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FDA Quality Management System Regulation (QMSR)
United States
v2026 (Final Rule 2024)
7 domains
34 controls
The FDA Quality Management System Regulation (QMSR), effective February 2026, replaces the Quality System Regulation (21 CFR Part 820) by incorporating ISO 13485:2016 by reference. It aligns FDA quality system requirements for medical device manufacturers with the international standard, reducing regulatory burden for manufacturers operating globally while maintaining FDA-specific requirements for design controls and post-market surveillance.
Verified
Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (7)
Design and Development
8 controls
| Code | Title |
|---|---|
| AQAP-5.6 | Design Verification |
| AQAP-5.7 | Dependability Requirements |
| ISO 13485 Cl. 7.3.1 | Design and Development Planning |
| ISO 13485 Cl. 7.3.2 | Design and Development Inputs |
| ISO 13485 Cl. 7.3.3 | Design and Development Outputs |
| ISO 13485 Cl. 7.3.4-5 | Design Review and Verification |
| ISO 13485 Cl. 7.3.6 | Design Validation |
| ISO 13485 Cl. 7.3.9 | Design Transfer |
Management Responsibility
4 controls
| Code | Title |
|---|---|
| ISO 13485 Cl. 5.1 | Management Commitment |
| ISO 13485 Cl. 5.4 | Quality Planning |
| ISO 13485 Cl. 5.5 | Responsibility and Authority |
| ISO 13485 Cl. 5.6 | Management Review |
Measurement, Analysis, and Improvement
5 controls
| Code | Title |
|---|---|
| ISO 13485 Cl. 8.2.1 | Feedback and Complaint Handling |
| ISO 13485 Cl. 8.2.2 | Internal Audits |
| ISO 13485 Cl. 8.3 | Nonconforming Product Control |
| ISO 13485 Cl. 8.5.2 | Corrective Action (CAPA) |
| ISO 13485 Cl. 8.5.3 | Preventive Action |
Production and Process Controls
5 controls
| Code | Title |
|---|---|
| ISO 13485 Cl. 7.4 | Purchasing Controls |
| ISO 13485 Cl. 7.5.1 | Control of Production and Service Provision |
| ISO 13485 Cl. 7.5.2 | Cleanliness and Contamination Control |
| ISO 13485 Cl. 7.5.6 | Process Validation |
| § 820.45 | Device Labeling and Packaging |
Quality Management System Requirements
4 controls
| Code | Title |
|---|---|
| ISO 13485 Cl. 4.1 | General QMS Requirements |
| ISO 13485 Cl. 4.2 | Documentation Requirements |
| § 820.10 | Requirements for a QMS |
| § 820.35 | Control of Records |
Regulatory Compliance and Traceability
4 controls
| Code | Title |
|---|---|
| § 820.10(a) | Unique Device Identification (UDI) |
| § 820.10(b) | Device Tracking |
| § 820.10(c) | Medical Device Reporting |
| § 820.10(d) | Corrections and Removals |
Resource Management
4 controls
| Code | Title |
|---|---|
| ISO 13485 Cl. 6.1 | Provision of Resources |
| ISO 13485 Cl. 6.2 | Human Resources and Competence |
| ISO 13485 Cl. 6.3 | Infrastructure |
| ISO 13485 Cl. 6.4 | Work Environment and Contamination Control |
Maps to 526 other frameworks
34 total controls
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
9 source controls mapped|12 target controls covered
26%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
9 source controls mapped|13 target controls covered
26%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
9 source controls mapped|8 target controls covered
26%
ILO Nursing Personnel Convention C149 (1977)
8 source controls mapped|8 target controls covered
24%
EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673)
8 source controls mapped|10 target controls covered
24%
ISO 8000 — Data Quality
8 source controls mapped|8 target controls covered
24%
FATF Recommendation 16 — Virtual Asset Travel Rule
8 source controls mapped|7 target controls covered
24%
Privacy by Design (PbD) — Seven Foundational Principles
8 source controls mapped|6 target controls covered
24%
BS 65000:2014 — Guidance on Organizational Resilience
8 source controls mapped|7 target controls covered
24%
ICH E6(R3) — Good Clinical Practice
7 source controls mapped|4 target controls covered
21%
ICH Q10 — Pharmaceutical Quality System
7 source controls mapped|7 target controls covered
21%
EU Medical Devices Regulation (MDR 2017/745)
7 source controls mapped|7 target controls covered
21%
CDP (formerly Carbon Disclosure Project)
6 source controls mapped|3 target controls covered
18%
FAA Cybersecurity Framework for Aviation
6 source controls mapped|6 target controls covered
18%
AASB S2 Climate-related Disclosures
6 source controls mapped|7 target controls covered
18%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
6 source controls mapped|6 target controls covered
18%
BRCGS Global Standard for Food Safety Issue 9
6 source controls mapped|12 target controls covered
18%
AS9100D — Aerospace Quality Management System
6 source controls mapped|10 target controls covered
18%
ISO/IEC 27003:2017
6 source controls mapped|10 target controls covered
18%
SQF Code Edition 9 — Safe Quality Food
6 source controls mapped|6 target controls covered
18%
ASEAN Data Management Framework
6 source controls mapped|9 target controls covered
18%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
6 source controls mapped|10 target controls covered
18%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
6 source controls mapped|9 target controls covered
18%
TISAX — Trusted Information Security Assessment Exchange
6 source controls mapped|7 target controls covered
18%
IEC 60601-1 — Medical Electrical Equipment Safety
5 source controls mapped|4 target controls covered
15%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
5 source controls mapped|6 target controls covered
15%
TEFCA — Trusted Exchange Framework and Common Agreement
5 source controls mapped|5 target controls covered
15%
Aged Care Quality Standards (Australia)
5 source controls mapped|4 target controls covered
15%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
5 source controls mapped|7 target controls covered
15%
NAIC Insurance Data Security Model Law (MDL-668)
5 source controls mapped|7 target controls covered
15%
Modern Slavery Act 2018 (Australia)
5 source controls mapped|6 target controls covered
15%
GAMP 5 — Good Automated Manufacturing Practice
5 source controls mapped|5 target controls covered
15%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
5 source controls mapped|7 target controls covered
15%
Security of Critical Infrastructure Act 2018 (SOCI)
5 source controls mapped|4 target controls covered
15%
IEC 62304:2015 Medical Device Software Lifecycle Processes
5 source controls mapped|6 target controls covered
15%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
5 source controls mapped|4 target controls covered
15%
DO-178C / ED-12C — Software Considerations in Airborne Systems
5 source controls mapped|7 target controls covered
15%
21 CFR Part 211 — Current Good Manufacturing Practice
