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Health Sector
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Why Cannot Be Left to Chance?

Certification in the healthcare sector is more than an operational requirement, it is proof of respect for human life.

  • Patient Safety & Quality
    Verifies the competencies of healthcare professionals and organizations. It minimizes the risk of medical errors and makes patients feel that the service provided complies with international norms.
  • Flawless Legal Compliance
    Creates a shield against strict scrutiny by local and international authorities. Resets risks by officially certifying that legal requirements are fully met.
  • Competitive Advantage
    For organizations providing services to international patients (medical tourism) or participating in global supply chains, it is the strongest reason for preference with insurance companies and buyers.
Sağlık belgelendirme

28+

Years of Experience

What is the Health Sector?

From the diagnosis, treatment and prevention of diseases to medical research and drug development, it is a huge ecosystem that cannot tolerate the slightest mistake.

Hospitals & Clinics

Emergency departments, intensive care and specialized clinics. Process standardization with ISO 9001 is essential.

Diagnosis & Laboratory

Radiology, imaging and medical testing laboratories. Accuracy and instrument calibration are essential.

Medicine & Pharmacy

Pharmaceutical development, manufacturing, distribution and consulting services. Subject to strict hygiene and quality standards.

Medical Device Production

Production of life-saving devices. Market entry is impossible without ISO 13485 and CE marking.

Rehabilitation & Care

Physical therapy, home health care and psychiatry services. Patient rights and comfort are at the forefront.

Public Health & Transportation

Vaccination, community health programs and ambulance/patient transport operations.

Standards Applied in the Health Sector

Certification Programs

Choose the standard that suits your healthcare organization’s needs and review the details.

Frequently Asked Questions

ISO 13485 has become de facto mandatory in international markets for all organizations that manufacture, distribute or provide services for medical devices. In the EU, it is a basic requirement in CE marking processes and local legislation.

ISO 9001 quality management system is the starting point for most hospitals. However, for hospitals with a strong digital infrastructure, ISO 27001 and ISO 45001 for patient transportation and clinical operations should be considered simultaneously.

ISO 13485 certification is usually completed between 5 and 10 months, depending on the organization’s existing system infrastructure. Product scope and production process complexity directly affect this timeframe.

Patient data is the most sensitive category of personal data. In the event of a breach, legal sanctions and loss of reputation come into play. ISO 27001 is the international framework for managing these risks in compliance with KVKK.