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ISO 30401

Self-Assess
International
v2018
4 domains
18 controls

Knowledge 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 (4)

ISO 30401: Improvement

3 controls

Continual improvement of quality management system (ISO 30401)

Controls in the ISO 30401: Improvement domain of ISO 30401 — 3 controls
CodeTitle
ISO30401-16Continual improvement methodology
ISO30401-17Corrective and preventive actions
ISO30401-18Innovation and change management

ISO 30401: Leadership & Planning

5 controls

Quality management leadership and planning (ISO 30401)

Controls in the ISO 30401: Leadership & Planning domain of ISO 30401 — 5 controls
CodeTitle
ISO30401-01Knowledge management systems — policy and objectives for organizational knowledge management
ISO30401-02Leadership commitment to quality
ISO30401-03Risk-based thinking and planning
ISO30401-04Resource management for quality
ISO30401-05Organizational roles and responsibilities

ISO 30401: Operational Controls

5 controls

Quality controls in operations (ISO 30401)

Controls in the ISO 30401: Operational Controls domain of ISO 30401 — 5 controls
CodeTitle
ISO30401-06Operational planning and control
ISO30401-07Requirements for products and services
ISO30401-08Design and development controls
ISO30401-09Control of externally provided processes
ISO30401-10Production and service provision controls

ISO 30401: Performance Evaluation

5 controls

Measuring and evaluating quality performance (ISO 30401)

Controls in the ISO 30401: Performance Evaluation domain of ISO 30401 — 5 controls
CodeTitle
ISO30401-11Monitoring, measurement, and analysis
ISO30401-12Internal audit program
ISO30401-13Management review process
ISO30401-14Customer satisfaction measurement
ISO30401-15Nonconformity and corrective action