5 source controls mapped|8 target controls covered
15%
US OFAC Sanctions Compliance Framework
5 source controls mapped|6 target controls covered
15%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
4 source controls mapped|4 target controls covered
12%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
4 source controls mapped|7 target controls covered
12%
HIPAA Security Rule
4 source controls mapped|7 target controls covered
12%
Australia My Health Records Act 2012
4 source controls mapped|7 target controls covered
12%
EU Clinical Trials Regulation (CTR 536/2014)
4 source controls mapped|4 target controls covered
12%
EU European Health Data Space (EHDS)
4 source controls mapped|4 target controls covered
12%
Connecticut Data Privacy Act (CTDPA)
4 source controls mapped|4 target controls covered
12%
Illinois Biometric Information Privacy Act (BIPA)
4 source controls mapped|4 target controls covered
12%
Florida Digital Bill of Rights (SB 262)
4 source controls mapped|2 target controls covered
12%
WELL Building Standard v2 (International WELL Building Institute)
4 source controls mapped|2 target controls covered
12%
Australian Energy Sector Cyber Security Framework (AESCSF)
4 source controls mapped|4 target controls covered
12%
WHO Global Strategy on Digital Health 2020-2025
4 source controls mapped|2 target controls covered
12%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
4 source controls mapped|4 target controls covered
12%
Wisconsin Data Privacy Act (SB 670)
4 source controls mapped|4 target controls covered
12%
Florida Digital Bill of Rights (FDBR)
4 source controls mapped|4 target controls covered
12%
Australia NHMRC National Statement on Ethical Conduct in Human Research
4 source controls mapped|3 target controls covered
12%
IATF 16949:2016 — Quality Management System for Automotive Production
4 source controls mapped|5 target controls covered
12%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
4 source controls mapped|3 target controls covered
12%
Voluntary Principles on Security and Human Rights (VPs)
4 source controls mapped|3 target controls covered
12%
ISO 28001:2007 Supply Chain Security Management
4 source controls mapped|8 target controls covered
12%
South Korea ISMS-P
4 source controls mapped|3 target controls covered
12%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
4 source controls mapped|3 target controls covered
12%
ISO 41001:2018 — Facility Management Systems
4 source controls mapped|8 target controls covered
12%
ISO 39001:2012 — Road Traffic Safety Management
4 source controls mapped|8 target controls covered
12%
ISO 50001:2018 — Energy Management Systems
4 source controls mapped|8 target controls covered
12%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
4 source controls mapped|8 target controls covered
12%
ISO 20400:2017 — Sustainable Procurement
4 source controls mapped|6 target controls covered
12%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
4 source controls mapped|3 target controls covered
12%
UK FCA/PRA Operational Resilience Framework
4 source controls mapped|4 target controls covered
12%
Defence Security Principles Framework (DSPF)
4 source controls mapped|10 target controls covered
12%
Protective Security Policy Framework (PSPF) Release 2024
4 source controls mapped|11 target controls covered
12%
3GPP Security Architecture (TS 33.501 — 5G Security)
4 source controls mapped|10 target controls covered
12%
EIOPA Guidelines on ICT Security and Governance (2020)
4 source controls mapped|6 target controls covered
12%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
4 source controls mapped|7 target controls covered
12%
NIS2 Directive Implementing Acts
4 source controls mapped|6 target controls covered
12%
UK Telecommunications (Security) Act 2021
4 source controls mapped|6 target controls covered
12%
ISO/IEC 27006:2024
4 source controls mapped|7 target controls covered
12%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
4 source controls mapped|6 target controls covered
12%
GLI-33 — Gaming Laboratories International Event Wagering Systems
4 source controls mapped|5 target controls covered
12%
Telecommunications Sector Security Reforms (TSSR)
4 source controls mapped|4 target controls covered
12%
ASIS SPC.1-2009 — Organizational Resilience Standard
4 source controls mapped|5 target controls covered
12%
ISO/IEC 25012:2008 — Data Quality Model
4 source controls mapped|4 target controls covered
12%
MDS2 (Medical Device)
3 source controls mapped|3 target controls covered
9%
Colorado AI Act (SB 24-205)
3 source controls mapped|1 target controls covered
9%
HITECH Act
3 source controls mapped|3 target controls covered
9%
UNESCO Recommendation on the Ethics of AI
3 source controls mapped|1 target controls covered
9%
Washington My Health My Data Act (MHMD)
3 source controls mapped|1 target controls covered
9%
ICAO Annex 17 — Aviation Security (AVSEC)
3 source controls mapped|4 target controls covered
9%
ISO/IEC 27014:2020
3 source controls mapped|4 target controls covered
9%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
3 source controls mapped|4 target controls covered
9%
ISO 56002
3 source controls mapped|7 target controls covered
9%
ISO 37002:2021 — Whistleblowing Management Systems
3 source controls mapped|6 target controls covered
9%
SA8000:2014 — Social Accountability Standard
3 source controls mapped|2 target controls covered
9%
AICPA Privacy Management Framework (PMF)
3 source controls mapped|2 target controls covered
9%
IRS Publication 1075 — Tax Information Security Guidelines
3 source controls mapped|1 target controls covered
9%
German Supply Chain Due Diligence Act (LkSG)
3 source controls mapped|3 target controls covered
9%
ITAR — International Traffic in Arms Regulations
3 source controls mapped|3 target controls covered
9%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
3 source controls mapped|3 target controls covered
9%
WCO Authorised Economic Operator (AEO) Framework
3 source controls mapped|7 target controls covered
9%
C-TPAT — Customs-Trade Partnership Against Terrorism
3 source controls mapped|4 target controls covered
9%
Digital Economy Partnership Agreement (DEPA)
3 source controls mapped|4 target controls covered
9%
EU Maritime Single Window Environment Regulation (EU 2019/1239) and EMSA Cybersecurity
3 source controls mapped|7 target controls covered
9%
Notifiable Data Breaches Scheme (Australia)
3 source controls mapped|6 target controls covered
9%
EU Digital Markets Act
3 source controls mapped|5 target controls covered
9%
FTC Health Breach Notification Rule
3 source controls mapped|7 target controls covered
9%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
3 source controls mapped|5 target controls covered
