Safe and Standards-Compliant

Assurance Through Standards in
Health Sector

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Why It Cannot Be Left to Chance?

In healthcare, certification is not merely an operational requirement; through an independent audit, it demonstrates the safety of your service to auditors and your business partners.

  • Patient Safety & Quality
    / It verifies the competence of health professionals and your organisation, reduces the risk of medical error and makes your service’s compliance with international norms visible.
  • Legal Compliance
    It keeps you ready for inspections by local and international authorities; by formally documenting that legal requirements are met, it reduces your compliance risk.
  • Competitive Advantage
    For organisations serving international patients in health tourism or entering global supply chains, it is a strong reason for preference in the eyes of insurers and buyers.
Sağlık belgelendirme

28+

Years of Experience

What is the Health Sector?

It is a broad field stretching from diagnosis and treatment to drug development and medical device manufacturing, leaving no room for error. Each sub-field has its own standards needs.

Hospitals & Clinics

Emergency services, intensive care units and specialist clinics. ISO 9001 is the starting point for standardising processes.

Diagnosis & Laboratory

Radiology, imaging and medical testing laboratories. Result accuracy and device calibration are decisive.

Medicine & Pharmacy

/ Drug development, production, distribution and consultancy. Subject to strict hygiene and quality requirements.

Medical Device Manufacturing

Manufacturing of vital devices. For market entry, ISO 13485 and the CE mark are mandatory in most cases.

Rehabilitation & Care

Physiotherapy, home care and psychiatric services. Patient rights and comfort are the priority.

Public Health & Transportation

Vaccination, community health programmes and ambulance/patient transfer operations.

Standards Applied in the Health Sector

Certification Programs

Choose the standard that fits your healthcare organisation’s needs; carry out certification with an accredited body.

Frequently Asked Questions

For organisations that manufacture or distribute medical devices, or provide services related to them, ISO 13485 has effectively become mandatory in international markets. It is a fundamental requirement in EU CE marking processes and in local legislation.

The ISO 9001 quality management system is the starting point for most hospitals. In hospitals with strong digital infrastructure, ISO 27001, and for patient transport and clinical operations, ISO 45001, can be assessed at the same time.

Depending on the organisation’s existing system infrastructure, ISO 13485 certification is usually completed in 5 to 10 months. The product scope and the complexity of the production process directly affect this timeline.

Patient data is one of the most sensitive categories of personal data; in the event of a breach, legal sanctions and reputational damage come into play. ISO 27001 provides an international framework for managing these risks in line with data protection law (KVKK).