TheArtOfService
Back to Frameworks

ISO 13485:2016

Self-Assess
International
5 domains
60 controls

ISO 13485:2016 Medical Devices Quality Management Systems Requirements.

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 (5)

4 Quality Management System

7 controls
Controls in the 4 Quality Management System domain of ISO 13485:2016 — 7 controls
CodeTitle
4.1.1General QMS Requirements
4.1.2Process Approach and Risk-Based Approach
4.1.5Outsourced Processes
4.1.6Validation of Software Used in QMS
4.2.3Medical Device File
4.2.4Control of Documents
4.2.5Control of Records

5 Management Responsibility

8 controls
Controls in the 5 Management Responsibility domain of ISO 13485:2016 — 8 controls
CodeTitle
5.1Risk management context
5.2Risk acceptance criteria
5.3Determining and Evaluating Audit Programme Risks
5.4.1Quality Objectives
5.5.1Responsibility and Authority
5.5.2Management Representative
5.6.1Management Review - General
5.6.2Management Review Inputs

6 Resource Management

4 controls
Controls in the 6 Resource Management domain of ISO 13485:2016 — 4 controls
CodeTitle
6.2Approach selection
6.3Information security awareness, education and training
6.4.1Work Environment
6.4.2Contamination Control

7 Product Realization

29 controls
Controls in the 7 Product Realization domain of ISO 13485:2016 — 29 controls
CodeTitle
7.1Risk identification
7.2.1Determination of Product Requirements
7.2.2Information security awareness, education and training (cloud)
7.2.3Communication
7.3.10Design and Development Files
7.3.2Design and Development Planning
7.3.3Design and Development Inputs
7.3.4Design and Development Outputs
7.3.5Design and Development Review
7.3.6Design and Development Verification
7.3.7Design and Development Validation
7.3.8Design and Development Transfer
7.3.9Control of Design Changes
7.4.1Purchasing Process
7.4.2Purchasing Information
7.4.3Verification of Purchased Product
7.5.1Control of Production and Service Provision
7.5.10Customer Property
7.5.11Preservation of Product
7.5.2Cleanliness of Product
7.5.3Installation Activities
7.5.4Servicing Activities
7.5.5Particular Requirements for Sterile Medical Devices
7.5.6Validation of Processes for Production and Service Provision
7.5.7Validation of Processes for Sterilization and Sterile Barrier Systems
7.5.8Identification and Traceability
7.5.9.1Traceability - General
7.5.9.2Traceability - Implantable Devices
7.6Vulnerability assessment

8 Measurement, Analysis and Improvement

12 controls
Controls in the 8 Measurement, Analysis and Improvement domain of ISO 13485:2016 — 12 controls
CodeTitle
8.2.1Service Portfolio
8.2.2Asset Management
8.2.3Configuration Management
8.2.4Internal Audit
8.2.5Monitoring and Measurement of Processes
8.2.6Monitoring and Measurement of Product
8.3.1Service Level Management
8.3.3Actions in Response to Nonconforming Product Detected After Delivery
8.3.4Rework
8.4Residual risk acceptance
8.5.2Service Design and Transition
8.5.3Release and Deployment Management

Your Compliance Coverage

If you comply with ISO 13485:2016, you already cover:

ISO 45001:2018

7%

4 controls mapped

Compare →

ISO 20000-1

7%

4 controls mapped

Compare →

ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence

7%

4 controls mapped

Compare →

+ 431 more: ISO 14001 (7%), SWIFT CSCF v2024 (7%)