9%
EAR — Export Administration Regulations
3 source controls mapped|5 target controls covered
9%
European Accessibility Act (Directive (EU) 2019/882)
3 source controls mapped|5 target controls covered
9%
EU Deforestation-Free Products Regulation (EUDR)
3 source controls mapped|5 target controls covered
9%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
3 source controls mapped|6 target controls covered
9%
EU NIS2 Directive — Energy Sector Cybersecurity Requirements (Directive 2022/2555)
3 source controls mapped|6 target controls covered
9%
US ITAR and EAR — Export Control and Data Security
3 source controls mapped|5 target controls covered
9%
US SEC Digital Assets and Crypto Regulatory Framework
3 source controls mapped|7 target controls covered
9%
Australia Consumer Data Right — Banking (CDR)
3 source controls mapped|5 target controls covered
9%
Australia eSafety Commissioner — Online Safety Expectations for Industry
3 source controls mapped|5 target controls covered
9%
EU Taxonomy Regulation (Regulation 2020/852)
3 source controls mapped|6 target controls covered
9%
GS1 Global Standards — Supply Chain Traceability and Data Security
3 source controls mapped|4 target controls covered
9%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2019/04)
3 source controls mapped|4 target controls covered
9%
CSA CCM v4
3 source controls mapped|7 target controls covered
9%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
3 source controls mapped|4 target controls covered
9%
WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)
3 source controls mapped|4 target controls covered
9%
Customs-Trade Partnership Against Terrorism (C-TPAT)
3 source controls mapped|4 target controls covered
9%
EU Critical Raw Materials Act (Regulation (EU) 2024/1252)
3 source controls mapped|4 target controls covered
9%
EU Chips Act (Regulation (EU) 2023/1781)
3 source controls mapped|4 target controls covered
9%
TNFD Recommendations
3 source controls mapped|7 target controls covered
9%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
3 source controls mapped|5 target controls covered
9%
South Korea Cloud Security Assurance Program (CSAP)
3 source controls mapped|4 target controls covered
9%
SASB Standards (ISSB Integrated)
3 source controls mapped|3 target controls covered
9%
SASB Standards
3 source controls mapped|3 target controls covered
9%
ISO 27001:2022
3 source controls mapped|5 target controls covered
9%
NIST SP 800-82 Rev 3 — Guide to OT Security
3 source controls mapped|5 target controls covered
9%
NIST Cybersecurity Framework 2.0
3 source controls mapped|8 target controls covered
9%
ECB TIBER-EU Framework
3 source controls mapped|3 target controls covered
9%
21 CFR Part 58 — Good Laboratory Practice (GLP)
3 source controls mapped|3 target controls covered
9%
EU Cyber Resilience Act
3 source controls mapped|5 target controls covered
9%
EU Better Internet for Kids (BIK+) Strategy
2 source controls mapped|1 target controls covered
6%
EASA Part-IS — Information Security in Aviation
2 source controls mapped|1 target controls covered
6%
COSO ERM
2 source controls mapped|1 target controls covered
6%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
2 source controls mapped|1 target controls covered
6%
ISO 30401
2 source controls mapped|1 target controls covered
6%
ISO 55001
2 source controls mapped|1 target controls covered
6%
ISO 19011
2 source controls mapped|1 target controls covered
6%
ISO 22000
2 source controls mapped|1 target controls covered
6%
ISO 9001
2 source controls mapped|3 target controls covered
6%
NFPA 1600 — Standard on Continuity, Emergency, and Crisis Management
2 source controls mapped|2 target controls covered
6%
ISO 37301
2 source controls mapped|1 target controls covered
6%
ISO 37001
2 source controls mapped|1 target controls covered
6%
ISO 31000
2 source controls mapped|1 target controls covered
6%
NIST SP 800-37
2 source controls mapped|1 target controls covered
6%
ISO 45001
2 source controls mapped|1 target controls covered
6%
NIST SP 800-39
2 source controls mapped|1 target controls covered
6%
NIST SP 800-30
2 source controls mapped|1 target controls covered
6%
ISO 27005
2 source controls mapped|1 target controls covered
6%
BIMCO Cyber Security
2 source controls mapped|4 target controls covered
6%
CDP Corporate Questionnaire
2 source controls mapped|3 target controls covered
6%
ASD Information Security Manual (ISM)
2 source controls mapped|5 target controls covered
6%
IEC 62443
2 source controls mapped|4 target controls covered
6%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
2 source controls mapped|3 target controls covered
6%
C2M2
2 source controls mapped|4 target controls covered
6%
EU Digital Services Act — Minors Protection Provisions (Regulation 2022/2065)
2 source controls mapped|4 target controls covered
6%
EU Digital Services Act — Online Gaming Platform Requirements
2 source controls mapped|2 target controls covered
6%
EU Machinery Regulation (Regulation (EU) 2023/1230)
2 source controls mapped|5 target controls covered
6%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
2 source controls mapped|6 target controls covered
6%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
2 source controls mapped|3 target controls covered
6%
EU Network Code on Cybersecurity for the Electricity Sector
2 source controls mapped|4 target controls covered
6%
African Union Malabo Convention
2 source controls mapped|4 target controls covered
6%
MiFID II / MiFIR
2 source controls mapped|2 target controls covered
6%
Morocco Data Protection Law (09-08)
2 source controls mapped|5 target controls covered
6%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
2 source controls mapped|3 target controls covered
6%
Côte d'Ivoire Law on Personal Data Protection (Law No. 2013-450)
2 source controls mapped|4 target controls covered
6%
Costa Rica Personal Data Protection Law (Law No. 8968)
2 source controls mapped|5 target controls covered
6%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|4 target controls covered
6%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
2 source controls mapped|5 target controls covered
6%
Georgia Law on Personal Data Protection (2012)
2 source controls mapped|5 target controls covered
6%
Colombia Data Protection Law (Law 1581 of 2012 — SIC Oversight)
2 source controls mapped|5 target controls covered
6%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
2 source controls mapped|7 target controls covered
6%
Serbia Law on Personal Data Protection (2018)
2 source controls mapped|5 target controls covered
6%
Lithuania Law on Legal Protection of Personal Data (2018)
2 source controls mapped|3 target controls covered
6%
