UNI EN 15224:2017 Certification
QUALITY MANAGEMENT SYSTEMS FOR HEALTHCARE SERVICES
Bureau Veritas Hellas, thanks to its expertise in the Healthcare sector, offers certification services in accordance with UNI EN 15224.
What is the UNI EN 15224 standard?
In the current social context, healthcare organizations must respond to complex challenges and increasingly stringent quality requirements. The management of costs, process-based quality, new technologies, and the implementation of new governance systems must enable the monitoring of activities and services provided. Such control activities are the basis for having an overview of the organizations' commitment to compliance and excellence. For complex realities such as Healthcare, it is necessary to add specific areas to be respected in addition to the usual requirements provided for by Quality Management Systems.
The UNI EN 15224 standard, based on the ISO 9001 standard, extends the requirements of this standard to the healthcare sector and, in detail, specifies the quality management systems for clinical processes, including Risk Assessment. The standard defines the specific requirements of the healthcare facility and provides guidance to demonstrate the ability to consistently provide services in Healthcare that meet stakeholder requirements and applicable statutory and regulatory requirements, as well as enhance customer/user satisfaction through the effective application of the system, including processes for the continuous improvement, clinical processes, and assurance of conformity with requirements related to quality characteristics.
How to obtain certification according to the UNI EN 15224 guideline?
The main steps of the certification process proposed by Bureau Veritas Hellas include:
- Definition of the certification scope;
- Preliminary verification (upon request)
Gap analysis and assessment of the organization's current compliance with the requirements; - Certification audit
Evaluation of the implementation and effectiveness of the organization's Management System - Issuance of the certificate of conformity (valid for three years);
- Renewal visits (typically annual) to monitor continuous improvement.
At the end of each visit, the company is provided with a clear and comprehensive Report, which allows for continuous improvement of product safety management performance.
FAQ - Frequently asked questions about the UNI EN 15224 guideline
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What are the main touchpoints between UNI EN 15224 and ISO 9001?
The UNI EN 15224 standard is complementary to ISO 9001 and allows interested parties (stakeholders) to have a dual assurance, both on the organization and on the service provided by the certified facility. The UNI EN 15224 certification (an increasingly required requirement in tenders) guarantees further recognition of the commitment with which the certified organization operates in the provision of healthcare services. The verification of compliance with the requirements of UNI EN 15224 can be carried out jointly with the verification under ISO 9001.
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What are the main benefits of UNI EN 15224 certification?
- Positioning in the healthcare market;
- Continuous improvement of processes;
- Achievement of quality objectives;
- Effective and efficient response to patient needs;
- Integration of clinical risk management within the planning, management and control of processes.
The implementation of the standard also testifies to the organization's commitment to the provision of services aligned with mandatory and voluntary regulations, through the application of proven organizational models aimed at continuous improvement, and has the advantage of representing a direct and independent verification to ensure qualitative and quantitative control of the social and healthcare assistance processes provided.