Back to Frameworks

ISO 13485

Self-Assess
International
v2016
5 domains
24 controls

Medical devices - Quality management systems

Unverified

ISO 13485 is a compliance framework from International with 5 domains and 24 controls that map to 211 other frameworks. The largest domains are ISO 13485: Administrative Safeguards (6 controls), ISO 13485: Patient Data Protection (5 controls), ISO 13485: Technical Safeguards (5 controls). Every control below carries what it requires and what an assessor expects to see.

Maintained by Gerard BlokdykControl text last updated

Framework summaries on this platform are interpretations grounded in the published source, 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 (5)

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

Your Compliance Coverage

If you comply with ISO 13485, you already cover:

NIST SP 800-66

50%

12 controls mapped

Compare →

MDS2 (Medical Device)

50%

12 controls mapped

Compare →

MARS-E

50%

12 controls mapped

Compare →

+ 208 more: ISO 27799:2025 (50%), NIST Privacy Framework (46%)

See all 211 mapped frameworks ↓

Maps to 211 other frameworks

24 total controls
NIST SP 800-66
12 source controls mapped|4 target controls covered
50%
MDS2 (Medical Device)
12 source controls mapped|5 target controls covered
50%
MARS-E
12 source controls mapped|7 target controls covered
50%
ISO 27799:2025
12 source controls mapped|12 target controls covered
50%
NIST Privacy Framework
11 source controls mapped|5 target controls covered
46%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
11 source controls mapped|8 target controls covered
46%
TISAX - Trusted Information Security Assessment Exchange
10 source controls mapped|6 target controls covered
42%
Oman National Cybersecurity Framework
10 source controls mapped|3 target controls covered
42%
FTC GLBA Safeguards Rule (16 CFR Part 314)
10 source controls mapped|2 target controls covered
42%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
10 source controls mapped|8 target controls covered
42%
Virginia CDPA
9 source controls mapped|2 target controls covered
38%
Vietnam PDPD
9 source controls mapped|2 target controls covered
38%
Uruguay DPL
9 source controls mapped|3 target controls covered
38%
Turkey KVKK
9 source controls mapped|2 target controls covered
38%
Texas Data Privacy and Security Act (TDPSA)
9 source controls mapped|2 target controls covered
38%
Taiwan PDPA
9 source controls mapped|2 target controls covered
38%
Qatar DPL
9 source controls mapped|2 target controls covered
38%
Privacy Act 2020
9 source controls mapped|3 target controls covered
38%
POPIA
9 source controls mapped|3 target controls covered
38%
Personal Data Act (personopplysningsloven)
9 source controls mapped|3 target controls covered
38%
PDPA Thailand
9 source controls mapped|3 target controls covered
38%
PDPA Singapore
9 source controls mapped|3 target controls covered
38%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
9 source controls mapped|2 target controls covered
38%
Oregon Consumer Privacy Act
9 source controls mapped|3 target controls covered
38%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
9 source controls mapped|4 target controls covered
38%
NIST SP 800-122
9 source controls mapped|2 target controls covered
38%
Nigeria Data Protection Regulation (NDPR)
9 source controls mapped|2 target controls covered
38%
Nigeria Data Protection Act 2023 (NDPA)
9 source controls mapped|5 target controls covered
38%
Nebraska Data Privacy Act
9 source controls mapped|5 target controls covered
38%
New Jersey Data Privacy Act
9 source controls mapped|3 target controls covered
38%
New Hampshire Data Privacy Act
9 source controls mapped|3 target controls covered
38%
Montana Consumer Data Privacy Act
9 source controls mapped|3 target controls covered
38%
Minnesota Consumer Data Privacy Act
9 source controls mapped|3 target controls covered
38%
Mexico LFPDPPP
9 source controls mapped|4 target controls covered
38%
Mauritius DPA
9 source controls mapped|4 target controls covered
38%
Maryland Online Data Privacy Act of 2024
9 source controls mapped|3 target controls covered
38%
Malaysia PDPA 2010
9 source controls mapped|3 target controls covered
38%
Liechtenstein DPA
9 source controls mapped|2 target controls covered
38%
LGPD
9 source controls mapped|2 target controls covered
38%
Kentucky Consumer Data Protection Act
9 source controls mapped|4 target controls covered
38%
Jamaica Data Protection Act 2020
9 source controls mapped|4 target controls covered
38%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
9 source controls mapped|4 target controls covered
38%
Bahrain PDPL
9 source controls mapped|4 target controls covered
38%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
9 source controls mapped|5 target controls covered
38%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
9 source controls mapped|7 target controls covered
38%
ISO/IEC 27011:2024
9 source controls mapped|7 target controls covered
38%
NIST SP 800-53 Rev 5
9 source controls mapped|20 target controls covered
38%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
9 source controls mapped|3 target controls covered
38%
Saudi Arabia PDPL
9 source controls mapped|4 target controls covered
38%
Peru DPL
