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ISO 13485

Self-Assess
International
v2016
11 domains
44 controls

Medical devices - Quality management systems

Unverified

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 (11)

ISO 13485: Administrative Safeguards

6 controls

Organizational security management (ISO 13485)

Controls in the ISO 13485: Administrative Safeguards domain of ISO 13485 — 6 controls
CodeTitle
ISO13485-06Security management process and risk analysis
ISO13485-07Workforce security and clearance procedures
ISO13485-08Information access management
ISO13485-09Security awareness and training program
ISO13485-10Contingency planning for ePHI
ISO13485-11Business associate management

ISO 13485: Organizational Requirements

4 controls

Policies, procedures, and documentation (ISO 13485)

Controls in the ISO 13485: Organizational Requirements domain of ISO 13485 — 4 controls
CodeTitle
ISO13485-21Security and privacy policies
ISO13485-22Documentation and record retention
ISO13485-23Compliance evaluation and review
ISO13485-24Incident reporting procedures

ISO 13485: Patient Data Protection

5 controls

Safeguarding protected health information (ISO 13485)

Controls in the ISO 13485: Patient Data Protection domain of ISO 13485 — 5 controls
CodeTitle
ISO13485-01ePHI access controls and authorization
ISO13485-02ePHI encryption at rest and in transit
ISO13485-03Minimum necessary standard enforcement
ISO13485-04Patient data de-identification procedures
ISO13485-05Audit trail for ePHI access

ISO 13485: Physical Safeguards

4 controls

Physical security for systems with ePHI (ISO 13485)

Controls in the ISO 13485: Physical Safeguards domain of ISO 13485 — 4 controls
CodeTitle
ISO13485-17Facility access controls
ISO13485-18Workstation security and use policies
ISO13485-19Device and media controls
ISO13485-20Disposal and re-use procedures

ISO 13485: Technical Safeguards

5 controls

Technical measures for ePHI protection (ISO 13485)

Controls in the ISO 13485: Technical Safeguards domain of ISO 13485 — 5 controls
CodeTitle
ISO13485-12Unique user identification and authentication
ISO13485-13Automatic logoff and session management
ISO13485-14Audit controls and monitoring
ISO13485-15Integrity controls for ePHI
ISO13485-16Transmission security and encryption

Improvement

1 controls
Controls in the Improvement domain of ISO 13485 — 1 controls
CodeTitle
8.5Control effectiveness review

Management Responsibility

2 controls
Controls in the Management Responsibility domain of ISO 13485 — 2 controls
CodeTitle
5.1Logical Access Control
5.6Monitoring Audit Programme

Measurement

5 controls
Controls in the Measurement domain of ISO 13485 — 5 controls
CodeTitle
8.2.1Service Portfolio
8.2.2Asset Management
8.2.3Configuration Management
8.2.6Monitoring and Measurement of Product
8.3Statement of Applicability linkage

Product Realisation

7 controls
Controls in the Product Realisation domain of ISO 13485 — 7 controls
CodeTitle
7.1Cyber Incident Response Planning
7.2Security Training and Awareness
7.3Risk evaluation
7.4Asset valuation
7.5Threat assessment
7.5.8Identification and Traceability
7.6Vulnerability assessment

QMS

2 controls
Controls in the QMS domain of ISO 13485 — 2 controls
CodeTitle
4.1Password Policy
4.2Multi-Factor Authentication

Resource Management

3 controls
Controls in the Resource Management domain of ISO 13485 — 3 controls
CodeTitle
6.2Approach selection
6.3Information security awareness, education and training
6.4Logging and Monitoring

Your Compliance Coverage

If you comply with ISO 13485, you already cover:

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements

36%

16 controls mapped

Compare →

NIST SP 800-66

30%

13 controls mapped

Compare →

MDS2 (Medical Device)

30%

13 controls mapped

Compare →

+ 391 more: MARS-E (30%), AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) (30%)

