purpose of the organization + commitment to comply + continually improve; (5.4) PLANNING - quality objectives at relevant functions + levels + planning of changes affecting the QMS; (5.5) RESPONSIBILITY + AUTHORITY - clear definition + communication; designation of management representative who has the authority + responsibility for the QMS; internal communication processes appropriate to the effectiveness of the QMS; (5.6) MANAGEMENT REVIEW - at planned intervals to ensure continuing suitability + adequacy + effectiveness of the QMS; review of feedback + complaints + monitoring + measurement + audit results + status of CAPA + follow-up actions from previous review + changes that could affect the QMS + recommendations for improvement; outputs including improvement decisions + resource needs + product / process improvements.
Maintained by Gerard Blokdyk · Verified against the published standard 31 May 2026 · Control text last updated 21 May 2026 What else in your programme already covers this This control maps to 119 controls across 73 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
FEDRAMP-CM-6 Configuration Settings FEDRAMP-CP-9 System Backup FedRAMP-Boundary Authorization Boundary, SSP, SAR, POA&M documentation FedRAMP-ConMon Continuous Monitoring (ConMon) and Significant Change Requests IEC62304-5.2 Software Requirements Analysis IEC62304-5.3 Software Architectural Design IEC62304-7.2 Risk Control Measures 27004-3 Terms and definitions 27004-A.2 Patching and Vulnerability Measures 27004-B.1 Example measurement definitions 27557-1 Scope 27557-3 Terms and definitions 27557-6.2 Scope, context, and criteria for privacy 29100-1 Scope 29100-3 Terms and definitions 29100-4.1 Actors and roles 58.1 Scope 58.3 Definitions AL-DPA-1 Scope and Definitions AL-DPA-3 Lawful Basis for Processing AT-DSG-2 Section 2 - Scope and application AT-DSG-8 Section 22 - Functions and powers of the DPA DA-1 Enterprise Data Architecture DIQ-2 Data Quality Management UAE-PDPL-Art.10 Data Protection Officer (DPO) (UAE PDPL Article 10) UAE-PDPL-Art.11_12_13_14_15_16 Data subject rights (UAE PDPL Articles 11-16) FDBR-702 Definitions (§501.702) FDBR-Scope-Defs Scope, Applicability Thresholds and Definitions (Fla. Stat. 501.701, 501.702, 501.703, 501.704) GAMP5-Lifecycle-VModel-URS-FS-DS-IQOQPQ V-Model Lifecycle - URS + FS + DS + IQ + OQ + PQ + Traceability GAMP5-Risk-CriticalThinking Risk-Based Approach, Critical Thinking and 5 Key Concepts IATF16949-Clause10-Improvement-Nonconformity-CorrectiveAction-Problem-ErrorProof IATF 16949 Clause 10 - Improvement + Nonconformity + Corrective Action + Problem Solving + Error Proofing + Continual Improvement IATF16949-Clause9-Performance-Monitoring-InternalAudit-ManagementReview IATF 16949 Clause 9 - Performance Evaluation + Monitoring + Internal Audit + Manufacturing Process Audit + Management Review 60601-1.3 Terminology and definitions 60601-1.4.1 General requirements 27011-1 Scope 27011-3 Terms and definitions 27014-1 Scope 27014-3 Terms and definitions 29147-3 Terms and definitions 29147-9.2 Contact mechanisms and scope 30111-3 Terms and definitions 30111-5.1 Organizational policy NISTSP34-1 Contingency Planning Policy, Programme, and Plan Coordination NISTSP34-2 Business Impact Analysis (BIA): Critical Resources, Recovery Priorities DSOMM-1 Culture, Organization, Education, and Governance DSOMM-2 Implementation Practices, Secure Coding, and Threat Modelling ASTWO-7 Deficiency Evaluation, Material