Portugal Law No. 58/2019 — Data Protection Implementation Act
2 source controls mapped|7 target controls covered
6%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
2 source controls mapped|6 target controls covered
6%
Oman Personal Data Protection Law (Royal Decree 6/2022)
2 source controls mapped|5 target controls covered
6%
South Korea Personal Information Protection Act (PIPA)
2 source controls mapped|6 target controls covered
6%
API 1164
2 source controls mapped|4 target controls covered
6%
Critical Infrastructure Risk Management Program (CIRMP) Rules 2023
2 source controls mapped|5 target controls covered
6%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
2 source controls mapped|2 target controls covered
6%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
2 source controls mapped|4 target controls covered
6%
OWASP Top 10:2025
2 source controls mapped|3 target controls covered
6%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
2 source controls mapped|3 target controls covered
6%
FBI CJIS Security Policy
2 source controls mapped|3 target controls covered
6%
OWASP DevSecOps Maturity Model (DSOMM)
2 source controls mapped|5 target controls covered
6%
FedRAMP Rev 5
2 source controls mapped|9 target controls covered
6%
DO-326A
2 source controls mapped|4 target controls covered
6%
ISO/IEC 27010:2015
2 source controls mapped|2 target controls covered
6%
IEEE 1686
2 source controls mapped|4 target controls covered
6%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
2 source controls mapped|2 target controls covered
6%
China Cybersecurity Law (CSL)
2 source controls mapped|2 target controls covered
6%
ISO/IEC 27011:2024
2 source controls mapped|4 target controls covered
6%
EU NIS2 Directive — Transport Sector Requirements
2 source controls mapped|3 target controls covered
6%
EU GMP Annex 11 — Computerised Systems
2 source controls mapped|3 target controls covered
6%
Philippines Cybercrime Prevention Act (RA 10175)
2 source controls mapped|2 target controls covered
6%
BREEAM — Building Research Establishment Environmental Assessment Method
2 source controls mapped|2 target controls covered
6%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
2 source controls mapped|3 target controls covered
6%
Japan FSA Cybersecurity Guidelines for Financial Institutions
2 source controls mapped|3 target controls covered
6%
RBI Cybersecurity Framework for Banks
2 source controls mapped|3 target controls covered
6%
Kuwait National Cybersecurity Framework
2 source controls mapped|3 target controls covered
6%
NIST AI Risk Management Framework (AI RMF 1.0)
2 source controls mapped|3 target controls covered
6%
NIST AI 600-1 Generative AI Profile
2 source controls mapped|3 target controls covered
6%
NIST SP 1800-32
2 source controls mapped|4 target controls covered
6%
NIS2 Directive
2 source controls mapped|4 target controls covered
6%
Cook Islands Electronic Transactions Act & Privacy Provisions (2003)
2 source controls mapped|4 target controls covered
6%
Canada ITSG-33 — IT Security Risk Management
2 source controls mapped|3 target controls covered
6%
New Zealand Information Security Manual (NZISM)
2 source controls mapped|3 target controls covered
6%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
2 source controls mapped|3 target controls covered
6%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
2 source controls mapped|5 target controls covered
6%
NIST SP 800-53 Rev 5
2 source controls mapped|4 target controls covered
6%
ISO 27019
2 source controls mapped|4 target controls covered
6%
Laos Law on Prevention and Combating Cybercrime (2015)
2 source controls mapped|5 target controls covered
6%
French Sapin II Law (Law No. 2016-1691)
2 source controls mapped|2 target controls covered
6%
UK Security and Emergency Measures Direction (SEMD) — Water Industry
2 source controls mapped|3 target controls covered
6%
ISO/IEC 23894:2023
2 source controls mapped|4 target controls covered
6%
NIST Privacy Framework 1.0
2 source controls mapped|2 target controls covered
6%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
2 source controls mapped|3 target controls covered
6%
UK Gambling Commission — Cyber Resilience Requirements
2 source controls mapped|4 target controls covered
6%
NIST SP 800-124 Rev 2 — Mobile Device Security
2 source controls mapped|4 target controls covered
6%
FSSC 22000 — Food Safety System Certification
2 source controls mapped|3 target controls covered
6%
EU Digital Services Act
2 source controls mapped|1 target controls covered
6%
Singapore Model AI Governance Framework (2nd Edition)
2 source controls mapped|1 target controls covered
6%
OECD AI Principles
2 source controls mapped|2 target controls covered
6%
UNECE WP.29 R155
2 source controls mapped|2 target controls covered
6%
NIST SP 800-183
2 source controls mapped|2 target controls covered
6%
NIST SP 800-218
2 source controls mapped|2 target controls covered
6%
NIST SP 800-61
2 source controls mapped|2 target controls covered
6%
SLSA
2 source controls mapped|2 target controls covered
6%
NIST SP 800-128
2 source controls mapped|2 target controls covered
6%
ISO/SAE 21434
2 source controls mapped|2 target controls covered
6%
NIST SP 800-144
2 source controls mapped|2 target controls covered
6%
ISO 27043
2 source controls mapped|2 target controls covered
6%
MITRE ATT&CK
2 source controls mapped|2 target controls covered
6%
NIST SP 800-137
2 source controls mapped|2 target controls covered
6%
BSIMM
2 source controls mapped|2 target controls covered
6%
China AI Regulations
2 source controls mapped|2 target controls covered
6%
NIST SP 800-63
2 source controls mapped|2 target controls covered
6%
NIST SP 800-88
2 source controls mapped|2 target controls covered
6%
NIST SP 800-115
2 source controls mapped|2 target controls covered
6%
UNECE WP.29 R156
2 source controls mapped|2 target controls covered
6%
ISO 27017
2 source controls mapped|2 target controls covered
6%
Australia AI Ethics Framework
2 source controls mapped|2 target controls covered
6%
ISO 27002:2022
2 source controls mapped|2 target controls covered
6%
SSDF (NIST)
2 source controls mapped|2 target controls covered
6%
C5 (Germany)
2 source controls mapped|2 target controls covered
6%
ISMAP (Japan)
2 source controls mapped|2 target controls covered
6%
UK PSTI Act
2 source controls mapped|2 target controls covered
6%
COSO Internal Control — Integrated Framework (2013)
2 source controls mapped|2 target controls covered
6%
SIG (Shared Assessments)
2 source controls mapped|2 target controls covered
6%
PTES
2 source controls mapped|2 target controls covered
6%
NIST SP 800-150
2 source controls mapped|2 target controls covered
6%
CSA STAR (Security, Trust, Assurance, and Risk)
