The mission Tecnoline is the development and manufacturing of products which can completely meet the requirements and expectations of our customers. In order to meet the requirements and the expectations of our clients, we think we have to provide high quality products and services, i.e. goods that, when used in the expected ways and for the expected purposes,
- Satisfy the customer as to technical characteristics and performances;
- Never compromise the health and the safety of patients and users.
We believe that our System of Quality Management, in compliance with the prescriptive documents ISO 13485:2012, is the primary mean in order to always guarantee high quality products to our customers. Therefore all the company functions, either those regarding the life cycle of the product,
or those operating in indirect, auxiliary and support activities, have to contribute with their commitment to the constant improvement of the System of Quality Management, in order to keep and increase our success on the market. Through the organizational structure of the System of Quality Management, the management promotes all the needed actions in order to develop processes and activities respecting criteria of efficiency and inexpensiveness, activating a system of company management based on the following principles:
- Constant improvement of the product with consequent improvement of customers’ satisfaction,
- Continuous research of new services in order to reinforce and expand the presence on the market,
- Constant commitment in prevention of problems and lacks,
- Spread the education on quality, ethics and security of information through informative actions towards staff and increase the awareness,
- Exploit the human resources and their professional increase on all levels.
The system of management is the mean in order to reach, and monitor, the above mentioned objectives.
This activity is annually documented and specified by the management, in the Management Re-examination, on special documents named “improvement objective”.
The Tecnoline Company started its activity in 1992 in Concordia Sul Secchia, Modena. At the beginning Tecnoline specialized as company of transformation and assemblage for third parties of disposable medical products, such as infusion controllers and transfusers. Then it widened the activity, diversifying the production in several areas. The active presence of the Management in daily activities leads to an involved, objective and conscious team work. The purposes of the Management aim to the continuous improvement, in order to reach customers’ satisfaction, and this leads the whole organization.
At the beginning of 2007, the Management decided to increase production, and transferred some activities in an adjacent seat, in order to allow a better productive logistics.
A cleanroom was built in this environment and all the present productive resources were transferred there, thus increasing the productive volumes.
The critical and periodical analysis of the Management on the whole organization and its processes contributes to the increase of the value of every single activity, function and person.
As to production, on January, 3rd 2011 Tecnoline started to operate in a new factory and there it concentrated all the production of bags for the Company Gambro.
The following working unit, whose area was 2500 mq, was in Mirandola, via 2 Giugno 111, but it collapsed because of the earthquake of May 20th and 29th 2012.
The turning point was in August 2012, when there was the opportunity to buy a field of 4000 mq in Concordia s/S, via Gelatti 18, opposite to the main seat of Tecnoline.
The new working unit is about 2000 mq, and has a cleanroom of 571 mq, which, after the specific particle and microbiological checks, was classified UNI EN ISO 8, a warehouse of 1013 mq and offices for 105 mq.
The seat of via Gelatti 11/A was restructured and two distinct areas were created.
The first area is about 160 mq and is dedicated to assembling, welding and blistering.
The second area is about 70 mq and is dedicated to the operations of serigraphy and pad printing.
The carried-out particle and microbiological checks classify the new cleanroom UNI EN ISO 8 rif. UNI EN ISO 14644-1:2016.
Particularly, the application sectors of the quality system regard: manufacturing, assembling, serigraphy, pad printing and packaging of disposable devices and bags for medical use on customer’s specifications.
Tecnoline has, as its main goal, the satisfaction of the needs, requirements and expectations of the clients and the respect of the compulsory requirements.
95% of Tecnoline customers are in the biomedical sector. The other activity (5%) regards a technical production.
The companies GAMBRO and DIALIFLUIDS are special clients: the company Tecnoline assigned a whole department to the production of their bags, which covers ca. 70% of the total production.
The Management, through a systematic process of control and correction, i.e. a continuous improvement of the system, guarantees that the customer’s requirements are defined and satisfied, in order to increase the satisfaction of the customers.