See all 434 mapped frameworks ↓

Maps to 434 other frameworks

60 total controls
ISO 45001:2018
4 source controls mapped|5 target controls covered
7%
ISO 20000-1
4 source controls mapped|4 target controls covered
7%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
4 source controls mapped|10 target controls covered
7%
ISO 14001
4 source controls mapped|3 target controls covered
7%
SWIFT CSCF v2024
4 source controls mapped|6 target controls covered
7%
ASIS SPC.1-2009 — Organizational Resilience Standard
4 source controls mapped|3 target controls covered
7%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
4 source controls mapped|7 target controls covered
7%
BRCGS Global Standard for Food Safety Issue 9
4 source controls mapped|10 target controls covered
7%
CIS Controls v8
4 source controls mapped|13 target controls covered
7%
ISO 22301:2019
4 source controls mapped|6 target controls covered
7%
ISO/IEC 42001:2023
4 source controls mapped|5 target controls covered
7%
ISO 9001:2015
4 source controls mapped|5 target controls covered
7%
21 CFR Part 211 — Current Good Manufacturing Practice
4 source controls mapped|4 target controls covered
7%
PCI DSS 4.0
4 source controls mapped|3 target controls covered
7%
SQF Code Edition 9 — Safe Quality Food
4 source controls mapped|4 target controls covered
7%
US OFAC Sanctions Compliance Framework
4 source controls mapped|4 target controls covered
7%
ISO/IEC 27006:2024
4 source controls mapped|6 target controls covered
7%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
4 source controls mapped|6 target controls covered
7%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
4 source controls mapped|6 target controls covered
7%
21 CFR Part 58 — Good Laboratory Practice (GLP)
4 source controls mapped|3 target controls covered
7%
3GPP Security Architecture (TS 33.501 — 5G Security)
4 source controls mapped|5 target controls covered
7%
FDA Quality Management System Regulation (QMSR)
4 source controls mapped|3 target controls covered
7%
DO-178C / ED-12C — Software Considerations in Airborne Systems
4 source controls mapped|6 target controls covered
7%
AS9100D — Aerospace Quality Management System
4 source controls mapped|4 target controls covered
7%
ISO/IEC 27003:2017
4 source controls mapped|4 target controls covered
7%
ISO/IEC 25012:2008 — Data Quality Model
4 source controls mapped|3 target controls covered
7%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
4 source controls mapped|6 target controls covered
7%
IEC 62304:2015 Medical Device Software Lifecycle Processes
4 source controls mapped|4 target controls covered
7%
NIS2 Directive Implementing Acts
4 source controls mapped|3 target controls covered
7%
UK Telecommunications (Security) Act 2021
4 source controls mapped|2 target controls covered
7%
EU Medical Devices Regulation (MDR 2017/745)
3 source controls mapped|2 target controls covered
5%
ISO 13485
3 source controls mapped|4 target controls covered
5%
ISO 14001:2015
3 source controls mapped|4 target controls covered
5%
FSSC 22000 — Food Safety System Certification
3 source controls mapped|3 target controls covered
5%
GS1 Global Standards — Supply Chain Traceability and Data Security
3 source controls mapped|2 target controls covered
5%
EU Digital Services Act
3 source controls mapped|1 target controls covered
5%
ISO 27005
3 source controls mapped|2 target controls covered
5%
Singapore Model AI Governance Framework (2nd Edition)
3 source controls mapped|1 target controls covered
5%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
3 source controls mapped|2 target controls covered
5%
C-TPAT — Customs-Trade Partnership Against Terrorism
3 source controls mapped|1 target controls covered
5%
ISO 19011
3 source controls mapped|2 target controls covered
5%
ISO 31000:2018
3 source controls mapped|2 target controls covered
5%
ICH E6(R3) — Good Clinical Practice
3 source controls mapped|1 target controls covered
5%
WCO Authorised Economic Operator (AEO) Framework
3 source controls mapped|1 target controls covered
5%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
3 source controls mapped|1 target controls covered
5%
WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)
3 source controls mapped|1 target controls covered
5%
Customs-Trade Partnership Against Terrorism (C-TPAT)
3 source controls mapped|1 target controls covered
5%
Critical Raw Materials Act (Proposed Regulation COM(2023) 192)
3 source controls mapped|1 target controls covered
5%
EU Chips Act (Regulation (EU) 2023/1781) — potential incorrect regulation number
3 source controls mapped|1 target controls covered
5%
CDP (formerly Carbon Disclosure Project)
3 source controls mapped|1 target controls covered
5%
ISO/IEC 27701:2019
2 source controls mapped|1 target controls covered
3%
US Foreign Corrupt Practices Act (FCPA)
1 source controls mapped|1 target controls covered
2%
ISO/IEC 27400:2022
1 source controls mapped|3 target controls covered
2%
ISO/IEC 27011:2024
1 source controls mapped|3 target controls covered
2%
ISO/IEC 27031:2011
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%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
1 source controls mapped|4 target controls covered
2%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
1 source controls mapped|3 target controls covered
2%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
1 source controls mapped|2 target controls covered
2%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
1 source controls mapped|1 target controls covered
2%
ISO/IEC 29147:2018
1 source controls mapped|3 target controls covered
2%
ISO/IEC 29134:2023
1 source controls mapped|3 target controls covered
2%
ISO/IEC 27014:2020
1 source controls mapped|3 target controls covered
2%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
1 source controls mapped|3 target controls covered
