EN 15224

Medical Devices – Quality Management System – Requirements for Regulatory Purposes

This standard incorporates ISO 9001 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

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

Appropriate, correct care, availability

Continuity of care

Effectiveness, efficiency

Equity, evidence/knowledge based care

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

Timeliness/accessibility

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

We are the largest Greek independent certification body, accredited by ESYD, with offices in more than 40 countries worldwide. Certification with Eurocert means evaluation and acceptance from an accredited and recognized/well-respected Certification body.
We have strong and experienced staff and associates, who as inspectors/auditors and / or technical experts carry out inspections of high added value for your company.
We make sure to keep you informed and updated of any local and/or international changes that concern your certification scope
Our accreditation covers a wide range of standards and products, thus we are able to provide you with holistic solutions regarding management system certification

Typically 3-6 months, although this may depend on various factors. The main issue is that the organization demonstrates that its management system is fully implemented and meets all the requirements of the standard. Top management and employees’ level of awareness is also a crucial point to determine the necessary time for gaining certification.

No. EN 15224 is a voluntary certification aiming at continual improvement and does not substitute any public or official audit. However, it improves the company’s organization, so that it complies with all relevant applicable legislation and helps avoiding any unexpected problems or fines during these audits acting pre-cautiously.