ISO 30401

International

v2018

28 domains

42 controls

Knowledge management systems requirements

Unverified

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Framework Domains (28)

Audit

1 controls

Controls in the Audit domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-9.2	Internal audit	Conduct internal audits of the KMS at planned intervals.

Awareness

1 controls

Controls in the Awareness domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-7.3	Awareness	Ensure persons under control are aware of the KM policy and their contribution.

CAPA

1 controls

Controls in the CAPA domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-10.1	Nonconformity and corrective action	React to nonconformities, evaluate causes, and take corrective action.

Communication

1 controls

Controls in the Communication domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-7.4	Communication	Determine internal and external communications relevant to the KMS.

Competence

1 controls

Controls in the Competence domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-7.2	Competence	Ensure persons doing KM work are competent through education, training, or experience.

Context

1 controls

Controls in the Context domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-4.1	Understanding organisation and context	Determine internal and external issues relevant to the knowledge management system.

Culture

1 controls

Controls in the Culture domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-4.8	Knowledge management culture	Cultivate a culture that values learning, sharing, collaboration, and innovation.

Documentation

1 controls

Controls in the Documentation domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-7.5	Documented information	Create, control, and retain documented information for the KMS.

Enablers

1 controls

Controls in the Enablers domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-4.7	Knowledge enablers	Address human capital, processes, technology, governance, and KM culture as enablers.

Governance

1 controls

Controls in the Governance domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-9.3	Management review	Top management reviews the KMS for suitability, adequacy, and effectiveness.

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
Code	Title	Description
ISO30401-16	Continual improvement methodology	Continual improvement methodology. Control from ISO 30401 framework, domain: ISO 30401: Improvement.
ISO30401-17	Corrective and preventive actions	Corrective and preventive actions. Control from ISO 30401 framework, domain: ISO 30401: Improvement.
ISO30401-18	Innovation and change management	Innovation and change management. Control from ISO 30401 framework, domain: ISO 30401: Improvement.

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
Code	Title	Description
ISO30401-01	Knowledge management systems - policy and objectives for organizational knowledge management	Quality policy and objectives. Control from ISO 30401 framework, domain: ISO 30401: Leadership & Planning.
ISO30401-02	Leadership commitment to quality	Leadership commitment to quality. Control from ISO 30401 framework, domain: ISO 30401: Leadership & Planning.
ISO30401-03	Risk-based thinking and planning	Risk-based thinking and planning. Control from ISO 30401 framework, domain: ISO 30401: Leadership & Planning.
ISO30401-04	Resource management for quality	Resource management for quality. Control from ISO 30401 framework, domain: ISO 30401: Leadership & Planning.
ISO30401-05	Organizational roles and responsibilities	Organizational roles and responsibilities. Control from ISO 30401 framework, domain: ISO 30401: Leadership & Planning.

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
Code	Title	Description
ISO30401-06	Operational planning and control	Operational planning and control. Control from ISO 30401 framework, domain: ISO 30401: Operational Controls.
ISO30401-07	Requirements for products and services	Requirements for products and services. Control from ISO 30401 framework, domain: ISO 30401: Operational Controls.
ISO30401-08	Design and development controls	Design and development controls. Control from ISO 30401 framework, domain: ISO 30401: Operational Controls.
ISO30401-09	Control of externally provided processes	Control of externally provided processes. Control from ISO 30401 framework, domain: ISO 30401: Operational Controls.
ISO30401-10	Production and service provision controls	Production and service provision controls. Control from ISO 30401 framework, domain: ISO 30401: Operational 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
Code	Title	Description
ISO30401-11	Monitoring, measurement, and analysis	Monitoring, measurement, and analysis. Control from ISO 30401 framework, domain: ISO 30401: Performance Evaluation.
ISO30401-12	Internal audit program	Internal audit program. Control from ISO 30401 framework, domain: ISO 30401: Performance Evaluation.
ISO30401-13	Management review process	Management review process. Control from ISO 30401 framework, domain: ISO 30401: Performance Evaluation.
ISO30401-14	Customer satisfaction measurement	Customer satisfaction measurement. Control from ISO 30401 framework, domain: ISO 30401: Performance Evaluation.
ISO30401-15	Nonconformity and corrective action	Nonconformity and corrective action. Control from ISO 30401 framework, domain: ISO 30401: Performance Evaluation.

Improvement

1 controls

Controls in the Improvement domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-10.2	Continual improvement	Continually improve suitability, adequacy, and effectiveness of the KMS.

Knowledge lifecycle

1 controls

Controls in the Knowledge lifecycle domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-4.5	Knowledge development	Address acquiring, applying, retaining, handling outdated, and developing new knowledge.

