TÜV NORD supports registration of medical devices in Ukraine
On July 1, 2015, Ukraine introduced new national regulations for the registration of medical devices which largely comply with the European directives for medical devices. After a transitional phase, all products requiring initial or renewed certification must comply with the current regulations as of July 1, 2017. According to the old regulations, certified products may still be used until the certificate expires, but for no longer than five years from the time they are placed on the market. Ukrainian notified bodies can conclude an agreement with a notified body recognized in the EU, such as TÜV NORD, to simplify registration. The results of TÜV NORD conformity assessments then form the basis for issuing certificates of conformity for Ukrainian market access. On the one hand, this simplifies and accelerates registration and, on the other hand, it avoids additional audits of medical device manufacturers by the corresponding Ukrainian notified bodies. TÜV NORD has concluded a contract with a Ukrainian Notified Body and can now effectively support manufacturers in the registration process in Ukraine.
Contact: Ralf Thomsen (firstname.lastname@example.org)
TÜV Netherlands now able to perform Safety Culture Ladder audits
TÜV Netherlands can now carry out audits for the Safety Culture Ladder in Europe (in Dutch or English). Safety Culture Ladder is a certifiable standard for the measurement of safety-conscious working practices in companies. It makes the safety awareness of a company visible. The aim is to reduce the number of unsafe situations and their potential consequences. Demand for Safety Culture Ladder is growing significantly. For example, the power grid operator TenneT has instructed several contractors to achieve level 3 of this standard throughout Europe in 2019. About 100 companies have already received the certificate for the Safety Culture Ladder in the Netherlands and we expect this number to double in 2019.
Contact: Alex de Wals (email@example.com)
TÜV NORD CERT was able to win Miele as a new well-known customer. In Europe, we will be carrying out monitoring and recertification in accordance with ISO 9001, ISO 14001, OHSAS 18001 and ISO 50001, as well as recertification in accordance with SA 8000. In addition, we will be monitoring and recertifying the integrated management systems for the Dongguan site in China. "After a year of continuous customer contact and various rounds of negotiations, I am now very happy that we have acquired MIELE as a customer. In particular, it underlines our performance in the area of social audits, as we now have one of the largest and most renowned SA 8000 customers in our portfolio", says Heiko Sepúlveda Barriga, Manager International Sales.
Contact: Heiko Sepúlveda Barriga (firstname.lastname@example.org)
Volkswagen – one of our major existing customers – has placed a new major order with TÜV NORD CERT: We will recertify the environmental and energy management system in Germany, European and selected international locations, as well as the occupational health and safety management system at some sites. "We are very pleased to have won this important tender and to have been awarded the contract again by Volkswagen. From our point of view, this is also a clear confirmation of the services we have provided in recent years within the scope of auditing at VW in accordance with EMAS, ISO 14001, ISO 50001 and OHSAS 18001", explains Steffen Nölck, Vice President Region Central-East.
Contact: Steffen Nölck (email@example.com)
TÜV NORD Brazil has acquired a major new customer in Randon Group, one of the biggest companys in Brazil. The order includes certification in a number of areas (IATF, Quality Management, Environmental Management, and ISO 45001 Occupational Health and Safety Management) at 20 Sites. Randon Group is the largest manufacturer of trailers and semi-trailers in Latin America and among the largest in the world, and has been manufacturing various types of road equipment for more than 60 years.
Contact: Reginaldo Maia (firstname.lastname@example.org)
Certification Handover Event
TÜV Nederland has successfully certified Inalfa Europe according to ISO 27001. Inalfa is one of the world's largest suppliers of vehicle roof systems. Inalfa designs, develops and manufactures sliding roofs and sliding roof systems for the major OEMs in the automotive industry. Paul van Enckevort, Senior Vice President Cluster Western Europe OBS SC, presented the certificates to Inalfa board member Klaus Billetter in an official ceremony.
Contact: Paul van Enckevort (email@example.com)