Maps to 140 other frameworks

18 total controls
IEC 62304:2015 Medical Device Software Lifecycle Processes
2 source controls mapped|4 target controls covered
11%
ISO 19011
2 source controls mapped|2 target controls covered
11%
TISAX — Trusted Information Security Assessment Exchange
2 source controls mapped|2 target controls covered
11%
ISO 9001
2 source controls mapped|4 target controls covered
11%
ISO 37301
2 source controls mapped|2 target controls covered
11%
ISO 37001
2 source controls mapped|2 target controls covered
11%
ISO 55001
2 source controls mapped|2 target controls covered
11%
ICH Q10 — Pharmaceutical Quality System
2 source controls mapped|2 target controls covered
11%
DO-178C / ED-12C — Software Considerations in Airborne Systems
2 source controls mapped|3 target controls covered
11%
ISO 56002
1 source controls mapped|3 target controls covered
6%
ISO 41001:2018 — Facility Management Systems
1 source controls mapped|3 target controls covered
6%
ISO 39001:2012 — Road Traffic Safety Management
1 source controls mapped|3 target controls covered
6%
ISO 37002:2021 — Whistleblowing Management Systems
1 source controls mapped|3 target controls covered
6%
ISO 50001:2018 — Energy Management Systems
1 source controls mapped|3 target controls covered
6%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
1 source controls mapped|3 target controls covered
6%
FDA Quality Management System Regulation (QMSR)
1 source controls mapped|2 target controls covered
6%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
1 source controls mapped|2 target controls covered
6%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
1 source controls mapped|1 target controls covered
6%
ASEAN Data Management Framework
1 source controls mapped|3 target controls covered
6%
ISO 28001:2007 Supply Chain Security Management
1 source controls mapped|3 target controls covered
6%
IATF 16949:2016 — Quality Management System for Automotive Production
1 source controls mapped|2 target controls covered
6%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
1 source controls mapped|3 target controls covered
6%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
1 source controls mapped|1 target controls covered
6%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
1 source controls mapped|1 target controls covered
6%
BRCGS Global Standard for Food Safety Issue 9
1 source controls mapped|2 target controls covered
6%
COSO ERM
1 source controls mapped|1 target controls covered
6%
ICH E6(R3) — Good Clinical Practice
1 source controls mapped|1 target controls covered
6%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
1 source controls mapped|1 target controls covered
6%
ISO 27005
1 source controls mapped|1 target controls covered
6%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
1 source controls mapped|3 target controls covered
6%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
1 source controls mapped|3 target controls covered
6%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
1 source controls mapped|1 target controls covered
6%
South Korea ISMS-P
1 source controls mapped|1 target controls covered
6%
AS9100D — Aerospace Quality Management System
1 source controls mapped|3 target controls covered
6%
ISO/IEC 27003:2017
1 source controls mapped|3 target controls covered
6%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
1 source controls mapped|1 target controls covered
6%
SQF Code Edition 9 — Safe Quality Food
1 source controls mapped|1 target controls covered
6%
ILO Nursing Personnel Convention C149 (1977)
1 source controls mapped|3 target controls covered
6%
EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673)
1 source controls mapped|3 target controls covered
6%
ISO 8000 — Data Quality
1 source controls mapped|3 target controls covered
6%
FATF Recommendation 16 — Virtual Asset Travel Rule
1 source controls mapped|3 target controls covered
6%
Privacy by Design (PbD) — Seven Foundational Principles
1 source controls mapped|3 target controls covered
6%
BS 65000:2014 — Guidance on Organizational Resilience
1 source controls mapped|3 target controls covered
6%
ISO 22000
1 source controls mapped|1 target controls covered
6%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
1 source controls mapped|1 target controls covered
6%
EASA Part-IS — Information Security in Aviation
1 source controls mapped|1 target controls covered
6%
Voluntary Principles on Security and Human Rights (VPs)
1 source controls mapped|1 target controls covered
6%
EU Better Internet for Kids (BIK+) Strategy
1 source controls mapped|1 target controls covered
6%
ICAO Annex 17 — Aviation Security (AVSEC)
1 source controls mapped|1 target controls covered
6%
ISO 20400:2017 — Sustainable Procurement
1 source controls mapped|1 target controls covered
6%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
1 source controls mapped|1 target controls covered
6%
Aged Care Quality Standards (Australia)
1 source controls mapped|1 target controls covered
6%
ISO/IEC 27014:2020
1 source controls mapped|1 target controls covered
6%
German Supply Chain Due Diligence Act (LkSG)
1 source controls mapped|1 target controls covered
6%
UK FCA/PRA Operational Resilience Framework
1 source controls mapped|1 target controls covered
6%
NFPA 1600 — Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|2 target controls covered
6%
IRS Publication 1075 — Tax Information Security Guidelines
1 source controls mapped|1 target controls covered
6%
ISO 31000
1 source controls mapped|1 target controls covered
6%
EU Medical Devices Regulation (MDR 2017/745)
1 source controls mapped|3 target controls covered
6%
SA8000:2014 — Social Accountability Standard
1 source controls mapped|1 target controls covered
6%
AICPA Privacy Management Framework (PMF)
1 source controls mapped|1 target controls covered
6%
ITAR — International Traffic in Arms Regulations
1 source controls mapped|1 target controls covered
6%
NIST SP 800-30
1 source controls mapped|1 target controls covered
6%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
1 source controls mapped|2 target controls covered
6%
NIST SP 800-39
1 source controls mapped|1 target controls covered
6%
ISO 45001
1 source controls mapped|1 target controls covered
6%
NIST SP 800-37
1 source controls mapped|1 target controls covered
6%
FTC Safeguards Rule (16 CFR Part 314)
1 source controls mapped|1 target controls covered
6%
CSA CCM v4
1 source controls mapped|3 target controls covered
6%
EIOPA Guidelines on ICT Security and Governance (2020)
1 source controls mapped|1 target controls covered
6%
ANSSI Cybersecurity Framework
1 source controls mapped|1 target controls covered
6%
BIMCO Cyber Security
1 source controls mapped|1 target controls covered