8 source controls mapped|2 target controls covered
33%
NAIC Insurance Data Security Model Law (MDL-668)
8 source controls mapped|3 target controls covered
33%
US Consumer Product Safety Act (CPSC) Manufacturer and Importer Duties
8 source controls mapped|3 target controls covered
33%
BSI IT-Grundschutz
8 source controls mapped|11 target controls covered
33%
South Korea ISMS-P
8 source controls mapped|7 target controls covered
33%
US ITAR and EAR - Export Control and Data Security
8 source controls mapped|3 target controls covered
33%
NIST SP 800-146
8 source controls mapped|3 target controls covered
33%
NIST SP 800-145
8 source controls mapped|3 target controls covered
33%
NIST SP 800-144
8 source controls mapped|4 target controls covered
33%
MTCS (Singapore)
8 source controls mapped|5 target controls covered
33%
ASD Strategies to Mitigate Cyber Security Incidents
8 source controls mapped|6 target controls covered
33%
NIST SP 800-190
8 source controls mapped|7 target controls covered
33%
SLSA
7 source controls mapped|2 target controls covered
29%
Sigstore - Software Artifact Signing and Verification
7 source controls mapped|4 target controls covered
29%
SIG (Shared Assessments)
7 source controls mapped|3 target controls covered
29%
PTES
7 source controls mapped|2 target controls covered
29%
OWASP SAMM
7 source controls mapped|2 target controls covered
29%
OWASP MASVS
7 source controls mapped|4 target controls covered
29%
OpenSSF Scorecard
7 source controls mapped|3 target controls covered
29%
O-RAN WG11 Security Specification
7 source controls mapped|3 target controls covered
29%
NIST SP 800-92
7 source controls mapped|3 target controls covered
29%
NIST SP 800-88
7 source controls mapped|3 target controls covered
29%
NIST SP 800-63-4
7 source controls mapped|3 target controls covered
29%
NIST SP 800-61 Rev. 3
7 source controls mapped|3 target controls covered
29%
NIST SP 800-137
7 source controls mapped|3 target controls covered
29%
NIST SP 800-123
7 source controls mapped|3 target controls covered
29%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
7 source controls mapped|2 target controls covered
29%
MITRE ATT&CK
7 source controls mapped|4 target controls covered
29%
South Korea PIPA
7 source controls mapped|2 target controls covered
29%
ISO/IEC 27043:2015
7 source controls mapped|9 target controls covered
29%
ISO/SAE 21434
7 source controls mapped|9 target controls covered
29%
ISO/IEC 27400:2022
7 source controls mapped|4 target controls covered
29%
TSA Pipeline Cybersecurity Directives
6 source controls mapped|2 target controls covered
25%
IEC 62351 - Power Systems Communication Security
6 source controls mapped|3 target controls covered
25%
ISO/IEC 27010:2015
6 source controls mapped|4 target controls covered
25%
Secure by Design: A Guide for Manufacturers (CISA)
6 source controls mapped|3 target controls covered
25%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
6 source controls mapped|4 target controls covered
25%
UK Gambling Commission LCCP and Remote Technical Standards
5 source controls mapped|1 target controls covered
21%
APPI
5 source controls mapped|2 target controls covered
21%
FFIEC Cybersecurity Assessment Tool (CAT)
5 source controls mapped|5 target controls covered
21%
Annex 11 to EU GMP - Computerised Systems
5 source controls mapped|3 target controls covered
21%
ISO 28001:2007 Supply Chain Security Management
5 source controls mapped|3 target controls covered
21%
FBI CJIS Security Policy
5 source controls mapped|5 target controls covered
21%
API 1164
4 source controls mapped|4 target controls covered
17%
ITU-T X.805 - Security Architecture for End-to-End Communications
4 source controls mapped|2 target controls covered
17%
ICAO Annex 17 - Aviation Security (AVSEC)
4 source controls mapped|2 target controls covered
17%
IATA Operational Safety Audit (IOSA) Standards Manual
4 source controls mapped|1 target controls covered
17%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
4 source controls mapped|2 target controls covered
17%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
4 source controls mapped|2 target controls covered
17%
IEC 62443
4 source controls mapped|4 target controls covered
17%
ISO/IEC 27019:2024
4 source controls mapped|4 target controls covered
17%
NIST SP 1800-32
4 source controls mapped|4 target controls covered
17%
UK Security and Emergency Measures Direction (SEMD) - Water Industry
4 source controls mapped|2 target controls covered
17%
UK Telecommunications (Security) Act 2021
4 source controls mapped|1 target controls covered
17%
Florida Digital Bill of Rights (FDBR)
4 source controls mapped|3 target controls covered
17%
3GPP 5G Security Architecture (TS 33.501)
4 source controls mapped|5 target controls covered
17%
New Zealand Information Security Manual (NZISM)
4 source controls mapped|2 target controls covered
17%
UNICEF Policy Guidance on AI for Children (2021)
4 source controls mapped|1 target controls covered
17%
UNESCO Recommendation on the Ethics of AI
4 source controls mapped|3 target controls covered
17%
UK GDPR (UK General Data Protection Regulation)
4 source controls mapped|2 target controls covered
17%
UK AI Regulation Framework
4 source controls mapped|2 target controls covered
17%
OECD AI Principles
4 source controls mapped|2 target controls covered
