Healthcare organizations and their suppliers operate where errors affect patients. Certification provides structured evidence of quality, information security and laboratory competence, alongside, never instead of, regulatory approvals.
Industry Challenges
- Patient safety and product quality
- Protection of patient and health data
- Regulatory approvals that certification cannot replace
- Supplier and outsourced service control
- Laboratory quality and result validity
Standards Commonly Requested
| Standard | Why it matters in healthcare |
|---|---|
| ISO 13485 | QMS for medical device manufacturers and suppliers |
| ISO 9001 | Quality management for providers and service organizations |
| ISO/IEC 27001 | Security of patient and clinical information |
| ISO 15189 | Compliance certification for medical laboratories |
| ISO 41001 | Facility management for hospital estates |
What Auditors Focus On
- Risk management throughout processes
- Validation, traceability and complaint handling
- Access control and data protection
- Competence and training records
- Supplier and service agreements
Your Certification Journey
- Confirm which standards your customers, tenders or regulators require.
- Define the scope: activities, sites and products.
- Optional: gap or readiness assessment.
- Stage 1 and Stage 2 audits, combined into one integrated audit if you need several standards.
- Independent certification decision and public listing.
- Annual surveillance, then recertification every three years.
FAQs
Does ISO 13485 certification replace FDA or EU MDR approval?
No. Regulatory market access is separate and mandatory where it applies.
Can medical laboratories get certified?
We offer ISO 15189 compliance certification. Accreditation, where required, is granted by an accreditation body.