2%
3GPP Security
1 source controls mapped|1 target controls covered
2%
MITRE D3FEND
1 source controls mapped|1 target controls covered
2%
EU Taxonomy Regulation
1 source controls mapped|3 target controls covered
2%
UNECE WP.29 R155
1 source controls mapped|1 target controls covered
2%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
1 source controls mapped|2 target controls covered
2%
EU AI Liability Directive
1 source controls mapped|4 target controls covered
2%
EU AI Act
1 source controls mapped|3 target controls covered
2%
6th Anti-Money Laundering Directive (AMLD6, Directive (EU) 2018/1673)
1 source controls mapped|5 target controls covered
2%
EU Carbon Border Adjustment Mechanism (CBAM)
1 source controls mapped|4 target controls covered
2%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
1 source controls mapped|4 target controls covered
2%
EU Energy Performance of Buildings Directive (EPBD Recast) – Draft Directive (2023/0317 COD)
1 source controls mapped|3 target controls covered
2%
EU European Media Freedom Act (EMFA)
1 source controls mapped|5 target controls covered
2%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
1 source controls mapped|5 target controls covered
2%
EU Maritime Single Window Environment Regulation (EU) 2019/1239
1 source controls mapped|5 target controls covered
2%
EU NIS2 Directive — Transport Sector Requirements
1 source controls mapped|2 target controls covered
2%
EU Pay Transparency Directive (Directive (EU) 2023/970)
1 source controls mapped|6 target controls covered
2%
Proposal for a Directive on improving working conditions in platform work (COM(2023) 491)
1 source controls mapped|6 target controls covered
2%
EU Product Liability Directive (Directive (EU) 2023/2845)
1 source controls mapped|6 target controls covered
2%
EU Seveso III Directive (Directive 2012/18/EU)
1 source controls mapped|5 target controls covered
2%
EU Taxonomy Regulation (Regulation 2020/852)
1 source controls mapped|4 target controls covered
2%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
1 source controls mapped|2 target controls covered
2%
Union Customs Code (UCC) - Regulation (EU) No 952/2013
1 source controls mapped|2 target controls covered
2%
EU Web Accessibility Directive (Directive 2016/2102)
1 source controls mapped|3 target controls covered
2%
EU ePrivacy Directive (2002/58/EC)
1 source controls mapped|4 target controls covered
2%
eIDAS 2.0 — EU Digital Identity Regulation
1 source controls mapped|3 target controls covered
2%
African Union Malabo Convention
1 source controls mapped|3 target controls covered
2%
Morocco Data Protection Law (09-08)
1 source controls mapped|4 target controls covered
2%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
1 source controls mapped|6 target controls covered
2%
Chile Personal Data Protection Law (Law No. 21.719)
1 source controls mapped|3 target controls covered
2%
Peru Personal Data Protection Law (Law No. 29733)
1 source controls mapped|3 target controls covered
2%
Côte d'Ivoire Law No. 2013-450 on the Protection of Personal Data
1 source controls mapped|3 target controls covered
2%
Costa Rica Personal Data Protection Law (Law No. 8968) as amended by Executive Decree No. 42089-MGP
1 source controls mapped|4 target controls covered
2%
Pakistan Personal Data Protection Bill 2023
1 source controls mapped|3 target controls covered
2%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
1 source controls mapped|4 target controls covered
2%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
1 source controls mapped|3 target controls covered
2%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
1 source controls mapped|4 target controls covered
2%
Senegal Law on Personal Data Protection (Law No. 2008-12)
1 source controls mapped|3 target controls covered
2%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
1 source controls mapped|4 target controls covered
2%
Uzbekistan Law on Personal Data (No. ZRU-547)
1 source controls mapped|4 target controls covered
2%
Georgia Law on Personal Data Protection (2012)
1 source controls mapped|4 target controls covered
2%
Colombia Data Protection Law (Law 1581 of 2012)
1 source controls mapped|4 target controls covered
2%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
1 source controls mapped|4 target controls covered
2%
Montenegro Law on Personal Data Protection (2023)
1 source controls mapped|6 target controls covered
2%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
1 source controls mapped|5 target controls covered
2%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
1 source controls mapped|6 target controls covered
2%
Act on the Implementation of the General Data Protection Regulation (OG 42/2018)
1 source controls mapped|3 target controls covered
2%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
1 source controls mapped|5 target controls covered
2%
Portugal Law No. 58/2019 — Data Protection Implementation Act
1 source controls mapped|6 target controls covered
2%
Malta Data Protection Act (Cap. 586, 2018)
1 source controls mapped|6 target controls covered
2%
Oman Personal Data Protection Law (Royal Decree 6/2022)
1 source controls mapped|4 target controls covered
2%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
1 source controls mapped|4 target controls covered
2%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
1 source controls mapped|6 target controls covered
2%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
1 source controls mapped|4 target controls covered
2%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
1 source controls mapped|5 target controls covered
2%
RICS Professional Standards — Data and Technology in Property
1 source controls mapped|1 target controls covered
2%
IEC 60601-1 — Medical Electrical Equipment Safety
1 source controls mapped|2 target controls covered
2%
