Project name:CATEH – introduction of quality and business process management system ISO 9001:2015 and ISO 13485:2016
User: CATEH d.o.o. for consulting, production and services
Project reference: KK.03.2.1.14.0290
Call: Introduction of business process and quality management system (ISO and similar standards)
A brief description of the project:
CATEH is a Croatian company specialized in the production of custom-made medical devices for a particular user by additive technologies. CATEH uses its own development and research, in cooperation with the world’s leading manufacturers of additive production devices as well as manufacturers of materials for them, and on the application of new certified materials in medicine, and as a result of its own research has developed two families of medical devices 3DmoldX individual bone cement implants and EVOPEEK individual implants from PEEK.
Influenced by the globalization of the market, and in order to maintain and improve the market position and increase competitiveness, CATEH d.o.o. strives for excellence of products and services guided by the demands and expectations of customers. An essential basis for success in this direction is the introduction of a quality management system. From the perspective of CATEH d.o.o. the fundamental reason for the introduction of the management system in accordance with the requirements of ISO 9001 and ISO 13485 is the standardization and improvement of business processes, and the management and control of business processes will consequently affect the higher level of product quality.
Quality management includes key components of process management, measuring performance through data collection, compliance with established goals, analysis of deviations and undertaking activities to eliminate errors and improve the system. An indispensable part of the preparation of the system is the participation of employees in continuous improvement of the system and identification and isolation of problems and their resolution, i.e. minimization. As an upgrade to the ISO 9001 quality management system, the implementation of the iso 13485 management system, compatible with ISO 9001, will also be implemented. Both standards ensure a harmonised quality management system, in such a way that ISO 9001 strives for continuous improvement of the system, while ISO 13485 requires a certified organization to confirm successfully implemented and maintained guidelines. Standard ISO 13485 presents requirements for a comprehensive quality management system for the design and production of medical devices and equipment, and focuses on the entire cycle of product development: design, development, production, transport, logistics, and on the installation and maintenance of products. ISO 13485 is, among other things, a prerequisite for certification of most medical devices under the Medical Devices Directive (MDD).
The project covers a number of activities that will improve primarily the quality of services, but also enable the further development of them. These are:
Implementation and certification of quality management systems according to ISO 9001:2015 requirements
Implementation and certification of quality management systems according to ISO 13485:2016 requirements
Project management and administration
Promotion and visibility of the project
Increasing competitiveness through project implementation:
One way to achieve and improve business excellence is to implement recognized quality management systems. The main reason for the introduction of the management system according to the requirements of ISO 9001 and ISO 13485 is mainly the desire of the company to improve and standardize business processes, and consequently the quality of the product. As an integral part of the development activities of the company, the Applicant will invest the funds received from the EU in the implementation and ultimately certification of the management system according to the requirements of ISO 9001 and ISO 13485 standards. The topic of the project proposal is the analysis of the cost-effectiveness of the investment in the implementation of the management system in order to come to the conclusion that the application in question will affect the quality of the company’s products and business solutions in future years, the growth of the number of customers, the growth of revenues, the organization of the process of providing services and the demand of customers in the market for the same ones that will arise as a result of the introduction of a certified management system based on ISO standards.
The role of the project in the plans:
raising competitiveness with the aim of increasing revenues, increasing applicants’ profits, strengthening human resources and creating capital for new investments over a three-year period.
Total project value: HRK 169,500.00
Total project value (eligible costs): HRK 135,600.00
EU aid amount:HRK 115,260.00
Implementation period: 02.03.2020. – 02.03.2021.
Contact person for more information:
Miodrag Katalenić, project manager and director
e-mail: mkatalenic@cateh.hr
Further information on EU funds and tenders can be found on the
EU funds
OP Competitiveness and Cohesion – Operational Programme 2014-2020
Ministry of Regional Development and EU Funds
The project was co-financed by the European Union from the European Regional Development Fund
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