Healthcare and medical device organizations must comply with stringent quality and safety standards. ISO 13485 is the primary standard for medical device quality management, while ISO 15189 addresses medical laboratory requirements.

These standards ensure patient safety, product effectiveness, and regulatory compliance with bodies like FDA, MDR, and other regional regulators.

Key Standards for Healthcare & Medical Devices

Benefits

  • Patient safety enhanced
  • Regulatory compliance globally
  • Market access worldwide
  • Risk management improved
  • Product quality assured
  • Liability protection

Industry Challenges

  • Strict regulatory requirements
  • Post-market surveillance
  • Clinical evidence needs
  • Recall management
  • Biocompatibility testing

All Standards for Healthcare & Medical Devices

ISO 9000

Quality Management - Fundamentals and Vocabulary

The reference document for quality management concepts, principles and terminology. ISO 9000:2026 is the fifth edition and replaces ISO 9000:2015; it supplies the definitions that ISO 9001 and the rest of the ISO/TC 176 portfolio rely on.

ISO 9001

Quality Management Systems

The requirements standard for a quality management system, and the most widely used certification standard in the world. The current edition is ISO 9001:2015 with Amendment 1:2024 (climate action); a revised edition is in preparation.

ISO 9004

Quality Management - Guidance for Sustained Success

Guidance for organizations that want to go beyond conformity with ISO 9001 and improve their overall ability to achieve sustained success, including a self-assessment tool for judging maturity.

ISO 10001

Customer Satisfaction - Codes of Conduct

Guidance on planning, designing, implementing and improving customer satisfaction codes of conduct — the promises an organization makes to its customers about how it will behave — as the first line of defence against complaints and disputes.

ISO 10002

Complaints Handling in Organizations

Guidance on handling complaints about products and services inside an organization — from receipt and acknowledgement through investigation, resolution and follow-up, to using complaint data for improvement.

ISO 10003

External Dispute Resolution for Customer Satisfaction

Guidance on resolving product- and service-related complaints that an organization has been unable to settle internally, by using dispute resolution providers external to the organization.

ISO 10004

Monitoring and Measuring Customer Satisfaction

Guidance on defining and implementing processes to monitor and measure customer satisfaction, covering what to measure, how to gather direct and indirect data, and how to analyse and act on the results.

ISO 45001

Occupational Health and Safety Management Systems

The international standard for occupational health and safety management systems, replacing OHSAS 18001. Current edition is ISO 45001:2018 with Amendment 1:2024 (climate action); a revision is at Draft International Standard stage.

ISO 27000

Information Security Management Systems - Overview and Vocabulary

The overview and vocabulary document for the ISO/IEC 27000 family. It explains how the ISMS standards fit together and defines the terms they use, and is available free of charge from ISO.

ISO 31010

Risk Assessment Techniques

A catalogue of risk assessment techniques with guidance on selecting and applying them. The second edition, IEC 31010:2019, replaces the 2009 edition and complements ISO 31000.

ISO 27001

Information Security Management Systems

The certifiable requirements standard for an information security management system. Current edition is ISO/IEC 27001:2022 with Amendment 1:2024 (climate action); Annex A lists 93 controls organised into four themes.

ISO 27002

Information Security, Cybersecurity and Privacy Protection - Security Controls

The implementation guidance companion to ISO/IEC 27001. It describes 93 information security controls in four themes, each with purpose, guidance and attributes, and is not itself a certifiable standard.

ISO 17025

Testing and Calibration Laboratories - Competence Requirements

The international standard against which testing and calibration laboratories are accredited. The third edition, ISO/IEC 17025:2017, was reviewed and confirmed in 2023 and remains current.

ISO 13485

Medical Devices - Quality Management Systems

The quality management system standard for organizations involved in the medical device life cycle, written for regulatory purposes. ISO 13485:2016 is the third edition; a systematic review confirmed it and it remains current.