AICPA SOC 1
1 source controls mapped|1 target controls covered
2%
Open Banking Security
1 source controls mapped|1 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%
China Personal Information Protection Law (PIPL)
1 source controls mapped|3 target controls covered
2%
NIST AI Risk Management Framework (AI RMF 1.0)
1 source controls mapped|2 target controls covered
2%
NIST AI 600-1 Generative AI Profile
1 source controls mapped|2 target controls covered
2%
Cook Islands Electronic Transactions Act 2003
1 source controls mapped|3 target controls covered
2%
US Americans with Disabilities Act (ADA) — Title III Digital Accessibility
1 source controls mapped|3 target controls covered
2%
EU Network Code on Cybersecurity for the Electricity Sector
1 source controls mapped|3 target controls covered
2%
EU Machinery Regulation (Regulation (EU) 2023/1230)
1 source controls mapped|4 target controls covered
2%
Digital Services Act (DSA) - Regulation (EU) 2022/2065
1 source controls mapped|3 target controls covered
2%
Laos Law on Prevention and Combating Cybercrime (2015)
1 source controls mapped|4 target controls covered
2%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
1 source controls mapped|4 target controls covered
2%
Jordan Draft Personal Data Protection Law (2022)
1 source controls mapped|4 target controls covered
2%
MTCS — Multi-Tier Cloud Security (Singapore)
1 source controls mapped|2 target controls covered
2%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
1 source controls mapped|5 target controls covered
2%
Tanzania Personal Data Protection Act (Draft)
1 source controls mapped|4 target controls covered
2%
Trinidad and Tobago Data Protection Act 2011
1 source controls mapped|4 target controls covered
2%
Cayman Islands Data Protection Act 2017 (DPA)
1 source controls mapped|4 target controls covered
2%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
1 source controls mapped|7 target controls covered
2%
Brunei Personal Data Protection Order 2024 (PDPO)
1 source controls mapped|6 target controls covered
2%
Defence Security Principles Framework (DSPF)
1 source controls mapped|3 target controls covered
2%
Protective Security Policy Framework (PSPF) Release 2024
1 source controls mapped|3 target controls covered
2%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
1 source controls mapped|3 target controls covered
2%
UAE Federal Data Protection Law
1 source controls mapped|2 target controls covered
2%
Saudi PDPL
1 source controls mapped|1 target controls covered
2%
GDPR
1 source controls mapped|1 target controls covered
2%
NIS2 Directive
1 source controls mapped|3 target controls covered
2%
DORA
1 source controls mapped|4 target controls covered
2%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
1 source controls mapped|5 target controls covered
2%
Nigeria Data Protection Act 2023 (NDPA)
1 source controls mapped|2 target controls covered
2%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
1 source controls mapped|3 target controls covered
2%
Connecticut Data Privacy Act (CTDPA)
1 source controls mapped|3 target controls covered
2%
Illinois Biometric Information Privacy Act (BIPA)
1 source controls mapped|3 target controls covered
2%
NAIC Insurance Data Security Model Law (MDL-668)
1 source controls mapped|5 target controls covered
2%
Modern Slavery Act 2018 (Australia)
1 source controls mapped|3 target controls covered
2%
Kenya Data Protection Act 2019
1 source controls mapped|3 target controls covered
2%
Czech Republic Act on the Protection of Personal Data (Act No. 110/2019 Coll.)
1 source controls mapped|4 target controls covered
2%
FAA Cybersecurity Framework for Aviation
1 source controls mapped|2 target controls covered
2%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|2 target controls covered
2%
Japan FSA Cybersecurity Guidelines for Financial Institutions
1 source controls mapped|2 target controls covered
2%
RBI Cybersecurity Framework for Banks
1 source controls mapped|2 target controls covered
2%
Kuwait National Cybersecurity Framework
1 source controls mapped|2 target controls covered
2%
NIST SP 800-115
1 source controls mapped|1 target controls covered
2%
ISO 27018
1 source controls mapped|1 target controls covered
2%
EN 50126, EN 50128, and EN 50129 — Railway Applications - Reliability, Availability, Maintainability and Safety (RAMS)
1 source controls mapped|3 target controls covered
2%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
1 source controls mapped|1 target controls covered
2%
EDM Council CDMC — Cloud Data Management Capability Framework
1 source controls mapped|3 target controls covered
2%
HL7 FHIR Security Framework
1 source controls mapped|1 target controls covered
2%
OWASP Top 10:2025
1 source controls mapped|1 target controls covered
2%
ITAR — International Traffic in Arms Regulations
1 source controls mapped|2 target controls covered
2%
SOC 2
1 source controls mapped|2 target controls covered
2%
SSAE 18 — Attestation Standards (SOC Reporting)
1 source controls mapped|2 target controls covered
2%
South Korea PIPA
1 source controls mapped|1 target controls covered
2%
Bermuda Personal Information Protection Act 2016 (PIPA)
1 source controls mapped|2 target controls covered
2%
Proposal for a Regulation on the European Health Data Space (EHDS)
1 source controls mapped|1 target controls covered
2%
UK Building Safety Act 2022
1 source controls mapped|2 target controls covered
2%
AWS Well-Architected Security Pillar
1 source controls mapped|1 target controls covered
2%
EU Data Act
1 source controls mapped|2 target controls covered
2%
SLSA
1 source controls mapped|1 target controls covered
2%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
1 source controls mapped|3 target controls covered
2%
Science Based Targets initiative (SBTi) Corporate Standard
1 source controls mapped|2 target controls covered