17%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
4 source controls mapped|2 target controls covered
17%
Japan AI Guidelines
4 source controls mapped|2 target controls covered
17%
Barbados Data Protection Act 2019
4 source controls mapped|3 target controls covered
17%
GDPR
4 source controls mapped|3 target controls covered
17%
ISO/IEC 23894:2023
4 source controls mapped|4 target controls covered
17%
UK Age Appropriate Design Code (Children's Code)
4 source controls mapped|2 target controls covered
17%
Uganda Data Protection and Privacy Act (2019)
4 source controls mapped|4 target controls covered
17%
Canada ITSG-33 - IT Security Risk Management
3 source controls mapped|1 target controls covered
13%
SOC 2
3 source controls mapped|2 target controls covered
13%
ITIL 4
3 source controls mapped|1 target controls covered
13%
ISO/IEC 20000-1:2018
3 source controls mapped|1 target controls covered
13%
W3C Verifiable Credentials (VC) Data Model 2.0
3 source controls mapped|2 target controls covered
13%
FIDO2 / WebAuthn
3 source controls mapped|1 target controls covered
13%
ISO/IEC 29115:2013 - Entity Authentication Assurance Framework
3 source controls mapped|4 target controls covered
13%
ISO/IEC 23837:2023
3 source controls mapped|4 target controls covered
13%
SSAE 18 - Attestation Standards (SOC Reporting)
3 source controls mapped|5 target controls covered
13%
UK Open Banking Standard
3 source controls mapped|4 target controls covered
13%
NIST Cybersecurity Framework 2.0
3 source controls mapped|5 target controls covered
13%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
3 source controls mapped|2 target controls covered
13%
Authorised Economic Operator (AEO) Programmes - Global Standards
3 source controls mapped|3 target controls covered
13%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|3 target controls covered
13%
Trinidad and Tobago Data Protection Act 2011
3 source controls mapped|3 target controls covered
13%
Tanzania Personal Data Protection Act 2022
3 source controls mapped|1 target controls covered
13%
Student Privacy Pledge 2020
3 source controls mapped|1 target controls covered
13%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
3 source controls mapped|1 target controls covered
13%
Nevada Gaming Control Board Cybersecurity Requirements
3 source controls mapped|1 target controls covered
13%
Jordan Personal Data Protection Law (Law No. 24 of 2023)
3 source controls mapped|2 target controls covered
13%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|3 target controls covered
13%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|2 target controls covered
13%
ISO 26000:2010
3 source controls mapped|1 target controls covered
13%
Albania Law No. 124/2024 on Personal Data Protection
3 source controls mapped|1 target controls covered
13%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
3 source controls mapped|1 target controls covered
13%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
3 source controls mapped|1 target controls covered
13%
TEFCA - Trusted Exchange Framework and Common Agreement
3 source controls mapped|1 target controls covered
13%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|2 target controls covered
13%
Telecommunications Sector Security Reforms (TSSR)
3 source controls mapped|1 target controls covered
13%
OWASP Top 10 for LLM Applications 2025
2 source controls mapped|4 target controls covered
8%
AML/CTF Act 2006 (Australia)
2 source controls mapped|2 target controls covered
8%
PSD2 SCA
2 source controls mapped|1 target controls covered
8%
OSFI B-13
2 source controls mapped|1 target controls covered
8%
Open Banking Security
2 source controls mapped|1 target controls covered
8%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
2 source controls mapped|3 target controls covered
8%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
2 source controls mapped|1 target controls covered
8%
Monetary Authority of Singapore Technology Risk Management Guidelines
2 source controls mapped|1 target controls covered
8%
FedRAMP Rev 5
2 source controls mapped|3 target controls covered
8%
FFIEC IT Examination Handbook
2 source controls mapped|1 target controls covered
8%
NSA Guidance for Transition to Quantum-Resistant Cryptography
2 source controls mapped|3 target controls covered
8%
PCI SSF
2 source controls mapped|1 target controls covered
8%
PCI P2PE
2 source controls mapped|1 target controls covered
8%
PCI PIN Security
2 source controls mapped|1 target controls covered
8%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
2 source controls mapped|1 target controls covered
8%
WCAG 2.2
1 source controls mapped|1 target controls covered
4%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
1 source controls mapped|1 target controls covered
4%
Illinois Biometric Information Privacy Act (BIPA)
1 source controls mapped|2 target controls covered
4%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
1 source controls mapped|1 target controls covered
4%
Armenia Law on Protection of Personal Data (2015)
1 source controls mapped|1 target controls covered
4%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
1 source controls mapped|1 target controls covered
4%
Aged Care Act 2024 (Australia)
1 source controls mapped|1 target controls covered
