Česky | English | Deutsch | Polski | По-русски | 中文 | 한국어 | Hrvatski | Türkie | ไทย |
About Us
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).


Impartiality

The principal activity of the Institute for Testing and Certification, joint-stock company, Zlín (hereinafter “ITC”) is provision of professional services to customers in the areas of testing, calibration, technical inspection, conformity assessment, product certification and management system certification. ITC acts as a third party assessor in the process whose procedures and outputs must be consistently impartial.

Impartiality

Impartiality may be defined as actual and perceived presence of an objective approach, where conflict of interests either does not exist or is addressed in order not to negatively affect subsequent activities in the context of order implementation. Typical features of impartiality include: honesty, non-existence of conflict of interests, no bias, no involvement, no prejudice, neutral approach, independence, justice or balance. Violation of the principle of impartiality might bear serious consequences for trustworthiness of and competence maintenance by ITC.

The requirement for impartiality in relation to the abovementioned activities is included in multiple legislative documents and standards and comprises the following aspects, including but not limited to:

  • ­ Non-existence of third party vested interests or interests of its employees (internal employees and external contractors) that might affect results of professional services (such as impartiality of performed tests and audits, conformity assessments, surveillance performance/review, issue of professional service outputs, independence on all stakeholders directly or indirectly interested in the products or services in question);
  • ­ Assurance of impartial and unbiased technical and administrative staff involved in the professional activity implementation. Their remuneration must be independent of the nature and scope of their professional activity and its results;
  • ­ Non-existence of third party involvement or stake in development, design, construction, manufacture, marketing or maintenance of subjects of the third party professional service. This principle excludes neither the possibility of technical information exchange between the manufacturer and the third party nor use of the products in question in the scope necessary for activities of the third party or their use for private purposes by employees or contractors of the third party.

Impartiality Assurance under ITC Conditions

In the context of professional activity implementation the commitment of impartiality is considered one of the critical factors of continued trustworthiness of services provided by ITC.

The impartiality principles are laid down in the Rules of Organization of ITC and in the Quality Policy, the basic document describing functioning of the joint-stock company. Internal employees of ITC have the impartiality commitment included in their employment contracts, are instructed in the impartiality principles in a documented manner, and know how to proceed in fulfillment of the tasks entrusted to them in order to prevent potential accusation of ITC or themselves of violation of impartiality and fair-mindedness principles. External contractors and subcontractors are bound with the same commitments of impartiality as ITC.

In the case of a substantiated suspicion that ITC position in a contractual relationship with its customer might be biased or dependent ITC reserves the right to refuse to accept such contractual commitment. 

Contact

 

Employee

phone.: fax: e-mail:
Ing. Tatana Pasiakova, marketing 577 601 328 577 104 855 marketingPostaitczlin.cz

 

Post address:
Institut pro testování a certifikaci, a. s.
Marketing department 
třída Tomáše Bati 299, Louky, 763 02 Zlín

The person responsible for accuracy of data: Ing. Taťána Pašiaková

Updated: 10.1.2017
 
> Webdesign studio