See all 394 mapped frameworks ↓

Maps to 394 other frameworks

44 total controls
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
16 source controls mapped|16 target controls covered
36%
NIST SP 800-66
13 source controls mapped|4 target controls covered
30%
MDS2 (Medical Device)
13 source controls mapped|5 target controls covered
30%
MARS-E
13 source controls mapped|7 target controls covered
30%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
13 source controls mapped|9 target controls covered
30%
TISAX - Trusted Information Security Assessment Exchange
13 source controls mapped|13 target controls covered
30%
ISO 27799
13 source controls mapped|12 target controls covered
30%
NIST Privacy Framework
12 source controls mapped|5 target controls covered
27%
FTC GLBA Safeguards Rule (16 CFR Part 314)
12 source controls mapped|3 target controls covered
27%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
12 source controls mapped|9 target controls covered
27%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
11 source controls mapped|5 target controls covered
25%
ISO 27001:2022
11 source controls mapped|10 target controls covered
25%
UK Gambling Commission - Cyber Resilience Requirements
11 source controls mapped|10 target controls covered
25%
Oman National Cybersecurity Framework
11 source controls mapped|3 target controls covered
25%
Protective Security Policy Framework (PSPF) Release 2024
11 source controls mapped|12 target controls covered
25%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
10 source controls mapped|14 target controls covered
23%
ISO 20000-1
10 source controls mapped|6 target controls covered
23%
US Consumer Product Safety Commission (CPSC) - Connected Product Safety
10 source controls mapped|5 target controls covered
23%
NIST SP 800-146
10 source controls mapped|3 target controls covered
23%
NIST SP 800-145
10 source controls mapped|3 target controls covered
23%
NIST SP 800-144
10 source controls mapped|4 target controls covered
23%
MTCS (Singapore)
10 source controls mapped|5 target controls covered
23%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
10 source controls mapped|2 target controls covered
23%
ISO 27018
10 source controls mapped|9 target controls covered
23%
South Korea ISMS-P
10 source controls mapped|7 target controls covered
23%
NIST SP 800-53 Rev 5
10 source controls mapped|20 target controls covered
23%
NIST SP 800-190
10 source controls mapped|8 target controls covered
23%
Azure Security Benchmark
10 source controls mapped|8 target controls covered
23%
ISO 27017
10 source controls mapped|8 target controls covered
23%
AWS Well-Architected Security Pillar
10 source controls mapped|8 target controls covered
23%
Nigeria Data Protection Act 2023 (NDPA)
10 source controls mapped|6 target controls covered
23%
Nebraska Data Privacy Act
10 source controls mapped|6 target controls covered
23%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
10 source controls mapped|5 target controls covered
23%
ISO/IEC 27011:2024
10 source controls mapped|10 target controls covered
23%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
10 source controls mapped|6 target controls covered
23%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
10 source controls mapped|7 target controls covered
23%
Telecommunications Sector Security Reforms (TSSR)
10 source controls mapped|7 target controls covered
23%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
9 source controls mapped|11 target controls covered
20%
ISO 19011
9 source controls mapped|5 target controls covered
20%
RBI Cybersecurity Framework for Banks
9 source controls mapped|7 target controls covered
20%
ISO/IEC 27400:2022
9 source controls mapped|7 target controls covered
20%
O-RAN WG11 Security Specification
9 source controls mapped|4 target controls covered
20%
NIST SP 800-92
9 source controls mapped|4 target controls covered
20%
NIST SP 800-88
9 source controls mapped|3 target controls covered
20%
NIST SP 800-63-4
9 source controls mapped|4 target controls covered
20%
NIST SP 800-61
9 source controls mapped|4 target controls covered
20%
NIST SP 800-137
9 source controls mapped|4 target controls covered
20%
NIST SP 800-123
9 source controls mapped|4 target controls covered
20%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
9 source controls mapped|3 target controls covered
20%
NAIC Insurance Data Security Model Law (MDL-668)
9 source controls mapped|3 target controls covered
20%
MITRE ATT&CK
9 source controls mapped|5 target controls covered
20%
NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)
9 source controls mapped|15 target controls covered
20%
BSI IT-Grundschutz
9 source controls mapped|11 target controls covered
20%
UNECE WP.29 R155
9 source controls mapped|9 target controls covered
20%
OWASP SAMM
9 source controls mapped|8 target controls covered
20%
ISO 27043
9 source controls mapped|10 target controls covered
20%
Spain ENS
9 source controls mapped|10 target controls covered
20%
OWASP MASVS
9 source controls mapped|8 target controls covered
20%
SSDF (NIST)
9 source controls mapped|10 target controls covered
20%
Regulation (EU) 2019/1239 on the Maritime Single Window (MSW)
9 source controls mapped|5 target controls covered
20%