Leadership

1 controls

Controls in the Leadership domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-5.1	Leadership and commitment	Top management demonstrates leadership and commitment to the KMS.

Monitoring

1 controls

Controls in the Monitoring domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-9.1	Monitoring, measurement, analysis, evaluation	Monitor and evaluate KM performance and effectiveness.

Objectives

1 controls

Controls in the Objectives domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-6.2	Knowledge management objectives	Establish measurable KM objectives at relevant functions and levels.

Operations

1 controls

Controls in the Operations domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-8.1	Operational planning and control	Plan, implement, and control processes needed to meet KM requirements.

Planning

1 controls

Controls in the Planning domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-6.1	Actions to address risks and opportunities	Identify and address risks and opportunities for the KMS.

Policy

1 controls

Controls in the Policy domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-5.2	Knowledge management policy	Establish and communicate a knowledge management policy.

Resources

1 controls

Controls in the Resources domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-7.1	Resources	Determine and provide resources for the KMS.

Roles

1 controls

Controls in the Roles domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-5.3	Roles, responsibilities, authorities	Assign and communicate KM roles, responsibilities, and authorities.

Scope

1 controls

Controls in the Scope domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-4.3	Scope of KMS	Define the boundaries and applicability of the knowledge management system.

Stakeholders

1 controls

Controls in the Stakeholders domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-4.2	Needs and expectations of stakeholders	Identify stakeholders and their knowledge needs and expectations.

System

1 controls

Controls in the System domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-4.4	Knowledge management system	Establish, implement, maintain, and improve the knowledge management system.

Transfer

1 controls

Controls in the Transfer domain of ISO 30401 — 1 controls
Code	Title	Description
ISO30401-4.6	Knowledge conveyance and transformation	Enable interactions, representations, and integrations that transform knowledge.

Your Compliance Coverage

If you comply with ISO 30401, you already cover:

IEC 62304:2015 Medical Device Software Lifecycle Processes

2 controls mapped

Compare →

ICH Q10 - Pharmaceutical Quality System

2 controls mapped

Compare →

ISO 20000-1

2 controls mapped

Compare →

+ 86 more: ISO 19011 (5%), TISAX - Trusted Information Security Assessment Exchange (5%)

See all 89 mapped frameworks ↓

Maps to 89 other frameworks

42 total controls

IEC 62304:2015 Medical Device Software Lifecycle Processes

2 source controls mapped|4 target controls covered

ICH Q10 - Pharmaceutical Quality System

2 source controls mapped|1 target controls covered

ISO 20000-1

2 source controls mapped|2 target controls covered

ISO 19011

2 source controls mapped|2 target controls covered

TISAX - Trusted Information Security Assessment Exchange

2 source controls mapped|2 target controls covered

ISO 9001

2 source controls mapped|4 target controls covered

ISO 37301

2 source controls mapped|2 target controls covered

ISO 37001

2 source controls mapped|2 target controls covered

ISO 55001

2 source controls mapped|2 target controls covered

NIST SP 800-39

1 source controls mapped|1 target controls covered

NIST SP 800-37

1 source controls mapped|1 target controls covered

NIST SP 800-30

1 source controls mapped|1 target controls covered

ITAR - International Traffic in Arms Regulations

1 source controls mapped|1 target controls covered

German Supply Chain Due Diligence Act (LkSG)

1 source controls mapped|1 target controls covered

ISO 56002

1 source controls mapped|3 target controls covered

ISO 41001:2018 - Facility Management Systems

1 source controls mapped|3 target controls covered

ISO 39001:2012 - Road Traffic Safety Management

1 source controls mapped|3 target controls covered

ISO 37002:2021 - Whistleblowing Management Systems

1 source controls mapped|3 target controls covered

ISO 50001:2018 - Energy Management Systems

1 source controls mapped|3 target controls covered

ISO 22313:2020 - Guidance on Business Continuity Management Systems

1 source controls mapped|3 target controls covered

NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems

1 source controls mapped|1 target controls covered

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

1 source controls mapped|1 target controls covered

SWIFT CSCF

1 source controls mapped|2 target controls covered

SWIFT CSCF v2024

1 source controls mapped|2 target controls covered

BRCGS Global Standard for Food Safety Issue 9

1 source controls mapped|2 target controls covered

DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)

1 source controls mapped|1 target controls covered

ISO 27005

1 source controls mapped|2 target controls covered

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories

1 source controls mapped|3 target controls covered

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

1 source controls mapped|3 target controls covered

ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)

