Quality

At BEZNOSKA s.r.o., building a partnership with customers is a matter of course. This fundamental principle is based on the conviction that only quality products and services meet the needs of the customer and fulfil the company’s motto: We bring the joy back into movement.

The high quality of products, organisation of production and control is based on the long tradition of the processing of refined steel applied to orthopaedics and is part of the company’s principal objectives.

In 1995, we were already the first company engaged in the production of implants and instruments for orthopaedics and traumatology in the Czech Republic to be granted the ISO:9001 certificate by the independent German certification company RW TÜV Essen. The certificate confirmed that the company had mastered the production processes and control mechanisms, and supplies its partners with quality implants and instruments.

As a producer of medical devices, we also meet the requirements of the European ISO 13485 standard, which sets down the requirements for the management and control system in this field. The quality management system has been introduced throughout our company, and each of our company workers is part of this system.
BEZNOSKA s.r.o. constantly works to raise the quality of its products and to constantly improve its processes. Since 1998, it has been meeting the conditions for the use of the CE marking according to European Council Directive 93/42/EEC.

Quality requirements are already ensured during the development of new implants and instruments. The task of development, based on cooperation with leading orthopaedic surgeons, involves not just clinical trials, but also biocompatibility tests and strength calculations as part of the development. An integral part of development is risk analysis, based on further recommendations and measures to ensure the maximum safety of our implants and instruments.

Prototypes are tested on special stress machines in a certified test room. Once a product has been developed and put into serial production, its parameters during production are tested and controlled on these machines.

Conditions for improving the control and observance of set parameters and regulations are created to ensure high quality in the production process. Equipment for the control of the chemical composition of the supplied material is used immediately upon the input of the material, which is the resulting semi-finished product. The material that arrives according to the orders is tested by this equipment. Only after the initial control is it marked and can it be stocked for further use.

Further control points are installed directly at the production facilities. This equipment can automatically control the progress of the production operation, and evaluate and control the parameters of machining depending on the finishing procedure.

During the production cycle, there are further control points in production, where not just the dimensions, but also the profiles and surfaces of produced components are controlled to ensure the required quality.

All operations, their progress, control measurement and methods of processing are documented in the accompanying production documentation for each product, which passes through the production together with the product. This documentation can be called the “Birth Certificate”. It contains the records of the “parents” – the input materials used in production – the name of the workers who worked on the product, control results, labelling and packaging.

Despite these measures, final control is an integral part of the production cycle, through which each product must pass according to binding regulations. Control procedures set down by control regulations are carried out in this section. Apart from standard measuring instruments, control workers also use slide gauges, micrometres and calibres, and special products and control measuring instruments designed and produced during the process of production of the prototype.

Besides these aids, the company is also equipped with a 3D coordinate measuring instrument to measure components. This device is used to measure the TEP conical hip joint stem. A measurement report is drawn up for each component, and only stems meeting the required parameters are released to customers.

 

Our company devotes considerable attention to product quality. Modern technologies and control instruments are available. However, without the expertise of our workers, their involvement in the entire quality system, and their responsibility for the work performed, this equipment would not be able to sufficiently ensure the high quality of our implants and their innovation. Therefore, we place great emphasis on cooperation between our workers, not just within our company, but also in cooperation with customers, who can provide the necessary ideas for further increasing the quality of our products. We appreciate ideas from customers and strive to meet customers’ needs by supplying products and services of the highest quality.

I personally guarantee the quality of our products!

Ing. Jan Beneš,

Head of Quality Management