2 source controls mapped|3 target controls covered
6%
ISO 42001
2 source controls mapped|2 target controls covered
6%
NIST SP 800-146
2 source controls mapped|2 target controls covered
6%
OpenSSF Scorecard
2 source controls mapped|2 target controls covered
6%
California IoT Security Law
2 source controls mapped|2 target controls covered
6%
NIST SP 800-161
2 source controls mapped|2 target controls covered
6%
NIST SP 800-160
2 source controls mapped|2 target controls covered
6%
ETSI EN 303 645
2 source controls mapped|2 target controls covered
6%
NIST SP 800-181
2 source controls mapped|2 target controls covered
6%
NIST SP 800-145
2 source controls mapped|2 target controls covered
6%
NIST SP 800-187
2 source controls mapped|2 target controls covered
6%
AWS Well-Architected Security Pillar
2 source controls mapped|2 target controls covered
6%
UK AI Regulation Framework
2 source controls mapped|2 target controls covered
6%
ISO 27018
2 source controls mapped|2 target controls covered
6%
EU AI Act
2 source controls mapped|2 target controls covered
6%
Japan AI Guidelines
2 source controls mapped|2 target controls covered
6%
OWASP MASVS
2 source controls mapped|2 target controls covered
6%
3GPP Security
2 source controls mapped|2 target controls covered
6%
OWASP ASVS
2 source controls mapped|2 target controls covered
6%
MTCS (Singapore)
2 source controls mapped|2 target controls covered
6%
Singapore AI Governance Framework
2 source controls mapped|2 target controls covered
6%
Brazil AI Framework
2 source controls mapped|2 target controls covered
6%
Azure Security Benchmark
2 source controls mapped|2 target controls covered
6%
NIST SP 800-123
2 source controls mapped|2 target controls covered
6%
IEEE 7000
2 source controls mapped|2 target controls covered
6%
CCSDS 350.0-G-3 — Space Communications Security (Consultative Committee for Space Data Systems)
2 source controls mapped|2 target controls covered
6%
NIST SP 800-190
2 source controls mapped|2 target controls covered
6%
OWASP SAMM
2 source controls mapped|2 target controls covered
6%
NIST SP 800-92
2 source controls mapped|2 target controls covered
6%
NIST SP 800-207
2 source controls mapped|2 target controls covered
6%
MITRE D3FEND
2 source controls mapped|2 target controls covered
6%
CAIQ (CSA)
2 source controls mapped|2 target controls covered
6%
ISO/IEC 38500:2024 — Governance of IT
2 source controls mapped|4 target controls covered
6%
IEC 62351 — Power Systems Communication Security
2 source controls mapped|3 target controls covered
6%
ISO/IEC 27031:2011
2 source controls mapped|3 target controls covered
6%
ISO/IEC 27007:2020
2 source controls mapped|2 target controls covered
6%
BCBS 239
2 source controls mapped|4 target controls covered
6%
PSD2 SCA
2 source controls mapped|4 target controls covered
6%
Open Banking Security
2 source controls mapped|4 target controls covered
6%
EU Taxonomy Regulation
2 source controls mapped|5 target controls covered
6%
DORA
2 source controls mapped|4 target controls covered
6%
FFIEC IT Examination Handbook
2 source controls mapped|4 target controls covered
6%
GLBA
2 source controls mapped|4 target controls covered
6%
UK Open Banking Standard
2 source controls mapped|3 target controls covered
6%
AICPA SOC 3
2 source controls mapped|4 target controls covered
6%
MTCS — Multi-Tier Cloud Security (Singapore)
2 source controls mapped|2 target controls covered
6%
South Africa Promotion of Access to Information Act (PAIA)
2 source controls mapped|2 target controls covered
6%
MAS TRM
2 source controls mapped|4 target controls covered
6%
OSFI B-13
2 source controls mapped|4 target controls covered
6%
HKMA SPM
2 source controls mapped|4 target controls covered
6%
AICPA SOC 1
2 source controls mapped|4 target controls covered
6%
SWIFT CSP
2 source controls mapped|4 target controls covered
6%
SOC 2
2 source controls mapped|5 target controls covered
6%
O-RAN Alliance Security Specifications (O-RAN.WG11)
2 source controls mapped|4 target controls covered
6%
PCI PIN Security
2 source controls mapped|4 target controls covered
6%
ASIC Cyber Resilience Good Practices
2 source controls mapped|3 target controls covered
6%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
2 source controls mapped|3 target controls covered
6%
SWIFT CSCF
2 source controls mapped|4 target controls covered
6%
PCI SSF
2 source controls mapped|4 target controls covered
6%
APRA CPS 234
2 source controls mapped|4 target controls covered
6%
SSAE 18 — Attestation Standards (SOC Reporting)
2 source controls mapped|3 target controls covered
6%
PCI P2PE
2 source controls mapped|4 target controls covered
6%
ECB TIBER-EU
2 source controls mapped|4 target controls covered
6%
HKMA Cyber Resilience Assessment Framework (C-RAF)
2 source controls mapped|3 target controls covered
6%
COBIT 2019
2 source controls mapped|2 target controls covered
6%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|3 target controls covered
6%
APRA CPS 230 Operational Risk Management
1 source controls mapped|2 target controls covered
3%
Authorised Economic Operator (AEO) Programmes — Global Standards
1 source controls mapped|3 target controls covered
3%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
1 source controls mapped|3 target controls covered
3%
Defence Industry Security Program (DISP)
1 source controls mapped|1 target controls covered
3%
CNCF Cloud Native Security (Cloud Native Computing Foundation)
1 source controls mapped|2 target controls covered
3%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|1 target controls covered
3%
Space ISAC (Information Sharing and Analysis Center) — Threat Framework
1 source controls mapped|1 target controls covered
3%
Solvency II
1 source controls mapped|3 target controls covered
3%
OWASP Top 10 for LLM Applications 2025
1 source controls mapped|1 target controls covered
3%
NERC CIP
1 source controls mapped|3 target controls covered
3%
ISO 26000:2010
1 source controls mapped|1 target controls covered
3%
US Executive Order 14028 — Improving the Nation's Cybersecurity
1 source controls mapped|2 target controls covered
3%
ISO 22317
1 source controls mapped|1 target controls covered
3%
Sigstore — Software Artifact Signing and Verification
1 source controls mapped|1 target controls covered
3%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
3%
ISO 22318
1 source controls mapped|1 target controls covered
3%
Responsible Minerals Initiative (RMI) — Responsible Minerals Assurance Process
1 source controls mapped|3 target controls covered
3%
TSA Pipeline Security
1 source controls mapped|3 target controls covered
3%
ISO 22301
1 source controls mapped|1 target controls covered
3%
ISO 22316
1 source controls mapped|1 target controls covered