1 source controls mapped|1 target controls covered

South Korea ISMS-P

1 source controls mapped|1 target controls covered

AS9100D - Aerospace Quality Management System

1 source controls mapped|3 target controls covered

ISO/IEC 27003:2017

1 source controls mapped|3 target controls covered

AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence

1 source controls mapped|1 target controls covered

ISO 14001

1 source controls mapped|1 target controls covered

ISO 45001:2018

1 source controls mapped|1 target controls covered

ISO 14001:2015

1 source controls mapped|1 target controls covered

ISO 9001:2015

1 source controls mapped|1 target controls covered

SQF Code Edition 9 - Safe Quality Food

1 source controls mapped|1 target controls covered

ISO 22000

1 source controls mapped|1 target controls covered

EASA Part-IS - Information Security in Aviation

1 source controls mapped|1 target controls covered

Voluntary Principles on Security and Human Rights (VPs)

1 source controls mapped|1 target controls covered

ISO 20400:2017 - Sustainable Procurement

1 source controls mapped|1 target controls covered

Aged Care Quality Standards (Australia)

1 source controls mapped|1 target controls covered

ISO/IEC 27014:2020

1 source controls mapped|1 target controls covered

UK FCA/PRA Operational Resilience Framework

1 source controls mapped|1 target controls covered

NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management

1 source controls mapped|2 target controls covered

ISO 31000

1 source controls mapped|1 target controls covered

SA8000:2014 - Social Accountability Standard

1 source controls mapped|1 target controls covered

AICPA Privacy Management Framework (PMF)

1 source controls mapped|1 target controls covered

PIC/S Guide to Good Manufacturing Practice for Medicinal Products

1 source controls mapped|2 target controls covered

ISO 45001

1 source controls mapped|1 target controls covered

ISO 26262:2018 - Functional Safety for Road Vehicles

1 source controls mapped|1 target controls covered

NIST SP 800-146

1 source controls mapped|1 target controls covered

NIST SP 800-145

1 source controls mapped|1 target controls covered

NIST SP 800-144

1 source controls mapped|1 target controls covered

NIST Privacy Framework

1 source controls mapped|1 target controls covered

NIS2 Directive

1 source controls mapped|1 target controls covered

NERC CIP

1 source controls mapped|1 target controls covered

MTCS (Singapore)

1 source controls mapped|1 target controls covered

FTC GLBA Safeguards Rule (16 CFR Part 314)

1 source controls mapped|1 target controls covered

Azure Security Benchmark

1 source controls mapped|1 target controls covered

ISO 27001:2022

1 source controls mapped|2 target controls covered

Annex 11 to EU GMP - Computerised Systems

1 source controls mapped|1 target controls covered

NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)

1 source controls mapped|1 target controls covered

Spain ENS

1 source controls mapped|1 target controls covered

BSI IT-Grundschutz

1 source controls mapped|1 target controls covered

AWS Well-Architected Security Pillar

1 source controls mapped|1 target controls covered

ISO 27019

1 source controls mapped|1 target controls covered

IEC 62443

1 source controls mapped|1 target controls covered

ISO 27017

1 source controls mapped|1 target controls covered

API 1164

1 source controls mapped|1 target controls covered

ISO 27018

1 source controls mapped|1 target controls covered

SSAE 18 - Attestation Standards (SOC Reporting)

1 source controls mapped|2 target controls covered

NIST SP 800-190

1 source controls mapped|1 target controls covered

NIST SP 1800-32

1 source controls mapped|1 target controls covered

SOC for Cybersecurity - Cybersecurity Risk Management Examination

1 source controls mapped|1 target controls covered

Saudi NCA ECC

1 source controls mapped|1 target controls covered

US NRC 10 CFR 73.54 - Cyber Security for Nuclear Power Plants

1 source controls mapped|1 target controls covered

SASB Standards (ISSB Integrated)

1 source controls mapped|1 target controls covered

SASB Standards

1 source controls mapped|1 target controls covered

NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security

1 source controls mapped|2 target controls covered

ITIL 4

1 source controls mapped|1 target controls covered

UK Gambling Commission - Cyber Resilience Requirements

1 source controls mapped|1 target controls covered

NRF Cybersecurity and Data Privacy Framework (National Retail Federation)

1 source controls mapped|1 target controls covered

Oman National Cybersecurity Framework

1 source controls mapped|1 target controls covered

TSA Pipeline Security

1 source controls mapped|1 target controls covered

NIST SP 800-53 Rev 5

1 source controls mapped|1 target controls covered

SOC 2

1 source controls mapped|1 target controls covered

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 28 domains and 42 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 42 controls organised across 28 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 89 other compliance frameworks. The top mapping partners are IEC 62304:2015 Medical Device Software Lifecycle Processes (5% coverage), ICH Q10 - Pharmaceutical Quality System (5% coverage), ISO 20000-1 (5% 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 42 controls and track your progress.

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