ISO 80001

ISO 80001:2021 is an internationally recognized standard that establishes a framework for risk management of IT networks incorporating medical devices, also known as Medical IT Networks. As healthcare facilities increasingly rely on interconnected medical devices and digital systems, ISO 80001 helps ensure that these networks operate safely, securely, and effectively.

This standard is essential for hospitals, healthcare IT providers, and device manufacturers to manage risks related to data security, patient safety, and device performance. At Quality Asia Certification, we offer accredited ISO 80001:2021 certification services to enable organizations to meet global expectations in medical IT governance.

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What is ISO 80001?

ISO 80001:2021 is a guideline-based standard focusing on Application of Risk Management for IT Networks Incorporating Medical Devices. It outlines processes to identify, assess, control, and monitor risks when medical devices are connected to hospital or clinical IT networks. The standard emphasizes three key areas:

  1. Patient safety
  2. Data integrity
  3. System effectiveness

This certification is particularly valuable for healthcare institutions that manage complex digital infrastructures where device interoperability, cybersecurity, and regulatory compliance are critical.

Why is ISO 80001 important?

In today’s healthcare landscape, the integration of medical devices with IT systems is inevitable. However, with connectivity comes the risk of data breaches, system failures, and patient harm. ISO 80001:2021 addresses these concerns by:

  1. Providing a structured risk management approach
  2. Ensuring safe operation of connected medical devices
  3. Helping institutions comply with regulatory frameworks like MDR, HIPAA, and GDPR
  4. Offering clarity in roles and responsibilities between device manufacturers, IT service providers, and healthcare facilities

ISO 80001:2021 is not just about technical compliance — it's a commitment to patient-centric and technology-safe practices in the digital age of healthcare.

What are the benefits of ISO 80001?

ISO 80001:2021 offers several tangible and long-term advantages:

  1. Improved patient safety by managing IT-network-related medical device risks
  2. Enhanced cybersecurity through defined protocols and response mechanisms
  3. Risk mitigation through systematic analysis of device-network interactions
  4. Interoperability support, ensuring smoother integration of devices across systems
  5. Compliance with legal and industry requirements for health information management
  6. Increased trust from patients, stakeholders, and regulators
  7. Alignment with ISO 14971 and other risk management standards in healthcare


What kind of businesses can benefit from ISO 80001?

Implementing and certifying your organization with ISO 80001:2021 leads to several business advantages:

  1. ✅ Strengthened brand reputation in the healthcare ecosystem as a safety-compliant organization
  2. ✅ Reduced legal liabilities due to standardized risk and incident management processes
  3. ✅ Faster integration of new medical technologies within IT infrastructure
  4. ✅ Support in winning contracts with hospitals and government health agencies that require certified safety standards
  5. ✅ Improved internal collaboration between IT, clinical staff, and equipment vendors
  6. ✅ Operational efficiency through clearly defined roles, policies, and procedures
  7. ✅ Competitive advantage in medical device manufacturing or hospital IT services sector


Top Tips on making ISO 9001 effective for you.

#1

Top management commitment while practicing and accomplishing the standard is the key to success.

#2

Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.

#3

Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.

#4

Review systems, policies, processes, and procedures for a smooth working of QMS.

#5

Speaking to customers & suppliers while getting feedback & working on improvements.

#6

Training staff carrying out the internal audits with the opportunity for improvement.

#7

Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.

#8

Ensure continuous improvement by regularly reviewing and updating your quality management practices.

#9

Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.

Why QualityAsia?

QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:

Initial Certification – Stage 1 (Preparatory Phase)
  • Thorough documented information review.
  • Exchange of information with staff through online or onsite presence.
  • Identification of key performances, processes & objectives as per the standard requisites.
  • Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.

Initial Certification – Stage 2 (On-site Audit)
  • Measurement, reporting & reviewing the performances against key performances objectives.
  • Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
  • Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
  • Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.


    Surveillance & Certification Renewal

    Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.

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