ASD Strategies to Mitigate Cyber Security Incidents
9 source controls mapped|6 target controls covered
20%
SLSA
9 source controls mapped|9 target controls covered
20%
OWASP Top 10:2025
9 source controls mapped|8 target controls covered
20%
OWASP ASVS
9 source controls mapped|10 target controls covered
20%
UK PSTI Act
9 source controls mapped|10 target controls covered
20%
OpenSSF Scorecard
9 source controls mapped|12 target controls covered
20%
SIG (Shared Assessments)
9 source controls mapped|9 target controls covered
20%
Saudi NCA ECC
9 source controls mapped|11 target controls covered
20%
PTES
9 source controls mapped|10 target controls covered
20%
ISO/SAE 21434
9 source controls mapped|10 target controls covered
20%
UNECE WP.29 R156
9 source controls mapped|10 target controls covered
20%
Turkey Personal Data Protection Law (KVKK - Law No. 6698)
9 source controls mapped|7 target controls covered
20%
NIST SP 800-122
9 source controls mapped|2 target controls covered
20%
Nigeria Data Protection Regulation (NDPR)
9 source controls mapped|2 target controls covered
20%
New Jersey Data Privacy Act
9 source controls mapped|3 target controls covered
20%
New Hampshire Data Privacy Act
9 source controls mapped|3 target controls covered
20%
Montana Consumer Data Privacy Act
9 source controls mapped|3 target controls covered
20%
Minnesota Consumer Data Privacy Act
9 source controls mapped|3 target controls covered
20%
Mexico LFPDPPP
9 source controls mapped|4 target controls covered
20%
Mauritius DPA
9 source controls mapped|4 target controls covered
20%
Maryland Online Data Privacy Act of 2024
9 source controls mapped|3 target controls covered
20%
Malaysia PDPA 2010
9 source controls mapped|3 target controls covered
20%
Liechtenstein DPA
9 source controls mapped|2 target controls covered
20%
LGPD
9 source controls mapped|2 target controls covered
20%
Kentucky Consumer Data Protection Act
9 source controls mapped|4 target controls covered
20%
Jamaica Data Protection Act 2020
9 source controls mapped|4 target controls covered
20%
Privacy Act 1988 (Australia)
9 source controls mapped|4 target controls covered
20%
APPI
9 source controls mapped|4 target controls covered
20%
Bahrain PDPL
9 source controls mapped|4 target controls covered
20%
Switzerland FADP
9 source controls mapped|4 target controls covered
20%
Turkey KVKK
9 source controls mapped|4 target controls covered
20%
Oregon Consumer Privacy Act
9 source controls mapped|4 target controls covered
20%
Qatar DPL
9 source controls mapped|4 target controls covered
20%
Uruguay DPL
9 source controls mapped|4 target controls covered
20%
Utah Consumer Privacy Act
9 source controls mapped|4 target controls covered
20%
Tennessee IPA
9 source controls mapped|4 target controls covered
20%
UK Data Protection Act 2018
9 source controls mapped|4 target controls covered
20%
PDPA Singapore
9 source controls mapped|4 target controls covered
20%
Personal Data Act (personopplysningsloven)
9 source controls mapped|4 target controls covered
20%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
9 source controls mapped|3 target controls covered
20%
Peru DPL
9 source controls mapped|4 target controls covered
20%
Rwanda DPL
9 source controls mapped|4 target controls covered
20%
PDPA Thailand
9 source controls mapped|4 target controls covered
20%
Virginia CDPA
9 source controls mapped|4 target controls covered
20%
Texas Data Privacy Act
9 source controls mapped|4 target controls covered
20%
Taiwan PDPA
9 source controls mapped|4 target controls covered
20%
Privacy Act 2020
9 source controls mapped|4 target controls covered
20%
Saudi Arabia PDPL
9 source controls mapped|4 target controls covered
20%
POPIA
9 source controls mapped|4 target controls covered
20%
Philippines DPA
9 source controls mapped|4 target controls covered
20%
Vietnam PDPD
9 source controls mapped|4 target controls covered
20%
SWIFT CSCF
8 source controls mapped|9 target controls covered
18%
PropTech Security Standards - Smart Building Cybersecurity
8 source controls mapped|5 target controls covered
18%
OWASP DevSecOps Maturity Model (DSOMM)
8 source controls mapped|9 target controls covered
18%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
8 source controls mapped|6 target controls covered
18%
MARS-E - Minimum Acceptable Risk Standards for Exchanges
8 source controls mapped|2 target controls covered
18%
Sigstore - Software Artifact Signing and Verification
8 source controls mapped|7 target controls covered
18%
South Korea PIPA
8 source controls mapped|3 target controls covered
18%
US ITAR and EAR - Export Control and Data Security
8 source controls mapped|3 target controls covered
18%
Philippines Data Privacy Act (RA 10173)
8 source controls mapped|5 target controls covered
18%
SQF Code Edition 9 - Safe Quality Food
7 source controls mapped|7 target controls covered
16%
ISO 27005
7 source controls mapped|6 target controls covered
16%
AS9100D - Aerospace Quality Management System
7 source controls mapped|8 target controls covered
16%
ISO/IEC 27003:2017
7 source controls mapped|8 target controls covered
16%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
7 source controls mapped|7 target controls covered
16%
ISO 31000:2018
