Quality in Health Care - ISO 9001 and EN 15224

Organized, transparent and reliable operations management earns trust of the public at large. We have developed a series of specialized services for health care institutions aimed at increasing the quality in health care. With an SIQ management system certificate you can increase your business efficiency while our established lecturers can offer you their assistance in improving the quality of your operations. Further on, we can conduct a series of measurements and inspection procedures, examine the condition of medical equipment, and check the level of electromagnetic radiation.

A growing number of health care institutions worldwide are becoming aware of the benefits of the introduction of an ISO 9001 standard in the operations of a health care institution:

  • Increased trust in the institution;
  • Lower risk of the occurrence of errors;
  • Enhanced satisfaction of patients;
  • Improved competitive position;
  • Defined and optimized processes;
  • Efficiency criteria and continuous improvement;
  • Involvement of all employees;
  • Improved communication;
  • Reduced costs and well managed documentation.

The ISO 9001 standard cannot replace other procedures, methods or systems that are being introduced in health care. It can only support them and facilitate their smoother and faster establishment.

SIST EN 15224:2012 Health care services – Quality management systems

EN 15224:2012 standard is a sector specific quality management system standard for health care organizations. It is intended to provide patient safety and risk management in health care organization and brings added value to quality management system in health care services.

This is a stand-alone standard and can be used for certification in health care.
The requirements in EN 15224 standard incorporate those from ISO 9001 with additional interpretations and specification for health care. The standard emphasizes clinical processes and risk management throughout planning, operation and control of processes.

The standard addresses the most basic requirements for quality in health care services. It specifies the following 11 characteristics: 

Appropriate, correct care
Availability
Continuity of care
Effectiveness
Efficiency
Equity
Evidence/knowledge based care
Patient centred care including physical, psychological and social integrity
Patient involvement
Patient safety
Timeliness/accessibility

SIQ - comprehensive solutions in health care:

Assessment of the status of a management system – we ascertain the gap between the established quality management system in accordance with requirements of ISO 9001 standard and requirements of EN 15224 standard. With this assessment you receive clear directions what needs to be done to fully meet the requirements of EN 15224 standard.

Certification of quality management systems in health care organizations
Training, seminars, courses - NOVELTY “The challenges of the management in health care: integration of various quality management systems and approaches to effective and efficient business operation”;
Testing and certification of medical devices;
Inspection of medical devices;
Identification of electromagnetic radiation and electromagnetic compatibility of devices.

 

 

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