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the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

On May 5, 2017 the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC was published in the Official Journal of the European Union.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 26 May 2020. By way of derogation, see the Article 123 Entry into force and date of application.


Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices

On May 5, 2017 the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU was published in the Official Journal of the European Union.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 26 May 2022. By way of derogation, see the Article 113 Entry into force and date of application.


Electronic communication – restriction of attachments in ZIP format.

ITC applied the restriction by which it will not be possible to deliver the electronic message with an attachment in ZIP format.

For delivery of large quantities of electronic documents, use a different method than compress into ZIP format.

Thank you for your understanding.


Termination of the contractual cooperation with the company Sastek, Turkey

On 31st August 2015 was terminated a contractual cooperation with the Turkish sales representative of ITC - the company “SASTEK Conformity Assessment Services Co.”.


nanotechnology - the analytical laboratory of ITC engage in cooperation with the Technical University of Dresden

The analytical laboratory of ITC engage in cooperation with the Technical University of Dresden in the project " nanotechnology – guidance on detection and identification of nano-objects in complex matrixes", which is demanded by the French Bureau of Standards (Association Francaise de Normalisation).


History

The Institute for testing and certification, a. s., Zlin is an independent testing, certification, supervisory, counselling – consulting and inspectional company with a wide scope.
The outset of organization goes back to the year 1969, when the activity of State testing department no. 224 was opened within VUGPT (Instituteof Rubber and Plastic Material Technology Research) in Gottwaldov. It was spinned off from the structure of VUGPT in 1990 and was named State testing Department of Chemical Industry (SZUCHP) since 1990, which was in 1993 transformed with all its competences into a joint-stock company under the same name.
The primary activity of the Institutewas orientated mostly on rubber and plastic material technologies. The company paid the efforts to offer a complex service what lead to a gradual revitalisation by means of the professional capacities and technical equipment in the field of testing the textile, tanning, shoemaking, grocery, chemical, constructional and electrotechnical industry products. As a consequence of this, several separated working places work within ITC.

  • Testing laboratory for asphalt testing, area of VUSH, Hnevkovskeho 65, 617 10 Brno
  • Testing laboratory for electric equipment and products, division 4 - MESIT QM, Sokolovska 573, 686 01 Uherske Hradiste


One of the first important certifications that confirm the technical qualification of the organization was the testing laboratories accreditation according to the CSN EN 45001. The certificate of the testing laboratories accreditation No. 1004 issued by National accreditating organ CIA in 1991 is activated all the time and new exams are being passed. Today the number of accreditated testing methods exceeds 700.
Our company assisted the birth of implementation of certification principles of the quality system into a structure of the companies in the Czech Republic. In 1992, the organization passed an accreditation process according to the criteria CSN EN 45012 and got a certificate of accreditation to certificate the quality systems (CSN EN ISO 9000) of production processes and services No. 3002. This certificate set out a successful series of authorizations ITC in the field of system certification, which was extended by competences of the certification organ No. 3002 (SM) and No. 5002 (EMAS).
A fundamental moment for a development of the company was the year 1997, when ITC gained the authorization by Department for technical normalization, metrology and state testing laboratories as Authorized body for the activities connected with evaluation of correspondence of products given by the statute of government according to the law No. 22/1997 Coll., about technical product requirements.
Since 1999 ITC has installed and certificated the system of quality management as the utter mostly first Czech testing laboratory according to the CSN EN ISO 9001:2001.  In 2000 the company gained an attestation of accreditation for the Calibration laboratory No. 2289, and in the year 2001 for Calibration laboratory 2222. ITC uses the authorization for official metering as a supplement of its primary activities.

The next important step in development of the company was a privatization. In 2000 all the shares and the corresponding rights were passed in private hands. At this time ITC, Inc. Zlin is an entirely private company.

Long-term efforts of the company to make the best of the wide potential of services abroad were crowned with a success. Signing of the international agreement PECA made possible gaining of European committee notification and the status of Notified body No. 1023.

INSTITUTE FOR TESTING AND CERTIFICATION, a. s. (Institut pro testovani a certifikaci, a. s.) is a company, which competences, technical capability and high employee qualification makes possible to realize the philosophy of a maximum utilization of its scope of activities in many branches to provide a complex, highly specialized and prompt service from one place.

Updated: 10.1.2017
 
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