2%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
1 source controls mapped|1 target controls covered
2%
Canada ITSG-33 — IT Security Risk Management
1 source controls mapped|1 target controls covered
2%
New Zealand Information Security Manual (NZISM)
1 source controls mapped|1 target controls covered
2%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
1 source controls mapped|1 target controls covered
2%
South Korea Cloud Security Assurance Program (CSAP)
1 source controls mapped|1 target controls covered
2%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
1 source controls mapped|3 target controls covered
2%
W3C Verifiable Credentials (VC) Data Model 2.0
1 source controls mapped|2 target controls covered
2%
NIST SP 800-150
1 source controls mapped|1 target controls covered
2%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
1 source controls mapped|3 target controls covered
2%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
1 source controls mapped|3 target controls covered
2%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
1 source controls mapped|5 target controls covered
2%
Armenia Law on Protection of Personal Data (2015)
1 source controls mapped|3 target controls covered
2%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
1 source controls mapped|3 target controls covered
2%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
1 source controls mapped|3 target controls covered
2%
Angola Personal Data Protection Law (Law No. 22/11)
1 source controls mapped|4 target controls covered
2%
EDM Council DCAM — Data Management Capability Assessment Model
1 source controls mapped|3 target controls covered
2%
NIST Cybersecurity Framework 2.0
1 source controls mapped|2 target controls covered
2%
ISO 8000 — Data Quality
1 source controls mapped|3 target controls covered
2%
NIST SP 800-218
1 source controls mapped|1 target controls covered
2%
EU Markets in Crypto-Assets Regulation (MiCA)
1 source controls mapped|5 target controls covered
2%
Barbados Data Protection Act 2019
1 source controls mapped|1 target controls covered
2%
ISMAP (Japan)
1 source controls mapped|1 target controls covered
2%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
1 source controls mapped|1 target controls covered
2%
TIBER-EU (Threat Intelligence-Based Ethical Red Teaming - European Union)
1 source controls mapped|1 target controls covered
2%
ICH Q10 — Pharmaceutical Quality System
1 source controls mapped|3 target controls covered
2%
MITRE ATT&CK
1 source controls mapped|1 target controls covered
2%
NIST SP 800-63
1 source controls mapped|1 target controls covered
2%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
1 source controls mapped|1 target controls covered
2%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
1 source controls mapped|3 target controls covered
2%
Wisconsin Data Privacy Act (SB 670)
1 source controls mapped|3 target controls covered
2%
Florida Digital Bill of Rights (FDBR)
1 source controls mapped|3 target controls covered
2%
UK Gambling Commission — Cyber Resilience Requirements
1 source controls mapped|3 target controls covered
2%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
1 source controls mapped|1 target controls covered
2%
COSO Enterprise Risk Management (ERM) Framework (2017)
1 source controls mapped|2 target controls covered
2%
BCBS 239
1 source controls mapped|3 target controls covered
2%
SWIFT Customer Security Programme (CSP)
1 source controls mapped|2 target controls covered
2%
ASIC Cyber Resilience Good Practices
1 source controls mapped|2 target controls covered
2%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|1 target controls covered
2%
South Africa Promotion of Access to Information Act (PAIA)
1 source controls mapped|1 target controls covered
2%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
1 source controls mapped|1 target controls covered
2%
ISO 20400:2017 — Sustainable Procurement
1 source controls mapped|2 target controls covered
2%
Israel Protection of Privacy Law (5741-1981)
1 source controls mapped|3 target controls covered
2%
SSDF (NIST)
1 source controls mapped|1 target controls covered
2%
GLBA
1 source controls mapped|1 target controls covered
2%
ETSI ISG QKD - Quantum Key Distribution
1 source controls mapped|3 target controls covered
2%
SANS Incident Handler's Handbook and PICERL Methodology
1 source controls mapped|2 target controls covered
2%
Notifiable Data Breaches Scheme (Australia)
1 source controls mapped|2 target controls covered
2%
GAMP 5 — Good Automated Manufacturing Practice
1 source controls mapped|2 target controls covered
2%
EU Payment Services Directive (PSD2) – Under Review
1 source controls mapped|3 target controls covered
2%
Philippines Cybercrime Prevention Act (RA 10175)
1 source controls mapped|1 target controls covered
2%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
1 source controls mapped|3 target controls covered
2%
AICPA SOC 3
1 source controls mapped|1 target controls covered
2%
SWIFT CSCF
1 source controls mapped|1 target controls covered
2%
NIST SP 800-124 Rev 2 — Mobile Device Security
1 source controls mapped|3 target controls covered
2%
ISO 28001:2007 Supply Chain Security Management
1 source controls mapped|1 target controls covered
2%
ECSS Software Engineering Standards
1 source controls mapped|3 target controls covered
2%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
1 source controls mapped|1 target controls covered
2%
C2M2
1 source controls mapped|1 target controls covered
2%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
1 source controls mapped|3 target controls covered
2%
US SEC Digital Assets and Crypto Regulatory Framework
1 source controls mapped|3 target controls covered
2%
Digital Economy Partnership Agreement (DEPA)
1 source controls mapped|2 target controls covered
2%