3%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
3%
Cyber Essentials Plus
1 source controls mapped|1 target controls covered
3%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
3%
CMMC 2.0
1 source controls mapped|1 target controls covered
3%
ANSSI Cybersecurity Framework
1 source controls mapped|1 target controls covered
3%
China Data Security Law (DSL)
1 source controls mapped|1 target controls covered
3%
NSA Quantum-Resistant (QR) Cryptography Migration Guidance
1 source controls mapped|1 target controls covered
3%
DISA Security Technical Implementation Guides (STIGs)
1 source controls mapped|1 target controls covered
3%
Oman National Cybersecurity Framework
1 source controls mapped|1 target controls covered
3%
NIST SP 800-171
1 source controls mapped|1 target controls covered
3%
FISMA
1 source controls mapped|1 target controls covered
3%
Saudi NCA ECC
1 source controls mapped|1 target controls covered
3%
CISA Zero Trust Maturity Model
1 source controls mapped|1 target controls covered
3%
NIST SP 800-172
1 source controls mapped|1 target controls covered
3%
DoD Zero Trust Reference Architecture
1 source controls mapped|1 target controls covered
3%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
3%
Spain ENS
1 source controls mapped|1 target controls covered
3%
NIST SP 800-53A
1 source controls mapped|1 target controls covered
3%
NATO Cyber Defence Standards and NCIRC (NATO Computer Incident Response Capability)
1 source controls mapped|1 target controls covered
3%
India CERT-In Cyber Security Directions 2022
1 source controls mapped|1 target controls covered
3%
ISO 20000-1
1 source controls mapped|1 target controls covered
3%
Right to Disconnect (Australia)
1 source controls mapped|1 target controls covered
3%
US EPA Safe Drinking Water Act (SDWA) — Cybersecurity Requirements
1 source controls mapped|3 target controls covered
3%
NIST Privacy Framework Version 1.0
1 source controls mapped|2 target controls covered
3%
ASD Strategies to Mitigate Cyber Security Incidents
1 source controls mapped|1 target controls covered
3%
SEC Climate Disclosure Rule
1 source controls mapped|1 target controls covered
3%
ITIL 4
1 source controls mapped|1 target controls covered
3%
ITU-T X.805 — Security Architecture for End-to-End Communications
1 source controls mapped|1 target controls covered
3%
FFIEC Cybersecurity Assessment Tool (CAT)
1 source controls mapped|1 target controls covered
3%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
1 source controls mapped|1 target controls covered
3%
FTC Safeguards Rule (16 CFR Part 314)
1 source controls mapped|2 target controls covered
3%
Nevada Gaming Control Board Cybersecurity Requirements
1 source controls mapped|1 target controls covered
3%
Lloyd's Minimum Standards — Cyber Security
1 source controls mapped|1 target controls covered
3%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
1 source controls mapped|4 target controls covered
3%
EU Markets in Crypto-Assets Regulation (MiCA)
1 source controls mapped|5 target controls covered
3%
ISO/IEC 27400:2022
1 source controls mapped|3 target controls covered
3%
EU Union Customs Code (UCC) — Data Protection and Security Provisions (Regulation 952/2013)
1 source controls mapped|2 target controls covered
3%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
1 source controls mapped|5 target controls covered
3%
EDM Council CDMC — Cloud Data Management Capabilities Framework
1 source controls mapped|3 target controls covered
3%
Chile Personal Data Protection Law (Law No. 21.719)
1 source controls mapped|3 target controls covered
3%
ISO/IEC 27004:2016
1 source controls mapped|3 target controls covered
3%
ISO/IEC 30111:2019
1 source controls mapped|3 target controls covered
3%
ISO/IEC 29147:2018
1 source controls mapped|3 target controls covered
3%
EU Carbon Border Adjustment Mechanism (CBAM)
1 source controls mapped|4 target controls covered
3%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
1 source controls mapped|4 target controls covered
3%
EU Energy Performance of Buildings Directive (EPBD Recast, Directive 2024/1275)
1 source controls mapped|3 target controls covered
3%
EU European Media Freedom Act (EMFA)
1 source controls mapped|5 target controls covered
3%
EU Pay Transparency Directive (Directive 2023/970)
1 source controls mapped|6 target controls covered
3%
EU Platform Work Directive (Directive 2024/2831)
1 source controls mapped|6 target controls covered
3%
EU Product Liability Directive (Directive (EU) 2024/2853)
1 source controls mapped|6 target controls covered
3%
EU Seveso III Directive (Directive 2012/18/EU)
1 source controls mapped|5 target controls covered
3%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
1 source controls mapped|2 target controls covered
3%
eIDAS 2.0 — EU Digital Identity Regulation
1 source controls mapped|3 target controls covered
3%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
1 source controls mapped|3 target controls covered
3%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
1 source controls mapped|6 target controls covered
3%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
1 source controls mapped|4 target controls covered
3%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
1 source controls mapped|4 target controls covered
3%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
1 source controls mapped|4 target controls covered
3%
Uzbekistan Law on Personal Data (No. ZRU-547)
1 source controls mapped|4 target controls covered
3%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
1 source controls mapped|4 target controls covered
3%
Montenegro Law on Personal Data Protection (2023)
1 source controls mapped|6 target controls covered
3%
North Macedonia Law on Personal Data Protection (2020)
1 source controls mapped|5 target controls covered
3%
Uruguay Personal Data Protection Act (Law No. 18.331)
1 source controls mapped|5 target controls covered
3%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
1 source controls mapped|6 target controls covered
3%
Malta Data Protection Act (Cap. 586, 2018)
1 source controls mapped|6 target controls covered
3%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
1 source controls mapped|4 target controls covered
3%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
1 source controls mapped|6 target controls covered
3%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
1 source controls mapped|4 target controls covered
3%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
1 source controls mapped|5 target controls covered
3%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
1 source controls mapped|5 target controls covered
3%
EU AI Liability Directive
