EN 15224 is the specific standard for healthcare facilities to sufficiently meet the special needs of health care services. It is based on ISO 9001 standard which is tailored to the requirements of organisations in the health care industry.
EN 15224 standard concerns companies and organizations whose operation is related to the provision of health services. For some organizations (eg Medical Assisted Reproduction Units), certification with this standard is a prerequisite for the establishment and operation of the organization by the competent authority.
The requirements of EN 15224 standard can be applied to all health care providers at primary, secondary and tertiary levels of medical care, such as hospitals, clinics, dental clinics, health centers, diagnostic centers, physical rehabilitation centers, pharmacies, as well as day care for people with special needs etc.
The benefits which are significant in such a critical and sensitive area as health are as follows:
experience and expertize in medical devices certifications
Be informed responsibly about the latest developments
Provision of consulting services to businesses and organizations in accordance with the increased requirements of EU regulations.
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