ISO/SAE 21434
1 source controls mapped|1 target controls covered
2%
ECSS-E-ST-40C: Space Engineering — Software
1 source controls mapped|3 target controls covered
2%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
1 source controls mapped|3 target controls covered
2%
Azerbaijan Law on Personal Data (2010)
1 source controls mapped|1 target controls covered
2%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
1 source controls mapped|1 target controls covered
2%
Online Safety Act 2021 (Australia)
1 source controls mapped|3 target controls covered
2%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
1 source controls mapped|1 target controls covered
2%
OWASP DevSecOps Maturity Model (DSOMM)
1 source controls mapped|3 target controls covered
2%
PCI DSS v4.0
1 source controls mapped|3 target controls covered
2%
FedRAMP Rev 5
1 source controls mapped|7 target controls covered
2%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
1 source controls mapped|4 target controls covered
2%
OWASP MASVS
1 source controls mapped|1 target controls covered
2%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
1 source controls mapped|2 target controls covered
2%
EU Audiovisual Media Services Directive (AVMSD, Directive 2010/13/EU as amended by Directive 2018/1808 and Directive (EU) 2023/2586)
1 source controls mapped|2 target controls covered
2%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
1 source controls mapped|2 target controls covered
2%
South Korea Personal Information Protection Act (PIPA)
1 source controls mapped|5 target controls covered
2%
North Macedonia Law on Personal Data Protection (2020)
1 source controls mapped|5 target controls covered
2%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
1 source controls mapped|6 target controls covered
2%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
1 source controls mapped|5 target controls covered
2%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
1 source controls mapped|4 target controls covered
2%
Uruguay Personal Data Protection Act (Law No. 18.331)
1 source controls mapped|5 target controls covered
2%
ILO Nursing Personnel Convention C149 (1977)
1 source controls mapped|3 target controls covered
2%
IFRS 17 — Insurance Contracts
1 source controls mapped|2 target controls covered
2%
FTC Health Breach Notification Rule
1 source controls mapped|3 target controls covered
2%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
1 source controls mapped|3 target controls covered
2%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
1 source controls mapped|2 target controls covered
2%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
1 source controls mapped|2 target controls covered
2%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
1 source controls mapped|4 target controls covered
2%
ICAO Annex 17 — Aviation Security (AVSEC)
1 source controls mapped|3 target controls covered
2%
Serbia Law on Personal Data Protection (2018)
1 source controls mapped|4 target controls covered
2%
Lithuania Law on Legal Protection of Personal Data (2018)
1 source controls mapped|2 target controls covered
2%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
1 source controls mapped|5 target controls covered
2%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
1 source controls mapped|5 target controls covered
2%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
1 source controls mapped|4 target controls covered
2%
Russia Federal Law on Personal Data (152-FZ)
1 source controls mapped|4 target controls covered
2%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
1 source controls mapped|2 target controls covered
2%
Botswana Data Protection Act (2024)
1 source controls mapped|5 target controls covered
2%
Fiji Data Protection Bill (2020)
1 source controls mapped|5 target controls covered
2%
Zimbabwe Data Protection Act (2021)
1 source controls mapped|4 target controls covered
2%
Uganda Data Protection and Privacy Act (2019)
1 source controls mapped|4 target controls covered
2%
ISO 56002
1 source controls mapped|4 target controls covered
2%
ISO 41001:2018 — Facility Management Systems
1 source controls mapped|3 target controls covered
2%
ISO 39001:2012 — Road Traffic Safety Management
1 source controls mapped|3 target controls covered
2%
ISO 37002:2021 — Whistleblowing Management Systems
1 source controls mapped|3 target controls covered
2%
ISO 50001:2018 — Energy Management Systems
1 source controls mapped|3 target controls covered
2%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
1 source controls mapped|3 target controls covered
2%
OWASP ASVS
1 source controls mapped|1 target controls covered
2%
China Cybersecurity Law (CSL)
1 source controls mapped|1 target controls covered
2%
EU Clinical Trials Regulation (CTR 536/2014)
1 source controls mapped|1 target controls covered
2%
ISO/IEC 23894:2023
1 source controls mapped|3 target controls covered
2%
Florida Digital Bill of Rights (SB 262)
1 source controls mapped|1 target controls covered
2%
CAIQ (CSA)
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%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
1 source controls mapped|3 target controls covered
2%
O-RAN Alliance Security Specifications (O-RAN.WG11)
1 source controls mapped|3 target controls covered
2%
ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
1 source controls mapped|3 target controls covered
2%
IATF 16949:2016 — Quality Management System for Automotive Production
1 source controls mapped|2 target controls covered
2%
EU Digital Services Act (Regulation (EU) 2022/2065)
1 source controls mapped|1 target controls covered
2%
MiFID II / MiFIR
1 source controls mapped|1 target controls covered
2%
ASEAN Data Management Framework
1 source controls mapped|2 target controls covered
2%
Australia NHMRC National Statement on Ethical Conduct in Human Research