ISO 14971

Medical Device Risk Management

The risk management standard for medical devices, specifying the process manufacturers use to identify hazards, estimate and evaluate risks, control them and monitor the effectiveness of controls across the device life cycle. Third edition, published 2019.

ISO 10993

Biological Evaluation of Medical Devices

The multi-part series governing biological evaluation (biocompatibility) of medical devices. Part 1, the framework document, was revised in 2025 as its sixth edition, reorganised to align with ISO 14971 and replacing ISO 10993-1:2018.

ISO 62304

Medical Device Software - Software Life Cycle Processes

The software life cycle standard for medical device software. It defines development, maintenance, risk management, configuration management and problem resolution processes, scaled by software safety class A, B or C. A second edition is in development.

ISO 15189

Medical Laboratories - Quality and Competence Requirements

The accreditation standard for medical laboratories. The fourth edition, ISO 15189:2022, replaces ISO 15189:2012 and also replaces ISO 22870:2016, bringing point-of-care testing into the main standard and aligning its structure with ISO/IEC 17025:2017.

ISO 62366

Medical Devices - Usability Engineering / Human Factors

The usability engineering standard for medical devices. It specifies a process for analysing, specifying, developing and evaluating the usability of a device as it relates to safety, addressing use errors and use-related hazards. Current text is the 2015 edition with Amendment 1:2020.

ISO 22301

Business Continuity Management Systems

The certifiable business continuity management system standard. Current edition is ISO 22301:2019 with Amendment 1:2024 (climate action); a revision is in preparation at committee draft stage.

ISO 37301

Compliance Management Systems

Certifiable requirements for a compliance management system, replacing the guidance-only ISO 19600:2014

ISO 42001

Artificial Intelligence Management Systems

The first certifiable AI management system standard (AIMS), specifying requirements for the responsible development, provision and use of AI systems

ISO 27005

Information Security Risk Management

Guidance on managing information security risks in support of an ISO/IEC 27001 information security management system; guidance only, not certifiable

ISO 27701

Privacy Information Management Systems

Certifiable requirements for a privacy information management system (PIMS); the 2025 second edition is a standalone standard, no longer an extension to ISO/IEC 27001

ISO 27032

Cybersecurity Guidelines for Cyberspace

Guidelines for Internet security, explaining how Internet security relates to network, web and cybersecurity; second edition published 2023, replacing the 2012 cyberspace-focused edition

ISO 23894

Artificial Intelligence - Risk Management

Guidance on managing risk specific to artificial intelligence, applying the ISO 31000 risk management model to AI development and use; guidance only, not certifiable

ISO 30141

Internet of Things - Reference Architecture

Reference architecture for Internet of Things systems, providing a conceptual model, architectural views and design patterns; second edition published 2024

ISO 24028

Artificial Intelligence - Overview of Trustworthiness in AI

A technical report surveying the factors that affect the trustworthiness of systems providing or using AI, including transparency, explainability, controllability, robustness, safety, security and privacy.

ISO 27030

IoT Security and Privacy - Guidelines (published as ISO/IEC 27400)

ISO/IEC 27030 was the working project number for IoT security and privacy guidelines; the work was renumbered and published as ISO/IEC 27400:2022, which is the standard to reference.

ISO 30409

Human Resource Management - Workforce Planning

Guidelines and a framework for strategic and operational workforce planning, scalable to organizations of any size, industry or sector. Reviewed and confirmed in 2022.

ISO 15223

Medical Devices - Symbols to be Used with Information Supplied by the Manufacturer

Specifies the symbols used to convey information supplied with medical devices, on the device, its packaging or accompanying documentation. The fourth edition (2021) is amended by Amendment 1:2025.

ISO 14155

Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice

Specifies good clinical practice for the design, conduct, recording and reporting of clinical investigations of medical devices in human subjects. The 2026 edition supersedes ISO 14155:2020.