EN 15224:2012

The system of quality management in health care EN 15224:2012

Why EN 15224 ?

Requirements are based on EN ISO 9001:2008 and this requirements are included. This is the latest European standard relating to quality, security, safety, clinical risk management and so on in the provision of health care services. It is actually the well-founded interpretation of quality and safety system for healthcare providers at all levels of clinical processes in medicine. The standard does not only deal with processes in scientific research and education and health resources. It is suitable for any health service provider regardless of the size and position in the health care system is clearly focused on clinical processes and risk management in order to provide appropriate quality health care.

Experience and our improvement

The system of quality management in health care EN 15224:2012 is clearly focused on many of the attributes of providing such proof of compliance with the requirements relating to the characteristics of quality , adequate and appropriate care , availability, continuity of care , effectiveness, efficiency , equity , evidence-based care , patient-centered care , including physical, psychological and social integrity , patient involvement , patient safety, timeliness and accessibility of services.

Standard combines system and process approach and it is superior to most of the evaluation systems now presented in health care by our means, whether it is the quality and safety in accordance with local laws or other evaluation standards (JCI, ISO 9001,SAK),. The current implementation of ISO 9001 and other standards will facilitate the transition to this standard. The advantage of implementing this standard is establishing and maintaining a comprehensive view of the clinical risk and quality management as well as effective care within the whole organization.

Our approach to the selected elements of the standard

5.3. Quality policy.

This is a part of the firmís strategic vision. Leading the defined policies of quality declares its future trend and view on the needs of clients and their solutions. During the audit we evaluate the policy of quality on the one hand of whether it is consistent to the general strategy of the firm, and whether it isnít formed perfunctorily or incomprehensibly. On the other hand we judge its objectivity for the firmís possibilities

7.2.2 Review of requirements related to the product.

From experience we know that the clientís most frequent complaint, misunderstanding or disappointment arises from an insufficient ascertainment of his requirements. The solution is a clear and understandable declaration of the parameters of your products, the conditions of their use or existence in the offer (catalogue, internet, package). The solution is a detailed assessment of the clientís needs and his purpose for needing your product or service. During the audit we concentrate on progress and also the experience of the employees for the review of the requirements.

7.5.3 Identification and traceability.

It isnít necessary to identify individual parts or products if it is proved that the method of their technological cultivation guarantees their irreplacability. Despite this we require the introduction of a certain method of identification or record-keeping because during a dispute, claim or simple analysis we need to know which particular product we are talking about.

8.2.3 Measurement and monitoring of processes.

Possibly this is the least popular element. Bear in mind, however, that with its good and informal application we can achieve savings when you will not have to perform several individual measurements.

Will the quality management system help marketing?

On the contrary, he marketing must create the requirements for quality management system. It is important how the quality is feeling by the customer. There are many fields where the supplier is sufficient compliance with product standards, but it is necessary to bear in mind that the customer perceives the quality not only as useful characteristics of the product, but also assesses the quality of related services and communication. In many fields of standardized requirements for quality standards do not exist or is insufficient to respond to modern trends.

What you will get passing the certification?

What you will get passing the certification? If Leaving aside the primary objective of the customer to obtain the certificate, and our obligation to assess compliance with standard. We realize that the audit takes a considerable amount of time of large number of busy workers and executives. Therefore, we try to client to compensate the time loss during the audit by added value. Our auditors focus on the essential things and finding opportunities for improvements. From this point of view, we nominate our auditors regard to their skills, communication skills and analytical thinking in particular.

Content of other rules

We respect the established practice in the firm; the scope of management documentation must respect the internal needs. Nevertheless, based on experience, that too detailed a wide range of documentation leads to the fact that not enough staff to get familiarized with the whole range. In present flexible market requirements the company management will not be able to carry out continuous changes in the documentation. If you have qualified and experienced staff, you do not to create extensive descriptions of their activities. Effective way is the practical training, software and automated solutions.

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