I am Tamás Kovács (Mr.) a sole proprietor and a mechanical engineer by education. Since 2001 I have been working on the development, auditing, and implementation of quality- and environment-focused management systems, as well as on the production of medical devices for my clients and on the full implementation of the requirements of the special standards to be developed accordingly. My second area of ​​expertise is the support and development of the machine manufacturing process in the mechanical and electrical fields.

My career began in 2001 at a sheet metal processing and cutting company, and then continued in 2009 at a company specializing in welding and custom manufacturing. In these places, I worked as a quality management coordinator, supporting the ISO 9001 quality and ISO 14001 environmental management systems, i.e. maintaining the operated systems, preparing them for audits, maximizing customer focus, employee training, and monitoring measuring instruments.

In 2011, my career led me to one of the largest automotive factories in Hungary, where I held the position of material testing laboratory manager. Here, my knowledge expanded through the use of specific material testing methods – the ISO TS 16949 (now IATF 16949) automotive requirements system (and LEAN manufacturing philosophy).

From 2015, I started working on the quality management system according to the ISO 13485 standard at a medical device manufacturer and distributor/exporter company, which combined with numerous legal requirements and underwent significant changes from 2016. During my career, I prepared and successfully audited two companies with ~40 employees in relation to the above-mentioned management system.

My sole proprietorship status was launched in September 2017 for micro, small and medium-sized enterprises in the spirit of their quality improvement, and in parallel I deepened my experience in the field of mechanical engineering full-time, first as a technologist, later as a production support engineer. With my completed internal and lead auditor experience (ISO 9001/ ISO 13485), I am at the service of my future partners in the following activities:

• Support for the establishment, certification and maintenance of ISO 9001 / ISO 13485 / ISO 14001 or their combined Integrated Management System (IMS) for manufacturing and trading/distributing companies

• Mechanical and electrical (3D modeling, design and manufacturing of machine elements, programming of PLC control of target machines, testing the conversion of older machines to a PLC system, etc.)

• Support for the establishment, certification and maintenance of ISO 13485 quality management system for companies manufacturing, importing or wishing to distribute medical devices

• Consulting on products intended for CE marking

• Training on quality issues (quality control, quality assurance, quality management), machine manufacturing, and related modules based on production processes on ad hoc or regular occasions

I trust that my introductory summary has aroused your interest, and that we will build a fruitful business relationship for all of us in the future. I look forward to your interest, questions and requests regarding the above topics at my contact details below.