Software, Cybersecurity and AI
ISO/IEC 27001: Information Security Management Systems
ISO/IEC 27001 specifies requirements for an information security management system (ISMS): how an organization identifies information security risks and selects, runs and improves controls for them. It isn't a medical device standard, and device regulations don't generally require it, but device makers adopt it more and more because their customers ask.
At a Glance
- Standard
- ISO/IEC 27001
- Subject
- Information Security Management Systems
- Group
- Software, Cybersecurity and AI
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The standard is risk-based. The organization defines the scope of its ISMS, assesses information security risks, decides how to treat them, and records which controls apply and why. Controls range across organizational, people, physical and technical measures, from access management and supplier security to logging, backup and incident response. Certification is available from accredited certification bodies through an audit cycle broadly similar to ISO 13485.
Device makers come to it for practical reasons. Hospital and health system security questionnaires often ask whether a vendor holds ISO/IEC 27001 certification, especially for connected devices and cloud services that handle patient data. It also gives structure to protecting design history, source code and other intellectual property, and to running the cloud systems that host software devices or device data.
It works best alongside the QMS rather than as a parallel bureaucracy. Document control, internal audit, management review and corrective action exist in both systems, and many firms run them once. What ISO/IEC 27001 doesn't do is address the security of the device itself; that's product security work under standards such as IEC 81001-5-1 and the device's design controls.
Who It Applies To
- Device makers selling connected devices or cloud software to hospitals and health systems
- Software device companies that host patient or device data in the cloud
- Firms protecting design history, source code and manufacturing data
- Organizations whose customers or partners write ISMS certification into contracts
What Auditors Check
ISMS Scope
A defined scope that covers the systems, locations and services customers actually rely on.
Risk Assessment and Treatment
A documented information security risk assessment with treatment decisions and named risk owners.
Statement of Applicability
A record of which controls apply, why, and whether each one is implemented.
Access and Supplier Security
Access reviews, joiner and leaver records, and security requirements placed on cloud and IT suppliers.
Incidents and Corrective Action
Security incident records with root cause and corrective action, ideally handled through the same CAPA process as the QMS.
Internal Audit and Management Review
ISMS internal audits and management reviews, with records of decisions and follow-up.
Related Services
Internal Audit Program
A risk-based internal audit program, run by your team or our advisors, with reports written for FDA to read.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
Ongoing Advisory and Continuous Readiness
Periodic re-assessments, a live action plan and yearly mock inspections that keep readiness from decaying.
Questions
Is ISO/IEC 27001 required for medical devices?
Device regulations don't generally require it. Customers often do, through security questionnaires and contracts, particularly for connected products and cloud services. Treat it as a commercial and information security decision, separate from your device regulatory obligations.
Can we combine it with our ISO 13485 system?
Many firms share processes such as document control, internal audit, management review and corrective action across both. The ISMS still needs its own scope, risk assessment and set of controls, and each audit will look at its own requirements.
Does ISO/IEC 27001 cover our device's cybersecurity?
No. It covers how your organization manages information security. Product cybersecurity, including threat modeling, security testing and vulnerability handling for the device, belongs to product lifecycle standards such as IEC 81001-5-1 and to your design controls.
ISO/IEC 27001
Check Your Quality System Against ISO/IEC 27001
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