1 source controls mapped|4 target controls covered
3%
EU Audiovisual Media Services Directive (AVMSD, Directive 2018/1808)
1 source controls mapped|2 target controls covered
3%
US Americans with Disabilities Act (ADA) — Title III Digital Accessibility
1 source controls mapped|3 target controls covered
3%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
1 source controls mapped|4 target controls covered
3%
Jordan Draft Personal Data Protection Law (2022)
1 source controls mapped|4 target controls covered
3%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
1 source controls mapped|5 target controls covered
3%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
1 source controls mapped|5 target controls covered
3%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
1 source controls mapped|4 target controls covered
3%
EU Web Accessibility Directive (Directive 2016/2102)
1 source controls mapped|3 target controls covered
3%
EU ePrivacy Directive (2002/58/EC)
1 source controls mapped|4 target controls covered
3%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
1 source controls mapped|2 target controls covered
3%
Senegal Law on Personal Data Protection (Law No. 2008-12)
1 source controls mapped|3 target controls covered
3%
Peru Personal Data Protection Law (Law No. 29733)
1 source controls mapped|3 target controls covered
3%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
1 source controls mapped|3 target controls covered
3%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
1 source controls mapped|5 target controls covered
3%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
1 source controls mapped|7 target controls covered
3%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
1 source controls mapped|5 target controls covered
3%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
1 source controls mapped|4 target controls covered
3%
Russia Federal Law on Personal Data (152-FZ)
1 source controls mapped|4 target controls covered
3%
Croatia Act on Implementation of the GDPR (Official Gazette 42/2018)
1 source controls mapped|3 target controls covered
3%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
1 source controls mapped|2 target controls covered
3%
Botswana Data Protection Act (2024)
1 source controls mapped|5 target controls covered
3%
Fiji Data Protection Bill (2020)
1 source controls mapped|5 target controls covered
3%
Zimbabwe Data Protection Act (2021)
1 source controls mapped|4 target controls covered
3%
Uganda Data Protection and Privacy Act (2019)
1 source controls mapped|4 target controls covered
3%
EDM Council DCAM — Data Management Capability Assessment Model
1 source controls mapped|3 target controls covered
3%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
1 source controls mapped|2 target controls covered
3%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
1 source controls mapped|1 target controls covered
3%
ECSS Software Engineering Standards (ESA)
1 source controls mapped|3 target controls covered
3%
ISO/IEC 29100:2024
1 source controls mapped|3 target controls covered
3%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
1 source controls mapped|3 target controls covered
3%
South Korea Credit Information Act
1 source controls mapped|1 target controls covered
3%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
1 source controls mapped|3 target controls covered
3%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
1 source controls mapped|3 target controls covered
3%
Angola Personal Data Protection Law (Law No. 22/11)
1 source controls mapped|4 target controls covered
3%
US Foreign Corrupt Practices Act (FCPA)
1 source controls mapped|1 target controls covered
3%
EN 50126/50128/50129 — Railway RAMS and Safety
1 source controls mapped|3 target controls covered
3%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
1 source controls mapped|4 target controls covered
3%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
1 source controls mapped|3 target controls covered
3%
ESA ECSS-E-ST-40C — Space Software Engineering Standard
1 source controls mapped|3 target controls covered
3%
Armenia Law on Protection of Personal Data (2015)
1 source controls mapped|3 target controls covered
3%
EU Data Act
1 source controls mapped|2 target controls covered
3%
China Personal Information Protection Law (PIPL)
1 source controls mapped|3 target controls covered
3%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
1 source controls mapped|3 target controls covered
3%
3GPP 5G Security Architecture (TS 33.501)
1 source controls mapped|2 target controls covered
3%
ISO/IEC 29134:2023
1 source controls mapped|3 target controls covered
3%
India Account Aggregator Framework (RBI)
1 source controls mapped|1 target controls covered
3%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
1 source controls mapped|3 target controls covered
3%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
1 source controls mapped|1 target controls covered
3%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
1 source controls mapped|2 target controls covered
3%
ETSI QKD Standards — Quantum Key Distribution (ETSI ISG QKD)
1 source controls mapped|3 target controls covered
3%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
1 source controls mapped|3 target controls covered
3%
IFRS 17 — Insurance Contracts
1 source controls mapped|2 target controls covered
3%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
1 source controls mapped|3 target controls covered
3%
HL7 FHIR Security Framework
1 source controls mapped|1 target controls covered
3%
IAIS Insurance Core Principles (ICPs)
1 source controls mapped|1 target controls covered
3%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
1 source controls mapped|1 target controls covered
3%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
1 source controls mapped|1 target controls covered
3%
RICS Professional Standards — Data and Technology in Property
1 source controls mapped|1 target controls covered
3%
W3C Verifiable Credentials (VC) Data Model 2.0
1 source controls mapped|2 target controls covered
3%
Science Based Targets initiative (SBTi) Corporate Standard
1 source controls mapped|2 target controls covered
3%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
1 source controls mapped|1 target controls covered
3%
Azerbaijan Law on Personal Data (2010)
1 source controls mapped|1 target controls covered
3%
Barbados Data Protection Act 2019
1 source controls mapped|1 target controls covered
3%
APRA Prudential Standard CPS 234 — Information Security (Australia)
1 source controls mapped|1 target controls covered
3%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