7 source controls mapped|3 target controls covered
16%
Florida Digital Bill of Rights (FDBR)
7 source controls mapped|4 target controls covered
16%
Wisconsin Data Privacy Act (SB 670)
7 source controls mapped|10 target controls covered
16%
Tennessee Information Protection Act (TIPA)
7 source controls mapped|8 target controls covered
16%
Secure by Design: A Guide for Manufacturers (CISA)
7 source controls mapped|5 target controls covered
16%
OWASP API Security Top 10 - 2023
7 source controls mapped|5 target controls covered
16%
TSA Pipeline Cybersecurity Directives
7 source controls mapped|4 target controls covered
16%
NIST AI Risk Management Framework (AI RMF 1.0)
7 source controls mapped|7 target controls covered
16%
IEC 62351 - Power Systems Communication Security
7 source controls mapped|4 target controls covered
16%
ISO/IEC 27006:2024
6 source controls mapped|7 target controls covered
14%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
6 source controls mapped|7 target controls covered
14%
SWIFT CSCF v2024
6 source controls mapped|7 target controls covered
14%
ISO/IEC 25012:2008 - Data Quality Model
6 source controls mapped|3 target controls covered
14%
NIS2 Directive Implementing Acts
6 source controls mapped|2 target controls covered
14%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
6 source controls mapped|5 target controls covered
14%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
6 source controls mapped|6 target controls covered
14%
TEFCA - Trusted Exchange Framework and Common Agreement
6 source controls mapped|5 target controls covered
14%
Zimbabwe Data Protection Act (2021)
6 source controls mapped|4 target controls covered
14%
TSA Pipeline Security
6 source controls mapped|5 target controls covered
14%
UK Telecommunications (Security) Act 2021
6 source controls mapped|2 target controls covered
14%
ISO 28001:2007 Supply Chain Security Management
6 source controls mapped|3 target controls covered
14%
Annex 11 to EU GMP - Computerised Systems
6 source controls mapped|6 target controls covered
14%
ISO/IEC 27010:2015
6 source controls mapped|4 target controls covered
14%
ICH E6(R3) - Good Clinical Practice
5 source controls mapped|2 target controls covered
11%
FDA Quality Management System Regulation (QMSR)
5 source controls mapped|3 target controls covered
11%
21 CFR Part 211 - Current Good Manufacturing Practice
5 source controls mapped|4 target controls covered
11%
ISO 45001:2018
5 source controls mapped|5 target controls covered
11%
BRCGS Global Standard for Food Safety Issue 9
5 source controls mapped|10 target controls covered
11%
ISO 9001:2015
5 source controls mapped|5 target controls covered
11%
US OFAC Sanctions Compliance Framework
5 source controls mapped|4 target controls covered
11%
21 CFR Part 58 - Good Laboratory Practice (GLP)
5 source controls mapped|3 target controls covered
11%
IEC 62304:2015 Medical Device Software Lifecycle Processes
5 source controls mapped|4 target controls covered
11%
ITU-T X.805 - Security Architecture for End-to-End Communications
5 source controls mapped|2 target controls covered
11%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
5 source controls mapped|5 target controls covered
11%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
5 source controls mapped|7 target controls covered
11%
Russia Federal Law on Personal Data (152-FZ)
5 source controls mapped|2 target controls covered
11%
W3C Verifiable Credentials (VC) Data Model 2.0
5 source controls mapped|5 target controls covered
11%
UK Open Banking Standard
5 source controls mapped|5 target controls covered
11%
NIST Cybersecurity Framework 2.0
5 source controls mapped|6 target controls covered
11%
US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements
5 source controls mapped|1 target controls covered
11%
RFC 2350 - Expectations for Computer Security Incident Response (BCP 21)
5 source controls mapped|5 target controls covered
11%
SSAE 18 - Attestation Standards (SOC Reporting)
5 source controls mapped|7 target controls covered
11%
SWIFT Customer Security Programme (CSP)
5 source controls mapped|3 target controls covered
11%
US Executive Order 14028 - Improving the Nation's Cybersecurity
5 source controls mapped|2 target controls covered
11%
3GPP 5G Security Architecture (TS 33.501)
5 source controls mapped|5 target controls covered
11%
ICAO Annex 17 - Aviation Security (AVSEC)
5 source controls mapped|3 target controls covered
11%
IATA Operational Safety Audit (IOSA) Standards Manual
5 source controls mapped|2 target controls covered
11%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
5 source controls mapped|4 target controls covered
11%
Trinidad and Tobago Data Protection Act 2011
5 source controls mapped|9 target controls covered
11%
Saudi PDPL
5 source controls mapped|5 target controls covered
11%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
5 source controls mapped|8 target controls covered
11%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
5 source controls mapped|4 target controls covered
11%
Barbados Data Protection Act 2019
5 source controls mapped|4 target controls covered
11%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
5 source controls mapped|4 target controls covered
11%
ISO/IEC 23894:2023
