General questions about healthcare standards
Q: What ISO standards are relevant for healthcare?
A: ISO has over 1,400 standards related to healthcare, covering quality management, medical devices, health informatics, cybersecurity, AI in healthcare, and sustainable healthcare management. Key standards include ISO 13485 (medical devices), ISO/IEC 27001 (cybersecurity), and ISO 9001 (quality management).
Q: How do I find the right ISO standard for my healthcare business or role?
A: Identify your activity area, such as medical devices, health IT, healthcare provider operations, or sustainability. Then you can be guided to relevant standards like ISO 13485 for medical devices, ISO/IEC 27001 for IT security, or ISO 14001 for environmental management in healthcare.
Medical devices
Q: Which ISO standard applies to quality management for medical device manufacturers?
A: ISO 13485:2016 is the global standard for quality management systems specifically for medical device design and manufacturing.
Q: Where can I find standards related to medical device quality and safety?
A: The ISO Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, develops these standards, including ISO 13485.
Health informatics and cybersecurity
Q: Are there ISO standards for managing healthcare information and IT?
A: Yes, the technical committee ISO/TC 215 focuses on health informatics, facilitating secure, interoperable exchange of electronic health data.
Q: How can healthcare organizations protect patient data using ISO standards?
A: ISO/IEC 27001 provides a comprehensive Information Security Management System (ISMS) framework commonly adopted by healthcare organizations to safeguard the confidentiality, integrity, and availability of patient data.
AI and digital health
Q: Does ISO provide any guidance for AI used in healthcare settings?
A: Yes, ISO/IEC 42001:2023 specifies requirements for AI management systems to ensure ethical, responsible, and transparent AI deployment, including applications in healthcare diagnostics and treatment.
Q: What ISO standards help with software as a medical device (SaMD)?
A: ISO 13485 supports SaMD manufacturers through quality management requirements, complemented by emerging AI and health IT standards.
Healthcare facility and operational management
Q: What standards help improve quality and safety in healthcare facilities?
A: ISO 9001 guides quality management processes across healthcare settings. For occupational health and safety, ISO 45001 helps manage workplace risks. Environmental and energy management in healthcare can align with ISO 14001 and ISO 50001 respectively.
Sustainability and regulatory compliance
Q: How does ISO support sustainable healthcare operations?
A: ISO 14001 helps healthcare organizations reduce environmental impact, and ISO 50001 focuses on energy efficiency, supporting overall sustainability goals.
Q: Are ISO standards aligned with global health goals?
A: Yes, ISO healthcare standards contribute to the United Nations Sustainable Development Goal 3 (SDG 3) to ensure healthy lives and promote well-being for all, supporting universal health coverage and patient-centered care.
How to get started
Q: How do I get involved or obtain ISO standards for healthcare? A: Official ISO standards can be acquired through the ISO website or your country’s National Standards Body (NSB). To participate in standards development, contact your NSB to join relevant ISO technical committees such as ISO/TC 210 or ISO/TC 215. While ISO itself does not certify organizations, hospitals and healthcare institutions must engage accredited certification bodies to achieve ISO certification. Certification involves independent verification of conformity to specific ISO standards, ensuring practices meet internationally recognized quality and safety benchmarks.
ISO Certification Steps for Healthcare Organizations
Identify Relevant ISO Standards: Determine which ISO standards align with your organizational goals, such as ISO 9001 for quality management or ISO 45001 for workplace safety.
Develop and Implement Management Systems: Align your processes to meet the requirements of the relevant standards, involving internal teams to streamline the transition.
Conduct Internal Audits: Review and assess your systems internally to identify any nonconformities or gaps.
Engage an Accredited Certification Body: Verify that the certification body you approach is accredited and experienced within the healthcare sector.
Certification Audits: Undergo a two-stage external audit process, which includes a documentation review followed by an implementation audit.
Achieve and Maintain Certification: Address any audit findings, and comply with regular surveillance to retain certification. By adhering to these steps, hospitals can effectively meet ISO standards and ensure alignment with global best practices.
Quick reference: key healthcare ISO standards and their roles
Standard/Committee | Focus area | Link |
ISO 13485 | Medical device quality management | |
ISO/IEC 27001 | Information security management in healthcare IT | |
ISO 9001 | Quality management | |
ISO 14001 | Environmental management | |
ISO 45001 | Occupational health and safety | |
ISO 50001 | Energy management | |
ISO/IEC 42001 | AI management systems for ethical AI | |
ISO/TC 210 | Medical device standards committee | |
ISO/TC 215 | Health informatics standards committee |
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