1 source controls mapped|1 target controls covered
3%
ISO/IEC 27050 — Electronic Discovery (Parts 1-4)
1 source controls mapped|1 target controls covered
3%
Israel Protection of Privacy Law (5741-1981)
1 source controls mapped|3 target controls covered
3%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
1 source controls mapped|3 target controls covered
3%
Virginia Consumer Data Protection Act (VCDPA)
1 source controls mapped|1 target controls covered
3%
UK Bribery Act 2010
1 source controls mapped|3 target controls covered
3%
ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
1 source controls mapped|3 target controls covered
3%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
1 source controls mapped|3 target controls covered
3%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
1 source controls mapped|4 target controls covered
3%
ISO 22320:2018
1 source controls mapped|3 target controls covered
3%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
1 source controls mapped|2 target controls covered
3%
Brunei Personal Data Protection Order 2024 (PDPO)
1 source controls mapped|6 target controls covered
3%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
1 source controls mapped|5 target controls covered
3%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
1 source controls mapped|3 target controls covered
3%
Australia Online Safety Act 2021
1 source controls mapped|4 target controls covered
3%
ISO 37000:2021 — Governance of Organizations
1 source controls mapped|3 target controls covered
3%
Tanzania Personal Data Protection Act (Draft)
1 source controls mapped|4 target controls covered
3%
Trinidad and Tobago Data Protection Act 2011
1 source controls mapped|4 target controls covered
3%
Jamaica Data Protection Act 2020
1 source controls mapped|3 target controls covered
3%
Mauritius Data Protection Act 2017
1 source controls mapped|2 target controls covered
3%
Kenya Data Protection Act 2019
1 source controls mapped|3 target controls covered
3%
Ghana Data Protection Act 2012 (Act 843)
1 source controls mapped|2 target controls covered
3%
Cayman Islands Data Protection Act 2017 (DPA)
1 source controls mapped|4 target controls covered
3%
Czech Republic Act on Personal Data Processing (Act No. 110/2019 Sb.)
1 source controls mapped|4 target controls covered
3%
Nigeria Data Protection Act 2023 (NDPA)
1 source controls mapped|2 target controls covered
3%
IATA Operational Safety Audit (IOSA) Standards Manual
1 source controls mapped|1 target controls covered
3%
UK Building Safety Act 2022
1 source controls mapped|2 target controls covered
3%
ISO 26262:2018 — Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
3%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
1 source controls mapped|3 target controls covered
3%
SANS Incident Handler's Handbook and PICERL Methodology
1 source controls mapped|2 target controls covered
3%
Bermuda Personal Information Protection Act 2016 (PIPA)
1 source controls mapped|2 target controls covered
3%
SWIFT Customer Security Programme (CSP)
1 source controls mapped|2 target controls covered
3%
EU PSD3 and Payment Services Regulation (Proposed)
1 source controls mapped|3 target controls covered
3%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
1 source controls mapped|3 target controls covered
3%
Tennessee Information Protection Act (TIPA)
1 source controls mapped|1 target controls covered
3%
WCAG 2.2
1 source controls mapped|1 target controls covered
3%
ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary
1 source controls mapped|3 target controls covered
3%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
1 source controls mapped|1 target controls covered
3%
Online Safety Act 2021 (Australia)
1 source controls mapped|3 target controls covered
3%
South Korea PIPA
1 source controls mapped|1 target controls covered
3%
UK GDPR (UK General Data Protection Regulation)
1 source controls mapped|1 target controls covered
3%
Singapore Cybersecurity Act 2018
1 source controls mapped|1 target controls covered
3%
Cyber Security Act 2024 (Australia)
1 source controls mapped|1 target controls covered
3%
COSO Enterprise Risk Management (ERM) Framework (2017)
1 source controls mapped|2 target controls covered
3%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
1 source controls mapped|1 target controls covered
3%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
1 source controls mapped|1 target controls covered
3%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
1 source controls mapped|1 target controls covered
3%
PCI DSS v4.0
1 source controls mapped|3 target controls covered
3%
Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions
1 source controls mapped|1 target controls covered
3%
ITU Radio Regulations and Space Security Standards
1 source controls mapped|1 target controls covered
3%
Frequently Asked Questions
What is FDA Quality Management System Regulation (QMSR)?
FDA Quality Management System Regulation (QMSR) is a compliance framework from United States with 7 domains and 34 controls. The FDA Quality Management System Regulation (QMSR), effective February 2026, replaces the Quality System Regulation (21 CFR Part 820) by incorporating ISO 13485:2016 by reference. It aligns FDA quality system requirements for medical device manufacturers with the international standard, reducing regulatory burden for manufacturers operating globally while maintaining FDA-specific requirements for design controls and post-market surveillance. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does FDA Quality Management System Regulation (QMSR) have?
FDA Quality Management System Regulation (QMSR) has 34 controls organised across 7 domains. The largest domains are Design and Development (8 controls), Measurement, Analysis, and Improvement (5 controls), Production and Process Controls (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does FDA Quality Management System Regulation (QMSR) map to?
FDA Quality Management System Regulation (QMSR) maps to 526 other compliance frameworks. The top mapping partners are ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories (26% coverage), ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence (26% coverage), PIC/S Guide to Good Manufacturing Practice for Medicinal Products (26% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with FDA Quality Management System Regulation (QMSR) compliance?
Start your FDA Quality Management System Regulation (QMSR) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about FDA Quality Management System Regulation (QMSR) requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 34 controls and track your progress.
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