5 source controls mapped|7 target controls covered
11%
UK GDPR (UK General Data Protection Regulation)
5 source controls mapped|4 target controls covered
11%
FFIEC Cybersecurity Assessment Tool (CAT)
5 source controls mapped|5 target controls covered
11%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
5 source controls mapped|4 target controls covered
11%
FBI CJIS Security Policy
5 source controls mapped|5 target controls covered
11%
GS1 Global Standards - Supply Chain Traceability and Data Security
4 source controls mapped|2 target controls covered
9%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
4 source controls mapped|2 target controls covered
9%
FSSC 22000 - Food Safety System Certification
4 source controls mapped|1 target controls covered
9%
ASIS SPC.1-2009 - Organizational Resilience Standard
4 source controls mapped|4 target controls covered
9%
ISO 14001:2015
4 source controls mapped|4 target controls covered
9%
Singapore Model AI Governance Framework (2nd Edition)
4 source controls mapped|1 target controls covered
9%
ISO 13485:2016
4 source controls mapped|3 target controls covered
9%
ISO/IEC 27701:2019
4 source controls mapped|1 target controls covered
9%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
4 source controls mapped|4 target controls covered
9%
ISO 26000:2010
4 source controls mapped|1 target controls covered
9%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
4 source controls mapped|3 target controls covered
9%
Tonga Communications Act (2015) - Privacy & Data Protection
4 source controls mapped|2 target controls covered
9%
FIDO2 / WebAuthn
4 source controls mapped|2 target controls covered
9%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
4 source controls mapped|7 target controls covered
9%
Proposal for a Directive on improving working conditions in platform work (COM(2023) 491)
4 source controls mapped|7 target controls covered
9%
Peru Personal Data Protection Law (Law No. 29733)
4 source controls mapped|4 target controls covered
9%
Pakistan Personal Data Protection Bill 2023
4 source controls mapped|5 target controls covered
9%
Senegal Law on Personal Data Protection (Law No. 2008-12)
4 source controls mapped|5 target controls covered
9%
Uzbekistan Law on Personal Data (No. ZRU-547)
4 source controls mapped|5 target controls covered
9%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
4 source controls mapped|6 target controls covered
9%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
4 source controls mapped|2 target controls covered
9%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
4 source controls mapped|7 target controls covered
9%
Portugal Law No. 58/2019 - Data Protection Implementation Act
4 source controls mapped|9 target controls covered
9%
Oman Personal Data Protection Law (Royal Decree 6/2022)
4 source controls mapped|5 target controls covered
9%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
4 source controls mapped|5 target controls covered
9%
Singapore Payment Services Act (PSA) - Digital Payment Token Regulation
4 source controls mapped|4 target controls covered
9%
Tanzania Personal Data Protection Act (Draft)
4 source controls mapped|7 target controls covered
9%
SOC 2
4 source controls mapped|4 target controls covered
9%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
4 source controls mapped|4 target controls covered
9%
South Africa Promotion of Access to Information Act (PAIA)
4 source controls mapped|2 target controls covered
9%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
4 source controls mapped|2 target controls covered
9%
Azerbaijan Law on Personal Data (2010)
4 source controls mapped|3 target controls covered
9%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
4 source controls mapped|2 target controls covered
9%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
4 source controls mapped|5 target controls covered
9%
Uruguay Personal Data Protection Act (Law No. 18.331)
4 source controls mapped|8 target controls covered
9%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
4 source controls mapped|4 target controls covered
9%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
4 source controls mapped|5 target controls covered
9%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
4 source controls mapped|5 target controls covered
9%
Serbia Law on Personal Data Protection (2018)
4 source controls mapped|6 target controls covered
9%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
4 source controls mapped|6 target controls covered
9%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
4 source controls mapped|3 target controls covered
9%
APRA CPS 234
4 source controls mapped|4 target controls covered
9%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
4 source controls mapped|2 target controls covered
9%
API 1164
4 source controls mapped|4 target controls covered
9%
NIS2 Directive
4 source controls mapped|2 target controls covered
9%
IEC 62443
4 source controls mapped|4 target controls covered
9%
UK Security and Emergency Measures Direction (SEMD) - Water Industry
4 source controls mapped|4 target controls covered
9%
ISO 27019
4 source controls mapped|4 target controls covered
9%
NIST SP 1800-32
4 source controls mapped|4 target controls covered
