Healthcare
ISO certification for healthcare companies.
Medical devices, patient data and continuity of care: we certify your organization to ISO 13485, 27001 and 22301 and support GDPR compliance, with a dedicated Lead Auditor and a platform that writes the documentation for you.
Challenges in healthcare
What makes compliance hard in healthcare.
Patients can’t wait, and sensitive data can’t leak. These are the issues we see most often in clinics, medical device makers and healthcare software companies, and how certification solves them.
Medical device requirements
The EU MDR requires a quality system for medical devices. ISO 13485 is the standard notified bodies expect to see.
Sensitive patient data
Health data is the most protected category under GDPR. ISO 27001 sets the controls that keep it safe and prove it to auditors.
Continuity of care
A system outage can stop appointments and treatments. ISO 22301 plans how to keep services running when something goes wrong.
Accreditation and tenders
Public health tenders and accreditation reward certified suppliers. Certification makes your quality and security verifiable.
How it works
From the first call to the certificate in three steps.
01
Gap analysis
Your Lead Auditor maps your processes, risks and documents and tells you exactly what is missing.
02
System built in the platform
Policies, procedures, risk assessments and records are generated for your company. You review, we refine.
03
Audit and surveillance
We prepare you for the certification body’s audit and manage yearly surveillance audits so nothing expires.
Resources
Free resources for healthcare companies.
Guide
ISO 27001: the complete guide
Controls, documents and timelines of the information security standard.
Read the guide
Guide
What GDPR is and where it comes from
The basics of the European data protection regulation.
Read the guide
Tool
Does NIS2 apply to your company?
Answer a few questions and find out in two minutes.
Use the free tool
Tool
Funding for ISO certification
Find the regional calls and vouchers that can fund your certification.
Use the free tool
Results
What our clients achieved.
Other industries
Not in healthcare? See your industry.
Manufacturing
ISO 9001, ISO 45001, ISO 14001 and ISO 50001 for production plants.
IT & Software
ISO 27001, NIS2 and ISO 42001 for software houses and IT services.
Construction
ISO 9001, ISO 45001 and ISO 37001 for construction firms.
Logistics & Transport
ISO 9001, ISO 45001 and ISO 14001 for carriers and warehouses.
Professional Services
ISO 9001, ISO 27001 and GDPR for firms and consultancies.
Food & Beverage
ISO 9001, ISO 14001 and ISO 22301 for food producers.
FAQ
ISO certification in healthcare: what companies ask us.
Which ISO certification does a healthcare company need?
Medical device makers need ISO 13485. Clinics and healthcare software companies usually start with ISO 27001 for patient data, often together with GDPR compliance and ISO 22301 for continuity.
Is ISO 13485 required by the MDR?
The MDR requires a quality management system. ISO 13485 is the harmonised standard used to demonstrate it, so in practice notified bodies expect it.
Do you also handle GDPR for clinics?
Yes. We keep the record of processing, DPIAs and privacy notices up to date, and we can act as your outsourced DPO.
How long does ISO certification take in healthcare?
It depends on your size and starting point. Most SMEs complete the path in 1 to 6 months, from the gap analysis to the certification body's audit.
Will audits disrupt patient care?
No. Visits and audits are planned around your schedules, and most of the documentation is handled in the platform, so care continues as usual.
