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HEALTH SERVICES (ISO 13485:2016 Standard)

ELOT EN 15224:2017

WHAT IS ELOT EN 15224:2017?

This standard incorporates EN ISO 9001:2015 and adds interpretations, explanations, examples and additional requirements for healthcare organizations. The standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes.

The standard identifies eleven basic quality aspects that by clinical experience are known to be relevant in healthcare organizations. To assess fulfilment of quality requirements the organization need to specify quality characteristics related to these requirements. These aspects are

Appropriate, correct care, availability

1

Continuity of care

2

Effectiveness, efficiency

3

Equity, evidence/knowledge based care

4

Patient centred care including physical, psychological and social integrity (ICF), patient involvement, patient safety

5

Timeliness/accessibility

6
APPLICABILITY

ELOT EN 15224:2017 is applicable to healthcare organizations, regardless of structure, organization, owner, size or types of healthcare services provided.

BENEFITS FROM ELOT EN 15224:2017 CERTIFICATION
BENEFITS FROM ELOT EN 15224:2017 CERTIFICATION

The basic benefits from setting and implementing a Quality Management System according to the requirements of this standard are the following:

  • Continuous improvement of the quality of healthcare services to the clients
  • Conformance with legal and regulatory requirements
  • Substantial contribution to the development and sustainability of the organization
  • It provides the organization with a competitive advantage as regards the provision of high quality of healthcare services
CERTIFΙCATION WITH EUROCERT
  • EUROCERT is the largest Greek independent certification body accredited by ESYD, with activities in over 40 countries worldwide. Certification with Eurocert means evaluation and acceptance by a reliable accredited and recognized certification organization.
  • EUROCERT has capable and experienced staff and partners, who as inspectors and/or technical experts conduct high value-added inspections and audits for your business.
  • EUROCERT ensures you are continuously informed about any local or international developments that interest you according to your certification field.
  • EUROCERT is capable of providing your business with a comprehensive solution for management system certification, having accreditation in a very wide range of certification services.
CERTIFΙCATION WITH EUROCERT
Relative Documents

Please read the attachments for more information

CONTACT PERSON
George Theodoropoulos

George Theodoropoulos

Vice Certification Director Quality Sector - BS in Physics UOA, MSc, MBA

Tel: +30 2106252495

Direct: *319

Mobile: 6981471180

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