ISO 13485 – Medical Device Quality Management
Ensuring the Quality and Safety of Medical Equipment from Manufacturing to Use
This standard is designed for manufacturers and suppliers of medical devices, ensuring their commitment to the highest standards of quality and safety throughout the product life cycle.
Key Requirements
- Comprehensive documentation of manufacturing and storage processes
- A system for tracking defective devices and implementing recall processes
- Periodic quality tests for medical devices
ISO 9001 – Quality Management in Healthcare Institutions
Improving the Patient Experience and Increasing the Efficiency of Healthcare Services
This standard is used to control and improve administrative and medical processes within healthcare facilities, focusing on patient satisfaction and operational effectiveness.
Key Requirements
- Reduce waiting time in emergency departments
- Standardize sterilization and diagnostic procedures
- Improve the management of patient complaints and satisfaction
ISO 45001 – Occupational Health and Safety Management System
Protecting Workers in the Healthcare Sector and Reducing Occupational Risks
This standard provides a comprehensive framework to ensure a safe working environment, especially in hospitals and laboratories facing biological and chemical hazards.
Key Requirements
- Prevention of infection transmission (such as COVID-19, hepatitis)
- Training medical staff on handling hazardous materials
- Improving safety procedures within care facilities
ISO 27799 – Health Information Security
Protecting Patient Privacy and the Confidentiality of Medical Records
This standard focuses on securing sensitive health data against breaches or loss, ensuring digital trust and legal compliance.
Key Requirements
- Encrypt medical records and sensitive information
- Prevent intrusions into booking and information systems
- Establish strict policies for access and data management