1 source controls mapped|2 target controls covered
2%
ISO 27017
1 source controls mapped|1 target controls covered
2%
PCI P2PE
1 source controls mapped|1 target controls covered
2%
Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions
1 source controls mapped|1 target controls covered
2%
ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary
1 source controls mapped|3 target controls covered
2%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
1 source controls mapped|1 target controls covered
2%
TEFCA — Trusted Exchange Framework and Common Agreement
1 source controls mapped|1 target controls covered
2%
FedRAMP High
1 source controls mapped|1 target controls covered
2%
NIST SP 800-53 Rev 5 HIGH
1 source controls mapped|1 target controls covered
2%
IRS Publication 1075
1 source controls mapped|1 target controls covered
2%
FedRAMP Moderate
1 source controls mapped|1 target controls covered
2%
NIST SP 800-53 Rev 5 MODERATE
1 source controls mapped|1 target controls covered
2%
NIST SP 800-53 Rev 5 LOW
1 source controls mapped|1 target controls covered
2%
HKMA Cyber Resilience Assessment Framework (C-RAF)
1 source controls mapped|2 target controls covered
2%
UK GDPR (UK General Data Protection Regulation)
1 source controls mapped|1 target controls covered
2%
Australia My Health Records Act 2012
1 source controls mapped|4 target controls covered
2%
California IoT Security Law
1 source controls mapped|1 target controls covered
2%
India Account Aggregator Framework (RBI)
1 source controls mapped|1 target controls covered
2%
Singapore Cybersecurity Act 2018
1 source controls mapped|1 target controls covered
2%
Cyber Security Act 2024 (Australia)
1 source controls mapped|1 target controls covered
2%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
1 source controls mapped|3 target controls covered
2%
ECB TIBER-EU Framework
1 source controls mapped|1 target controls covered
2%
FATF Recommendation 16 — Virtual Asset Travel Rule
1 source controls mapped|2 target controls covered
2%
UK Open Banking Standard
1 source controls mapped|1 target controls covered
2%
EU GMP Annex 11: Computerised Systems
1 source controls mapped|3 target controls covered
2%
TNFD Recommendations
1 source controls mapped|4 target controls covered
2%
CSA STAR (Security, Trust, Assurance, and Risk)
1 source controls mapped|2 target controls covered
2%
South Korea Credit Information Act
1 source controls mapped|1 target controls covered
2%
Virginia Consumer Data Protection Act (VCDPA)
1 source controls mapped|1 target controls covered
2%
IRS Publication 1075 — Tax Information Security Guidelines
1 source controls mapped|1 target controls covered
2%
NIST SP 800-181
1 source controls mapped|1 target controls covered
2%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
1 source controls mapped|3 target controls covered
2%
Australia Online Safety Act 2021
1 source controls mapped|4 target controls covered
2%
Jamaica Data Protection Act 2020
1 source controls mapped|3 target controls covered
2%
Mauritius Data Protection Act 2017
1 source controls mapped|2 target controls covered
2%
Ghana Data Protection Act 2012 (Act 843)
1 source controls mapped|2 target controls covered
2%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
1 source controls mapped|3 target controls covered
2%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
1 source controls mapped|4 target controls covered
2%
MAS TRM
1 source controls mapped|1 target controls covered
2%
PCI PIN Security
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%
FTC GLBA Safeguards Rule (16 CFR Part 314)
1 source controls mapped|2 target controls covered
2%
CCSDS 350.0-G-3 — Space Communications Security (Consultative Committee for Space Data Systems)
1 source controls mapped|1 target controls covered
2%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
1 source controls mapped|1 target controls covered
2%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
1 source controls mapped|1 target controls covered
2%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
1 source controls mapped|3 target controls covered
2%
BREEAM — Building Research Establishment Environmental Assessment Method
1 source controls mapped|1 target controls covered
2%
AICPA Privacy Management Framework (PMF)
1 source controls mapped|2 target controls covered
2%
IAIS Insurance Core Principles (ICPs)
1 source controls mapped|1 target controls covered
2%
Proposal for a Regulation on Cyber Resilience Act (CRA)
1 source controls mapped|1 target controls covered
2%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
1 source controls mapped|2 target controls covered
2%
AASB S2 Climate-related Disclosures
1 source controls mapped|2 target controls covered
2%
GLI-33 — Gaming Laboratories International Event Wagering Systems
1 source controls mapped|2 target controls covered
2%
EIOPA Guidelines on ICT Security and Governance (2023)
1 source controls mapped|1 target controls covered
2%
TISAX — Trusted Information Security Assessment Exchange
1 source controls mapped|1 target controls covered
2%
Telecommunications Sector Security Reforms (TSSR)
1 source controls mapped|1 target controls covered
2%
Privacy by Design (PbD) — Seven Foundational Principles
1 source controls mapped|1 target controls covered
2%
BS 65000:2014 — Guidance on Organizational Resilience
1 source controls mapped|1 target controls covered
2%
EU Digital Markets Act
1 source controls mapped|1 target controls covered
2%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
1 source controls mapped|1 target controls covered
2%
EAR — Export Administration Regulations
1 source controls mapped|1 target controls covered
2%
European Accessibility Act (Directive (EU) 2019/882)
1 source controls mapped|1 target controls covered
2%
Regulation (EU) 2023/1115 on deforestation-free supply chains