9%
New Zealand Information Security Manual (NZISM)
4 source controls mapped|2 target controls covered
9%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
4 source controls mapped|2 target controls covered
9%
Japan AI Guidelines
4 source controls mapped|2 target controls covered
9%
GDPR
4 source controls mapped|3 target controls covered
9%
Singapore AI Governance Framework
4 source controls mapped|2 target controls covered
9%
UNICEF Policy Guidance on AI for Children (2021)
4 source controls mapped|2 target controls covered
9%
UK AI Regulation Framework
4 source controls mapped|2 target controls covered
9%
UK Age Appropriate Design Code (Children's Code)
4 source controls mapped|2 target controls covered
9%
UNESCO Recommendation on the Ethics of AI
4 source controls mapped|3 target controls covered
9%
Zambia Data Protection Act (2021)
4 source controls mapped|3 target controls covered
9%
OECD AI Principles
4 source controls mapped|2 target controls covered
9%
Uganda Data Protection and Privacy Act (2019)
4 source controls mapped|4 target controls covered
9%
ISO 14001
3 source controls mapped|3 target controls covered
7%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
3 source controls mapped|6 target controls covered
7%
WCAG 2.2
3 source controls mapped|3 target controls covered
7%
Illinois Biometric Information Privacy Act (BIPA)
3 source controls mapped|4 target controls covered
7%
OWASP Top 10 for LLM Applications 2025
3 source controls mapped|4 target controls covered
7%
AML/CTF Act 2006 (Australia)
3 source controls mapped|2 target controls covered
7%
Regulation on the European Health Data Space (EHDS)
3 source controls mapped|2 target controls covered
7%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
3 source controls mapped|4 target controls covered
7%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
3 source controls mapped|2 target controls covered
7%
Monetary Authority of Singapore Technology Risk Management Guidelines
3 source controls mapped|2 target controls covered
7%
Aged Care Quality Standards (Australia)
3 source controls mapped|3 target controls covered
7%
Open Banking Security
3 source controls mapped|2 target controls covered
7%
US NRC 10 CFR 73.54 - Cyber Security for Nuclear Power Plants
3 source controls mapped|4 target controls covered
7%
PCI P2PE
3 source controls mapped|2 target controls covered
7%
PCI PIN Security
3 source controls mapped|2 target controls covered
7%
SWIFT CSP
3 source controls mapped|2 target controls covered
7%
PCI SSF
3 source controls mapped|2 target controls covered
7%
OSFI B-13
3 source controls mapped|2 target controls covered
7%
FFIEC IT Examination Handbook
3 source controls mapped|2 target controls covered
7%
PSD2 SCA
3 source controls mapped|2 target controls covered
7%
Canada ITSG-33 - IT Security Risk Management
3 source controls mapped|1 target controls covered
7%
ITIL 4
3 source controls mapped|1 target controls covered
7%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
3 source controls mapped|2 target controls covered
7%
Authorised Economic Operator (AEO) Programmes - Global Standards
3 source controls mapped|3 target controls covered
7%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|3 target controls covered
7%
Nevada Gaming Control Board Cybersecurity Requirements
3 source controls mapped|1 target controls covered
7%
Jordan Draft Personal Data Protection Law (2022)
3 source controls mapped|2 target controls covered
7%
Student Privacy Pledge 2020
3 source controls mapped|1 target controls covered
7%
IATF 16949:2016 - Quality Management System for Automotive Production
2 source controls mapped|5 target controls covered
5%
Virginia Consumer Data Protection Act (VCDPA)
2 source controls mapped|2 target controls covered
5%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
2 source controls mapped|4 target controls covered
5%
ACSC Essential Eight
2 source controls mapped|6 target controls covered
5%
MITRE D3FEND
2 source controls mapped|2 target controls covered
5%
ISMAP (Japan)
2 source controls mapped|2 target controls covered
5%
GLI-33 - Gaming Laboratories International Event Wagering Systems
2 source controls mapped|2 target controls covered
5%
FedRAMP Rev 5
2 source controls mapped|2 target controls covered
5%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
2 source controls mapped|3 target controls covered
5%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
2 source controls mapped|1 target controls covered
5%
Armenia Law on Protection of Personal Data (2015)
2 source controls mapped|1 target controls covered
5%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
2 source controls mapped|1 target controls covered
5%
ITAR - International Traffic in Arms Regulations
2 source controls mapped|3 target controls covered
5%
French Sapin II Law (Law No. 2016-1691)
2 source controls mapped|3 target controls covered
5%
ISO/IEC 27031:2011
2 source controls mapped|2 target controls covered
5%
ISO/IEC 29147:2018
2 source controls mapped|4 target controls covered
5%
ISO/IEC 29134:2023
2 source controls mapped|5 target controls covered
5%
ISO/IEC 27014:2020
2 source controls mapped|4 target controls covered
5%