Weakness, and Communication ASTWO-8 ICFR Opinion, Basis, Definition, Limitations, Combined vs Separate Reports PAKPDPB-7 NCPDP, Registration, Records, Processor Contracts, DPO PAKPDPB-8 Enforcement, Penalties, Complaints, Retention, Training C1 Organizational Boundary C3 Scope 1 and 2 Coverage CFR211-A-3 Section 211.3 - Definitions 4.4.1 Resources, Roles, Responsibility, and Authority AWWA-1.1 Security Policy and Governance AZ-DPA-2 Article 2 - Basic Concepts CPG-6.B Supply Chain Incident Reporting COBIT-BAI02 Managed requirements definition FFIEC-05 Roles and responsibilities definition CA-9 Internal System Connections CA-9 Internal System Connections GLBA-Sec6801-PolicyDuty-SafeguardingStandard GLBA Section 6801 - Privacy Obligation Policy and Safeguarding Standard GLI33-EventWagering-System-Architecture GLI-33 Event Wagering System Architecture, Wager Engine, Odds Engine and Risk Management HKMA-CRAF-Domain1-2-Governance-Identification HKMA C-RAF Domain 1 (Governance) + Domain 2 (Identification) - Cyber Strategy, Risk Management, Asset Management, Threat Assessment HKMA-SPM-CG-IC-AC-Governance-Control-Audit HKMA SPM Corporate Governance (CG-1/2/3/5/6), Internal Control (IC-1/5), Auditing (AC-G) ICP-1 Objectives, Powers and Responsibilities of the Supervisor ICAO-ANX17-Chap1-Definitions-Scope-Chicago-Convention-AVSEC ICAO Annex 17 Chapter 1 - Definitions + Scope + Chicago Convention Article 37 + AVSEC Coverage 62351-2 Glossary of terms IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilities IMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA 27007-5.2 Audit Programme Objectives 27050-1.4 Terms and definitions 27400-3 Terms and definitions 29115-3 Terms and definitions 29134-3 Terms and definitions BIPA-SEC5-1 Biometric Identifier Definition RBI-AA-Ecosystem-FIPs-FIUs-Interoperability-Onboarding-Sahamati-DPI-IndiaStack RBI AA Ecosystem - Financial Information Providers (FIPs) + Financial Information Users (FIUs) + Interoperability + Sahamati SRO Onboarding + DPI India Stack + Cross-Sector Regulators ItalyCodice-DataSubjectRights-Limitations-Deceased-Minors-14-Years-Italian-2undecies-2duodecies-2terdecies Italy Codice Data Subject Rights + Article 2-undecies Limitations + Article 2-duodecies Deceased Persons Rights + Article 2-terdecies Minors Rights (14 Years Consent Age) + GDPR Articles 15-22 + Italian Civil Procedure Remedies PQC-4 FIPS 205 SLH-DSA Implementation - Stateless Hash-Based Digital Signature OCCHS-1 Scope, Applicability, and Definitions of Heightened Standards OWASPASVS-1 Architecture, Design and Threat Modelling (V1) 2.2.2 2.2.2 Vendor default accounts managed PSPF24-1 Security Culture, Governance, Risk Management EHDSREG-1 Mandatory Requirements for EHR Systems (Articles 14-29) SWIFTCSCF-1 Restrict Internet Access and Protect Critical Systems (Objective 1) IM8-RES.2 Disaster Recovery ISMSP-SYS-04 Vulnerability Management FADP-5 Definitions (Article 5) TEFCAREC-1 Common Agreement Conformance and Onboarding 15 U.S.C. § 78dd-2(h) Definition of Domestic Concern USMCADIGITAL-1 Cross-Border Data Flows and Localisation VIETNAMCYBER-2 Prohibited Acts (Access, Interception, Forgery, Content) W3CVCDM-1 Three-Party Ecosystem (Issuer, Holder, Verifier) Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected .
Other controls in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) Query this from an agent The graph holds this control, the 119 it maps to, and the evidence behind each claim, over MCP and REST.