4%
UK FCA/PRA Operational Resilience Framework
1 source controls mapped|1 target controls covered
4%
SEC Climate Disclosure Rule
1 source controls mapped|1 target controls covered
4%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
1 source controls mapped|2 target controls covered
4%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
4%
NIST SP 800-39
1 source controls mapped|1 target controls covered
4%
NIST SP 800-37
1 source controls mapped|2 target controls covered
4%
NIST SP 800-30
1 source controls mapped|3 target controls covered
4%
NERC CIP
1 source controls mapped|1 target controls covered
4%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|2 target controls covered
4%
German Supply Chain Due Diligence Act (LkSG)
1 source controls mapped|2 target controls covered
4%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|2 target controls covered
4%
APRA CPS 230 Operational Risk Management
1 source controls mapped|1 target controls covered
4%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|2 target controls covered
4%
EASA Part-IS - Information Security in Aviation
1 source controls mapped|2 target controls covered
4%
ISO/IEC 29134:2023
1 source controls mapped|3 target controls covered
4%
SQF Code Edition 9 - Safe Quality Food
1 source controls mapped|2 target controls covered
4%
ISO 26262:2018 - Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
4%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
1 source controls mapped|2 target controls covered
4%
ASIS SPC.1-2009 - Organizational Resilience Standard
1 source controls mapped|1 target controls covered
4%
ISO/IEC 29147:2018
1 source controls mapped|1 target controls covered
4%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
4%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
1 source controls mapped|1 target controls covered
4%
Singapore Cybersecurity Act 2018
1 source controls mapped|1 target controls covered
4%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|1 target controls covered
4%
AICPA Privacy Management Framework (PMF)
1 source controls mapped|1 target controls covered
4%
Responsible Minerals Initiative (RMI) - Responsible Minerals Assurance Process
1 source controls mapped|3 target controls covered
4%
UK Modern Slavery Act 2015
1 source controls mapped|1 target controls covered
4%
Kuwait National Cybersecurity Framework
1 source controls mapped|1 target controls covered
4%
ISO/IEC 27003:2017
1 source controls mapped|1 target controls covered
4%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|1 target controls covered
4%
FedRAMP High
1 source controls mapped|1 target controls covered
4%
FedRAMP Moderate
1 source controls mapped|1 target controls covered
4%
SANS Incident Handler's Handbook and PICERL Methodology
1 source controls mapped|1 target controls covered
4%
ISO 22000:2018
1 source controls mapped|1 target controls covered
4%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
4%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
1 source controls mapped|1 target controls covered
4%
ISO/IEC 25012:2008 - Data Quality Model
1 source controls mapped|1 target controls covered
4%
ITAR - International Traffic in Arms Regulations
1 source controls mapped|2 target controls covered
4%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
1 source controls mapped|1 target controls covered
4%
US Automated Commercial Environment (ACE) - CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
4%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
1 source controls mapped|1 target controls covered
4%
Samoa Telecommunications Act 2005
1 source controls mapped|2 target controls covered
4%
Compare ISO 13485 with NIST SP 800-66

Coverage is not the same as your position

This page shows what ISO 13485 overlaps with in general. Where your organisation actually stands, against the standard you are going for and the certifications you already hold, is a different question. Same graph and the same recorded refutations, scoped to you rather than to a pair.

The Compliance Position Diagnostic, $5,000 fixed, ten business days

What is ISO 13485 and who does it apply to?

ISO 13485 is a compliance framework from International with 5 domains and 24 controls. Medical devices - Quality management systems It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

What does ISO 13485 actually require?

ISO 13485 has 24 controls organised across 5 domains. The largest domains are ISO 13485: Administrative Safeguards (6 controls), ISO 13485: Patient Data Protection (5 controls), ISO 13485: Technical Safeguards (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

If I already comply with another framework, how much of ISO 13485 do I already cover?

ISO 13485 maps to 211 other compliance frameworks. The top mapping partners are NIST SP 800-66 (50% coverage), MDS2 (Medical Device) (50% coverage), MARS-E (50% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I implement ISO 13485?

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 24 controls and track your progress.

Start Your Compliance Journey

Create a free account to run self-assessments, get AI advisory, and track your compliance progress across 1,120 frameworks.

Get Started Free →

Free forever, no credit card required