Union Customs Code (UCC) - Regulation (EU) No 952/2013
2 source controls mapped|4 target controls covered
5%
SANS Incident Handler's Handbook and PICERL Methodology
2 source controls mapped|2 target controls covered
5%
ISO 41001:2018 - Facility Management Systems
2 source controls mapped|4 target controls covered
5%
ISO 39001:2012 - Road Traffic Safety Management
2 source controls mapped|4 target controls covered
5%
ISO 50001:2018 - Energy Management Systems
2 source controls mapped|4 target controls covered
5%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
2 source controls mapped|4 target controls covered
5%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
2 source controls mapped|4 target controls covered
5%
FedRAMP High
2 source controls mapped|2 target controls covered
5%
NIST SP 800-53 Revision 5.1 HIGH
2 source controls mapped|2 target controls covered
5%
FedRAMP Moderate
2 source controls mapped|2 target controls covered
5%
NIST SP 800-53 Rev 5 MODERATE
2 source controls mapped|2 target controls covered
5%
NIST SP 800-53 Rev 5 LOW
2 source controls mapped|2 target controls covered
5%
Singapore Cybersecurity Act 2018
2 source controls mapped|2 target controls covered
5%
AICPA Privacy Management Framework (PMF)
2 source controls mapped|3 target controls covered
5%
ISO 26262:2018 - Functional Safety for Road Vehicles
2 source controls mapped|2 target controls covered
5%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
2 source controls mapped|5 target controls covered
5%
NSA Guidance for Transition to Quantum-Resistant Cryptography
2 source controls mapped|3 target controls covered
5%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
1 source controls mapped|1 target controls covered
2%
Washington My Health My Data Act (MHMD)
1 source controls mapped|3 target controls covered
2%
IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
1 source controls mapped|1 target controls covered
2%
HL7 FHIR Security Framework
1 source controls mapped|1 target controls covered
2%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
2%
FISMA
1 source controls mapped|1 target controls covered
2%
FDA 21 CFR Part 11
1 source controls mapped|1 target controls covered
2%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
2%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
1 source controls mapped|1 target controls covered
2%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
1 source controls mapped|2 target controls covered
2%
Notifiable Data Breaches Scheme (Australia)
1 source controls mapped|1 target controls covered
2%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
1 source controls mapped|2 target controls covered
2%
ITU Radio Regulations and Space Security Standards
1 source controls mapped|1 target controls covered
2%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
1 source controls mapped|1 target controls covered
2%
Israel Protection of Privacy Law (5741-1981)
1 source controls mapped|2 target controls covered
2%
India Account Aggregator Framework (RBI)
1 source controls mapped|1 target controls covered
2%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
1 source controls mapped|1 target controls covered
2%
ICH Q10 - Pharmaceutical Quality System
1 source controls mapped|2 target controls covered
2%
HKMA SPM
1 source controls mapped|1 target controls covered
2%
HKMA Cyber Resilience Assessment Framework (C-RAF)
1 source controls mapped|1 target controls covered
2%
GLBA
1 source controls mapped|1 target controls covered
2%
GAMP 5 - Good Automated Manufacturing Practice
1 source controls mapped|2 target controls covered
2%
FATF Recommendation 16 - Virtual Asset Travel Rule
1 source controls mapped|1 target controls covered
2%
ANSSI Cybersecurity Framework
1 source controls mapped|1 target controls covered
2%
NIST SP 800-218
1 source controls mapped|1 target controls covered
2%
US Foreign Corrupt Practices Act (FCPA)
1 source controls mapped|1 target controls covered
2%
ISO/IEC 27007:2020
1 source controls mapped|1 target controls covered
2%
ISO/IEC 29100:2024
1 source controls mapped|3 target controls covered
2%
ISO/IEC 27004:2016
1 source controls mapped|3 target controls covered
2%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
1 source controls mapped|1 target controls covered
2%
ISO/IEC 30111:2019
1 source controls mapped|3 target controls covered
2%
ISO/IEC 38500:2024 - Governance of IT
1 source controls mapped|3 target controls covered
2%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
1 source controls mapped|3 target controls covered
2%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
1 source controls mapped|4 target controls covered
2%
IEC 60601-1 - Medical Electrical Equipment Safety
1 source controls mapped|2 target controls covered
2%
ISO 37000:2021 - Governance of Organizations
1 source controls mapped|3 target controls covered
2%
ISO 22320:2018
1 source controls mapped|3 target controls covered
2%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
1 source controls mapped|1 target controls covered
2%
UK Building Safety Act 2022
1 source controls mapped|2 target controls covered
2%
Science Based Targets initiative (SBTi) Corporate Standard
1 source controls mapped|2 target controls covered
2%
ISO 8000 - Data Quality