1 source controls mapped|1 target controls covered
2%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
1 source controls mapped|1 target controls covered
2%
NIS2 Directive (Directive (EU) 2022/2555)
1 source controls mapped|1 target controls covered
2%
US ITAR and EAR — Export Control and Data Security
1 source controls mapped|1 target controls covered
2%
Australia Consumer Data Right — Banking (CDR)
1 source controls mapped|1 target controls covered
2%
Australia eSafety Commissioner — Online Safety Expectations for Industry
1 source controls mapped|1 target controls covered
2%
SIG (Shared Assessments)
1 source controls mapped|1 target controls covered
2%
NIST SP 800-145
1 source controls mapped|1 target controls covered
2%
NIST SP 800-61
1 source controls mapped|1 target controls covered
2%
IEC 62351 — Power Systems Communication Security
1 source controls mapped|1 target controls covered
2%
IATA Operational Safety Audit (IOSA) Standards Manual
1 source controls mapped|1 target controls covered
2%
NIST SP 800-144
1 source controls mapped|1 target controls covered
2%
HKMA SPM
1 source controls mapped|1 target controls covered
2%
NIST SP 800-137
1 source controls mapped|1 target controls covered
2%
NIST SP 800-92
1 source controls mapped|1 target controls covered
2%
NIST SP 800-82 Rev 3 — Guide to OT Security
1 source controls mapped|2 target controls covered
2%
BSIMM
1 source controls mapped|1 target controls covered
2%
NIST SP 800-183
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%
UK PSTI Act
1 source controls mapped|1 target controls covered
2%
ISO 26262:2018 — Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
2%
LGPD
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%
C5 (Germany)
1 source controls mapped|1 target controls covered
2%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)
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%
NIST SP 800-207
1 source controls mapped|1 target controls covered
2%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
1 source controls mapped|3 target controls covered
2%
UK Bribery Act 2010
1 source controls mapped|3 target controls covered
2%
SWIFT CSP
1 source controls mapped|1 target controls covered
2%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
1 source controls mapped|2 target controls covered
2%
FBI CJIS Security Policy
1 source controls mapped|2 target controls covered
2%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
1 source controls mapped|2 target controls covered
2%
NIST SP 800-128
1 source controls mapped|1 target controls covered
2%
NIST SP 800-160
1 source controls mapped|1 target controls covered
2%
Azure Security Benchmark
1 source controls mapped|1 target controls covered
2%
NIST SP 800-88
1 source controls mapped|1 target controls covered
2%
APRA CPS 234
1 source controls mapped|1 target controls covered
2%
OpenSSF Scorecard
1 source controls mapped|1 target controls covered
2%
NIST SP 800-190
1 source controls mapped|1 target controls covered
2%
MTCS (Singapore)
1 source controls mapped|1 target controls covered
2%
PCI SSF
1 source controls mapped|1 target controls covered
2%
PTES
1 source controls mapped|1 target controls covered
2%
ASD Information Security Manual (ISM)
1 source controls mapped|1 target controls covered
2%
UNECE WP.29 R156
1 source controls mapped|1 target controls covered
2%
ETSI EN 303 645
1 source controls mapped|1 target controls covered
2%
NIST SP 800-146
1 source controls mapped|1 target controls covered
2%
ISO 27002:2022
1 source controls mapped|1 target controls covered
2%
OSFI B-13
1 source controls mapped|1 target controls covered
2%
NIST SP 800-161
1 source controls mapped|1 target controls covered
2%
FFIEC IT Examination Handbook
1 source controls mapped|1 target controls covered
2%
PSD2 SCA
1 source controls mapped|1 target controls covered
2%
COBIT 2019
1 source controls mapped|1 target controls covered
2%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
1 source controls mapped|1 target controls covered
2%
NIST SP 800-123
1 source controls mapped|1 target controls covered
2%
NIST SP 800-187
1 source controls mapped|1 target controls covered
2%
South Korea ISMS-P
1 source controls mapped|1 target controls covered
2%
WCAG 2.2
1 source controls mapped|1 target controls covered
2%
ISO 27043
1 source controls mapped|1 target controls covered
2%
OWASP SAMM
1 source controls mapped|1 target controls covered
2%
Tennessee Information Protection Act (TIPA)
1 source controls mapped|1 target controls covered
2%
APRA Prudential Standard CPS 234 — Information Security (Australia)
1 source controls mapped|1 target controls covered
2%
Compare ISO 13485:2016 with ISO 45001:2018

Frequently Asked Questions

What is ISO 13485:2016?

ISO 13485:2016 is a compliance framework from International with 5 domains and 60 controls. ISO 13485:2016 Medical Devices Quality Management Systems Requirements. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

How many controls does ISO 13485:2016 have?

ISO 13485:2016 has 60 controls organised across 5 domains. The largest domains are 7 Product Realization (29 controls), 8 Measurement, Analysis and Improvement (12 controls), 5 Management Responsibility (8 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does ISO 13485:2016 map to?

ISO 13485:2016 maps to 434 other compliance frameworks. The top mapping partners are ISO 45001:2018 (7% coverage), ISO 20000-1 (7% coverage), ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence (7% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with ISO 13485:2016 compliance?

Start your ISO 13485:2016 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 13485:2016 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 60 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 769 frameworks.

Get Started Free →

Free forever — no credit card required