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ITC
International Trade Fair MEDICA 2019

Dear business partners, let us invite you to visit our exposition at the International Trade Fair for medical sector Medica 2019, which will be held 18. – 21. 11. 2019 in Düsseldorf. Our stand will be located in Hall 15, Stand E42 (Czech exhibitors stand Ministry of Industry and Trade). For detailed information please contact Ms Barbora Hajkova, e-mail: bhajkova@itczlin.cz. Contact details of ITC HERE


Determination of resistance to cutting by sharp objects

Laboratory of textile has successfully accredited testing procedure EN ISO 13997 - Determination of resistance to cutting by sharp objects. The test is performed mainly on protective gloves and similar PPE.

For further information and testing, please, contact our laboratory: textile@itczlin.cz, phone: +420 577 601 268.


New telephone numbers were launched

Dear clients. New telephone numbers of workers who moved from workplace Zlín-Louky to workplace Zlín, Svit area, Building nr.113 were launched. In case of problems, please contact the headquarters at +420 572 77 99 22. Thank you for your understanding.


Sale of the part of CSI plant – effective date 1st July 2019

Institut pro testování a certifikaci, a.s., and Centrum stavebního inženýrství a.s. concluded a contract on sale of part of plant, which came into effect 1st July 2019


new service in the field of static and dynamic testing on tensile tester Instron 8503

Dear Clients,

laboratories of ITC can offer you a new service in the field of static and dynamic testing on tensile tester Instron 8503, which can be run in static or dynamic mode.


ISO 13485

Management systems certification » Certification of management system

Certification of quality systems for manufacturers of medical devices is based onEN ISO 13485:2016, which has been declared as a harmonized standard to the European Directives 93/42/ EEC, 90/385/EEC and 98/79/ EC in the Official Journal of European Union, which enables it to be used to demonstrate compliance with the requirements of these European directives.. This standard is applied in conformity assessment processes.

 

Application
  Manual for clients  
Application questionnaire   Searching the database of certificates  
Rules for Use Certificate        

PRINCIPLES OF THE CERTIFICATION ACCORDING TO ISO 13485

Due to the growing demands on the quality management system of suppliers and manufacturers of medical devices, ISO 13485:2016 has been developed. The standard includes criteria for the full range of quality management system for medical devices. A certificate issued by an independent accredited certification body ensures that the quality management system of the supplier and the manufacturer of medical devices is implemented, documented and used in accordance with the requirements of ISO 13485.For the implementation of ISO 13485:2016, a three-year transition period is set for companies, till March 31, 2019.

BENEFITS OF CERTIFICATION

  • it guarantees the constancy of the manufacturing process, resulting in a stable and high quality of the services and products provided
  • it simplifies the process to demonstrate conformity with the requirements of EU regulations and applicable government decrees
  • it proves the effectiveness of the quality management systems by an independent third party
  • cost optimisation – lower operational costs, reduction of the costs of non-conforming products, savings in raw materials, energy and other resources
  • increased confidence of the public and state authorities for the manufacturers of medical devices

CERTIFICATION PROCESS

  • The certification procedure consists of the following basic phases:
  • processing of documentation
  • implementation of a management system into practice
  • certification by an accredited certification body
    • assessment and registration of client's application for certification
    • contract for the certification audit (the initial certification audit takes place in two stages)
    • forming the team of auditors
    • preparing the audit plan
    • verification of facts in stages:
      a) review of client’s documentation
      b) verification of facts on site
    • report of the results of the audit
    • assessment of the audit report by a certification body
    • issuance of certificate
  • surveillance audit
    an annual surveillance audit shall conducted during the three year validity of the certificate. Depending on the results, a decision confirming (or suspending) the validity of the certificate until the next surveillance audit is issued. In the event of significant deviations from the standard, and as an extreme measure, the certificate may be revoked.
  • recertification audit
    In order to ensure the continuity of the validity of the certificate, and according to the decision of the holder, a recertification audit should be conducted in the third year, before the expiration of the certificate.

IQNET – international certificate

Institute for Testing and Certification is a member of the CQS, which is a member of the international network IQNet. Through this co-operation, it is possible to issue upon request both the ITC certificate and the CQS certificate and the internationally recognized IQNet certificate within the framework of a single certification process.

IQNet CQS

RELATED SERVICES

  • Certification according to other system and industry standards (ISO 9001, ISO 14001, ISO 50001, OHSAS 18001 / OHSMS – ISO 45001)
  • Assessment of conformity of products to the requirements of European directives (CE marking of products)
  • Testing of products, ATEST ITC
  • Calibration, verification of standards and measuring instruments
  • Voluntary certification – “ITC – certified quality“ mark
  • Technical standardization

CONTACTS

Person Phone e-mail
Jaroslav Rapant +420 572 779 982 qscertPostaitczlin.cz


Post address:
Institute for testing and certification
management system certification department
trida Tomase Bati 299, Louky, 763 02 Zlin
Czech Republic

The person responsible for accuracy of data: Jaroslav Rapant

Updated: 4.10.2019
 
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