Healthcare & Medical Devices
Standards for healthcare organizations, medical devices, and clinical laboratories ensuring patient safety
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.
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