1 source controls mapped|2 target controls covered
2%
ISO 20400:2017 - Sustainable Procurement
1 source controls mapped|2 target controls covered
2%
Philippines Cybercrime Prevention Act (RA 10175)
1 source controls mapped|1 target controls covered
2%
US SEC Digital Assets and Crypto Regulatory Framework
1 source controls mapped|2 target controls covered
2%
ISO 56002
1 source controls mapped|4 target controls covered
2%
ISO 37002:2021 - Whistleblowing Management Systems
1 source controls mapped|3 target controls covered
2%
Singapore Payment Services Act 2019 (PSA) - Digital Payment Token Provisions
1 source controls mapped|1 target controls covered
2%
South Korea Credit Information Act
1 source controls mapped|1 target controls covered
2%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
1 source controls mapped|3 target controls covered
2%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
1 source controls mapped|1 target controls covered
2%
IAIS Insurance Core Principles (ICPs)
1 source controls mapped|1 target controls covered
2%
WHO Global Strategy on Digital Health 2020-2025
1 source controls mapped|1 target controls covered
2%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
1 source controls mapped|2 target controls covered
2%
UK Bribery Act 2010
1 source controls mapped|3 target controls covered
2%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
1 source controls mapped|2 target controls covered
2%
TNFD Recommendations
1 source controls mapped|1 target controls covered
2%
AASB S2 Climate-related Disclosures
1 source controls mapped|1 target controls covered
2%
COBIT 2019
1 source controls mapped|1 target controls covered
2%
WCO Authorised Economic Operator (AEO) Framework
1 source controls mapped|1 target controls covered
2%
NIST SP 800-39
1 source controls mapped|1 target controls covered
2%
NIST SP 800-37
1 source controls mapped|2 target controls covered
2%
NIST SP 800-30
1 source controls mapped|3 target controls covered
2%
NERC CIP
1 source controls mapped|1 target controls covered
2%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|2 target controls covered
2%
German Supply Chain Due Diligence Act (LkSG)
1 source controls mapped|2 target controls covered
2%
APRA CPS 230 Operational Risk Management
1 source controls mapped|1 target controls covered
2%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|2 target controls covered
2%
EASA Part-IS - Information Security in Aviation
1 source controls mapped|2 target controls covered
2%
US Gramm-Leach-Bliley Act (GLBA) - Higher Education Safeguards Rule
1 source controls mapped|2 target controls covered
2%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|1 target controls covered
2%
Responsible Minerals Initiative (RMI) - Responsible Minerals Assurance Process
1 source controls mapped|3 target controls covered
2%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
2%
UK Online Safety Act 2023
1 source controls mapped|3 target controls covered
2%
SEC Climate Disclosure Rule
1 source controls mapped|1 target controls covered
2%
UK FCA/PRA Operational Resilience Framework
1 source controls mapped|1 target controls covered
2%
UK Modern Slavery Act 2015
1 source controls mapped|1 target controls covered
2%
ISO 31000
1 source controls mapped|3 target controls covered
2%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|1 target controls covered
2%
ISO 45001
1 source controls mapped|1 target controls covered
2%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
1 source controls mapped|3 target controls covered
2%
South Korea Cloud Security Assurance Program (CSAP)
1 source controls mapped|1 target controls covered
2%
ISO 22000
1 source controls mapped|1 target controls covered
2%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
2%
NIST SP 800-171
1 source controls mapped|1 target controls covered
2%
US Automated Commercial Environment (ACE) - CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
2%
Samoa Telecommunications Act (2005) - Privacy & Data Protection
1 source controls mapped|2 target controls covered
2%
Compare ISO 13485 with NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements

Frequently Asked Questions

What is ISO 13485?

ISO 13485 is a compliance framework from International with 11 domains and 44 controls. Medical devices - Quality management systems It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

How many controls does ISO 13485 have?

ISO 13485 has 44 controls organised across 11 domains. The largest domains are Product Realisation (7 controls), ISO 13485: Administrative Safeguards (6 controls), ISO 13485: Patient Data Protection (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does ISO 13485 map to?

ISO 13485 maps to 394 other compliance frameworks. The top mapping partners are NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements (36% coverage), NIST SP 800-66 (30% coverage), MDS2 (Medical Device) (30% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with ISO 13485 compliance?

Start your ISO 13485 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ISO 13485 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 44 controls and track your progress.

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