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 Systems - Fundamentals and Vocabulary

Foundation standard providing fundamental concepts, principles, and vocabulary for quality management systems (QMS), establishing common terminology across all ISO 9000 family standards

ISO 9001

Quality Management Systems

The world's most recognized quality management standard for organizations of any size

ISO 9004

Quality Management - Guidance for Sustained Success

Comprehensive guidance standard for organizations seeking to achieve sustained success through effective quality management beyond ISO 9001 requirements, providing a self-assessment maturity model and alignment with business excellence frameworks

ISO 10001

Customer Satisfaction - Codes of Conduct

Guidelines for establishing customer satisfaction codes of conduct containing organizational promises and commitments to enhance transparency, fairness, and customer trust

ISO 10002

Complaints Handling in Organizations

Guidelines for establishing effective and efficient complaints-handling processes to enhance customer satisfaction

ISO 10003

External Dispute Resolution for Customer Satisfaction

Guidelines for establishing fair and effective external dispute resolution processes for customer complaints that cannot be resolved internally through ADR methods

ISO 10004

Monitoring and Measuring Customer Satisfaction

Comprehensive guidelines for defining and implementing processes to monitor and measure customer satisfaction through KPIs, surveys, and systematic feedback analysis

ISO 45001

Occupational Health and Safety Management Systems

International standard for occupational health and safety management systems to reduce workplace injuries and illnesses

ISO 27000

Information Security Management Systems - Overview and Vocabulary

Foundation standard providing overview and comprehensive vocabulary for the ISO/IEC 27000 family of information security management system standards, defining fundamental terminology including the CIA triad

ISO 31010

Risk Assessment Techniques

Comprehensive guidance on selection and application of 41 risk assessment techniques supporting ISO 31000, covering qualitative, quantitative, and semi-quantitative methods

ISO 27001

Information Security Management Systems

Leading international standard for information security management systems

ISO 27002

Information Security, Cybersecurity and Privacy Protection - Security Controls

Comprehensive code of practice providing detailed implementation guidance for 93 information security controls organized into four themes: organizational, people, physical, and technological

ISO 17025

Testing and Calibration Laboratories - Competence Requirements

International standard specifying requirements for competence, impartiality, and consistent operation of testing and calibration laboratories, enabling accreditation and global recognition

ISO 13485

Medical Devices - Quality Management Systems

International standard for quality management systems in medical device design and manufacturing, harmonized with FDA regulations and global regulatory requirements

ISO 14971

Medical Device Risk Management

International standard specifying terminology, principles and processes for risk management throughout medical device lifecycle

ISO 10993

Biological Evaluation of Medical Devices

Comprehensive series of 23 standards for evaluating biocompatibility and biological safety of medical devices

ISO 62304

Medical Device Software - Software Life Cycle Processes

International standard specifying life cycle requirements for safe development and maintenance of medical device software, including SaMD, recognized by FDA and global regulators

ISO 15189

Medical Laboratories - Quality and Competence Requirements

International standard specifying quality and competence requirements for medical laboratories covering complete diagnostic workflow from pre-examination through post-examination, including POCT

ISO 62366

Medical Devices - Usability Engineering / Human Factors

International standard specifying usability engineering processes for medical devices to assess and mitigate risks from use errors, recognized by FDA and global regulators

ISO 22301

Business Continuity Management Systems

International standard specifying requirements for business continuity management systems (BCMS) to ensure organizational resilience and continuity of critical operations during disruptive incidents

ISO 37301

Compliance Management Systems

International standard for establishing and maintaining effective compliance management systems

ISO 42001

Artificial Intelligence Management Systems

World's first certifiable AI management system standard (AIMS) providing requirements for responsible development and use of AI systems, aligned with EU AI Act and global AI regulations

ISO 27005

Information Security Risk Management

Comprehensive guidelines for information security risk management supporting ISO 27001 implementation with systematic risk assessment and treatment approaches

ISO 27701

Privacy Information Management Systems

Privacy extension to ISO 27001 establishing requirements for Privacy Information Management Systems (PIMS) to manage personally identifiable information and support GDPR compliance

ISO 27032

Cybersecurity Guidelines for Cyberspace

Guidelines for improving cybersecurity by addressing information security, network security, internet security, and critical information infrastructure protection (CIIP) with stakeholder collaboration framework

ISO 23894

Artificial Intelligence - Risk Management

Comprehensive guidance standard for managing risks specific to artificial intelligence systems throughout their lifecycle, complementing ISO 42001 and based on ISO 31000 principles

ISO 30141

Internet of Things - Reference Architecture

Reference architecture standard for Internet of Things systems and applications

ISO 24028

Artificial Intelligence - Trustworthiness

Framework defining trustworthiness characteristics for AI systems including accountability, transparency, reliability, fairness, privacy protection, and robustness

ISO 27030

IoT Security and Privacy - Guidelines

Comprehensive security and privacy guidelines for Internet of Things (IoT) systems, addressing unique challenges of connected devices, data flows, and distributed architectures

ISO 30409

Human Resource Management - Workforce Planning

Guidelines for workforce planning enabling organizations to align workforce capabilities with strategic objectives through systematic assessment, planning, and development

ISO 15223

Medical Devices - Symbols for Labels

Standard defining symbols used on medical device labels, instructions, and packaging ensuring international understanding of device information

ISO 14155

Clinical Investigation of Medical Devices for Human Subjects

Good clinical practice standard for clinical investigations of medical devices ensuring ethical conduct, subject safety, and reliable data collection