6%
ISO 26262:2018 — Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
6%
Azure Security Benchmark
1 source controls mapped|1 target controls covered
6%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
1 source controls mapped|1 target controls covered
6%
HIPAA Security Rule
1 source controls mapped|1 target controls covered
6%
C5 (Germany)
1 source controls mapped|1 target controls covered
6%
C2M2
1 source controls mapped|1 target controls covered
6%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
1 source controls mapped|1 target controls covered
6%
ISO 27001:2022
1 source controls mapped|2 target controls covered
6%
EU GMP Annex 11 — Computerised Systems
1 source controls mapped|1 target controls covered
6%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
1 source controls mapped|1 target controls covered
6%
EDM Council DCAM — Data Management Capability Assessment Model
1 source controls mapped|1 target controls covered
6%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
6%
NIST SP 800-171A — Assessing CUI Security Requirements
1 source controls mapped|1 target controls covered
6%
Spain ENS
1 source controls mapped|1 target controls covered
6%
DO-326A
1 source controls mapped|1 target controls covered
6%
DoD Zero Trust Reference Architecture
1 source controls mapped|1 target controls covered
6%
Australian Energy Sector Cyber Security Framework (AESCSF)
1 source controls mapped|1 target controls covered
6%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
6%
AWS Well-Architected Security Pillar
1 source controls mapped|1 target controls covered
6%
ISO 27019
1 source controls mapped|1 target controls covered
6%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2019/04)
1 source controls mapped|1 target controls covered
6%
Cyber Essentials Plus
1 source controls mapped|1 target controls covered
6%
CMMC 2.0
1 source controls mapped|1 target controls covered
6%
FISMA
1 source controls mapped|1 target controls covered
6%
ISO 20000-1
1 source controls mapped|1 target controls covered
6%
IEC 62443
1 source controls mapped|1 target controls covered
6%
IEEE 1686
1 source controls mapped|1 target controls covered
6%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
1 source controls mapped|1 target controls covered
6%
CISA Zero Trust Maturity Model
1 source controls mapped|1 target controls covered
6%
ISO 27017
1 source controls mapped|1 target controls covered
6%
ISMAP (Japan)
1 source controls mapped|1 target controls covered
6%
API 1164
1 source controls mapped|1 target controls covered
6%
ISO 27018
1 source controls mapped|1 target controls covered
6%
CAIQ (CSA)
1 source controls mapped|1 target controls covered
6%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
6%
NIST SP 800-144
1 source controls mapped|1 target controls covered
6%
SSAE 18 — Attestation Standards (SOC Reporting)
1 source controls mapped|2 target controls covered
6%
NIST SP 800-190
1 source controls mapped|1 target controls covered
6%
NIST SP 1800-32
1 source controls mapped|1 target controls covered
6%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
1 source controls mapped|1 target controls covered
6%
Saudi NCA ECC
1 source controls mapped|1 target controls covered
6%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
1 source controls mapped|1 target controls covered
6%
Canada ITSG-33 — IT Security Risk Management
1 source controls mapped|1 target controls covered
6%
New Zealand Information Security Manual (NZISM)
1 source controls mapped|1 target controls covered
6%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
1 source controls mapped|1 target controls covered
6%
South Korea Cloud Security Assurance Program (CSAP)
1 source controls mapped|1 target controls covered
6%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
1 source controls mapped|1 target controls covered
6%
SASB Standards (ISSB Integrated)
1 source controls mapped|1 target controls covered
6%
SASB Standards
1 source controls mapped|1 target controls covered
6%
NIS2 Directive
1 source controls mapped|1 target controls covered
6%
NIST SP 800-171
1 source controls mapped|1 target controls covered
6%
NIST SP 800-146
1 source controls mapped|1 target controls covered
6%
NIST SP 800-53A
1 source controls mapped|1 target controls covered
6%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
1 source controls mapped|1 target controls covered
6%
NIST Privacy Framework 1.0
1 source controls mapped|1 target controls covered
6%
MTCS (Singapore)
1 source controls mapped|1 target controls covered
6%
NIST SP 800-172
1 source controls mapped|1 target controls covered
6%
NIST SP 800-82 Rev 3 — Guide to OT Security
1 source controls mapped|2 target controls covered
6%
ITIL 4
1 source controls mapped|1 target controls covered
6%
NERC CIP
1 source controls mapped|1 target controls covered
6%
UK Gambling Commission — Cyber Resilience Requirements
1 source controls mapped|1 target controls covered
6%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
1 source controls mapped|1 target controls covered
6%
Oman National Cybersecurity Framework
1 source controls mapped|1 target controls covered
6%
TSA Pipeline Security
1 source controls mapped|1 target controls covered
6%
NIST SP 800-53 Rev 5
1 source controls mapped|1 target controls covered
6%
SOC 2
1 source controls mapped|1 target controls covered
6%
NIST SP 800-145
1 source controls mapped|1 target controls covered
6%
FTC GLBA Safeguards Rule (16 CFR Part 314)
1 source controls mapped|1 target controls covered
6%
Compare ISO 30401 with IEC 62304:2015 Medical Device Software Lifecycle Processes

Frequently Asked Questions

What is ISO 30401?

ISO 30401 is a compliance framework from International with 4 domains and 18 controls. Knowledge management systems requirements It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

How many controls does ISO 30401 have?

ISO 30401 has 18 controls organised across 4 domains. The largest domains are ISO 30401: Leadership & Planning (5 controls), ISO 30401: Operational Controls (5 controls), ISO 30401: Performance Evaluation (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does ISO 30401 map to?

ISO 30401 maps to 140 other compliance frameworks. The top mapping partners are IEC 62304:2015 Medical Device Software Lifecycle Processes (11% coverage), ISO 19011 (11% coverage), TISAX — Trusted Information Security Assessment Exchange (11% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with ISO 30401 compliance?

Start your ISO 30401 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 30401 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 18 controls and track your progress.

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